The events of the past 10 days, as we awaited approval of COVID-19 booster shots, have been nothing short of dramatic/unexpected. Throughout the FDA and CDC meetings and votes (to approve a booster shot and for whom), I have experienced the emotions and anxiety captured by Edvard Munch’s The Scream.
The key takeaways from the past 10 days and all of the booster shot news/drama are —
Getting first doses into the arms of unvaccinated individuals is of the utmost importance. Seventy million Americans are unvaccinated against COVID. We need to get these folks vaccinated. The quickest way to slow the spread of disease is to vaccinate individuals who are currently unvaccinated.
We CANNOT booster shot our way to the end of the pandemic.Approving the COVID vaccine for children ages 5-11 is a top priority. Data from Pfizer shows that the vaccine is safe and effective for kids. The goal is to have kids vaccinated before the holidays. Fingers crossed…!
Boosters were approved only for individuals who received the Pfizer vaccine (read: no boosters approved for individuals who received Moderna or J&J).
Booster shots must be given six months after completing the primary series of the Pfizer vaccine (i.e., six months after the first two doses).
Individuals SHOULD receive a booster shot if they —
Are greater than 65 years old.
Are at least 18 years old and living in a long-term care setting.
Are aged 50-64 with underlying medical conditions.
Individuals MAY receive a booster shot if they —
Are aged 18-49 years with underlying medical conditions.
Are aged 18-64 years and are at increased risk of COVID-19 exposure and transmission because of their occupational or institutional setting.
WHAT does this all mean?!?!?! Here is the decision tree to determine if you can and should you get a booster shot from the PA Dept of Health —
Do you understand why I am feeling all things Munch and The Scream?
Not only was the process for determining if boosters are needed complicated, but now the decision-making process regarding whether you can or should get a booster shot is wicked complicated. And messaging across news agencies and social media has really made this whole process messy.
If you are still trying to determine if you should get a booster shot, please go back and read 1-6 above. If you are interested in trying to make sense of what happened over the past few days, read on…
The process of officially approving booster shots began on September 17th when FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) met. Following a vote by the VRBPAC to provide regulatory approval of a booster dose of the Pfizer vaccine, FDA approved the Pfizer booster dose on September 22nd.
At this point in the timeline, most people ask me where does CDC and its Advisory Committee on Immunization Practices (ACIP) fit in? And what is the purpose of ACIP?
FDA has the authority to regulate vaccines (and other medications). They are authorized by Congress to determine if the benefits of a vaccine outweigh the risks, and if so, FDA can approve a vaccine for use. In the case of the COVID vaccines, this has involved issuing Emergency Use Authorizations and full licensure of the Pfizer vaccine. Administering a vaccine (putting the needle into a person’s arm) is considered “the practice of medicine,” which is NOT under the purview of the FDA. Therefore, ACIP makes recommendations for how the medical community should be administering an FDA-approved vaccine to the public. If you are a visual learner, the process looks like this —
This process was disrupted in a couple of ways during the booster shot approval. First, President Biden announced in August that booster shots would be available for individuals who received either the Pfizer or Moderna shot by September 20th. This announcement came before the review of the data. And it put the entire process of data-driven decision-making at risk. Pfizer rushed to have its booster shot data approved by September 17th. Moderna hasn’t completed its trials and has not shared data with FDA for review.
The second disruption occurred last week. ACIP voted (9-6) AGAINST the approval of a booster dose for individuals aged 18-64 at increased risk of COVID exposure because of occupational or institutional settings. However, the CDC Director overruled that decision and approved booster shots for individuals in that group; making the vaccine available to ~50 million healthcare workers, teachers, and frontline workers. This is the second time in my lifetime that the CDC Director has overruled the ACIP (the first time was post-9/11 and involved smallpox vaccines after threats of bioterrorism).
At the end of the day, Pfizer booster shots are available for individuals who qualify (and can successfully make their way through the decision tree above).
So… you might want to know - what do I think? and am I seeking a booster shot?
First, I am encouraging my dad (who is above 65 and received two doses of Pfizer in early 2021) to get a booster dose. Note — my mom received the Moderna vaccine so I am not encouraging her to get a booster dose. I have also encouraged friends in my age group (the 18-64-year-olds) who have had (or currently have) cancer, diabetes, or an underlying health condition to get the booster shot. For friends who live with older parents or partners or are living with unvaccinated kids AND work in a school or healthcare environment, I am encouraging them to get a booster shot.
More importantly — I am reminding everyone that I know that the primary series of all three vaccines are STILL EFFECTIVE at preventing severe illness, hospitalization, and death from COVID-19. The COVID-19 vaccines (none of them) do NOT provide neutralizing antibodies — meaning they do not provide full protection against illness and transmission — we need to continue to use multiple mitigation strategies to stop the spread of disease.
Personally, I am not rushing out to get a booster dose. The data presented last week give me every reason to believe that I have effective immunity to prevent severe disease, hospitalization, and death from COVID-19. My plan is to get my flu shot in mid-October. And then I hope to get my booster dose alongside my 9-year-old son when he is eligible to get his Pfizer vaccine. Halloween vaccinations, yes!!
This means — we need to prioritize vaccines & masking. We need to continue to gather in smaller groups & avoid large crowds where vaccinated and unvaccinated, masked and unmasked individuals are mixing (especially indoors). We need to continue to wash our hands, work to increase ventilation indoors, and recognize that the pandemic is not over.
Getting a booster shot may increase your immune response, but it does not serve as a substitute for masking and reducing your risk of exposure to the SARS-CoV-2 virus.
Still have questions? I am doing a live COVID-19 Q&A tonight (9/27) at 7 pm on the Crawford County COVID-19 Facebook page. All are welcome. And if you cannot join live, there will be a recording on Facebook.