FDA panel considers Pfizer’s COVID-19 vaccine for emergency use in US


Pfizer’s coronavirus vaccine has already been approved for emergency use in the UK and Canada.

Sarah Tew/CNET

A US Food and Drug Administration advisory panel is meeting Thursday to decide whether to recommend emergency use authorization for Pfizer’s COVID-19 vaccine in the states. Pharmaceutical giant Pfizer, which developed the vaccine with German partner BioNTech, said last month that the vaccine demonstrated 95% effectiveness in clinical trials. 

The companies applied for emergency use authorization from the FDA in late November. A review published by the FDA on Tuesday confirmed that the vaccine meets the standard for emergency use authorization.

The FDA’s daylong meeting kicked off on Thursday morning. An independent panel of experts, known as the Vaccines and Related Biological Products Advisory Committee, has been discussing the Pfizer vaccine in detail. If the advisory panel votes to recommend emergency use authorization, and if FDA then chooses to accept the committee’s recommendation, the vaccine could be rolled out in the US within days. 

Pfizer and BioNTech have conducted human trials on more than 43,000 people in six countries. They initially reported more than 90% effectiveness for the vaccine, before a final data analysis found that it was 95% effective in preventing COVID-19, with no serious side effects.

The Pfizer vaccine — as well as another from US drug developer Moderna, which is said to be 94% effective — is an experimental RNA vaccine. It uses synthetic messenger RNA, or mRNA, a molecule that tells cells how to build proteins. It can then trick cells into producing proteins typically found in SARS-CoV-2, the virus that causes COVID-19, which in turn can then stimulate the immune system — without making patients sick — to protect against infection. Moderna has also applied for FDA emergency approval for its coronavirus vaccine.

Given that there are more than 330 million people in the US, not everyone will be able to get the vaccine right away. Health care workers will be prioritized, as well as people at higher risk of infection due to age, underlying conditions or profession. 

On Tuesday, the UK became the first country to start administering the Pfizer COVID-19 vaccine, following clinical approval. The first person to receive the vaccine outside of a clinical trial was 90-year-old Margaret Keenan, who was given the first of two injections needed. Four million people in the UK are expected to begin the process by the end of December. Canada approved Pfizer’s vaccine on Wednesday. 

There are several dozen coronavirus vaccines in various stages of clinical trials, with some almost ready to be submitted for potential authorization. Most experts say we’ll have many more ready to distribute by early 2021

In a panel earlier this week, Dr. Anthony Fauci, director of the US National Institute of Allergy and Infectious Diseases, said the sooner the United States can convince the overwhelming majority of people to get vaccinated, the sooner things will be “close to normal.”

The first cases of COVID-19 were reported in China a year ago this month. By March, a pandemic was in full force. According to the Johns Hopkins coronavirus dashboard, more than 69 million cases have been confirmed worldwide and nearly 1.6 million people have died of COVID-19 as of Thursday.

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