As COVID-19 is affecting everyone’s lives, especially those with medical conditions, we have added a few updates about the COVID-19 vaccines. The top article is the most recent one.
Here are the links to the available updates:
Update # 21: Lighting Up Long Covid
Update # 20: Find 2023-2024 COVID-19 Vaccine Locations Near You
Update # 19: Coronavirus (COVID-19) Update: FDA Authorizes Changes to Simplify Use of Bivalent mRNA COVID-19 Vaccines
Update # 18: The Increasing Community Access to Testing (ICATT) program
Update # 17: CDC: People Who Are Immunocompromised, “Know how to protect yourself and what to do if you get sick”
Update # 16: COVID-19 Vaccines Are Safe for People Receiving Cancer Immunotherapy, Study Confirms, posted November 15, 2022
Update # 15: CDC: Recommendations for Bivalent COVID-19 Booster Doses in People Ages 12 Years and Older. September 13, 2022
Update # 14: Recommendations for the Novavax COVID-19 Vaccine Primary Series in Adults Ages 18 and Older. July 28, 2022
Update #13: COVID 19 Current Safety Measures, Updated July 18th, 2022
Update #12: New Covid-19 Test to Treat Initiative, April 9th, 2022
Update #11: COCA Call: Updated Guidance for Clinicians on COVID-19 Vaccines, February 24, 2022
Update #10: COVID-19 Booster Shots. November 11th, 2021
Update #9: Additional mRNA COVID-19 Vaccines for Moderately to Severely Immunocompromised People. August 17, 2021
Update #8: When You’ve Been Fully Vaccinated. CDC Guidelines. May 20, 2021
Update #7: FDA and CDC Lift Recommended Pause on Johnson & Johnson (Janssen) COVID-19 Vaccine Use Following Thorough Safety Review May 4th, 2021
Update #6: Johnson & Johnson/Janssen COVID-19 Vaccine Pause. April 15th, 2021
Update #5: CDC Guidance for Fully Vaccinated People. March 24th, 2021
Update #4: J&J Janssen COVID-19 Vaccine. March 8th, 2021
Update #3: Contact Tracing. Dated February 14th, 2021
Update #2: COVID-19 Vaccine Side effects. January 18th, 2021
Update #1: COVID-19 VACCINE UPDATE. December 20th, 2020
COVID-19-related Resource Links
COVID-19 Update # 21 Lighting Up Long Covid
Have you taken advantage of the latest COVID-19 vaccination?
We don’t hear enough about Long Covid & its debilitating effects that can last a lifetime. This scientific article explains the data that is available regarding Long Covid. The bottom line is:
“The new publications confirm the protective power of vaccination against Long Covid cannot be underscored enough. There is a general lack of awareness of this benefit of vaccines, and except for not getting Covid or reinfection, it is the best way to protect against Long Covid.”
Read More: Lighting Up Long Covid
COVID-19 Update # 20 Find 2023-2024 COVID-19 Vaccine Locations Near You.
“As of September 12, 2023, the 2023–2024 updated Pfizer-BioNTech and Moderna COVID-19 vaccines were recommended by CDC for use in the United States.
The 2023–2024 updated COVID-19 vaccines more closely targets the XBB lineage of the Omicron variant and could restore protection against severe COVID-19 that may have decreased over time. We anticipate the updated vaccines will be better at fighting currently circulating variants.”
COVID-19 Update # 19 Coronavirus (COVID-19) Update: FDA Authorizes Changes to Simplify Use of Bivalent mRNA COVID-19 Vaccines
“Today, the U.S. Food and Drug Administration amended the emergency use authorizations (EUAs) of the Moderna and Pfizer-BioNTech COVID-19 bivalent mRNA vaccines to simplify the vaccination schedule for most individuals. This action includes authorizing the current bivalent vaccines (original and omicron BA.4/BA.5 strains) to be used for all doses administered to individuals 6 months of age and older, including for an additional dose or doses for certain populations. The monovalent Moderna and Pfizer-BioNTech COVID-19 vaccines are no longer authorized for use in the United States.”
On April 18, 2023 the FDA released the above Press Announcement. The new vaccine schedules are meant to simplify the previous Covid-19 Vaccine Schedule. The following is our interpretation of the new schedule. Please refer to the link above for the official announcement if you have any questions.
- Most people who’ve been vaccinated with the original ‘Monovalent’, mRNA, vaccine series; Moderna, Pfizer or Janssen, & have not had the new Bivalent vaccine may receive one dose of either the Moderna Bivalent or Pfizer Bivalent.
- Most people who have already had a single dose, booster, of the Bivalent vaccine, either Moderna or Pfizer, are NOT eligible for the 2nd Bivalent Booster. This may change after June.
- People aged 65 & older & who have had the first Bivalent Booster are eligible for a second dose; Moderna or Pfizer. The second dose may be given at least 4 months after the first dose.
- Most people who are immunocompromised and who have already had a single dose of a Bivalent Booster may receive a second dose of the Bivalent vaccine. It may be given at least 2 months after the first dose. The FDA is leaving it up to the Healthcare Providers of these patients for additional Boosters. See the original press release for children 6 months to 4 years under this schedule.
- Most unvaccinated people may skip the original mRNA, monovalent, series and receive a single dose of the Bivalent Booster; Moderna, or Pfizer.
- For unvaccinated children 6 months through 5 years please check the original press release for their schedule.
- For vaccinated children 6 months through 5 years, please check the original press release for their schedule.
For more information about the new schedule & future schedules read the FDA’s Press Release.
For those of you who have had Covid recently this is a recommendation from the CDC:
“How long should I wait to get the vaccine after having Covid?
“You should get a COVID-19 vaccine even if you already had COVID-19. Getting a COVID-19 vaccine after you recover from COVID-19 infection provides added protection against COVID-19. You may consider delaying your vaccine by 3 months from when your symptoms started or, if you had no symptoms, when you received a positive test.
People who already had COVID-19 and do not get vaccinated after their recovery are more likely to get COVID-19 again than those who get vaccinated after their recovery.”
With Warm Regards to our SDCRI community,
Mary Hollander, R.N.
Daniel Vicario, M.D.
COVID-19 Update #18: The Increasing Community Access to Testing (ICATT) program
Good news!
The CDC has launched a new website: “Increasing Community Access to Testing (ICATT) program provides no-cost testing sites to communities greatly affected by the pandemic. ICATT sites operate as a partnership between the federal government, state and local jurisdictions, and a federal testing contractor.
The ICATT program provides testing resources for people who are experiencing symptoms related to COVID-19 or have been exposed to someone with COVID-19. People without health insurance do not have to pay for COVID-19 testing at ICATT locations. The tests are billed to third-party payers, such as Medicare, Medicaid, and private health insurers, to increase program sustainability.“
Did you know that they extended the expiration dates on the earlier tests they sent out? You can check your test’s new expiration date on this site as well. Visit the website to find a place near you that is a part of this program. Once you find the ICATT site you just call & make an appointment. You will find information regarding free COVID-19 Home Tests at this link: Order Free Home Tests
With Warm Regards to our SDCRI community,
Mary Hollander, R.N.
Daniel Vicario, M.D.
Covid-19 Update # 17: CDC: “People Who Are Immunocompromised, Updated December 5, 2022 “Know how to protect yourself and what to do if you get sick”
As you have probably seen on the news, Covid cases have increased in California. Hospitalization & deaths from Covid have risen sharply. Los Angeles & a few other Counties are considering masking mandates again. I wish I didn’t have to post Covid updates but it looks like this pandemic is not over. Learn how to protect yourself & your family.
This next link takes you to a pdf you can download or copy; CDC: COVID-19 Personal Plan, “Tools, information, and action steps to share with your family, friends, and healthcare provider.”
With Warm Regards to our SDCRI community,
Mary Hollander, R.N.
Daniel Vicario, M.D.
Covid-19 Update #16: COVID-19 Vaccines Are Safe for People Receiving Cancer Immunotherapy, Study Confirms. November 15, 2022 by Edward Winstead
People with cancer who are treated with certain immunotherapy drugs can receive mRNA COVID-19 vaccines without an increased risk of immune-related side effects, new research suggests. The findings are in line with the results of earlier, smaller studies.
A study of more than 400 people treated for cancer provides additional reassurance to doctors and patients about the safety of COVID-19 vaccines.
