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Fri May 7, 2021, 11:41 AM

Pfizer and BioNTech apply for full U.S. approval for their Covid vaccine.

Source: New York Times

Pfizer and the German company BioNTech have become the first companies to apply to the U.S. Food and Drug Administration for full approval of their Covid-19 vaccine for use in people 16 and older. The vaccine is currently being administered to adults in America under an emergency use authorization granted in December. The approval process is likely to take months. The companies said in a statement on Friday that they had submitted their clinical data, which includes six months of information on the vaccine’s safety and efficacy, to the F.D.A. They plan to submit additional material, including information about the manufacturing of the vaccine, in the coming weeks.

“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,” Dr. Albert Bourla, Pfizer’s chief executive, said in the statement. “We look forward to working with the F.D.A. to complete this rolling submission and support their review, with the goal of securing full regulatory approval of the vaccine in the coming months.” As of Thursday, more than 134 million doses of the vaccine had been administered in the United States, according to the Centers for Disease Control and Prevention. Full approval would allow Pfizer and BioNTech to market the vaccine directly to customers.

It could also make it easier for companies, government agencies and schools to require vaccinations. The Equal Employment Opportunity Commission said in December that employers could mandate vaccination, and legal experts have generally agreed. Many companies have been hesitant to require the vaccines, especially while they have only emergency authorization, which is designed to be temporary. Some institutions, like the University of California and California State University systems, have said that they would do so only after a vaccine has full approval. Full approval could also prompt the U.S. military, which has had low uptake of Covid-19 vaccines, to mandate vaccinations for service members.

If the F.D.A. grants full approval, it could also help raise confidence in the vaccine. The pace of vaccination has slowed in the United States in recent weeks, and a recent national survey indicated that most people in the country who planned to get the shots had already done so. The agency is also expected to issue an emergency authorization for use of the Pfizer-BioNTech vaccine in 12- to 15-year-olds next week. The companies have said that they plan to file for emergency authorization for 2- to 11-year-olds in September. Moderna plans to apply for full approval for its Covid-19 vaccine this month, the company said during its quarterly earnings call on Thursday.

Read more: https://www.nytimes.com/2021/05/07/world/pfizer-vaccine.html

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Reply Pfizer and BioNTech apply for full U.S. approval for their Covid vaccine. (Original post)
BumRushDaShow May 7 OP
dalton99a May 7 #1
SayitAintSo May 8 #8
marie999 May 8 #9
Bleacher Creature May 7 #2
BumRushDaShow May 7 #3
speak easy May 8 #5
BumRushDaShow May 8 #6
AllyCat May 7 #4
Deminpenn May 8 #7

Response to BumRushDaShow (Original post)

Fri May 7, 2021, 11:53 AM

1. I guess there is enough data

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Response to dalton99a (Reply #1)

Sat May 8, 2021, 10:16 AM

8. Do we really want to GUESS that there's enough data?

Does it give no one pause that the FDA will be altering its own protocol to accelerate the approval process? Politics does make strange bedfellows. I wish more people would read the fine print... , and do their own research, as opposed to just easily drinking the Kool-Aid.

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Response to SayitAintSo (Reply #8)

Sat May 8, 2021, 10:34 AM

9. In what way is the FDA altering its own protocol?

I thought it was 6 months of data.

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Response to BumRushDaShow (Original post)

Fri May 7, 2021, 11:58 AM

2. Good - this should kill that stupid talking point that they are just "experimental."

I assume that most anti-vaxxers will just come up with another lame excuse for refusing to be vaccinated, but even if this moves just a small subset of them it could make a big difference.

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Response to Bleacher Creature (Reply #2)

Fri May 7, 2021, 12:51 PM

3. But interestingly enough, since I forgot that BioNTech was German

it explains why Germany has been against waiving the patent protections during the W.H.O/W.T.O negotiations -

Covid: Germany rejects US-backed proposal to waive vaccine patents

Published

20 hours ago

Germany has voiced opposition to a US-backed proposal to waive patents on Covid-19 vaccines, saying they were not hindering production of the jabs. Its government said "the protection of intellectual property is a source of innovation and must remain so".

(snip)

The idea was originally proposed by India and South Africa, who have been leading a group of about 60 countries at the World Trade Organization (WTO) - an intergovernmental body that promotes global commerce. The group is pushing for the temporary removal of intellectual property protections on vaccines.

(snip)

In a statement on Thursday, the German government said the US-backed proposal would have "significant implications for vaccine production as a whole". "The limiting factors in the production of vaccines are the production capacities and the high quality standards and not patents," it said, adding that pharmaceutical companies were already working with partners to ramp up manufacturing. Germany is the EU's biggest economic power and home to a major pharmaceutical sector, including BioNTech which developed one of the most widely-used coronavirus vaccines.

The remarks by the German government came after European Commission President Ursula von der Leyen said the bloc was "ready to discuss" the proposal on waiving patents. Ms von der Leyen has previously spoken about her opposition to lifting intellectual property rights, telling the New York Times just weeks ago that she was "not at all a friend of releasing patents".

https://www.bbc.com/news/world-europe-57013096


So there is other interesting "drama" going on at a different level.

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Response to BumRushDaShow (Reply #3)

Sat May 8, 2021, 06:53 AM

5. You can waive patents - Moderna has (in full)

but technology transfer is something else altogether.

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Response to speak easy (Reply #5)

Sat May 8, 2021, 07:15 AM

6. Oh I know

https://www.businessinsider.com/coronavirus-vaccine-waiver-moderna-ceo-says-didnt-lose-sleep-2021-5

And remember, Moderna is an entirely U.S. company (and vaccine). All the others (Pfizer partnering with German BioNtech, J & J through their Belgium subsidiary Janssen, as well as the UK-Swede AstraZeneca) have foreign involvement. Merck gave up their attempt and is partnering with J & J. So different countries have different interests.

When you look at articles about the negotiations between the U.S., the E.U., and other countries, Germany (as part of the EU) has been making a fuss!

I would expect that the UK might have too had the AstraZeneca vaccine not run into the same sorts of issues that the Janssen (J&J) vaccine has.

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Response to BumRushDaShow (Original post)

Fri May 7, 2021, 03:43 PM

4. Excellent! Let the vaccine mandates to work or go to school begin!!

I was all for making it voluntary for those who felt it wasn't fully approved. And they are right. We really sit in a precarious position requiring a treatment or procedure that is not fully approved. Once this is done, I fully expect my hospital, all the clinics, and the schools and military to make this SAFE VACCINE completely mandatory. I have to get a flu shot every year. I should have to get a covid shot and any approved boosters.

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Response to BumRushDaShow (Original post)

Sat May 8, 2021, 10:02 AM

7. Companies will require employees to be vaccinated

once this full approval happens. Schools won't be able to mandate it for K-5 students because it's not approved for those under 12 yet, but everyone else will have to get it. DoD will require it, too, for troops. I'm betting all federal, state and local civil servants and govt contractors will need to be vaccinated as well.

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