FDA panel recommends approval for emergency use

A key advisory board to the Food and Drug Administration voted 17-4 on Thursday, with one abstaining, to recommend the approval of Pfizer and BioNTech’s emergency coronavirus vaccine. This is the final step before the FDA issues the final OK for the wide distribution of the first doses across the state of the United States. One person abstained.

If the FDA accepts the non-binding recommendation of the Advisory Committee on Vaccines and Related Biological Products – which is expected – it would be a defining moment for the Covid-19 pandemic, which infects more than 15.4 million people and around 290,000 in the US Has killed people less than a year.

The committee plays a key role in approving influenza and other vaccines in the United States and verifying that the vaccines are safe for public use. While the FDA does not need to follow the advisory board’s recommendation, it often does.

The FDA could approve the emergency use of Pfizer’s vaccine on Friday, committee member James Hildreth told NBC’s Weekend Today on Saturday. An Emergency Authorization (EUA) generally allows a drug or vaccine to be administered to a limited population or environment, e.g. B. to hospital patients, as the authority continues to evaluate safety data.

It is unclear whether the FDA will approve Pfizer and BioNTech’s vaccine for use in certain groups. Some people, including pregnant women and young children, will likely have to wait to receive the vaccine in the United States until Pfizer can complete trials with these specific groups. The FDA said Tuesday that there is currently insufficient data to draw any conclusions about the safety of the vaccine in children under 16, pregnant women, and people with compromised immune systems. Regulatory agencies in Canada, the UK and Bahrain have approved the vaccine for most adults.

The committee recommended emergency approval of the vaccine for people aged 16 and over. Prior to the vote, some experts at the meeting argued to limit the recommendation to people who are at least 18 years old, saying the safety data for 16- and 17-year-olds is “thin”.

“I just want to join this group of people who are committed to this. I think the data is very thin and it is not enough to really say that given the low incidence of disease, we are safe,” said Dr. Mark Sawyer panel member and infectious disease expert at the University of California’s San Diego School of Medicine said at the meeting.

An EUA is not the same as a full authorization, which can typically take months. Pfizer has only submitted safety data for two months, but it typically takes the agency six months for full approval.

In a statement after the vote, Albert Bourla, Pfizer CEO, said the company was “happy” with the vote. “If the FDA approves, be ready to make this vaccine available to the people of the US to help fight it.” this devastating pandemic. “

US officials say they are ready to distribute the vaccine within 24 hours of approval. The initial doses will be limited as production increases. Officials predict it will be months before everyone in the US who wants to be vaccinated is vaccinated. Pfizer has announced that it will ship 50 million doses of vaccine this year, enough to vaccinate 25 million people. The vaccine is expected to be distributed in phases, with the most critical U.S. workers and those in need of protection receiving it first. The Centers for Disease Control and Prevention has provided states with an overview recommending that priority be given to health workers and nursing homes first. However, states may distribute the vaccine at their own discretion.

U.S. officials plan to continue to monitor for side effects of the Pfizer vaccine among the health care workers and nursing homes who receive it, said Dr. Nancy Messonnier, director of the CDC’s National Center for Immunization and Respiratory Diseases, during the agency’s meeting on Thursday. The officers will use an SMS system called v-safe, which is designed to provide early warning of possible side effects of the vaccines.

The UK, which approved Pfizer’s emergency vaccine last week, began mass vaccination on Tuesday. The vaccine there is given to healthcare workers, nursing home workers and those over 80 before it is widely used in the UK population.

Pfizer’s vaccine uses messenger RNA or mRNA technology. It’s a new approach to vaccines that uses genetic material to trigger an immune response. Data from late-stage clinical trials show the vaccine is 95% effective at preventing Covid, is safe, and appears to fight off serious illness. For maximum effectiveness, the vaccine requires two doses about three weeks apart.

The FDA has announced that it will approve a Covid-19 vaccine that is safe and at least 50% effective. In comparison, the flu vaccine generally reduces the risk of developing influenza by 40% to 60% compared to people who were not vaccinated, according to the CDC.

Two days before the meeting, the FDA posted documents on its website showing that the trial data submitted by Pfizer was consistent with the agency’s recommendations for the emergency. It was also confirmed that the vaccine was highly effective with no major safety concerns and that more safety data about the vaccine is needed in children, pregnant women and people with compromised immune systems.

During the meeting, FDA vaccine reviewer Dr. Susan Wollersheim found that the study data showed a “numerical imbalance” in Bell’s palsy, a condition that causes temporary weakness or paralysis of the muscles in the face. She said there were four cases in the vaccine group and none in the placebo group. While the incidence of the cases was no higher than that of the general population, the FDA recommended further surveillance if the vaccine is approved for wider use.

Pfizer’s vaccine requires a storage temperature of minus 94 degrees Fahrenheit, which poses potential logistical challenges for rural areas and inner cities that may not have good health infrastructure. For comparison: According to Moderna, the vaccine can be stored for up to six months at minus 4 degrees Fahrenheit.

President Donald Trump’s Czar of Coronavirus Vaccine Dr. Moncef Slaoui said the US should be able to distribute enough coronavirus vaccine doses by the end of February to immunize 100 million Americans, nearly a third of the US population. He said the entire US population could be vaccinated against Covid-19 by June.

Pfizer said last week that its US and European production lines are now complete and it is “confident” of delivering the targeted doses.

– CNBC’s Noah Higgins-Dunn and Will Feuer contributed to this report.

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