Credit: iStock
The new study involved more than 400 people with cancer who were treated at Memorial Sloan Kettering Cancer Center (MSKCC). Each received an mRNA COVID-19 vaccine before or after treatment with a type of immunotherapy drug known as an immune checkpoint inhibitor.
An analysis of the patients’ medical records revealed no evidence that mRNA COVID-19 vaccination had increased the type, frequency, or severity of immune-related side effects, such as inflammation in the lungs or colon, researchers found.
“It is safe for people to receive immune checkpoint inhibitors and COVID-19 vaccines,” said Adam Widman, M.D., who was part of the research team. “We hope our findings will allay concerns about immune-related side effects among patients as well as oncologists.”
There were no signs of increased immune-related side effects among specific groups of patients in the study (e.g., older patients or those with a specific cancer type), the researchers reported in the October issue of the Journal of the National Comprehensive Cancer Network.
“This is an important study,” said James Gulley, M.D., Ph.D., who codirects NCI’s Center for Immuno-Oncology but was not involved in the research.
“The findings add to what is known about the safety of giving COVID-19 vaccines to people taking immune checkpoint inhibitors, which are an important treatment option for a growing number of patients with cancer,” Dr. Gulley added.
Medical groups recommend COVID-19 vaccines for people with cancer
People with cancer have a higher risk of severe complications from COVID-19. Approved vaccines against SARS-CoV-2 have been shown to reduce the risk of hospitalization and death from COVID-19 among people with cancer.
The Centers for Disease Control and Prevention (CDC) and other medical groups generally recommend that people with cancer receive an mRNA COVID-19 vaccine.
But some people with cancer have been reluctant to be vaccinated while being treated with immune checkpoint inhibitors out of concerns that the additional stimulation of the immune system could contribute to side effects.
“Some clinicians and patients at Memorial Sloan Kettering had concerns that the COVID-19 vaccine might interfere with immunotherapy and might spur immune-related adverse events, which can be serious,” said Dr. Widman.
“Fortunately, we found no evidence to support those concerns,” he added.
Providing reassurance about the safety of COVID-19 vaccines
People with cancer were not included in the initial studies of the mRNA COVID-19 vaccines. As a result, when the vaccines became available there were no studies of these vaccines in patients receiving immune checkpoint inhibitors.
Studies of other vaccines have suggested that patients undergoing treatments for cancer that involve suppressing the immune system, such as stem cell therapy, should hold off on vaccination for several months because the response to the vaccine may be temporarily lessened.
In terms of side effects, a 2019 study found that the flu vaccine did not contribute to increased immune-related side effects in patients being treated with immune checkpoint inhibitors. The flu vaccine study was led by Mini Kamboj, M.D., the chief medical epidemiologist at MSKCC, who also led the new COVID-19 study.
Two studies published in 2021 also found no signs that COVID-19 vaccines contribute to immune-related side effects. One study was conducted in Israel, and the other in the United States. The MSKCC study was larger and followed patients for longer after vaccination than the earlier studies did.
The new findings should provide additional reassurance to doctors and patients about the safety of COVID-19 vaccines, noted Ido Wolf, M.D., of Tel Aviv University, who led the Israeli study.
“These vaccines can save lives, particularly for patients with cancer who may be older and have weakened immune systems and other health conditions,” said Dr. Wolf.
Most of the immune-related side effects were mild
The 408 patients in the MSKCC study had received a first dose of an mRNA COVID-19 vaccine within 90 days before or after receiving an immune checkpoint inhibitor.
Most patients in the study received the Pfizer-BioNTech vaccine, and their median age was 71 years old. The patients had many different types of cancer.
The immune checkpoint inhibitors they received included pembrolizumab (Keytruda), nivolumab (Opdivo), ipilimumab (Yervoy), and combinations of these drugs. During the follow-up period (90 days from vaccination), the researchers found:
- 27 patients (7%) experienced a new immune-related side effect, such as a rash, diarrhea, or colitis. Most of the side effects were mild.
- 4 patients (1%) developed severe immune-related side effects. In all cases these side effects were gastrointestinal, either colitis or diarrhea.
- None of the 28 patients who received the first vaccine dose and immune checkpoint inhibitor on the same day developed an immune-related side effect.
- 3 of the 54 (6%) patients with a history of immune-related side effects prior to getting vaccinated had an immune-related side effect after vaccination.
- 9 of the 52 (17%) patients who began an immune checkpoint inhibitor after vaccination developed an immune-related side effect.
Patients who started a new immune checkpoint inhibitor during the follow-up period were more likely to experience an immune-related side effect than other patients in the study. A limitation of the study was the lack of a comparison group of people who received immunotherapy but were not vaccinated, the researchers noted.
A clear message: “The vaccines are indeed safe”
The rate of immune-related side effects in vaccinated people treated with immune checkpoint inhibitors in the current study is similar to rates of these side effects in unvaccinated people treated with immune checkpoint inhibitors, according to the researchers.
Developing reliable evidence on the safety of COVID-19 vaccines in people with cancer is extremely important, noted Dr. Wolf. “Concerns about the safety of these vaccines are often based only on theoretical speculation and are not supported by the evidence,” he said.
But the message of the new study, he continued, “is loud and clear. The vaccines are indeed safe and should be given to patients with cancer who are treated with immunotherapy.”
The new findings have been “tremendously useful” at MSKCC in recent months, Dr. Widman noted. “Doctors have been reassured by the results, and they have recommended the vaccine to their patients receiving immunotherapy.”
Covid-19 Update #15: CDC: Recommendations for Bivalent COVID-19 Booster Doses in People Ages 12 Years and Older. September 13, 2022
Before we discuss the new update on the Covid-19 booster, I want to add a few points from a recent CDC update regarding this year’s flu shot.
CDC COCA Call, September 8, 2022: 2022-2023 Influenza Vaccination Recommendations and Guidance on Coadministration with COVID-19 Vaccines If you would like to listen to the call, read the transcript or see the slide presentation then click on the link.
Each year the flu vaccine is updated to be effective against the prevailing flu. It is a process that adds the predominant variant to the existing vaccine. It is not a brand-new vaccine. Here are the highlights from this call.
- Everyone should get their flu shot this year.
- October is the best time to get your flu shot. This is based on documented case trends from previous years.
- Flu vaccinations may be given at the same time as a Covid Booster vaccination. It is recommended to get them in separate arms.
- When given at the same time as the Covid-19 vaccination the reactions remain the same; sore arm, fatigue, fever, etc. In most people, they are not more pronounced due to the combination.
- Flu vaccinations are 40-60% effective. Hospitalization & death from flu is significantly lower for those who are vaccinated.
CDC COCCA call: Recommendations for Bivalent COVID-19 Booster Doses in People Ages 12 Years and Older. If you would like to listen to the call, read the transcript, or see the slide presentation then click on the link.
We have put together a list of points from the talk that we feel are important for you to know.
- Both Moderna & Pfizer have updated their original monovalent vaccines to be effective against both predominant Omicron variants. The updated version is called a bivalent vaccine.
- The original monovalent mRNA vaccines were updated the same way our flu shots are updated every year. They are NOT new vaccines.
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- The recommendations for people to get the bivalent booster vaccination is based on data from the last 2 years of administering the mRNA monovalent vaccines & their clinical trials.
- Clinical trials have been completed with both Moderna & Pfizer bivalent vaccines. The studies were small, still, greater than 1700 persons, showing a high degree of safety.
- Both Moderna & Pfizer Bivalent Booster shots show an increase in immune response in people who have completed their primary series of vaccinations plus 1 booster.
- It is recommended that a single dose of the Pfizer Bivalent Covid-19 Booster vaccine be given to ages 12 years and older at least 2 months after their primary series or their last monovalent booster dose.
- It is recommended that a single dose of the Moderna Bivalent Covid-19 Booster vaccine be given to ages 18 years & older at least 2 months after their primary series or their last monovalent booster dose.
- The bivalent booster dose replaces the previous monovalent booster vaccines. The monovalent booster vaccine will no longer be available.
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- You cannot get the Bivalent Booster unless you have completed at least a primary series of one of the vaccines; Pfizer, Moderna, or Janssen. Janssen does not have a booster vaccine.
We hope that these Covid-19 updates continue to help you in your decision-making for your health care. If you have any further questions, ask your healthcare provider for guidance.
With Warm Regards to our SDCRI community,
Mary Hollander, R.N.
Daniel Vicario, M.D.
