FDA is Working "As Quickly As Possible" to Authorize Pfizer and Moderna Vaccines

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The US Food and Drug Administration is working "as quickly as possible" to authorize Pfizer and Moderna's vaccines.

The US Food and Drug Administration is working "as quickly as possible" to authorize Pfizer and Moderna's vaccines for emergency use, according to CNBC.

Health and Human Services Secretary, Alex Azar, made the statement after Moderna reported that its vaccine candidate was more than 94 percent effective in preventing COVID-19. The news came a week after Pfizer and BioNTech reported their vaccine candidate was more than 90 percent effective. Azar called the results a “historic day in public health.”

The Department of Health and Human Services oversees the FDA. Azar revealed that teams within the departments have been working with both companies to “remove any unnecessary bureaucratic barriers” and helping them complete authorization applications “as we speak.”

“We hope those applications from both Pfizer and Moderna will get in as quickly as possible,” Azar said. “We will independently call those balls and strikes on the data and evidence, but we’re going to do so as quickly as possible, consistent with just making sure the science, the evidence and the law support authorization.”

The US has already made an investment of more than $2 billion in Moderna's vaccine candidate. In August, Moderna made a deal with the US government to provide 100 million doses of its vaccine, with an option to purchase an additional 400 million doses.

The US also made a deal with Pfizer in July for an additional 100 million doses of its vaccine candidate, with the option to purchase an additional 500 million doses.

Estimates show that there could be 40 million doses of coronavirus vaccines from both Moderna and Pfizer by the end of 2020. However, the vaccines require two shots so that would equate to an inoculation pool of around 20 million people. The goal is to provide coronavirus vaccines to all Americans before the end of quarter 2 in 2021.

“The product will role off the production lines — tens and tens of millions of doses each month — and we’ll vaccinate as we get them and as they’re quality controlled and released,” he said.

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Comments (1)
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FrankSterleJr
FrankSterleJr

I don’t hold much confidence in FDA decisions, especially on matters where consumer health should be placed well ahead of corporate profit interests.

For example, there was U.S. Food and Drug Administration commissioner Arthur Hull Hayes Jr.; after permitting the potentially health damaging artificial sweetener Aspartame to be placed in food and drinks, he left his FDA position for a lucrative job with the public relations firm owned by the Aspartame patent holder and producer, G.D. Searle Company.

This, despite being urged by credible health academics to refrain from immediately granting FDA approval of the sweetener—a chemical concoction discovered accidently in 1965 while G.D. Searle Company chemist James Schlatter was testing an anti-ulcer drug.


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