By: Joseph Mechak, MD
The Pfizer-BioNTech COVID-19 vaccine is nearing Emergency Use Authorization (EUA) for the 5 to 11 year old age group. On October 26th, the EUA passed the first of several check-points but still has a few hurdles to go. We wanted to provide some information on what has happened so far and what still needs to occur for shots to go in arms of our 5 to 11 year old patients.
In order for the vaccine to be approved under EUA it needs to pass three major hurdles:
- FDA recommendation for EUA
- CDC guidelines recommendations for vaccine use
- Final sign off by CDC Director
Here is what has happened so far and what to expect in the coming days to weeks:
1. October 26th – FDA Advisory Panel Meeting recommends EUA
On October 26th an independent advisory committee to the FDA met to discuss the Pfizer BioNTech vaccine. They were tasked with answering 1 question: “Based on the totality of scientific evidence available, do the benefits of the PfizerBioNTech COVID-19 Vaccine when administered as a 2-dose series (10 µg each dose, 3 weeks apart) outweigh its risks for use in children 5-11 years of age?” This committee spent 8+ hours discussing data submitted by Pfizer, data submitted by the FDA, reviewing complex risk/benefit models, hearing public comment, and a having a lengthy discussion about the question at hand. The committee voted 17-0 (with one abstention) that the benefits of the Pfizer/BioNTech vaccines did outweigh the risks of the vaccine in the 5- 11 year old age group.
** For those with questions or concerns about the vaccine, or its side effects, Dr. Atwood and Dr. Mechak will be hosting a separate Facebook Live event to discuss and translate much of the data and considerations reviewed by this committee. More on this to come**
2. In the next day or two – FDA will provide its official recommendation for EUA
The FDA advisory committee will submit their recommendation to the FDA for formal consideration. The FDA scientists review the data and the panel’s recommendations to make the final decision on whether to recommend the vaccine for EUA. For the past several COVID-19 vaccine EUAs, the FDA has gone along with the recommendation of the advisory committee but that is not a guarantee.
3. November 2-3rd – Advisory Committee on Immunization Practices (ACIP) meets to formalize guidelines and recommendations for the vaccine
ACIP is an independent panel of medical and public health experts that advise the CDC on vaccine related matters. Similar to the FDA advisory committees, ACIP will review the data, public comment, and other information to make a recommendation to the CDC on to who and how the vaccine will actually be administered.
4. Final step – Final CDC approval
The final step in the process is a sign-off from CDC Director Rochelle Walensky to formally recommend the vaccine and finalize guidelines for its use. This signature is expected hours to days following the ACIP recommendation.
If all goes as planned, the vaccine could be approved and available by late next week (November 3rd or 4th). In anticipation of the EUA, mass production and distribution of the pediatric vial of the COVID-19 vaccine has already begun. The COVID-19 task force is planning to lean more on community health centers and primary care doctors (that’s us) for vaccine administration that with previous age groups. We have already been working to secure vaccine doses for our patients and hope to have them within days of the approval. You have already received some information about how Potomac Pediatrics plans to administer the vaccine. Be on the lookout for more information as approval (hopefully) occurs.
We know some of you cannot wait to get your children the vaccine while others have some reservations. We hope to help answer questions, clear up misconceptions, and provide our input on the vaccine though a Facebook Live event once we have seen all of the available information for ourselves. We will focus on the specific risks and benefits of the vaccine in this age group. Keep an eye on your emails and the website for more information.