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US Pfizer Urged to Wait for November to Seek Vaccine Authorization

04:40  26 september  2020
04:40  26 september  2020 Source:   bloomberg.com

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Russia’s Sputnik V vaccine was excoriated in western media for seeking just such an emergency approval months ago. Despite ominous clinical results, the firm had already started churning out millions of doses to ship in July, boasting it sought to make enough “to be able to vaccinate

Pfizer and BioNTech said on Tuesday they have begun delivering doses of their experimental coronavirus vaccines for initial human testing in the United States. Pfizer , BioNTech to begin Covid-19 vaccine trial with US participants.

(Bloomberg Law) --

a glass with a blue toothbrush: A lab technician uses a pipette dropper during the antigen quantification process of the coronavirus vaccine research at the Valneva SA laboratories in Vienna, Austria, on Thursday, Aug. 6, 2020. The U.K. has signed agreements to buy 90 million doses of vaccines in development by drugmakers including Pfizer Inc., BioNTech SE and Valneva SE, joining countries around the world racing to secure supplies of protection against Covid-19. © Bloomberg A lab technician uses a pipette dropper during the antigen quantification process of the coronavirus vaccine research at the Valneva SA laboratories in Vienna, Austria, on Thursday, Aug. 6, 2020. The U.K. has signed agreements to buy 90 million doses of vaccines in development by drugmakers including Pfizer Inc., BioNTech SE and Valneva SE, joining countries around the world racing to secure supplies of protection against Covid-19.

Pfizer Inc. should wait until at least late November before seeking FDA authorization of its Covid-19 vaccine to meet rigorous safety standards, more than 60 leading researchers and bioethicists said.

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Pfizer Inc. and BioNTech SE announced separately that the agreement is with HHS and the Defense Department for a vaccine candidate the companies Pfizer and BioNTech said the U.S. will pay .95 billion upon receipt of the first 100 million doses it produces, following FDA authorization or approval.

In an interview on CNBC, Pfizer (PFE +4.0%) chief Albert Bourla said the company plans to seek regulatory review of its emergency use authorization application for COVID-19 vaccine candidate BNT162b2 as early as October. Most of the 30K trial participants will be vaccinated by the end of

The letter, obtained by Bloomberg Law and verified by six signatories, was sent Friday following reports that Pfizer’s clinical trial will yield conclusive results in October. That would likely put the company ahead of Moderna Inc. and AstraZeneca PLC and other promising vaccine candidates.

But the researchers said Pfizer’s clinical trial needs to monitor participants for at least two months after they received the second dose. That would bring the New York-based pharmaceutical giant into at least late November before the Food and Drug Administration should consider granting an emergency use authorization, according to the letter.

text: A sign sits on a building at the Pfizer Inc. medical manufacturing facility at Discovery Park in Sandwich, U.K., on Friday, Aug. 21, 2020. Pfizer Inc. and BioNTech SE said the Covid-19 vaccine they are jointly developing is on track to be submitted for regulatory review as early as October, as they released additional data from an early-stage study © Bloomberg A sign sits on a building at the Pfizer Inc. medical manufacturing facility at Discovery Park in Sandwich, U.K., on Friday, Aug. 21, 2020. Pfizer Inc. and BioNTech SE said the Covid-19 vaccine they are jointly developing is on track to be submitted for regulatory review as early as October, as they released additional data from an early-stage study

“To be successful, the public needs to have the utmost trust in the vaccine and the science behind it,” the letter said. “Submission of an application for an EUA before this standard is met would severely erode public trust and set back efforts to achieve widespread vaccination.”

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Few vaccine developers were expected to have definitive trial results before the presidential election. Pfizer Inc (NYSE:PFE) had been the exception Two months of follow-up would make it unlikely the companies would have enough data before mid- November . Pfizer said on Tuesday that based on

Pfizer would know whether their vaccine candidate is effective by end of October The vaccine candidate being developed by Pfizer and its German partner BioNTech SE is considered the frontrunner in the race. The company plans to seek emergency authorisation for high-risk groups

The scientists added that “a premature application would prolong the pandemic, with disastrous consequences.”

A Pfizer spokeswoman confirmed the company received the letter and that the company is working on a response. Pfizer signed a pledge earlier this month not to cut corners on a vaccine.

The recommendation would put Pfizer’s vaccine on the market after the presidential election and comes amid increasing concerns about the White House pressuring the FDA to rush a vaccine. The letter focused only on safety and rigor and didn’t mention any concerns of political interference.

The signatories of the letter include scientists from a variety of public health backgrounds, including: Joshua M. Sharfstein, vice dean for public health practice and community engagement at Johns Hopkins University and a former second-in-command at the FDA; Esther K. Choo, an emergency medicine physician and professor at Oregon Health & Science University; and Jeffrey R. Botkin, a University of Utah professor of pediatrics and medical ethics.

To contact the reporter on this story: Jeannie Baumann in Washington at jbaumann@bloomberglaw.com

To contact the editors responsible for this story: Fawn Johnson at fjohnson@bloomberglaw.com; Alexis Kramer at akramer@bloomberglaw.com; Meghashyam Mali at mmali@bloombergindustry.com

For more articles like this, please visit us at bloomberg.com

©2020 Bloomberg L.P.

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usr: 1
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