U.S. FDA advisers vote 17-4 in favor of authorizing Pfizer's COVID-19 vaccine

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U.S. FDA advisers vote 17-4 in favor of authorizing Pfizer's COVID-19 vaccine

By Manas Mishra and Julie Steenhuysen

 

FILE PHOTO: A vial of the Pfizer/BioNTech COVID-19 vaccine is seen ahead of being administered at the Royal Victoria Hospital in Belfast, Northern Ireland December 8, 2020. Liam McBurney/Pool via REUTERS

 

(Reuters) - A panel of outside advisers to the U.S. Food and Drug Administration on Thursday voted overwhelmingly to endorse emergency use of Pfizer Inc's coronavirus vaccine, paving the way for the agency to authorize the shot for a nation that has lost more than 285,000 lives to COVID-19.

 

The FDA is widely expected to authorize the vaccine, developed with German partner BioNTech SE, for emergency use in the United States within days.

 

The committee voted 17-4 that the known benefits of the vaccine outweighed the risks of taking the shot for individuals 16 and older, with 1 member of the panel abstaining.

 

Pfizer has asked that the two-dose vaccine be approved for use in people aged 16 to 85. Several advisory panel members discussed whether 16 and 17 year olds should be included in the recommendation because the risk to these individuals is low, and the evidence in the trial was scant.

 

In the end, they voted on the question as put them by the FDA, which included 16 to 17 year olds. The FDA typically follows the advice of its expert panels, but is not bound to do so.

 

The panel also discussed concerns raised by two reports of serious allergic reactions among vaccine recipients in Britain and spent a large portion of the discussion on Pfizer's plan to give volunteers who received a placebo in its trial the option to get the vaccine when they become eligible for it under recommendations set by state and local health officials.

 

Documents prepared by the FDA ahead of the meeting did not point out any new safety or efficacy issues, raising optimism that the United States would soon follow the UK and Canada authorizing the vaccine.

 

Britain's health regulator on Wednesday advised some people with a history of anaphylaxis, an overreaction of the body's immune system related to medicine or food, to avoid the getting the vaccine.

 

FDA Commissioner Steven Hahn, ahead of Thursday's meeting, said the agency was carefully reviewing all the data on Pfizer's vaccine, including potential allergic reactions following the UK warning.

 

He said the vaccine's label would include details about who the vaccine was recommended for - and who should not get it - if it is ultimately approved.

 

Pfizer and BioNTech last month said a two-dose regimen of the vaccine was 95% effective in preventing illness from COVID-19, and detailed data released in the agency's documents showed the vaccine began showing some protection even before volunteers received a second dose.

 

The documents also disclosed data on safety including cases of Bell's palsy among volunteers in the placebo and vaccine groups, though it said the cases in the trial occurred at the same rate as in the general population. Other reactions included fever, fatigue and chills.

 

(Reporting by Manas Mishra in Bengaluru and Julie Steenhuysen in Chicago, Additional reporting by Michael Erman in Maplewood, NJ; Editing by Caroline Humer and Bill Berkrot)

 

-- © Copyright Reuters 2020-12-11

 

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[pegman]

Would be curious to know the reason 4 voted against.

[thaitero]

34 minutes ago, pegman said:

Would be curious to know the reason 4 voted against.

Yes but to have this info would have meant some journalistic work so why bother when you can make your money easier,,,

[Scott]

1 hour ago, pegman said:

Would be curious to know the reason 4 voted against.

It was covered on the national television news, but not in a great depth.  A big issue was the age range.  Some didn't feel that allowing people who are 16 and 17 had not been studied enough to approve it for people 16 and older.  

 

I believe there was also concern because of the two cases in the UK who had allergic reactions.  

 

[Tug]

I’m ready for the (jab)I trust the scientific community they say it’s good I’m all in until then and after I and my family will follow all safety protocols it’s certainly a bright spot perhaps it’s the beginning of the end of the pandemic hope so!want to start traveling again!

[ukrules]

The very same vaccine Fauci was 'having a go' at the UK for approving only last week ????

[Antonymous]

5 hours ago, Tug said:

I’m ready for the (jab)I trust the scientific community they say it’s good I’m all in until then and after I and my family will follow all safety protocols it’s certainly a bright spot perhaps it’s the beginning of the end of the pandemic hope so!want to start traveling again!

 

This rather begs the question: which scientific community do you trust? The one paid by the pharmaceutical companies who say the vaccine is good, or the ones independent of vested interests who say it is not and who at best advise caution?

[Emdog]

7 hours ago, pegman said:

Would be curious to know the reason 4 voted against.

There was the age issue, concerns over any ill effects on pregnant women (any of you recall Thalidomide birth defects?), wanting more data on people with allergies. Perhaps there were others

[vandeventer]

5 hours ago, Tug said:

I’m ready for the (jab)I trust the scientific community they say it’s good I’m all in until then and after I and my family will follow all safety protocols it’s certainly a bright spot perhaps it’s the beginning of the end of the pandemic hope so!want to start traveling again!

It's a shame ,we have to wait until May, and we have no choice where is comes from, but this might change as the vaccine become more available.