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Pfizer/BioNTech seek full FDA approval for their Covid-19 vaccine

Pfizer/BioNTech has initiated its application to the US Food and Drug Administration for full FDA approval of its Covid-19 vaccine for people ages 16 and older, the companies said Friday. This is the first Covid-19 vaccine in the United States to be assessed for full approval from the FDA.

Pfizer’s mRNA two-shot vaccine is currently being used in the US under emergency use authorization (EUA) from the FDA. The companies say 170 million doses of the vaccine have been distributed across the US to date.

“We are proud of the tremendous progress we’ve made since December in delivering vaccines to millions of Americans, in collaboration with the U.S. Government,” Albert Bourla, chairman and chief executive officer of Pfizer, said in a statement. “We look forward to working with the FDA to complete this rolling submission and support their review, with the goal of securing full regulatory approval of the vaccine in the coming months.”

To apply for full FDA approval Pfizer/BioNTech submitted a Biologics License Application, known as a BLA. The FDA requires vaccine manufacturers submit data on manufacturing processes, facilities and additional information that demonstrates that the vaccine can be produced reliably and consistently. They are also required to submit all pre-clinical and clinical trial data.

Pfizer/BioNTech will submit that information to the FDA over the next few weeks on a rolling basis. Once all the required information is submitted, a goal date will be set for a decision by the FDA. Pfizer/BioNTech has requested priority review, which asks the FDA to take action within 6 months, compared to the 10 months designated under standard review.

The application to the FDA is only intended for adults 16 and older. Pfizer/BioNTech is simultaneously applying to expand its EUA to include children ages 12 to 15. The companies then plan to submit an additional BLA to cover this younger age group once the essential data has been collected six months after administering second doses.

EUA vs. approval

The vaccine, named BNT162b2, was the first Covid-19 vaccine to be awarded FDA emergency use authorization in December.

Emergency use authorization is what its name suggests — a medical product, such as a vaccine, that gets special FDA authorization to be used during an emergency. For an EUA to be issued for a vaccine, the FDA says there must be adequate manufacturing information to ensure quality and consistency, and the known and potential benefits of the vaccine must outweigh its known and potential risks.

Due to the seriousness of the pandemic, vaccine makers originally applied for EUAs because the authorization process takes less time than what would be required for full approval. As a condition of the EUA, the companies were expected to work toward full approval from the FDA.

Progressing from authorization to approval could have an impact on vaccine mandates, as some organizations and schools have said they intend to require vaccination against Covid-19, but only once a vaccine is approved by the FDA. It could also have an impact on vaccine hesitancy; a Kaiser Family Foundation survey released this week says about 15% of American adults say they’ll “wait and see” to get a Covid-19 vaccine, and some cite the lack of full approval as a reason to delay.

Clinical trials and recently published real-word data show the vaccine is up to 95% effective at preventing infection, severe illness and hospitalization. Pfizer/BioNTech reported last month that trial results show the vaccine remains more than 91% effective against disease with any symptoms for six months.

Recent research suggests the vaccine is effective against some worrying virus variants, and Pfizer/BioNtech is currently testing booster and variant-specific vaccines.

CNN

Comments

13 Comments

  1. It will be nice to have them be “FDA Approved”. It had significant testing before the EAU but I agree it’s a more assuring status to know that it has been thoroughly tested and proven safe. I’m hoping this will buoy the confidence level because a lot of people have worked very hard to get this tool available so that we can squash this bug and get back to normal ASAP!

      1. Not sure why the link didn’t fully create a hyperlink, but anyway, the info mentions the following:
        “Due to the urgent need for a vaccine in a surging pandemic, Pfizer and Moderna were given approval to simultaneously test their vaccines on animals while they were conducting Phase 1 trials on humans. The vaccines were tested on mice and macaques.”
        So, although the testing was done in parallel rather than sequentially, it doesn’t mean it wasn’t tested on animals. I know there is a lot of misinformation out there, but please try to get info from reputable sources rather than folksy social media memes. These vaccines are a great logistical and medical achievement that we should be proud of, not scared of.

  2. Despite a significant minority of idiots in this country that won’t get vaccinated, this mRNA technology is an historic breakthrough finally being recognized and put to use outside of cancer treatment. Much thanks is due to the cancer patients going back a couple of decades that were brave enough to let it work.

