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 #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


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:

18 years or older

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

CDC Booster Recommendations

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.

Overview

“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.”

The presenters were:

    • 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

***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.

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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.

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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!

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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:

Mary Hollander, R.N.
Daniel Vicario, M.D.

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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.

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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.

  1. 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.
  2. 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.
  3. This vaccine is authorized for persons aged 18 and above; it is given intramuscularly (same as the other 2 vaccines: Pfizer and Moderna)
  4. 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.
  5. The clinical trial demonstrated efficacy against symptomatic, laboratory-confirmed COVID-19. The overall efficacy was 66.3%
  6. Vaccine efficacy against hospitalization was 93%
  7. Vaccine efficacy against all-cause mortality was 75%
  8. Similar efficacy after 2 weeks post-vaccination was seen for all, across age, sex, race, and ethnicity categories, and those with underlying medical conditions
  9. Higher efficacy against severe outcomes: Vaccine Efficacy against deaths due to COVID-19 was 100%
  10. Efficacy against severe disease remained high across world regions, suggesting protection against severe illness with variant strains
  11. 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%.
  12. 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.
  13. 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:

  1. Currently authorized COVID-19 vaccines are all inactivated vaccines
  2. 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.
  3. All authorized COVID-19 vaccines demonstrated efficacy against symptomatic laboratory-confirmed COVID-19 (range 65 to 95%)
  4. All authorized COVID-19 vaccines demonstrated HIGH efficacy (above 89%) against COVID-19 severe enough to require hospitalization
  5. In all the vaccine trials, NO participants who received the COVID-19 vaccine died from COVID-19
  6. Any of the three COVID-19 vaccines can be used when indicated; no product preference
  7. COVID-19 vaccines are not interchangeable (safety and efficacy of a mixed series has not been evaluated).
  8. 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.
  9. 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.
  10. 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.
  11. 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
  12. 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.
  13. 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.

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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:

  1. CDC COVID-19 Contact Tracing
  2. California COVID-19 Contact Tracing. Also, Sign up for ‘CA Notify’
  3. 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.

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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:

      • 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

Some people have had mild flu symptoms:

      • Cough
      • Mild shortness of breath
      • Muscle aches
      • Loss of sense of smell or taste

The side effects usually subside within 48 hours. They will vary by person depending on their overall health and any chronic conditions.

      • 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.

There are a few points that we want to stress:

      • 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.

“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.

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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.”

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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:

      1. Both vaccines have demonstrated over 90% effectiveness across age groups, racial and ethnic groups. No vaccine is 100% effective
      2. 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.
      3. 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.
      4. These vaccines are considered to be safe for everyone, including people with underlying chronic conditions, autoimmune diseases, severe comorbidities, etc.
      5. There are no contraindications except for those with a history of a severe allergic reaction (for example anaphylaxis) to any component of the vaccines.
      6. The risk/benefit ratio highly weighs toward the significant benefits for all to be vaccinated
      7. The risk/benefit ratio is considered for all vaccines, medicines, and medical recommendations.
      8. Before vaccination, medical providers will counsel vaccine recipients about expected local and systemic post-vaccination symptoms
      9. For those who are on cancer treatment, your physicians will be discussing with you what would be the best timing to receive the vaccine.
      10. 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.
      11. 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
      12. 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.
      13. 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.
      14. After the COVID-19 vaccination, we may have some side effects. This is a normal sign that our body is building protection.
      15. 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.
      16. Around the injection site we may notice some pain and swelling.
      17. Throughout the rest of the body: fever, chills, tiredness, headache.
      18. 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.
      19. For further details, please click on this link: What to Expect after Getting a COVID-19 Vaccine | CDC
      20. 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.
      21. The vaccines do NOT contain the virus.
      22. 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
      23. 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
      24. The vaccine creates a specific immune response with neutralizing antibodies and cell-mediated immunity against the COVID virus.
      25. The vaccines contain NO preservatives or additives; just lipids, salts, and sugar
      26. See “Table 1” below with the Ingredients included in both mRNA COVID-19 approved vaccines.
      27. 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
      28. 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
      29. 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.
      30. 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:
        1. Wearing a mask
        2. Staying at least 6 feet away from others
        3. Avoiding crowds
        4. Washing hands often
        5. Following CDC travel guidance
        6. Following quarantine guidance after exposure to someone with COVID-19
        7. Following any applicable workplace or school guidance
      31. This is until most people in the US are vaccinated & the numbers of COVID cases significantly decrease.
      32. 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.
      33. 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.
      34. 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.”
      35. 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

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)

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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

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