Update # 14: Recommendations for the Novavax COVID-19 Vaccine Primary Series in Adults Ages 18 and Older . COCA Call July 28, 2022:
The FDA has issued an emergency use authorization (EUA) for a new Covid-19 vaccine, Novavax. This vaccine is different from the previous 3; Pfizer, Moderna & Janssen. Why do we need yet another Covid-19 vaccine? This one is targeting those who remain unvaccinated due to concerns about the mRNA & adenovirus vector (Janssen) technology. Novavax is based on well-known traditional vaccine models.
From the FDA website: “The Novavax COVID-19 vaccine is the first COVID-19 protein subunit vaccine recommended for use in the United States that is built on a familiar type of vaccine technology. Other protein subunit vaccines have been used for more than 30 years in the United States, including for hepatitis B, HPV, and acellular pertussis (whooping cough) vaccines.”
After taking part in the Zoom call with the CDC, Recommendations for the Novavax COVID-19 Vaccine Primary Series in Adults Ages 18 and Older , we have put together a list of the information we feel you need to know about Novavax.
- 9% of the adults in the USA have not received a single Covid-19 vaccine dose as of July 27th, 2022. It doesn’t sound like many but it actually means that 37 million adults are still unvaccinated. The majority are in rural areas.
- Unvaccinated adults, 18 years +, are the targets for use right now. Priority is for those who are severely immunocompromised.
- Novavax is a 2 doses series given 3-8 weeks apart. The interval depends on the health of the individual & how important it is to get both doses quickly.
- As of this date, there is no authorized booster of Novavax.
- You are not to mix the series with other, mRNA or adenovirus vector (Janssen) vaccines. There are exceptions but the decision lies with your healthcare provider.
- The precautions & contraindications are the same as for Moderna, Pfizer & Janssen vaccines.
- Side effects are the same as for the Moderna, Pfizer & Janssen vaccines. Myocarditis & pericarditis adverse events occurred but were rare.
- Novavax effectiveness is the same as the Moderna, Pfizer & Janssen vaccines for the original Covid-19 infection. It appears that it will be effective against most of the variants as are the other vaccines. More data is needed to comment on the newer variants such as Omicron.
Resources for you that include the Novavax vaccine.
- CDC: Stay Up to Date with Your COVID-19 Vaccines, updated July 19, 2022.
- CDC: Data Tracker, updated Monday-Friday. Tracks by county.
- FDA: Coronavirus (COVID-19) Update: FDA Authorizes Emergency Use of Novavax COVID-19 Vaccine, Adjuvanted. This site outlines the research & safety data for Novavax.
- CDC: Novavax COVID-19, Adjuvanted Vaccine: Overview and Safety. Updated July 20, 2022.
With Warm Regards to our SDCRI community,
Mary Hollander, R.N.
Daniel Vicario, M.D.
Update #13: COVID 19 Current Safety Measures, Updated July 18th, 2022
“Thanks to millions of vaccinations, California’s economy is open. But COVID-19 has not gone away. To safely go about our daily lives, we need to keep taking steps to prevent the spread.”
Scroll down the page and you will find a search area where you can choose your state & county for current updates. Find out how you can stay healthy, protect others, and still have a life during this ongoing pandemic.
Update #12: New Covid-19 Test to Treat Initiative.
A new program, Test to Treat, was started by the Biden/Harris Administration in March 2022. This is an important nationwide, FREE, program. It allows everyone to be tested at specific locations for Covid-19 and be treated, if the test is positive, at the same time. If you are displaying symptoms don’t wait, these drugs can be life-saving.
At the ‘one-stop’ Test to Treat site near you, you will be able to:
- Get tested or bring in your positive home test.
- See a healthcare provider.
- Get a prescription, if it is right for you.
- Receive your medication to take home.
The COVID-19 medications that are available, if appropriate for you, from your doctor, local pharmacies, and health clinics are the oral antiviral pills, Lagevrio (molnupiravir) from Merck, and Paxlovid from Pfizer. These medications must be taken within 5 days of your first symptoms.
On the Test to Treat website is all the information you need to find a site near you; “These “One-Stop Test to Treat” sites are available at hundreds of locations nationwide, including pharmacy-based clinics, Health Resources Services Administration (HRSA)-supported federally-qualified health centers (FQHCs), and long-term care facilities.”
On this site, you will also find the following links to what we consider to be the most important pages for information about the program.
- Find Locations: All you need to do is type in your address or just your Zip code. You can also call 1-800-232-0233 (TTY 1-888-720-7489) to get help in English, Spanish, and more than 150 other languages – 8:00 am to midnight ET, 7 days a week.
- For Individuals and Families: This site explains how it works & what you need to do.
- Fact Sheet: From the main page you can click on the link for an English fact sheet, Spanish or Chinese. These can be printed out or can be shared with family & friends.
- Frequently Asked Questions: A must-read page. All your questions will be answered in one spot!
Remember, if you are displaying symptoms, don’t wait to be treated. These drugs can be life-saving & must be taken within 5 days of your first symptoms.
With Warm Regards to our SDCRI community,
Mary Hollander, R.N.
Daniel Vicario, M.D.
Update #11: COCA Call: Updated Guidance for Clinicians on COVID-19 Vaccines. Thursday: February 24, 2022
The COCA/CDC call today was primarily to update medical care workers on the new COVID-19 Vaccine guidelines for moderately to severely immunocompromised individuals. The following is information we thought you need to know.
The beginning of the call was to emphasize the safety of COVID-19 Vaccines & how many lives they have saved. Being vaccinated is the most critical tool in curtailing this pandemic. I quote: “preventing millions of COVID-19 hospitalizations & deaths.”
For those who have not been vaccinated yet, the CDC has recommended longer intervals between doses with the mRNA vaccines. The reason for this is based on two major studies done in the UK & Canada. The results found that lengthening the intervals has minimized the risks & maximized the benefits.
Explanation of terms CDC is using.
- Fully Vaccinated: Primary series; 2 mRNA doses; Pfizer or Moderna or 1 dose of Janssen.
- Up-to-date: Primary series; 2 mRNA doses; Pfizer or Moderna or 1 dose of Janssen, plus a booster or all doses you are eligible for.
- CDC recommends that ALL boosters be either Pfizer or Moderna no matter what primary series you had.
- Brand name Spikevax = Moderna
- Brand name Comirnaty = Pfizer
The CDC’s recommendation for a 4th dose of mRNA vaccines; Moderna or Pfizer, for moderately to severely immunocompromised individuals due to the following:
- They are at increased risk for severe COVID-19
- After the primary series, they did not have a protective immune response.
- There is a waning protection over time.
The CDC listed the following list of what they consider moderately to severely immunocompromised individuals.** This list is not complete & you should speak with your health care provider to see if your individual case fits.
- Been receiving active cancer treatment for tumors or cancers of the blood
- Received an organ transplant and are taking medicine to suppress the immune system
- Received a stem cell transplant within the last 2 years or are taking medicine to suppress the immune system
- Moderate or severe primary immunodeficiency (such as DiGeorge syndrome, Wiskott-Aldrich syndrome)
- Advanced or untreated HIV infection
- Active treatment with high-dose corticosteroids or other drugs that may suppress their immune response
**CDC: COVID-19 Vaccines for Moderately or Severely Immunocompromised People For more information regarding ages & which vaccine series you have received.
Guidance for moderately to severely immunocompromised individuals:
- You can self-attest. Meaning you can tell them you are immunocompromised & the vaccinator must take your word for it.
- You do not need to provide documentation.
- Vaccinators are NOT to deny a COVID-19 Vaccination if you do not have documentation.
- Moderately to severely immunocompromised individuals should ask their health care workers if they have questions about whether or not they should get the 2nd booster.
- CDC offers a pre-vaccination checklist, where people can check if they are considered moderately or severely immunocompromised.
Current Recommendations for mRNA Vaccines for this group.
- Those who are moderately or severely immunocompromised should receive a booster dose at least 3 months after the last (third) dose of an mRNA COVID-19 vaccine.
- This is what they mean: people who are moderately or severely immunocompromised should receive a 3-dose primary series (this includes booster #1) & booster #2. (Equals 4 doses)
Current recommendations for Janssen Vaccines for this group.
- For those of you who had a Janssen COVID-19 vaccine it is recommended that you receive a 2nd (additional) dose using an mRNA COVID-19 vaccine at least 28 days after the Janssen dose, followed, in 2 months, by a booster dose of mRNA vaccine. (Equals 3 doses)
- You can choose either Pfizer or Moderna.
