Pfizer Says Its Covid Vaccine Is Ready for FDA’s Green Light

Pedestrians walk past Pfizer world headquarters in New York earlier this month. (AP Photo/Bebeto Matthews)

WASHINGTON (CN) — Pharmaceutical giant Pfizer and its partner BioNTech will forge ahead in their pursuit of emergency use authorization for their Covid-19 vaccine, a booster the company declared this week was 95% effective. 

The request to the Food and Drug Administration is a “critical” next step on the path toward distribution before full scale testing of the vaccine is complete, BioNTech CEO Ugur Sahin said in a statement Friday. 

“Our work to deliver a safe and effective vaccine has never been more urgent as we continue to see an alarming rise in the number of cases of Covid-19 globally,” Dr. Albert Bourla, Pfizer’s CEO, said Friday. “Filing in the U.S. represents a critical milestone in our journey to deliver a Covid-19 vaccine to the world and now we have a more complete picture of both the efficacy and safety profile of the vaccine, giving us confidence in its potential.”

Once through its final hurdles, the vaccine known as BNT162b2 will be portioned out first to high-risk populations. Pfizer says there will be an estimated 50 million doses distributed by the end of December.

The vaccine will require two separate shots and takes effect after about 28 days, giving the body 95% protection from the novel respiratory virus that has now surged through the world for 10 months, infecting more than 12 million Americans and leaving more than 250,000 dead.

With success, Pfizer said, another 30 million doses could follow as soon as January. Another 35 million doses are anticipated to follow between February and into March, just as the United States begins to thaw out from what is expected to be a grim, virus-laden winter. 

As of Friday, with the death toll continuing its climb, hospitalizations have followed suit in most states according to the Covid Tracking Project. The pandemic data cultivator reports 80,698 occupied hospital beds in the U.S. as of Nov. 19.

Requesting emergency use means the third phase of clinical trial testing is complete, and Pfizer and BioNTech are confident in the data driving its claim of efficacy in the final analysis of its 43,000-person study. 

A competing vaccine from the Massachusetts-based Moderna is also coming along, according to preliminary data it announced Nov. 16. It expects to seek emergency use for a vaccine that it has said is 94.5% effective.

According to Pfizer, of the 170 infected test subjects, just eight received the real vaccine while 162 received a placebo. The status of nearly 40,000 test participants was also tracked for eight weeks after the initial dose was administered. 

With the authorization in play, the ball goes next to the FDA, which will review the data and determine how quickly distribution gets underway to states.

During a White House Coronavirus task force briefing held Thursday — the first one in months — Brigadier General David Sanford, who oversees supply chain logistics for the Trump administration — was enthusiastic. Sanford told reporters that he expects distribution, while a massive undertaking, would start quickly.

Centers for Disease Control and Prevention Director Robert Redfield has said the same in recent weeks. Once the FDA gives its final stamp of approval to the vaccine, it will be the CDC that will review and recommend who is dosed first. 

Vice President Mike Pence said Thursday that the administration “has a plan in place” for the moment the FDA concludes the vaccine is safe to distribute.

Pfizer’s vaccine uses something known as messenger RNA to essentially direct cells in the body to recreate the spike proteins found on top of the novel coronavirus cell. By doing this, the body’s immune system can begin to create antibodies and kill off the virus.

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