May 14, 2021
Earlier this week, the federal government adopted recommendations paving the way for the Pfizer-BioNTech COVID-19 vaccine to be made available to adolescents ages 12-15.
What it means.
On Monday May 10, the FDA granted an Emergency Use Authorization (EUA) for the use of the Pfizer–BioNTech COVID-19 vaccine in adolescents 12-15. The vaccine previously held an EUA for individuals 16 and up, and FDA is currently considering full licensure (BLA) of the vaccine in that population.
In setting recommendations for use of a vaccine, CDC relies heavily on the Advisory Committee for Immunization Practices (ACIP) panel. ACIP is a group of medical and public health experts who develop recommendations on the use of vaccines in the United States. For instance, this Advisory Committee helps CDC set the childhood immunization schedule. In relation to COVID-19, the ACIP has voted on vaccination prioritization schemes, recommendations for the three products with Emergency Use Authorization – Pfizer, Moderna, and J&J, and the pause and un-pausing of the J&J vaccine due to reports of rare blood clots.
On Wednesday May 12, the ACHIP held an Emergency Meeting and voted 14-0 to recommend the vaccine for the 12-15 year old population.
The ACIP also discussed updates on the J&J blood clot data and the efficacy of all the vaccines against viral variants.
The discussion largely focused on vaccine safety and the co-administration of the Pfizer-BioNTech vaccine with other vaccines on the childhood vaccination schedule.
CDC Director Dr. Rochelle Walensky issued a statement adopting ACIP’s recommendation that endorsed the safety and effectiveness of the Pfizer-BioNTech COVID-19 vaccine and its use in 12- through 15-year-old adolescents. CDC now recommends that this vaccine be used among this population, and providers may begin vaccinating them right away.
What’s Next.
Now that 12-15 year olds are eligible to be vaccinated, the CDC may use this step as cover to alter some of its guidance for schools and camps (which have received extensive criticism by Congress, the press, and even progressive public health influencers for being too conservative) in the coming weeks.
Expect more COVID-19 vaccine data and more EUA filings from Pfizer. Check out slide 7 of the investor presentation from last week to take a peek at the populations and anticipated timelines. As mentioned above, Pfizer has begun a rolling submission of its data to support full licensure for persons 16 and up.
One question we’ve heard several times is “will products under EUA with the same indication have to leave the market once FDA issues a full approval for another?” This is the first time we’ve used EUAs to this magnitude since the creation of the pathway, but your author (who is not a lawyer nor is giving legal advice) believes that the agency has clear authority to issue a BLA for a COVID-19 vaccine while leaving others under an EUA on the market.
Section 564 of the Federal Food Drug and Cosmetic Act [21 USC 360bbb-3] includes the criteria to issue and preserve an EUA. These include that there is a public health emergency in place and “that there is no adequate, approved, and available alternative”… One could argue that one vaccine on the market alone is not an “adequate” or “available” alternative and therefore keep others under EUAs until they submit their application. The BLAs might also be different in terms of populations, and so eliminating certain available EUA products that may impact certain populations more than others could play into a determination of “adequate” here.
An example of how this is already playing out – FDA has given clearance to a COVID-19 test under the traditional medical device framework and that has not impacted the EUAs of the other tests. That being said, earlier this week, the Director of FDA’s Center for Devices and Radiological Health Jeff Shuren indicated that for certain COVID-19 device products (which include tests), the agency will be expecting standard applications for new entrants into some product categories. This further builds the case that FDA will be using the “adequate, approved, and available alternative” standard, and that it is likely going to be applied product category by product category based on the realities of COVID-19 management on the ground.
But again – we’ve never been down this road so let’s see how this plays out and we’ll keep you up to date as things continue to evolve!
Resources.