What You Need to Know About COVID Booster Shots
Saturday, September 25, 2021
All parties involved in making decisions regarding COVID vaccine booster shots have now made their pronouncements – the Food and Drug Administration (FDA), the FDA Advisory Committee on Vaccines and Related Biological Products, the Centers for Disease Control (CDC), and the CDC Advisory Committee on Vaccination Practices (ACIP). Third (booster) shots of COVID vaccine are now available in the U.S. and in Rhode Island starting Friday, September 24. This is a summary of what it all means.
Who is eligible to receive a booster dose?
GET THE LATEST BREAKING NEWS HERE -- SIGN UP FOR GOLOCAL FREE DAILY EBLASTA select group of people who received their second Pfizer COVID vaccine dose at least 6 months ago can now receive a booster shot. Those eligible include:
- All individuals 65 years old and older.
- Residents of long-term care facilities.
- People aged 50-64 with underlying medical conditions, such as high blood pressure, diabetes, obesity, cancer, heart disease, chronic lung or kidney disease, dementia, and certain disabilities. A full list of qualifying medical conditions can be found on the CDC website.
- People aged 18-49 with underlying medical conditions are recommended to weigh their individual benefits and risks. If you fall into this category, you may want to talk with your doctor.
- People who work in occupations with a high risk of exposure to the SARS-CoV-2 virus, such as health care workers, teachers and daycare staff, grocery workers, and people who work in homeless shelters or prisons.
How and when can you can get a booster shot?
Booster doses are available to eligible Rhode Islanders as of Friday, September 24. Eligible Rhode Islanders can now make appointments for booster doses. You can make an appointment at C19vaccineRI.org. If you need assistance making an appointment, you can call 844-930-1779, 401-222-8022, or 211.
What about people who received the Moderna or Johnson & Johnson vaccine?
The regulatory agencies and their advisory groups did not consider or make any decisions regarding the Moderna or Johnson & Johnson vaccines. The Moderna vaccine uses very similar mRNA technology as the Pfizer vaccine, and the company has submitted an application with the FDA for approval of a third dose of its vaccine. The process of reviewing and approving a booster dose of the Moderna vaccine is expected to be similar to what it just was for the Pfizer product.
Johnson & Johnson has not yet asked for approval of a booster dose of its vaccine. This would be a second dose of the vaccine as the initial administration is a single shot. The company has announced clinical results showing that a second dose of its vaccine two months after the first dose increases protection against moderate and severe COVID disease from 66% with the first dose to 94% after the second dose.
What are the side effects of a booster dose of the Pfizer vaccine?
A study by the CDC in immunocompromised people found that most symptoms were mild to moderate and similar to the side effects seen after the initial two-dose series. The most commonly reported side effects are fatigue and pain at the injection site.
A study in Israel found that 88% of people receiving a third dose reported they felt “similar or better” to how they felt after the second dose.
At the FDA Advisory Committee meeting last week, the Israel Ministry of Health made an unusual presentation on that country’s experiences with administering 2.8 million booster doses to date. Among a great deal of other data, the experience in Israel reported one case of myocarditis out of 2.8 million people receiving booster doses. Myocarditis is much more common from COVID infection than a risk with the vaccine.
If you got a Moderna or Johnson & Johnson vaccine, can you get a Pfizer booster?
This approval from the FDA and CDC is specific to those who initially received two shots of the Pfizer vaccine, and are now eligible to receive a third, booster dose. The CDC panel extensively discussed the possibility of mixing COVID vaccines, but had little hard data on which to make a recommendation.
Currently, regarding the use of third, booster doses in immunocompromised individuals, the CDC recommends that the additional mRNA COVID-19 vaccine dose should be the same vaccine product as the initial 2-dose mRNA COVID-19 primary vaccine series (Pfizer or Moderna). If the mRNA COVID-19 vaccine product given for the first two doses is not available, the other mRNA COVID-19 vaccine product may be administered.
Why is the process so complicated and requires both the FDA and CDC?
The FDA regulates vaccine clinical trials, licenses vaccines, and monitors vaccine safety after the product has been approved and is being used by the public. The FDA approval process includes both internal review by FDA employees, and also reviews and recommendations by advisory committees of outside experts who are not direct FDA employees.
With the Pfizer COVID vaccine, the first step in the process was the review by the FDA Advisory Committee that met on September 17.
The next step was review by the FDA itself, which issued its approval of booster doses of the Pfizer vaccine on September 22 https://www.fda.gov/news-events/press-announcements/fda-authorizes-booster-dose-pfizer-biontech-covid-19-vaccine-certain-populations.
Once the FDA approves a vaccine, the CDC's Advisory Committee on Immunization Practices (ACIP) considers not only FDA-approved labeling, but also disease epidemiology, burden of disease, economic analyses and implementation issues in establishing how the vaccine should be used in the civilian population. Similarly to the FDA, the CDC both uses an outside panel of experts, as well as renders its own decisions internally.
On September 23 the CDC Advisory Committee (ACIP) recommended essentially following the previous guidance of the FDA Advisory Committee in approving booster shots of the Pfizer vaccine and in which specific groups of people.
However, this process with the Pfizer COVID vaccine was unusual in that Dr. Rochelle Walensky, Director of the CDC, overruled the Advisory Committee recommendations and subsequently added people who work in occupations at high risk of exposure to SARS-CoV-2 to also being eligible for booster shots.
The process seems very complicated, and is – but it is designed to provide multiple layers of review and maximize safety for the general public by minimizing the chance that something will be overlooked and people could be exposed to undue risk.
As with everything relating to your health, if you have any questions you should talk with your doctor.
Nick Landekic is a retired scientist and biotechnology executive with over 35 years of experience in the pharmaceutical industry.
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