For more information visit: CDC: Vaccines for COVID-19
Presenters:
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- Sara Oliver, MD, MSPH
LCDR, U.S. Public Health Service
Lead, Advisory Committee for Immunization Practices COVID-19 Vaccines Work Group
COVID-19 Response
Centers for Disease Control and Prevention - Elisha Hall, PhD, RD
Lead, Clinical Guidelines, Vaccine Task Force
COVID-19 Response
Centers for Disease Control and Prevention - Evelyn Twentyman, MD, MPH
Chief Medical Officer, Vaccine Task Force
COVID-19 Response
Centers for Disease Control and Prevention
- Sara Oliver, MD, MSPH
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With Warm Regards to our SDCRI community,
Mary Hollander, R.N.
Daniel Vicario, M.D.
Update #10 COVID-19 Vaccine Booster Shots. November 11, 2021
IF YOU RECEIVED
Pfizer-BioNTech or Moderna
You are eligible for a booster if you are:
65 years or older
Age 18+ who live in long-term care settings
Age 18+ who have underlying medical conditions
Age 18+ who work or live in high-risk settings
When to get a booster:
At least 6 months after your second shot
Which booster should you get?
Any of the COVID-19 vaccines authorized in the United States
IF YOU RECEIVED
Johnson & Johnson’s Janssen
You are eligible for a booster if you are:
When to get a booster:
At least 2 months after your shot
Which booster should you get?
Any of the COVID-19 vaccines authorized in the United States
Mary Hollander RN
Update #9 Additional mRNA COVID-19 Vaccines for Moderately to Severely Immunocompromised People. August 17, 2021
On August 12th, 2021 the FDA decided to make a 3rd dose of the mRNA COVID-19 vaccines, Pfizer and Moderna, available for moderately to severely immunocompromised people. The information below are highlights of the above presentation we felt would be of benefit to you.
The following paragraph is an overview of the FDA authorization.
“The U.S. Food and Drug Administration (FDA) has issued Emergency Use Authorizations (EUA) for additional doses of mRNA COVID-19 vaccines for moderately to severely immunocompromised people. People with immunocompromising conditions or who take immunosuppressive medications or therapies are at increased risk for severe COVID-19. Studies indicate that some immunocompromised people have a reduced immune response following a primary COVID-19 vaccine series compared to vaccine recipients who are not immunocompromised. Studies have further demonstrated that an additional mRNA COVID-19 vaccine dose after an initial 2-dose primary mRNA COVID-19 vaccine series in some immunocompromised populations may enhance immune response.”
The following information has links to the slides we gathered the information from.
According to the FDA, these are the only people who need that 3rd vaccination at this time.
A patient’s healthcare team knows the patient’s state of immune compromise and will be the best source for knowing when to give the additional dose of the vaccine.
Definition of moderately to severely immunocompromised people.
- Active or recent treatment for solid tumor and hematologic malignancies
- Receipt of solid-organ or recent hematopoietic stem cell transplants
- Severe primary immunodeficiency
- Advanced or untreated HIV infection
- Active treatment with high-dose corticosteroids, alkylating agents, antimetabolites, tumor-necrosis (TNF) blockers, and other biologic agents that are immunosuppressive or immunomodulatory
The reasoning behind this authorization is as follows:
Immunocompromised People and SARS-CoV-2 Infection
- Immunocompromised people comprise ~2.7% of U.S. adults (~7 million adults)
- More likely to get severely ill from COVID-19
- Higher risk for:
– Prolonged SARS-CoV-2 infection and shedding
– Viral evolution during infection and treatment (hospitalized patients) - Lower antibody/neutralization titers to SARS-CoV-2 variants compared to non-immunocompromised people
- More likely to transmit SARS-CoV-2 to household contacts
Immunocompromised People and Vaccine Breakthrough Infection
- More likely to have a breakthrough infection
– 40-44% of hospitalized breakthrough cases are immunocompromised people in US study - Lower vaccine effectiveness (VE)
– 59–72% VE among immunocompromised people vs. 90–94% among non-immunocompromised people after 2nd dose
These are the recommendations given for the additional dose. Your healthcare team will be able to help you with the timing.
Intervention: An Additional Dose of mRNA COVID-19 Vaccine
- An additional dose of
- Pfizer-BioNTech COVID-19 vaccine (BNT162b2) (≥12 years old)
- Moderna COVID-19 vaccine (mRNA-1273) (≥18 years old)
- Given after an initial 2-dose primary series of mRNA COVID-19 vaccine, in immunocompromised people
- Attempts should be made to match the additional dose type to the mRNA primary series, however, if that is not feasible, a heterologous additional dose is permitted
- The additional dose of mRNA COVID-19 vaccine should be administered at least 28 days after completion of the primary mRNA COVID-19 vaccine series
The FDA stressed that even with the 3rd dose the person should continue to wear a mask, stay 6 ft. away from other individuals, avoid crowds and poorly ventilated indoor spaces. Close contacts of these people need to be vaccinated to help protect them.
The benefits weighed against the risks are always an important part of any study. In order to be authorized the benefits must outweigh the harm as in this case.
Summary of the Available Evidence Benefits:
Benefits:
- Emerging experimental and observational data in adults suggest that an additional mRNA COVID19 vaccine dose in immunocompromised people enhances antibody response and increases the proportion who respond to the COVID-19 vaccine
- No efficacy or effectiveness studies of COVID-19 prevention following a 3rd dose.
Harms:
- In small studies of an additional dose of mRNA vaccine
– No serious adverse events were observed
– Reactogenicity of the 3rd dose of the mRNA vaccine was similar to prior doses. - mRNA COVID-19 vaccines are associated with rare but serious adverse events, including anaphylaxis as well as myocarditis and pericarditis in young adults. The impact of immunocompromising conditions on these rare events is unknown. “Again, the benefits of the vaccines still remain very high compared to any potential side effect from them.”
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- Kathleen Dooling, MD, MPH
ACIP Workgroup Team Lead
Vaccine Task Force
COVID-19 Response
Centers for Disease Control and Prevention - Neela Goswami, MD, MPH
Clinical Guidelines Team Lead
Vaccine Task Force
COVID-19 Response
Centers for Disease Control and Prevention - Tom Shimabukuro, MD, MPH, MBA
CAPT, U.S. Public Health Service
Vaccine Task Force
COVID-19 Response
Centers for Disease Control and Prevention - Katherine Shealy, MPH, IBCLC
Vaccine Clinical Inquiry Management Team Lead
Vaccine Task Force
COVID-19 Response
Centers for Disease Control and Prevention
- Kathleen Dooling, MD, MPH
***For more information you are able to access the entire presentation here & the slide presentation here.
With Warm Regards to our SDCRI community,
Mary Hollander, R.N.
Daniel Vicario, M.D.
Update #8: When You’ve Been Fully Vaccinated. CDC Guidelines. May 20, 2021
There has been some confusion regarding the new CDC guidelines for fully vaccinated people. The new guidelines took into consideration that about 37% of the population have been fully vaccinated and at least 47% percent have received one dose at this writing. The following are points to remember from the guidelines.
- These guidelines DO NOT apply to non-vaccinated people.
- Fully vaccinated means that you are 2 weeks past your 2nd dose of the Moderna or Pfizer vaccine or 2 weeks past the single dose of the J&J Janssen vaccine.
- You can go back to your normal activities without social distancing or wearing a mask. These guidelines DO NOT supersede federal, state, local, tribal, or territorial laws, rules, and regulations, including local business and workplace guidance.
- Travel within the United States: no need to get tested before or after your travel and you do not need to self-quarantine when you return.
- International travel: Check the rules closely before you decide to travel internationally.
- You still need to wear a mask on “planes, buses, trains, and other forms of public transportation traveling into, within, or out of the United States, and in U.S. transportation hubs such as airports and stations.” (CDC)
- If you have visited or been around anyone with COVID-19, you do not need to self-quarantine or get tested unless you have symptoms. Vaccinated healthcare workers have different requirements. Check with your employer.
- If you are immuno-compromised you should continue using a mask and social distance. Talk to your healthcare team.
From the CDC Guidelines: Interim Public Health Recommendations for Fully Vaccinated People.
Guiding Principles for Fully Vaccinated People
- Indoor and outdoor activities pose minimal risk to fully vaccinated people.