    1. And it’s been under study for years.

      It’s almost humorous how people are prescribed certain RX with multiple side effects …

      But for the C19 vaccine….”oh no I can’t / won’t”.
      A good example ~ cholesterol medications (statins).

  3. VIOOX was FDA approved. A high percentage of those who used it died.
    Avastin was FDA approved for many cancers. It turned out not to do a thing for the patients except make Genentech a lot of money.

    If you think you know the FDA and big pharma why don’t you read some of Dr. Donald Lights papers on “Institutional Corruption” at the FDA. Maybe then you will understand why even some medical doctors are hesitant to use something that has not been out for very long. These papers are from Harvard.

    https://ethics.harvard.edu/person/donald-light

    Then consider that if these drug companies are all about helping people, why are they fighting Biden on patent protection elimination for the Covid-19 vaccines?

    I thought people didn’t trust big corporations, but now people want me to trust the largest ones with my very life especially when I know how corrupt they are from working with them.

    1. I agree that the medical industry can be a love/hate thing. Some great examples of medical miracles, and some examples of dumpster fires. But to compare this to Vioxx isn’t really apples to apples (although point taken). Vioxx is a pain killer/anti-inflammatory for treating arthritis, a different type of drug altogether, and taken daily, and in large doses. If what you’re saying is, “my gut feeling is that the vaccine hasn’t been tested enough”, then ok fine. But that is a feeling, an emotion. And it’s fine that you feel that, but there is also significant evidence to suggest that it has undergone significant testing and is safe and effective.
      The vaccine is a completely different category of medicine than Vioxx, for a completely different purpose, and taken in completely different ways and in completely different doses. I get the sentiment that caution is practical, and we should want to make sure things are vetted before we take them. Valid point. But there is a lot of info on reputable medical sites about the extensive testing that took place, and continues to take place on the vaccines, with miniscule negative findings. Given the scale of how many doses are needed, and how quickly, it’s not like some mom-and-pop medical shop was going to be able to crank out hundreds of millions of doses, so no other portion of the industry had the resources to produce it.

  4. BTW I am not an anti-vax person. I am just against using drugs that have not been around for a number of years. A lot of doctors also share that position. Scientifically speaking, It takes years to really determine the long-term effects of any drug on the human body. If you want to take the vaccine then go for it. As for me, because of past experience, I will wait. I already had Covid and it was minor for me. So I already have the antibodies to fight off Covid. I believe that people should have the right to decide what they do with their bodies, as in “My body, my choice.”

    1. So maybe 5% of Doctors won’t get the vaccine, but almost 17% smoke!

      “Out of nearly 3,000 physician respondents, 95% said that they had either already received or planned to receive their COVID-19 vaccine.Feb 9, 2021”

      “CPS II data show that 16.7 percent of doctors currently smoke cigarettes, as do 14.1 percent of dentists, and 23.4 percent of nurses. Twice as many doctors and den tists have quit smoking as are currently smoking. Among nurses, 25.5 percent have quit smoking; more than 50 percent of the nurses never smoked.”

    2. Just to distinguish between things, a vaccine isn’t really a “drug” is it? It’s a vaccine. Maybe splitting hairs, but a “drug” to me is something that is administered for continuous (daily type) of doses over a longer time period to treat chronic diseases (blood pressure, diabetes, heart disease, cancer).
      A vaccine is different in that it is a biological method administered to create proactive immunity within our immune system. Usually taken one time. Or in cases of viruses that mutate, taken once a year.
      Given that “drugs” are taken repeatedly (usually daily) over longer periods, the potential for longer-term effects on the body would seem “more likely” with drugs vs. vaccines. Nothing is 100% safe, but it seems like there are some inherent risks that come along with “drugs” that don’t have the same comparison to “vaccines”.
      But again, I get your sentiment that you’d feel more comfortable if this specific covid vaccine was around for several years. I hear ya. But don’t let an inequal comparison turn you too paranoid. This isn’t the last time the human race will encounter a new virus that requires quick action, and we won’t have the luxury of waiting several years to stop viruses especially when one eventually comes along that kills 5%, 10%, 50% of everyone who gets it.

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