US FDA advisors recommend authorisation of Pfizer Covid vaccine

WION Web Team
Washington, DC, United States of America Published: Dec 11, 2020, 07:23 AM(IST)

Pfizer-BioNTech Covid vaccine Photograph:( Reuters )

Story highlights

Pfizer and BioNTech last month said a two-dose regimen of the vaccine was 95% effective in preventing illness from COVID-19.

A panel of outside advisors to the US Food and Drug Administration (FDA) has voted to endorse the emergency use of Pfizer Inc's coronavirus vaccine. Among other things, the overwhelming vote has paved the way for the agency to authorise the shot for the nation.

The United States has so far lost more than 285,000 lives to COVID-19.

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 FDA 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.

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

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.

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.

(with inputs)

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