- Fully vaccinated people have a reduced risk of transmitting SARS-CoV-2 to unvaccinated people.
- Fully vaccinated people should still get tested if experiencing COVID-19 symptoms.
- Fully vaccinated people should not visit private or public settings if they have tested positive for COVID-19 in the prior 10 days or are experiencing COVID-19 symptoms.
- Fully vaccinated people should continue to follow any applicable federal, state, local, tribal, or territorial laws, rules, and regulations.
What We Know
- COVID-19 vaccines are effective at preventing COVID-19 disease, especially severe illness and death.
- COVID-19 vaccines reduce the risk of people spreading COVID-19.
What We’re Still Learning
- How effective the vaccines are against variants of the virus that causes COVID-19. Early data show the vaccines may work against some variants but could be less effective against others.
- How well the vaccines protect people with weakened immune systems, including people who take immunosuppressive medications.
- How long COVID-19 vaccines can protect people.
As of the 19th of May, in California, 39% of residents are fully vaccinated and 12% have had at least one dose according to the California Department of Public Health. Governor Newsome announced on May 17th that California will wait until June 15th before the CDC Guidelines will be in effect. The state is planning to implement its re-opening guidelines on that date.
With Warm Regards to our SDCRI community,
Mary Hollander, R.N.
Daniel Vicario, M.D.
Update #7 FDA and CDC Lift Recommended Pause on Johnson & Johnson (Janssen) COVID-19 Vaccine Use Following Thorough Safety Review April 23, 2021
“Agencies Underscore Confidence in Vaccines Safety and Effectiveness Following Data Assessment; Available Data Suggest Potential Blood Clots Are Very Rare Events
Following a thorough safety review, including two meetings of the CDC’s Advisory Committee on Immunization Practices, the U.S. Food and Drug Administration, and the U.S. Centers for Disease Control and Prevention have determined that the recommended pause regarding the use of the Johnson & Johnson (Janssen) COVID-19 Vaccine in the U.S. should be lifted and use of the vaccine should resume…”
Read more here!
Update #6: Johnson & Johnson/Janssen COVID-19 Vaccine Pause. April 15, 2021
The CDC has paused the use of the Johnson & Johnson/Janssen Vaccination since April 13th until further notice. This action was due to 6 cases of women who were diagnosed with a rare type of blood clot that occurred in the sinus cavities of the brain, CVST (Cerebral Venous Sinus Thrombosis), along with a low blood platelet count (Thrombocytopenia). The fact that it was 6 cases out of 7 million doses of the vaccine already given has made it even rarer. Attending the Zoom CDC(#1) briefing this morning regarding this turn of events, we would like to share with you what we have learned. What they do know.
- The CDC started monitoring the J&J Vaccine as soon as the reports of blood clots from the European vaccine AstraZeneca were seen. Both of these vaccines are made with replication-incompetent adenoviral vectors. J&J’s from humans and AstraZeneca from chimpanzees.
- Being extremely cautious, the CDC and Johnson & Johnson are moving quickly to assess the situation.
- They are waiting for more data from the 6 cases in the U.S. and are putting together a team of experts from specialties such as Oncology & Hematology. This team will write up a risk analysis report before the vaccine can be authorized for use again. This will take at least 2 weeks.
- All 6 cases were Caucasian women, between 18-48 years of age and their symptoms appeared 1-2 weeks after their vaccination.
- All 6 were tested for COVID-19 and were negative.
- One died, 3 are in the hospital (1 in ICU) and 2 have been sent home as of today.
- There was not an issue with a specific Vaccine Lot#.
What they don’t know.
- Enough background information about the cases reported.
- Specific risk factors for this type of rare condition.
- If there were other cases of blood clots in other areas of the body.
- If the J&J vaccine cases can be compared to the AstraZeneca vaccine cases.
- The actual incidence of this rare, CVST/Thrombocytopenia, event until more cases come to light.
Recommendations
- If you have had the J&J vaccine, do not use prophylactic treatment, for example taking Aspirin daily. You do not need to be monitored or tested. This is a rare diagnosis and has a specific treatment due to the location of the clot.
- Call your healthcare provider at the first sign of any of the following symptoms within 3 weeks of your vaccination:
- Severe headache
- Abdominal pain
- Leg pain
- Shortness of breath
- Fatigue
- Vomiting
- Fever
- Chills
If you haven’t been vaccinated yet, it is important that you do so. Severe COVID-19 is not to be taken lightly. You should be vaccinated as soon as you can. If you were scheduled for a J&J injection, call and ask if you can change it to one of the following.
- Pfizer & Moderna are both mRNA vaccines. A different technology than the Janssen & AstraZeneca vaccines.
- Pfizer has administered 97.9 million doses of vaccine with NO reports of CVST.
- Moderna has administered 84.7 million doses of vaccine with 3 reports of CVST but with normal blood platelet counts after 2, 6 and 12 days after their vaccine.
Sources:
- CDC Webinar, April 15, 21: Johnson & Johnson/Janssen COVID-19 Vaccine and Cerebral Venous Sinus Thrombosis with Thrombocytopenia – Update for Clinicians on Early Detection and Treatment
- White House: J&J Pause Won’t Affect Vaccine Program, By Lindsay Kalter, April 14, 2021
- What to Know About the J&J COVID Vaccine Pause, By Kathleen Doheny, April 13, 2021
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With Warm Regards to our SDCRI community,
Mary Hollander, R.N.
Daniel Vicario, M.D.
Update #5: CDC Guidance for Fully Vaccinated People March 24, 2021
The CDC has published a set of public health recommendations for fully vaccinated people on their website: CDC Guidance for Fully Vaccinated People. These guidelines will be updated as more people are vaccinated and new information is available.
A ‘fully vaccinated person’ for COVID-19 is one who has had both of their injections of Moderna or Pfizer, or in the case of Janseen one dose, & has passed the recommended waiting period of 2 weeks from the last dose. Fully vaccinated individuals have a very low risk of contracting COVID-19 disease.
These guidelines are for those who are in non-healthcare settings. The fully vaccinated person may do the following.
- You can visit with other fully vaccinated people indoors or outdoors without wearing a mask or social distancing. These visits present a low risk. This means that you can invite people into your house for a meal or just a visit as long as everyone is fully vaccinated.
- You can now visit with unvaccinated people but they must be from a single household and are at low risk for severe COVID-19. This can be an indoor event & you do not have to wear masks or social distance. This means that you can visit with unvaccinated, healthy family members or healthy friends from a single household. An example given by CDC for someone who is at risk of severe COVID-19 is a friend or family member who is unvaccinated & 70 years old. In this case the visit should be outdoors taking precautions: wear a mask & adhere to the 6 foot distancing guideline.
- If you are exposed to COVID-19 after being fully vaccinated & you do not have symptoms, asymptomatic, then you do not have to quarantine or be tested.
Until CDC updates their guidelines with new information, the fully vaccinated person should continue doing the following.
- When in public, continue to wear a mask, maintain the 6 foot distancing recommendation & of course continue to use hand sanitizer & hand washing.
- When visiting with people who are unvaccinated who are at risk for severe COVID-19, or if there is an unvaccinated individual within a household of fully vaccinated people who is at risk, then wear a mask, social distance, use hand sanitizer & hand washing.
- When visiting unvaccinated people from several households then you must follow the preventative guidelines; mask, distance & hand washing.
- Even though you are fully vaccinated you should continue to avoid medium & large in-person gatherings. Avoid crowds, poorly ventilated places & obviously ill individuals. Follow the local guidance restricting the size of gatherings.
- Dining inside a restaurant, public or social gatherings or going to the gym are high risk areas for transmission. Although your risk as a fully vaccinated person is lower you should take the recommended precautions.
- Fully vaccinated individuals who have not been exposed to COVID-19 test negative. If you have been exposed & have COVID-19 symptoms then get tested. If it comes back positive you have the disease & must follow the CDC & Public Health guidelines for quarantine.
- Follow the guidelines set out by schools, employers & shopkeepers. If a store asks that everyone mask then you should follow their rules & mask up!
- Travelers must follow the CDC & Health Department travel requirements. Check what they are before you travel. The recommendations & requirements are different for domestic travel & travel outside the U.S.A.
As more people become fully vaccinated these guidelines will be relaxed to reflect the ongoing risk of exposure to COVID-19 disease. The more people fully vaccinated, the better the chance of returning to our new normal routines. Encourage your family & friends to take the first vaccine they are offered.
