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Coronavirus vaccine breakthrough? One drug expert says…

September 14, 2020 By: Stephen Dietrich

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Pfizer CEO Albert Bourla said the coronavirus vaccine trial currently underway could be finalized and approved by the Food and Drug Administration by the “end of October.”

That would end the global pandemic by the end of the year.

The Trump administration paid Pfizer nearly $2 billion for a December delivery of 100 million doses of a COVID-19 vaccine the pharmaceutical company is developing, Health and Human Services Secretary Alex Azar announced in July.

The promising vaccine is currently in it’s third and final trial phase.

The U.S. could buy another 500 million doses under the agreement, Azar said.

“Now those would, of course, have to be safe and effective” and approved by the Food and Drug Administration, Azar said during an appearance on Fox News.

Pfizer Inc. and BioNTech SE announced separately that the agreement is with HHS and the Defense Department for a vaccine candidate the companies are developing jointly. It is the latest in a series of similar agreements with other vaccine companies.

The race for a vaccine is part of Trump’s Operation Warp Speed program, under which multiple COVID-19 vaccines are being developed simultaneously. The program aims to deliver 300 million doses of a safe and effective COVID-19 vaccine by January 2021.

Under the initiative, the government will speed development and buy vaccines — before they are deemed safe and effective — so that the medication can be in hand and quickly distributed once the FDA approves or authorizes its emergency use after clinical trials.

Pfizer and BioNTech said the U.S. will pay $1.95 billion upon receipt of the first 100 million doses it produces, following FDA authorization or approval.

Americans will receive the vaccine for free, the companies said.

Azar said the contract brings to five the number of potential coronavirus vaccines that are under development with U.S. funding. Nearly two dozen are in various stages of human testing around the world, with several in the final test to prove if they really work and are safe.

Other countries are also scrambling to get a vaccine for COVID-19, which has killed more than 925,000 people, according to a tally kept by Johns Hopkins University.

Over 6.5 million Americans have been infected by the coronavirus and at least 194,000 have died from COVID-19, the disease it causes, according to Johns Hopkins.

The FDA has told manufacturers it expects any vaccine to be at least 50% effective to qualify. Executives from five leading vaccine companies testified that they will take no shortcuts in their testing of the shots, so that people can be confident in the results.

In addition, it won’t be just the FDA rendering an opinion — each vaccine will likely be judged nearly simultaneously by regulatory authorities in Britain and Europe.

“I don’t think any of the regulatory bodies that we have interacted with are lowering their standards,” said Menelas Pangalos, executive vice president of AstraZeneca, which is manufacturing a potential vaccine developed by Oxford University. “We would not be trying to launch a medicine that is not effective.”

 

The Associated Press contributed to this article

About the Author

Stephen Dietrich

Stephen is a U.S. Army veteran with over a decade of combined experience in political commentary, economics, and news.

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