Pfizer urged to wait until November to seek vaccine authorisation

Washington: More than 60 leading researchers and bioethicists have called on pharmaceutical giant Pfizer to wait until at least late November to meet rigorous safety standards for its COVID-19 vaccine before seeking US Federal Drugs Administration approval.

Their appeal came in a letter, obtained by Bloomberg Law and verified by six signatories, that was sent on Friday, US time, after reports that Pfizer's clinical trial would yield conclusive results in October. That would likely put the company ahead of Moderna, AstraZeneca and other promising vaccine candidates.

Pfizer says it should be able to make millions of doses this year, and hundreds of millions in 2021, if it succeeds with one of its vaccine candidates.Credit:Bloomberg

But the researchers said Pfizer's clinical trial needed to monitor participants for at least two months after they received the second dose. That would bring the New York-based company into at least late November before the FDA should consider granting an emergency-use authorisation (EUA), according to the letter.

"To be successful, the public needs to have the utmost trust in the vaccine and the science behind it," they 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."

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

A Pfizer spokeswoman confirmed the company received the letter and was 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 rigour and didn’t mention any concerns of political interference.

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

The letter comes as the World Health Organisation warned the global death toll from COVID-19 could double to 2 million before a successful vaccine is widely used and could be even higher without concerted action to curb the pandemic.

"Unless we do it all, [2 million deaths] … is not only imaginable but, sadly, very likely," Mike Ryan, head of the UN agency's emergencies program, told a briefing on Friday (Saturday AEST).

The total number of deaths since the novel coronavirus was discovered in China is nearing 1 million. There have been more than 32 million confirmed cases around the world, and more than 7.2 million in the US alone.

The UN agency published on Friday draft criteria for the assessment of emergency use of COVID-19 vaccines to help guide drugmakers as trials reach advanced stages, said WHO assistant director-general, Mariangela Simao.

The document will be available for public comment until October 8.

Bloomberg, Reuters

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