Warm Regards to our SDCRI community,
Mary Hollander, R.N.
Daniel Vicario, M.D.
Update #4: Johnson & Johnson’s Janssen COVID-19 Vaccine. March 8th, 2021
The FDA has approved a third COVID-19 Vaccine this past week: from J&J Janssen, under an0 2.3 1+6 EUA (Emergency Use Authorization). After extensive reading about this vaccine and listening to several experts, we feel that the 3 currently available vaccines are highly recommended. We would take any of the three and would accept the first one available if we weren’t vaccinated already. This third vaccine supports rapid vaccination/increase in population immunity, does not single out any group, and allows more individuals to be vaccinated with the earliest vaccine available.
The CDC (Centers for Disease Control) has regular webinars for health care professionals. We’ve been watching all those that give updates on the COVID-19 disease, treatment, and vaccines. Last week the CDC had a webinar titled: “What Clinicians Need to Know about the Johnson & Johnson’s Janssen COVID-19 Vaccine”. Here is a link to the CDC webinar site: https://emergency.cdc.gov/coca/calls/2021/callinfo_030221.asp
Below is a summary of their presentation.
- The J&J Janssen vaccine is an adenovirus vector platform which has been used for other clinical development programs including a large-scale Ebola vaccine trial, RSV (Respiratory Syncytial Virus), HIV, and Zika vaccines.
- The adenovirus vector in this Janssen vaccine is a recombinant, replication-incompetent adenovirus vector that expresses the SARS-CoV-2 (COVID-19) virus spike (S) antigen (without virus propagation). The vaccine then elicits an immune response to the COVID-19 “Spike” antigen/protein, which contributes to protection against COVID-19 disease.
- This vaccine is authorized for persons aged 18 and above; it is given intramuscularly (same as the other 2 vaccines: Pfizer and Moderna)
- Difference/benefits between this vaccine and the other two mRNA vaccines: shipment and storage at refrigerator temperature, it is a SINGLE dose, no diluent/reconstitution is necessary and it may have better protection against some variants.
- The clinical trial demonstrated efficacy against symptomatic, laboratory-confirmed COVID-19. The overall efficacy was 66.3%
- Vaccine efficacy against hospitalization was 93%
- Vaccine efficacy against all-cause mortality was 75%
- Similar efficacy after 2 weeks post-vaccination was seen for all, across age, sex, race, and ethnicity categories, and those with underlying medical conditions
- Higher efficacy against severe outcomes: Vaccine Efficacy against deaths due to COVID-19 was 100%
- Efficacy against severe disease remained high across world regions, suggesting protection against severe illness with variant strains
- Side effects: local reactions (pain at the injection site) was common at approximately 50% of vaccine recipients; systemic reactions (headache, fatigue, and body aches) occurred in approximately 55%; most symptoms resolved after 1-2 days. Of interest, systemic reactions still occurred in those who received placebo at a rate of approximately 38%.
- Contraindications and precautions for this J&J Janssen vaccine are similar to the other two vaccines, Pfizer and Moderna. See the write-up below from December 20th.
- Special considerations for utilization of this new vaccine: in mobile clinics, sites with no freezer capacity, people who want to be fully vaccinated quickly, for those who don’t want to return or can’t return for a second dose, mobile or homebound populations
UPDATE REGARDING ALL 3 VACCINES: PFIZER, MODERNA, J&J JANSSEN:
- Currently authorized COVID-19 vaccines are all inactivated vaccines
- No trials compared efficacy between vaccines in the same study at the same time. All Phase 3 trials differed by calendar time and geography; they were tested against different variants.
- All authorized COVID-19 vaccines demonstrated efficacy against symptomatic laboratory-confirmed COVID-19 (range 65 to 95%)
- All authorized COVID-19 vaccines demonstrated HIGH efficacy (above 89%) against COVID-19 severe enough to require hospitalization
- In all the vaccine trials, NO participants who received the COVID-19 vaccine died from COVID-19
- Any of the three COVID-19 vaccines can be used when indicated; no product preference
- COVID-19 vaccines are not interchangeable (safety and efficacy of a mixed series has not been evaluated).
- In exceptional situations, when the first dose of mRNA COVID-19 vaccine (Pfizer or Moderna) was received but the person is unable to complete the series with same or different mRNA vaccine, for example due to a contraindication, then a single dose of J&J Janssen COVID-19 vaccine may be administered at a minimum interval of 28 days from mRNA dose.
- COVID-19 vaccines should be administered alone with minimum interval of 14 days before or after administration of other vaccines, such as flu vaccine, shingles vaccine, etc.
- Any currently authorized COVID-19 vaccine can be administered to persons with underlying medical conditions who have no contraindications to vaccination, including ~a. Immunocompromised persons ~b. People with autoimmune conditions ~c. People with history of Guillain-Barre syndrome, Bell’s palsy, etc.
- Clinical trials demonstrate similar safety and efficacy profiles in persons with underlying medical conditions, including those that place them at increased risk for severe COVID-19, compared to persons without comorbidities
- As mentioned in previous write-ups, if you have any medical condition, questions or doubts, please discuss your particular situation with your physician before receiving the COVID-19 vaccine.
- All vaccinated individuals should continue to observe effective public health measures (wearing a mask in public, physical distancing, limiting gatherings, etc.) due to current unknowns about duration of protection and impact on transmissibility. See CDC recommendations regarding recommendations for vaccinated persons
We will continue to update our readers as soon as important new information is available.
Best wishes and blessings to our SDCRI community,
Mary Hollander, R.N.
Daniel Vicario, M.D.
Update #3: Contact Tracing. February 14th, 2021
During the pandemic, the most important job that our local Public Health Department has had is contact tracing. It has slowed down the spread of COVID-19. It sounds easy to do but in fact, it is very time-consuming & complicated. It is like dropping a pebble into a calm lake. Like the pebble, one person creates a long list of people whom they have been in contact with who in turn create a long list & on & on it continues. It is important to stop the ripple effect from the beginning.
What is Contact Tracing? (ca.gov) (From the California Department of Public Health website): Contact tracing is a common public health practice used to identify and notify anyone who has been exposed to someone with an infectious disease. Contact Tracers reach out to people who have been identified as having been in close contact with an infected person to inform them of their exposure and provide them with information on what they can do to keep themselves and their loved ones safe. Public health departments have used contact tracing for decades to fight the spread of infectious diseases like measles, tuberculosis, HIV, and other serious infectious illnesses. If people participate in the contact tracing process, it can be a very powerful strategy for slowing the spread of disease transmission in a community.
Contact tracing for COVID-19 starts with public health workers reaching out to people who have tested positive for the infection. They might do this by calling these individuals on the phone or by sending them a short survey by text or email. During this call or in this survey, the people who have tested positive will usually be asked about anyone they were close to who they may have exposed while they were contagious. Based on this information, public health workers will next call or text those “close contacts” to let them know that they may have been exposed. When they do this, they keep the name of the person who exposed them confidential.
Many people think that it is an invasion of their privacy when in fact it is confidential. To protect your privacy, contacts are only told that they may have been exposed to a person with COVID-19. They are not told the identity of the person who may have exposed them. So please answer the phone call from the Public Health Department.
This is how it works. Information is from the following websites:
- CDC COVID-19 Contact Tracing
- California COVID-19 Contact Tracing. Also, Sign up for ‘CA Notify’
- California Department of Public Health What is Contact Tracing?
During contact tracing, the health department staff will not ask you for: (from #1 above)
- Money
- Social Security number
- Bank account information
- Salary information
- Credit card numbers
- Immigration Status (from #’s 2 and 3 above)
If you were around someone who has been diagnosed with COVID-19, someone from the health department may call you. (from #’s 1, 2 and 3 above) Stay home and away from others: (from #1 above)
- Stay away from others, especially people who are at higher risk for getting very sick from COVID-19, such as older adults and people with other medical conditions, if possible.
- If you have been around someone with COVID-19, stay home and away from others for 14 days (self-quarantine) after your last contact with that person and monitor your health.
- If you have a fever, cough or other symptoms of COVID-19, stay home and away from others (except to get medical care or testing, if recommended).
- If you need support or assistance while in self-quarantine, your health department or community organizations may be able to provide assistance.
- The best way to protect yourself and others is to stay home for 14 days if you think you’ve been exposed to someone who has COVID-19. Check your local health department’s website for information about options in your area to possibly shorten this quarantine period.
