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After US Hits 250K COVID-19 Deaths Milestone, Pfizer Vaccine Ready for FDA Review within Days

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After US Hits 250K COVID-19 Deaths Milestone, Pfizer Vaccine Ready for FDA Review within Days

2020-11-19 13:52:55

By Laura Tucker, Staff writer; Image: Health care professional giving a vaccine (Image source: Public domain)

Despite hitting the jaw-dropping milestone of 250,000 deaths caused by the coronavirus, there is some good news. Pfizer has said it will be seeking emergency authorization from the Food and Drug Administration within days.

While last week Pfizer was reporting a 90-percent efficacy for its COVID-19 vaccine, developed along with biotechnology company BioNTech, now it's reporting a 95-percent efficacy, the same as the Moderna vaccine that was announced earlier this week. Additionally, the new data shows a 94 percent efficacy among people over 65 and that it prevented both severe and mild cases.

Time is of the essence with this virus. Along with the 250,000 deaths milestone, on Wednesday alone, more than 1,800 people died, and there were more than 166,000 new cases and more than 79,000 people hospitalized across the country.

At this point, Pfizer's data on its vaccine has not been published or peer-reviewed. However, the pharmaceutical company will be asking the Food and Drug Administration and an independent advisory committee to review it within days.

The advisory committee is expected to meet publicly to discuss the Pfizer vaccine during the second week of December, according to people with knowledge. With the Moderna vaccine being about a week behind Pfizer's, it's expected the committee would be examining it the following week.

In a briefing with reporters, Health and Human Services Secretary Alex Azar said both vaccines could be authorized by the FDA and be ready for distribution "within weeks."

"It looks great. It looks like a home run," said Peter Hotez, dean of the National School of Tropical Medicine at Baylor College of Medicine in Houston, of the Pfizer vaccine data. Between the two vaccines, he believes they suggest that "there is an end date" in sight for the global health crisis.

To show why the experts are so excited, of the 170 COVID-19 cases in the Pfizer trial, 162 were in the placebo group. Among the 10 severe cases in the trial, nine of them were in the placebo group.

"We continue to move at the speed of science to compile all the data collected thus far and share with regulators around the world," said Pfizer chief executive Albert Bourla in a statement.

Officials with the U.S. government anticipate 40 million doses of both vaccines by the end of the year. With two doses required to reach that efficacy, it means they are expecting enough to vaccinate 20 million people. Pfizer's goal is to create 50 million doses globally, of which the United States would receive about half.

Even before it receives applications from Pfizer and Moderna, the FDA asked its advisory panel to keep December 8, 9, and 10 open for possible meetings with Pfizer. It may take a look at the data for Moderna the following week.

Experts explained that in typical circumstances, the FDA examines vaccine data for a year or more before consulting with its advisory committee. "If someone says, 'We are not rushing,' that is not true," said Baylor. "They are rushing."

An emergency use authorization from the FDA is meant to be a temporary approval to accelerate the availability of medical products during public health emergencies. It requires less data and can be done much more quickly. The FDA has already used the authorization for many coronavirus tests and a few treatments. It hasn't been used for a vaccine since a 2005 vaccine for anthrax.

The director of the Scripps Research Translational Institute, Eric Topol, said the vaccine data and other recent coronavirus developments mean "things are looking up. It's a really good turning point right now. We are hitting on all cylinders." 

Along with the pair of vaccines, the FDA has authorized an at-home coronavirus test. It has also given the go-ahead to the first monoclonal antibody treatment. Its purpose is to keep those with mild coronavirus out of the hospital.

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