The FDA can approve Pfizer’s this week


Dr. Joseph Varon (left) and other medical workers speak to a patient in the COVID-19 Intensive Care Unit (ICU) at the United Memorial Medical Center in Houston, Texas on December 6, 2020.

Go Nakamura | Getty Images

The Food and Drug Administration could approve a coronavirus vaccine as early as this week. The move would be a pivotal moment in the pandemic as health officials say the US is likely to face the worst public health crisis in history this winter.

The FDA is expected to hold a meeting of its Advisory Committee on Vaccines and Related Biological Products, known as VRBPAC, on Thursday to discuss Pfizer’s Covid-19 vaccine with German drug maker BioNTech. Two days before the meeting, the FDA is expected to release a roughly 100-page document evaluating the companies’ clinical trial data, said Dr. Paul Offit, a voting member of the Advisory Board, provided an insight into the agency’s view of the vaccine.

“The public will see everything we see,” said Offit, who is also director of the Vaccination Education Center at the Philadelphia Children’s Hospital.

If Thursday’s meeting goes well and the advisory panel officially votes to approve the vaccine, the FDA could announce its approval “within a few days,” Alex Azar, secretary of health and human services, told ABC News on Sunday This Week “. “But it will follow the FDA’s gold standard process and I will make sure it does,” he added.

The vaccine couldn’t come at a more crucial time. Hospitals in the U.S. already have higher numbers of Covid patients than ever before, and the country’s outbreak is poised to break even worse records this week. Dr. Deborah Birx, the White House’s coronavirus response coordinator, warned on Sunday that the escalating surge in coronavirus is likely to be the most difficult event in U.S. history.

“This is not just the worst public health event. This is the worst event this country will face not just on the public health side,” she told NBC’s Meet the Press, reiterating the director’s comments of the Centers for Disease Control and Prevention Dr. Robert Redfield on Wednesday.

“This fall / winter tide combines everything we saw in spring with everything we saw in summer – plus the fall tide that turns into winter tide. I think that is why Dr. Redfield addressed the American people so absolutely . ” She added.

The approval would also mark a record-breaking timeframe for a process that typically lasts around a decade. The fastest vaccine development of all time, mumps, lasted more than four years and was approved in 1967. Last week, the UK approved Pfizer’s emergency vaccine, becoming the first country to do so.

Pfizer submitted its Covid-19 vaccine data to the FDA on November 20. A final analysis of its Phase 3 clinical trial of more than 43,000 participants found the vaccine to be 95% effective against Covid, safe, and appeared to fight off serious illness.

The FDA’s review of the vaccine should take a few weeks as the agency reviews all aspects of the data submitted in the application, including reviewing all safety information “to make sure there are no cracks” and everything is “solid”.

“If you’re talking about a study involving 44,000 people, that’s a lot of clinical data,” Offit said in a recent interview with CNBC.

US officials say they will distribute the vaccine within 24 hours of approval. Starting doses of the vaccine will be limited as production increases. Leading U.S. health officials predict it will take months to vaccinate anyone who wants to be vaccinated against Covid in the U.S. The federal government has made agreements with several drug manufacturers to buy some of their first doses.

Drug manufacturers and states are preparing to sell the vaccine from around a week on. The Federal Aviation Administration said it supported the “first mass air delivery” of vaccines late last month. United Airlines transported Pfizer’s Covid-19 vaccine from Brussels to Chicago O’Hare International Airport, people familiar with the matter told CNBC.

The vaccine will likely be distributed in phases. A CDC panel voted 13: 1 on Tuesday for healthcare workers and residents of long-term care facilities in the United States to receive the first coronavirus vaccine doses once they are cleared for public use. There are approximately 21 million healthcare workers and 3 million long-term care residents in the United States, according to the CDC.

U.S. officials say they should be able to hand out enough coronavirus vaccine doses to immunize 100 million people, roughly a third of the U.S. population, by the end of February.

Former Presidents Barack Obama, George W. Bush and Bill Clinton said last week that they may be taking a coronavirus vaccine publicly, as polls suggest that many Americans are skeptical about getting vaccinated. According to a recent Gallup poll, black people in particular who are disproportionately affected by the virus appear to be less willing to take it.

When asked about the skepticism about Covid-19 vaccines on Monday, President Donald Trump’s coronavirus vaccine tsar Dr. Moncef Slaoui told CNBC that he was “very concerned” about it.

“In recent months, politicization, the context in which vaccine development took place, has exacerbated these sentiments,” said Slaoui, who heads the Trump administration’s Operation Warp Speed ​​vaccination program, in a “Squawk Box” interview. We plan to be 100% transparent and have as many independent experts as possible examine all data. “

He urged Americans to “keep your thoughts open”.

“Listen to the experts you trust. When you’ve heard the data in full, make up your mind,” he said.

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