For COVID-19, close contact is anyone who was within 6 feet of an infected person for a total of 15 minutes or more. An infected person can spread COVID-19 starting from 48 hours (or 2 days) before the person has any symptoms or tests positive for COVID-19. (from #’s 1, 2, and 3 above)
Monitor your health:
- Watch for fever, cough, shortness of breath, or other symptoms of COVID-19. Remember, symptoms may appear 2-14 days after exposure to COVID-19.
Here is how you can help: Please answer the phone call from the health department. If someone from the health department calls you, answer the call to help slow the spread of COVID-19 in your community.
- Discussions with health department staff are confidential. This means that your personal and medical information will be kept private and only shared with those who may need to know, like your health care provider.
- Your name will not be shared with those you came in contact with. The health department will only notify people you were in close contact with (within 6 feet for a total of 15 minutes or more) that they might have been exposed to COVID-19.
Tell the health department staff if you develop symptoms of COVID-19. If your symptoms worsen or become severe, you should seek emergency medical care.
In California, you’ll get free, confidential testing and assistance in accessing medical care, regardless of income, health insurance, or immigration status. (from #’s 2 and 3 above)
Help stop the spread of COVID-19 in our communities; please answer the call!
Best Wishes and Blessings to our SDCRI community,
Mary Hollander, R.N.
Daniel Vicario, M.D.
Update #2: COVID-19 Vaccine Side effects. January 18th, 2021
We want to remind everyone how important it is to receive your COVID-19 vaccine when it is available to you. You will be protecting yourself, family, friends, and your community; “It takes a village!”
The news has reported on the side effects, but as usual, they have sensationalized them. Severe problems after receiving either vaccine are very rare.
As you saw in our previous post, Dr. Vicario received his 1st vaccine shot. The side effect that he experienced is by far the most common: a very sore arm.
The CDC has published a good article: What to Expect after Getting a COVID-19 Vaccine
As described by the CDC, common side effects are:
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- Pain and swelling in the arm you received your injection. You can use a cool, wet cloth to help with the discomfort. Using your arm will also help reduce the swelling & the pain.
- Fever
- Chills
- Feeling tired
- Headache
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Some people have had mild flu symptoms:
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- Cough
- Mild shortness of breath
- Muscle aches
- Loss of sense of smell or taste
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The side effects usually subside within 48 hours. They will vary by person depending on their overall health and any chronic conditions.
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- Call your health care team if you experience an increase in the swelling or pain in your arm; if your symptoms are not going away or are becoming worse and concerning in the first 24-48 hours.
- Call your health care team if you have any concerns about how you feel.
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There are a few points that we want to stress:
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- Before receiving your first injection, let your healthcare team know if you have had any reactions to previous vaccinations.
- Stay around the location you receive your COVID-19 vaccination for the 15 or 30 minutes as they ask of you. This is important just in case you develop symptoms that need attention, evaluation and assistance.
- After receiving your vaccine, sign up on your smartphone for V-Safe from the CDC: “V-safe is a smartphone-based tool that uses text messaging and web surveys to provide personalized health check-ins after you receive a COVID-19 vaccination. Through V-safe, you are able to give feedback to the CDC on any side effects that occur after receiving the COVID-19 vaccine. It asks you a few brief questions that you answer on a daily basis until your side effects subside. Depending on your answers, someone from CDC may possibly contact you to get more information.” But in case of urgent or concerning symptoms, always call your health care team. Do not wait or expect to get a call from the CDC.
- To sign up for V-Safe: open the web browser on your smartphone: Safari or other web browser and type: https://vsafe.cdc.gov (or click here) and follow the instructions.
- You will need a second injection for the vaccine to be effective. Get the second shot, the same one you received the first time, even if you had experienced flu-like symptoms after the first one. The Pfizer-BioNTech vaccine: 3 weeks (or 21 days) after your first shot; the Moderna vaccine: 1 month (or 28 days) after your first shot.
- It takes time for your body to build up immunity to any vaccine. In this instance, it will take about 2 weeks after the second dose. As recommended by the CDC, you must continue to practice the safety precautions; wear a mask, practice physical separation (social distancing), hand washing, and do not spend time with people outside of your household.
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“If you are still unsure about getting vaccinated for COVID-19 this is an interesting and insightful write up shared by Dr. Lissa Rankin on her website. Lissa is a colleague I’ve known for several years. If you feel it is helpful, please consider sharing with others.
Thank you,
Dr. Vicario”
A Note To The Vaccine Hesitant From A COVID Researcher & Front Line COVID Physician
“With all due respect to those who are understandably vaccine-hesitant, let me share a few thoughts. The vaccine-hesitant are valuing an imagined (but granted not impossible) long-term side effect with no current evidence of existing, against the risks of infection by a virus that 100% exists, and has 100% probability of killing and disabling some folks who contract it. The hypothetical negatives of a vaccine- negatives that may not even exist- are less “real” than a virus with confirmed death and disability events that are happening in front of us and are guaranteed to take down some of our patients…” Excellent article.
Click here to continue reading.
We anticipate writing another follow up within the next few weeks, as information about the COVID-19 vaccine continues to evolve.
Best Wishes and Blessings to our SDCRI community,
Mary Hollander, R.N.
Daniel Vicario, M.D.
January 11th, 2021
Here is a note from SDCRI’s Medical Director, Dr. Daniel Vicario:
“I just had my first dose of Covid-19 vaccine. I’m deeply grateful to ALL the scientists, the thousands of volunteers who signed up for the clinical trials, the thousands involved in making & delivering the vaccine and those who administer them. I can’t wait for the vaccine to be available to everyone! We are all praying for that! 🙏🏼
We of course continue to pray for the millions who are affected by this terrible virus, in EVERY aspect; for the first responders and health care professionals caring for those affected. 🙏🏼
As the hospitals are preparing for the reality of massive increases in inpatient volumes in the next few weeks due to Covid-19, I’ve signed up to be available in the pool of physicians to help anywhere needed.”
Update #1: COVID-19 Vaccine Update. December 20th, 2020
We would like to share with our readers a summary of the new COVID-19 vaccines. There is such extensive information available that we feel it may be helpful to give a brief summary and include several reference sites for you to review if needed or desired. We’ve been regularly watching updated webinars and websites of the CDC (Centers for Disease Control), FDA, Health and Human Services (HSS), the California Department of Public Health, and several others.
We now have at least two different vaccines for COVID-19, and both of them are safe and highly effective, in the view of the FDA scientific advisory panels.
We know that there is significant vaccine skepticism in the general population. We also know that, in order for there to be an impact in fighting this pandemic, at least 70% of the population needs to receive the vaccine. COVID-19 has already been responsible for the deaths of more than 300,000 Americans, with mortality and hospitalization continuing to increase at an alarming rate. The pandemic has threatened the welfare of health care workers who risk everything in the line of service. Thankfully, the science tells us that the vaccine has close to 95% efficacy, and now that it’s here, we can begin to see the end of the pandemic.
Here are the highlights of the two vaccines that have been approved by the FDA under an “Emergency Use Authorization (EUA)”: The Pfizer-BioNTech and the Moderna COVID-19 vaccines:
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- Both vaccines have demonstrated over 90% effectiveness across age groups, racial and ethnic groups. No vaccine is 100% effective
- They are considered safe to be given to all adults. The Pfizer vaccine is approved for ages 16 and up. The Moderna vaccines, which was just approved, is for ages 18 and up.
- There were over 35,000 participants in the Pfizer clinical trial that was a cross-section of a large population, including those with medical comorbidities associated with a high risk of severe COVID-19.
- These vaccines are considered to be safe for everyone, including people with underlying chronic conditions, autoimmune diseases, severe comorbidities, etc.
- There are no contraindications except for those with a history of a severe allergic reaction (for example anaphylaxis) to any component of the vaccines.
- The risk/benefit ratio highly weighs toward the significant benefits for all to be vaccinated
- The risk/benefit ratio is considered for all vaccines, medicines, and medical recommendations.
- Before vaccination, medical providers will counsel vaccine recipients about expected local and systemic post-vaccination symptoms
- For those who are on cancer treatment, your physicians will be discussing with you what would be the best timing to receive the vaccine.
- Unless a person develops a contraindication to vaccination, they should be encouraged to complete the series even if they develop post-vaccination symptoms in order to optimize protection against COVID-19.
