Pfizer Submits Data To FDA For Authorization of Covid Vaccine Booster Shot For General Population

[appalachiablue]

Source: MSN/CNBC

Pfizer and BioNTech said they have submitted early stage clinical trial data to the FDA as part of their U.S. application seeking authorization of a Covid-19 vaccine booster shot.

In a phase one trial, a booster dose generated "significantly higher neutralizing antibodies" against the original coronavirus strain as well as the beta and delta variants, the companies said. Federal health officials aren't recommending booster doses for the general public at this time.

Pfizer and BioNTech said Monday they have submitted early stage clinical trial data to the Food and Drug Administration as part of their U.S. application seeking authorization of a Covid vaccine booster for everyone 16 and older — not just people with weak immune systems.

In a phase one trial, a booster dose of the vaccine generated "significantly higher neutralizing antibodies" against the original coronavirus strain as well as the beta and delta variants, the companies said in a press release...

Read more: https://www.msn.com/en-us/health/medical/pfizer-submits-data-to-fda-for-authorization-of-covid-vaccine-booster-shot-for-general-population/ar-AANnGS1

[Tommymac]

1. Awesome news

I got my Pfizer in April...will feel much better psychologically if I get a booster in the Winter.

[LiberatedUSA]

2. Hell yes! N/t

[LeftInTX]

3. Called my pharmacy today about unrelated matter...

Got to listen to recording about booster shots.



They're currently available for those who are immunocompromised.



Definition:

Only a very small group of people with weakened immune systems qualify for the third dose. The CDC is recommending it for moderately to severely immunocompromised people, including those who have:

Been receiving active cancer treatment for tumors or cancers of the blood
Received an organ transplant and are taking medicine to suppress the immune system
Received a stem cell transplant within the last two years or are taking medicine to suppress the immune system
Moderate or severe primary immunodeficiency (such as DiGeorge syndrome, Wiskott-Aldrich syndrome)
Advanced or untreated HIV infection
Active treatment with high-dose corticosteroids or other drugs that may suppress your immune response

[SWBTATTReg]

5. Thanks for the heads up. I didn't think it would be so rapidly available for those weakened ...

systems already so this is a very good thing for these people.

I'm eager to see when the rest of us can get the booster shots too, the 3rd dose which I assume will further boost our immune system against COVID 19 and the latest COVID variations running out there...for those still resisting any vaccination, that's their issue and not mine. Just don't get everyone else around them sick too (my primary concern, that these holdouts will continue to make others sick around them)...

--snip--
The booster dose elicited a significantly higher antibody response against the initial strain of coronavirus and the Delta and Beta variants, compared to what was seen among people who got two doses. The booster dose seemed to be equally protective against the Delta and Beta variants as against the original coronavirus.

"Given the high levels of immune responses observed, a booster dose given within 6 to 12 months after the primary vaccination schedule may help maintain a high level of protection against COVID-19," the company said in a statement.

"This initial data indicate that we may preserve and even exceed the high levels of protection against the wild-type virus and relevant variants using a third dose of our vaccine," added Dr. Ugur Sahin, CEO and co-founder of BioNTech.
--snip--

[winstars]

6. Its my understanding that the "booster shots" available now at CVS etc. are just 3rd shots

of what we received in the spring. I think.

The booster shots in the OP story have I think have been "tweaked" to do more on the new variants. And are not yet available to anyone other than those in the trials.

I think.

[SWBTATTReg]

8. Thank you. I think you mght be right...I'm seeing...

--snip--
Last week, the FDA and Centers for Disease Control and Prevention authorized and recommended a third dose of vaccine for some immunocompromised people who likely had little or no response to the first two shots.
--snip--

ME==> But I am thinking that efforts are underway to develop another shot (I am not 100% sure yet, it's confusing (in my mind perhaps)...

--snip--
Pfizer and BioNTech said they expect results from the trial to evaluate a booster dose "shortly" and the companies plan to submit the data to the FDA and other regulatory authorities. The companies plan to submit this early data to the European Medicines Agency and other regulatory authorities in the coming weeks.
Pfizer and BioNTech said after FDA grants approval for their vaccine in the US, they would then seek approval of a booster dose through a supplement to their license application. The companies said they would seek approval for this booster dose for people 16 or older. Currently the Pfizer Covid-19 vaccine is authorized for people 12 and older.
--snip--

[winstars]

9. The word booster is being used haphazardly by media. 3rd shot is a 3rd shot. The real booster is

still being tested. I think.

[SWBTATTReg]

10. That's my take on this too, still being tested...thanks again!

[SWBTATTReg]

11. I just saw this posted by a fellow DUer ... FYI

U.S. to Advise Boosters for Most Americans 8 Months After Vaccination
Source: New York Times

WASHINGTON — The Biden administration has decided that most Americans should get a coronavirus booster shot eight months after they completed their initial vaccination, and could begin offering the extra shots as early as mid-September, according to two administration officials familiar with the discussions. Officials are planning to announce the administration’s decision as early as this week.

Their goal is to let Americans know now that they will need additional protection against the Delta variant that is causing surging caseloads across the nation. The first boosters are likely to go to nursing home residents and health care workers, followed by other older people who were near the front of the line when vaccinations began late last year. Officials envision giving people the same vaccine they originally received.

Among other worrisome signals, Biden administration officials are particularly concerned about data from Israel suggesting that the Pfizer-BioNTech’s protection against severe disease has fallen significantly for elderly people who were vaccinated in January or February. Some administration officials have viewed Israel as a kind of template for the United States because it started vaccinating its population sooner. Israel has almost exclusively used the Pfizer-BioNTech vaccine, and it has a nationalized health care system that allows it to systematically track patients.

The latest data from Israel, posted on the government’s website on Monday, shows what some experts describe as continued erosion of the efficacy of the Pfizer vaccine over time — both against mild or asymptomatic Covid-19 infections in general and against severe disease among the elderly.

Read more: https://www.nytimes.com/2021/08/16/us/vaccination-booster-shots.html

[winstars]

12. Yes, this is a 3rd shot of "regular vaccine" being used as a "booster"...

Its not the "tweaked" booster thats talked about from the OP...


Pretty confusing to me...

[bahboo]

4. bring it on....

[Deminpenn]

7. Reported on local news today that the

standard Moderna vaccine dose is higher than the standard Pfizer dose. This might explain why the clinical trial participants Moderna is tracking seem to have a longer period of high anti-body levels countering the need for a booster shot at this time. It might also explain why those vaccinated with the Moderna shot seemed to have more intense reactions than those who got the Pfizer.

Regardless, be happy to get a booster whenever it's authorized for my cohort.