Warp Speed: FDA Set To Grant Pfizer Covid Vaccine Approval Surprisingly Soon

Written By BlabberBuzz | Saturday, 21 November 2020 16:30

Pharmaceutical companies Pfizer and partner BioNTech seek emergency government approval for their coronavirus vaccine, Health and Human Services Secretary Alex Azar said, paving the way for millions of doses to be distributed within 24 hours.

“We will ship millions of doses of vaccine within 24 hours of FDA approval. So my message is hope and help are on the way,” Aazar said Thursday as he announced the pending emergency use application during a White House coronavirus task force briefing.

Pfizer’s German partner BioNTech had said this week that it would seek the emergency approval for the vaccine, which showed 94.5 percent efficacy in clinical trials.

Vice President Mike Pence announced at the briefing that “literally, we could well be a matter of just a few weeks away from a vaccine being available across this country for the most vulnerable among us.”

The Pfizer vaccine requires ultra-cold storage, but task force leaders said at the briefing that distribution was ready to go.

Azar said “there is light at the end of the tunnel, this isn’t forever.” He said a second drugmaker, Moderna, is likely to also seek permission for its vaccine, which was 95 percent effective, and does not require special ultra-cold storage.

“For the last two weeks, we’ve seen just unprecedented historic news about vaccines. Two vaccines, each with 95 percent efficacy, rivaling the 98 percent accuracy of our measles vaccine, produced in some of the largest vaccine clinical trials ever conducted in history — over 40,000 patients in each of these clinical trials demonstrating good safety profiles,” Azar said.

“BioNTech has announced that tomorrow they intend to file for emergency use authorization at the FDA. We would expect to see Moderna filing soon also. We also have this comprehensive distribution plan that… builds on a public-private partnership… with a goal to make the distribution of this vaccine as convenient to you as the flu vaccine is.”

Earlier this week, Azar said that the US could distribute 40 million doses of the Pfizer and Moderna vaccines by the end of the year.

Army General Gustave Perna, the chief operating officer of the task force’s Operation Warp Speed, shared flow charts for the “relatively simple” rapid distribution of vaccines that are approved.

Perna stated that Pfizer is “capable of distributing on their own. They will be utilizing FedEx and UPS in order to execute distribution.”

“Simultaneously we will ship ancillary kits, needles, syringes, alcohol wipes and the diluent required for the vaccine to meet the vaccine at the end-state facilities,” Perna said. “For the Moderna vaccine, what we’re going to do is meet up the vaccine with the ancillary kits at a distribution warehouse, we’re going to put them together, and then we’re going to distribute to FedEx and UPS down to our distribution sites.”

Perna said the vaccine doses will be shipped to “any place that a state wants to administer a vaccine” and that 100 million kits have been prepared for the vaccines, meaning supplies shortages won’t slow the process.

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