- Protection from the vaccine is not immediate; the vaccine is a 2-dose series and will take 1 to 2 weeks following the second dose to be considered fully vaccinated
- The Pfizer vaccine is given 21 days apart. The Moderna vaccine is repeated 28 days later. Both are effective 1 to 2 weeks after the second dose. Even though they are similar they are not interchangeable. You must get both doses from the same product.
- All those who receive the vaccine will be monitored closely. Serious allergic reactions are extremely rare. The vaccination sites are prepared for the potential management of any serious allergic reaction to the vaccine that may occur.
- After the COVID-19 vaccination, we may have some side effects. This is a normal sign that our body is building protection.
- The side effects of the COVID-19 vaccination may feel like the flu and might even affect our ability to do daily activities, but they should go away in a few days.
- Around the injection site we may notice some pain and swelling.
- Throughout the rest of the body: fever, chills, tiredness, headache.
- If you have a reaction like a fever, soreness at the injection site, and/or fatigue, both products say it will last approximately 24 hours. Tylenol can help. They both say to get the second dose even if you have these mild side effects. As with any side effects, let your healthcare team know.
- For further details, please click on this link: What to Expect after Getting a COVID-19 Vaccine | CDC
- The vaccines were made as soon as scientists knew the genetic code of the virus back in January 2020. It is NOT a brand-new technology. Scientists have been working on this technology for the last several years.
- The vaccines do NOT contain the virus.
- They both contain a messenger RNA (mRNA): “Spike Protein encoded mRNA” that will make our cells produce the “spike protein” that mimics the spike glycoprotein (S) antigen on the surface of the SARS-CoV-2 (Coronavirus). This in turn will make our immune system be prepared to react against the virus
- In other words, the vaccine mRNA can neither interact with nor integrate into our DNA. The mRNA enters our cells to create the protein that mimics the COVID virus and will make our immune system reject the virus. The mRNA does not enter the nucleus of the cell and it does not change our cell’s DNA
- The vaccine creates a specific immune response with neutralizing antibodies and cell-mediated immunity against the COVID virus.
- The vaccines contain NO preservatives or additives; just lipids, salts, and sugar
- See “Table 1” below with the Ingredients included in both mRNA COVID-19 approved vaccines.
- For more details on the Pfizer vaccine, you can refer to the FDA Briefing Document Pfizer-BioNTech COVID-19 Vaccine in the link below: Vaccines and Related Biological Products Advisory Committee December 10, 2020 Meeting Briefing Document- FDA
- The Advisory Committee on Immunization Practices (ACIP) recommends that the Initial Phase of the COVID-19 vaccination program (Phase 1a) is offered to health care personnel and residents of long-term care facilities. You can see all phases of the program in the “Table 2”
- Anthony S. Fauci, Director of the National Institute of Allergy and Infectious Disease at the NIH, has explained who should be next in line to receive this highly anticipated vaccine, “the ones that have a more likely chance of getting a severe outcome” if infected with COVID-19. They include the “vulnerable people, the elderly individuals with underlying conditions, diabetes, obesity, heart disease, individuals with those types of diseases. In addition, people who are immunocompromised, for example, cancer patients who are on chemotherapy and a variety of autoimmune patients who might have a suppressed immune response.
- Given the currently limited information on how well the vaccine works in the general population; how much it may reduce disease, severity, or transmission; and how long protection lasts, vaccinated persons should continue to follow all current CDC guidelines to protect themselves and others, including:
- Wearing a mask
- Staying at least 6 feet away from others
- Avoiding crowds
- Washing hands often
- Following CDC travel guidance
- Following quarantine guidance after exposure to someone with COVID-19
- Following any applicable workplace or school guidance
- This is until most people in the US are vaccinated & the numbers of COVID cases significantly decrease.
- The vaccine is also recommended to be given to those who already had Covid-19. Scientists at the CDC believe that natural immunity is around 90 days for them, but not sure beyond that. It is also recommended for people who are asymptomatic. They should finish their quarantine before getting it. Speak with the doctor first.
- For those who have been seriously ill with COVID-19, hospitalized, and received convalescent plasma or monoclonal antibodies, they will be asked to wait approximately 90 days after receiving the antibody treatment to be vaccinated. In this situation, the antibodies administered may still be circulating and can potentially block the spike protein produced by the vaccine mRNA, not allowing the person’s own immune system to create the desired specific immune response with neutralizing antibodies and cell-mediated immunity.
- From the CDC website: https://www.cdc.gov/coronavirus/2019-ncov/vaccines/8-things.html “You should receive a vaccination card or printout that tells you what COVID-19 vaccine you received, the date you received it, and where you received it. You should receive a paper or electronic version of a fact sheet that tells you more about the specific COVID-19 vaccine you are being offered. Each authorized COVID-19 vaccine has its own fact sheet that contains information to help you understand the risks and benefits of receiving that specific vaccine.”
- V-safe is a smartphone-based tool that uses text messaging and web surveys to provide personalized health check-ins after you receive a COVID-19 vaccination. V-safe After Vaccination Health Checker | CDC
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The information above is a guide. You will be making your own choice about whether to take the vaccine whenever it is offered to you. The decisions you make about being immunized will have an impact on the decisions made by your family and your community.
We hope you will take this opportunity to contribute to our collective safety and success by encouraging others to protect themselves—and all of us—by getting vaccinated when they can.
Our goal is to share updates regularly, especially if there is any significant new information available. In the meantime, please refer to the below-recommended websites, as these are updated regularly.
Sending best wishes and many blessings to our SDCRI community,
Mary Hollander, R.N.
Daniel Vicario, M.D.
Table 1: 
Table 2: 
See more here: Phases (sandiegocounty.gov)
Recommended Websites:
Coronavirus Disease 2019 (COVID-19) | CDC
Vaccines | CDC
8 Things to Know about the U.S. COVID-19 Vaccination Program | CDC
COVID-19 Vaccines | FDA
Home | Clinician Outreach and Communication Activity (COCA) (cdc.gov)
Calls/Webinars | Clinician Outreach and Communication Activity (COCA) (cdc.gov)
Webinar December 18, 2020 – What Clinicians Need to Know About the Pfizer-BioNTech and Moderna COVID-19 Vaccines (cdc.gov)
Slides from above Webinar: What Clinicians Need to know about the Pfizer and Moderna Vaccines. December 18, 2020:
–COCA Crisis Standards of Care (cdc.gov)
American Society of Clinical Oncology (ASCO) Coronavirus resources:
–ASCO Coronavirus Resources | ASCO
California Department of Public Health COVID-19 Vaccine Information:
–COVID-19 Vaccines (ca.gov)
–Patients Undergoing Immunosuppressive Cancer Therapy Can Shed Viable Covid-19 Virus For at Least Two Months | Memorial Sloan Kettering Cancer Center (mskcc.org)
County of San Diego website:
–Coronavirus Disease 2019 (sandiegocounty.gov)
County of SD COVID December 16 Update:
–(4) COVID-19 Update 12-16-2020 – YouTube
COVID-19 Exposure Notifications:
–CA Notify
–More than 6 million have signed up for California’s COVID-19 alert system – The San Diego Union-Tribune
FDA Briefing Document Pfizer-BioNTech COVID-19 Vaccine:
–Vaccines and Related Biological Products Advisory Committee December 10, 2020 Meeting Briefing Document- FDA
FDA Briefing Document Moderna COVID-19 Vaccine:
–Vaccines and Related Biological Products Advisory Committee December 17, 2020 Meeting Briefing Document – FDA
–Fact Sheet for Health Care Providers: Emergency Use Authorization (EUA) of Bamlanivimab (fda.gov)
Society of Integrative Oncology: COVID Resources
–Covid Resources (integrativeonc.org)
COVID-19 Resources, Info, and News
Considerations for Travelers – Coronavirus in the US
How to Detect Skin Cancer, Even During COVID-19
Centers for Disease Control (CDC)
California Department of Public Health
San Diego County Health and Human Services
San Diego County.gov – information on coronavirus
NIH: National Institutes of Health
WHO: World Health Organization
Johns Hopkins University
Medicare Website regarding Coronavirus
Medicaid website regarding Coronavirus Disease 2019
Resources & Guidance for COVID-19, San Diego via SanDiegoCounty.gov
Pregnancy and COVID-19 Vaccines with Sandy Ramos, MD, Perinatologist
Embarazo y vacunas contra el COVID-19 en Español
Cleaning and Disinfecting Your Home