• Login
  • Register
The Daily Sceptic
No Result
View All Result
  • Articles
  • About
  • Archive
    • ARCHIVE
    • NEWS ROUND-UPS
  • Podcasts
  • Newsletter
  • Premium
  • Donate
  • Log In
The Daily Sceptic
No Result
View All Result

U.S. Medicines Regulator Will Decide Whether to Fully Approve the Pfizer Covid Vaccine by January 2022

by Michael Curzon
16 July 2021 6:16 PM

The Food and Drug Administration (FDA) will decide on whether to fully approve the use of the Pfizer Covid vaccine in the U.S. for those aged 16 and over no later than January 2022, it has been announced. The vaccine is currently only authorised for emergency use in Americans aged 12 and over and has been given to millions of people across the world. The MailOnline has the story.

According to a press release from the [Pfizer and BioNTech] on Friday, the federal health agency’s goal date for a decision is by January 2022.

If approved, the vaccine will be the first fully approved Covid shot and could help ease vaccine hesitancy among some Americans due to the longer-term data required for full FDA approval. 

As of Friday, more than 186.5 million shots of the vaccine have been administered in the U.S., according to data from the Centers for Disease Control and Prevention (CDC). 

Because Pfizer’s vaccine is currently approved for use on an emergency basis, it is still considered somewhat experimental despite data showing it is safe and effective.

Additionally, emergency use authorisation requires less clinical trial data, with the FDA only requiring two months of follow-up before approving the shot for those 16 and older in December 2020.

The designation is also intended to be temporary.

If and when the shot is fully approved, companies and schools may feel more comfortable requiring employees and students to get it. 

The decision would also allow the vaccine makers to market their shots directly to the general public.

According to the press release, Pfizer and BioNTech completed the rolling submission of data to the FDA in May 2021.

It includes data from the Phase III trial completed last year and six months of follow-up data rather than two months.

Although the shot is currently approved for use in teenagers and adults, the full approval would only be for those aged 16 and older because emergency authorization for Americans aged 12 to 15 only occurred in May.

The companies plan to apply for full approval in teens as well, but only after six months of follow-up data is available, the press release states. …

Moderna Inc has also filed for full approval from FDA for its Covid vaccine, announcing the news on June 1st. …

The decision to fully approve Moderna’s vaccine will likely come after the Pfizer decision due to Moderna submitting its application later.   

Worth reading in full.

Tags: FDAPfizerVaccine

Donate

We depend on your donations to keep this site going. Please give what you can.

Donate Today

Comment on this Article

You’ll need to set up an account to comment if you don’t already have one. We ask for a minimum donation of £5 if you'd like to make a comment or post in our Forums.

Sign Up
Previous Post

Government Not Planning to Change Sensitivity of NHS Covid App

Next Post

What SAGE Gets Wrong: The Evidence that Almost Everyone is Exposed During a Surge and Most Are Immune

Subscribe
Login
Notify of
Please log in to comment

To join in with the discussion please make a donation to The Daily Sceptic.

Profanity and abuse will be removed and may lead to a permanent ban.

66 Comments
Oldest
Newest Most Voted
Inline Feedbacks
View all comments

NEWSLETTER

View today’s newsletter

To receive our latest news in the form of a daily email, enter your details here:

DONATE

PODCAST

The Sceptic | Episode 43: William Yarwood on Labour’s Welfare Farce, Niall Gooch on Catholicism vs Lib Dems & Tilak Doshi on Trump’s Climate Science Fightback

by Richard Eldred
4 July 2025
0

LISTED ARTICLES

  • Most Read
  • Most Commented
  • Editor’s Picks

Germany is Not Being Honest About Who is Assaulting Children at Swimming Pools

5 July 2025
by Eugyppius

The Renewable Industry’s Dirty Little Secret Has Just Been Exposed

5 July 2025
by Will Jones

News Round-Up

5 July 2025
by Toby Young

Pet Hates: Are Muslims in Britain Really Trying to Ban Dogs?

5 July 2025
by Steven Tucker

Defunding Gavi is Good for Public Health

5 July 2025
by Dr David Bell

Germany is Not Being Honest About Who is Assaulting Children at Swimming Pools

20

The Renewable Industry’s Dirty Little Secret Has Just Been Exposed

15

Pet Hates: Are Muslims in Britain Really Trying to Ban Dogs?

13

Defunding Gavi is Good for Public Health

12

News Round-Up

10

Germany is Not Being Honest About Who is Assaulting Children at Swimming Pools

5 July 2025
by Eugyppius

Defunding Gavi is Good for Public Health

5 July 2025
by Dr David Bell

Pet Hates: Are Muslims in Britain Really Trying to Ban Dogs?

5 July 2025
by Steven Tucker

Aberdeen’s Ditching of ESG Proves the Green Finance Revolution is Dead

4 July 2025
by Tilak Doshi

The UK’s Crisis Point is Fast Approaching

3 July 2025
by Dr David McGrogan

POSTS BY DATE

July 2021
M T W T F S S
 1234
567891011
12131415161718
19202122232425
262728293031  
« Jun   Aug »

SOCIAL LINKS

Free Speech Union

NEWSLETTER

View today’s newsletter

To receive our latest news in the form of a daily email, enter your details here:

POSTS BY DATE

July 2021
M T W T F S S
 1234
567891011
12131415161718
19202122232425
262728293031  
« Jun   Aug »

DONATE

LISTED ARTICLES

  • Most Read
  • Most Commented
  • Editor’s Picks

Germany is Not Being Honest About Who is Assaulting Children at Swimming Pools

5 July 2025
by Eugyppius

The Renewable Industry’s Dirty Little Secret Has Just Been Exposed

5 July 2025
by Will Jones

News Round-Up

5 July 2025
by Toby Young

Pet Hates: Are Muslims in Britain Really Trying to Ban Dogs?

5 July 2025
by Steven Tucker

Defunding Gavi is Good for Public Health

5 July 2025
by Dr David Bell

Germany is Not Being Honest About Who is Assaulting Children at Swimming Pools

20

The Renewable Industry’s Dirty Little Secret Has Just Been Exposed

15

Pet Hates: Are Muslims in Britain Really Trying to Ban Dogs?

13

Defunding Gavi is Good for Public Health

12

News Round-Up

10

Germany is Not Being Honest About Who is Assaulting Children at Swimming Pools

5 July 2025
by Eugyppius

Defunding Gavi is Good for Public Health

5 July 2025
by Dr David Bell

Pet Hates: Are Muslims in Britain Really Trying to Ban Dogs?

5 July 2025
by Steven Tucker

Aberdeen’s Ditching of ESG Proves the Green Finance Revolution is Dead

4 July 2025
by Tilak Doshi

The UK’s Crisis Point is Fast Approaching

3 July 2025
by Dr David McGrogan

SOCIAL LINKS

Free Speech Union
  • Home
  • About us
  • Donate
  • Privacy Policy

Facebook

  • X

Instagram

RSS

Subscribe to our newsletter

© Skeptics Ltd.

Welcome Back!

Login to your account below

Forgotten Password? Sign Up

Create New Account!

Fill the forms below to register

All fields are required. Log In

Retrieve your password

Please enter your username or email address to reset your password.

Log In
No Result
View All Result
  • Articles
  • About
  • Archive
    • ARCHIVE
    • NEWS ROUND-UPS
  • Podcasts
  • Newsletter
  • Premium
  • Donate
  • Log In

© Skeptics Ltd.

wpDiscuz
You are going to send email to

Move Comment