F.D.A. Aims to Give Final Approval to Pfizer Vaccine by Early Next Month

[JoanofArgh]

WASHINGTON — With a new surge of Covid-19 infections ripping through much of the United States, the Food and Drug Administration has accelerated its timetable to fully approve Pfizer-BioNTech’s coronavirus vaccine, aiming to complete the process by the start of next month, people involved in the effort said.

President Biden said last week that he expected a fully approved vaccine in early fall. But the F.D.A.’s unofficial deadline is Labor Day or sooner, according to multiple people familiar with the plan. The agency said in a statement that its leaders recognized that approval might inspire more public confidence and had “taken an all-hands-on-deck approach” to the work.

Giving final approval to the Pfizer vaccine — rather than relying on the emergency authorization granted late last year by the F.D.A. — could help increase inoculation rates at a moment when the highly transmissible Delta variant of the virus is sharply driving up the number of new cases.

https://www.nytimes.com/2021/08/03/us/politics/pfizer-vaccine-approval.html?campaign_id=60&emc=edit_na_20210803&instance_id=0&nl=breaking-news&ref=cta&regi_id=72416910&segment_id=65265&user_id=20a86bb77f8705e060212c90659bdb01

[Peppertoo]

1. Good news

[Ilsa]

2. No more excuses about being "experimented on." nt

[Ms. Toad]

3. Hmm . . .

Most medicines are approved first for adults. Any medical use of those medicines is "off label" when used for children. (My daughter, at age 5, was taking a newly approved medicine for the exact same condition for which it was approved for adults. She took it from 1995 - 2015, or so. As of 2018 it was still not approved for use by children.)

I wonder if, once approved for adults, the Pfizer vaccine could be used off label for children who are not yet eligible under the current guidelines?

[LeftInTX]

4. One of our frequent commenters (Lisa L) stated there were a few cases of carditis

After the vaccine in younger males, hence this is probably the reason it has not received EUA for those younger than 12.

I believe they are researching the carditis etc...

[Ms. Toad]

5. That may be true,

and certainly for most children I wouldn't push the issue.

But there are children who are more at risk from COVID than others. For those, I am wondering if vaccines (like drugs) can be used off-label for whatever a physician chooses to use them for once full approval has been granted.

In other words - the FDA grants full approval for the Pfizer vaccine for use in adults.

A pediatrician evaluates her asthmati 8 year old and decdes that the risk of asthma + COVID is greater than the risks associated with the vaccine, so uses the fully approved for adults "off label" to treat her asthma patient.

ETA: I'm not the first to think of this:

The administration of the vaccine in an age group other than recommended is another
possibility that fully falls in the context of off-label use of the drug according to the
shared definitions.

This could happen in a number of cases of vulnerable subjects (i.e., oncohaematological patients), for which the doctor could prescribe the administration of the vaccine
even outside the age range recommended by the SmPC/Fact Sheet. This decision would
result from a weighted benefit-risk assessment delegated to the opinion of the individual
prescriber doctor and therefore disengaged from clinical studies (not available at the moment) especially in subjects under the age of 16 (Comirnaty) or the age of 18 (Moderna,
AstraZeneca). The ethical implications of this choice are relevant since they place the doctor
in front of a risk in any case: On the one hand, the prescription of a drug that has not been
tested in that age group, and on the other hand, the lack of prescription of a drug which is
protective against a disease potentially serious or lethal considering the comorbidities of
the patient.

https://www.mdpi.com/2076-393X/9/5/423/pdf