Pfizer Seeking Full FDA Approval for COVID Vaccine
By Ralph Ellis
May 10, 2021 -- Pfizer and its European partner BioNTech are seeking the FDA’s full approval for their COVID-19 vaccine, which is already being widely administered in the United States under an emergency use authorization.
If the FDA says yes, Pfizer would be the first COVID vaccine to gain full approval in the United States.
In a news release, Pfizer said it will initiate a Biologics License Application and submit information to the FDA on a rolling basis over the coming weeks. The vaccine application is only for people 16 and over.
Pfizer says it’s seeking a priority review, which the FDA defines as “a 6-month review of the entire BLA rather than the usual 10-month review.”
https://www.webmd.com/vaccines/covid-19-vaccine/news/20210510/pfizer-seeking-full-fda-approval-for-covid-vaccine
And like Moderna, they are submitting data on a "rolling basis".
The EUA approval doesn't really count in the time clock for review although obviously there will be a data overlap for what was submitted for the EUA and what was submitted for the final approval (probably with any corrections/updates from the earlier submissions).
Pfizer also noted this about their submission -
Pfizer and BioNTech initiated the BLA by submitting the nonclinical and clinical data needed to support licensure of the COVID-19 vaccine for use in individuals 16 years of age and older. This includes
the most recent analyses from the pivotal Phase 3 clinical trial, where the vaccine’s efficacy and favorable safety profile were observed up to six months after the second dose. The companies will submit the required manufacturing and facility data for licensure in the coming weeks to complete the BLA.
Pfizer and BioNTech also have submitted an application to expand the current EUA for their COVID-19 vaccine to include individuals 12 to 15 years of age. The companies intend to submit a supplemental BLA to support licensure of the vaccine in this age group once the required data six months after the second vaccine dose are available.
https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-initiate-rolling-submission-biologicsThere was a recent news item that FDA is basically now in "all hands on deck" mode -
https://www.statnews.com/2021/07/30/fda-under-pressure-plans-sprint-to-accelerate-review-of-pfizers-covid-19-vaccine-for-full-approval/
And from that above link (and something I have noted in other posts) you have this -
The process requires FDA staff to review millions of pages of complex data, conduct plant inspections, and negotiate with Pfizer over issues including the terms of the FDA’s approved label and the company’s postmarketing responsibilities.
They have to do final cGMP inspections of the plants, look at the sterility, batch records (and probably collect samples and have them analyzed), look at the written testing criteria and equipment calibrations, the employee training, and what will be new is that the final product labeling will need to be reviewed, including even something that became an issue early on, like the doses per vial. That's because as some might recall, in an effort to get more doses out quicker, there were evaluations of extracting an additional dose from a vial using the normal overfill amount, and determining/ensuring that the last dose extracted would have the same amount of the substance as the first dose -
Health
Labeling confusion led to wasted doses of Pfizer Covid-19 vaccine in first days of rollout
By Olivia Goldhill Dec. 16, 2020
With the Covid-19 vaccine in short supply, hospital pharmacists found themselves in the unexpected position of throwing away one in every six doses of the first Pfizer-BioNTech vaccines distributed this week in the United States. The confusion came over labeling: The vaccine comes in vials labeled as containing enough for five doses. But pharmacists discovered that, after thawing and mixing the contents with a diluent, each vial contained enough vaccine for six doses. Without explicit approval from the manufacturer, that final dose had to be discarded.
“It was overtly clear early on there’s some extra volume,” said Russell Findlay, pharmacy manager at University of Utah Health. His colleagues called Pfizer on Tuesday to ask if they could use the extra dose, said Findlay, but the company wouldn’t give a definitive answer. Pharmacists and executives at several health care systems said they didn’t feel they could risk using the extra dose, especially as Pfizer’s vaccine requires two doses, 21 days apart, to be effective. “We’re not fully confident of our future supply. Let’s say we use the six but we get fewer doses in the future, we might not have enough for the second dose,” said Findlay. “We need to be very cautious in managing that supply.”
Across the country in Boston, Paul Biddinger, medical director for emergency preparedness at Mass General Brigham, said he’d heard of the extra doses from the British vaccine rollout earlier this month. Despite being prepared, his team still had to throw out the additional doses on the first day of distribution. In Texas, the extra doses were discarded on the first day of distribution but, by Wednesday morning, Houston Methodist Hospital chief executive Roberta Schwartz said her team heard from Pfizer that it was okay to use what’s in the vial.
Finally, on Wednesday afternoon, the U.S. Food and Drug Administration updated its guidance, saying health care providers should feel free to use all the full doses within each vial. “At this time, given the public health emergency, FDA is advising that it is acceptable to use every full dose obtainable (the sixth, or possibly even a seventh) from each vial, pending resolution of the issue,” spokesperson Abigail Capobianco wrote in an email to STAT. But any spare half doses should not be combined with half doses from other vials to create a whole one, she added.
https://www.statnews.com/2020/12/16/labeling-confusion-led-to-wasted-doses-of-pfizer-covid-19-vaccine-in-first-days-of-rollout/What else is new is approval of how they will market the product (which is really the main difference between full approval and an EUA), including their brochures and whatever info is being put in them as well as any other labeling (on the vials, on the boxes that contain the vials, and on what is often a huge insert (folded up) that would accompany the product, with info on contraindications and other things, and since the vaccine gets diluted, any final instructions on prep).
= new reply since forum marked as read
