Big Pharma CEOs Vow No Shortcuts On COVID-19 Vaccine

By Adam Lidgett
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Law360 (September 8, 2020, 10:55 PM EDT) -- The CEOs of leading drugmakers on Tuesday pledged not to cut any scientific corners on COVID-19 vaccines that are being developed with unprecedented velocity, an announcement followed hours later by news of AstraZeneca pausing a vaccine trial for safety reasons.

The chief executives of nine companies — including AstraZeneca PLC, Pfizer Inc., Moderna Inc., Johnson & Johnson and Novavax Inc. — signed a promise to use sound science while pursuing possible COVID-19 vaccines. The commitment came amid mounting concerns of political pressure on the U.S. Food and Drug Administration, which will decide whether and when to clear a vaccine.

Among other things, the company leaders promised Tuesday to only seek "approval or Emergency Use Authorization after demonstrating safety and efficacy through a Phase 3 clinical study that is designed and conducted to meet requirements of expert regulatory authorities such as FDA."

The CEOs added that they would "always make the safety and well-being of vaccinated individuals our top priority."

"We believe this pledge will help ensure public confidence in the rigorous scientific and regulatory process by which COVID-19 vaccines are evaluated and may ultimately be approved," the CEOs said.

Separately, in a development that aligned with the safety pledge, AstraZeneca on late Tuesday announced a pause in one of its COVID-19 vaccine trials, citing "a potentially unexplained illness" that required review by an independent committee.

"We are working to expedite the review of the single event to minimize any potential impact on the trial timeline," AstraZeneca said in a statement, adding that the halt was "a routine action" in response to such a development.

The pledge from the CEOs came one day after President Donald Trump said that when a vaccine does come about, it will be both effective and safe. Trump also said Monday that there would be "a very big surprise coming up" in relation to COVID-19.

The president's eagerness to swiftly push a vaccine through clinical trials has alarmed his critics, who fear that Trump will lean on public health officials to clear an unproven vaccine before the Nov. 3 election, exposing patients to unknown safety risks and jeopardizing public faith in COVID-19 vaccines. A number of polls — including surveys released this month by CBS News and USA Today/Suffolk — have found that more than 20% of Americans would refuse to get a coronavirus vaccine and that sizable blocs of additional Americans would at least wait for others to be vaccinated first. 

When the FDA earlier this summer released guidance on its approval standards for coronavirus vaccines, it did so with the explicit hope that transparency would help build public trust.

Critics have cited several actions by Trump as examples of undue interference with clearance of COVID-19 treatments and vaccines. They point to his pressure on the FDA to authorize hydroxychloroquine, which it did but later revoked amid safety and efficacy concerns. The FDA also granted emergency authorization for convalescent plasma to treat COVID-19 after Trump suggested some people at the FDA were trying to delay treatments until after the election.

Drug distribution giant McKesson Corp. is gearing up to deliver COVID-19 vaccines, and the Centers for Disease Control and Prevention recently told states that it wants McKesson vaccine distribution centers ready by Nov. 1, just two days before the presidential election.

As of Tuesday afternoon, there had been about 6.3 million confirmed cases of COVID-19 in the U.S. and about 190,000 deaths, according to the Johns Hopkins Coronavirus Resource Center.

The FDA has scheduled a public meeting for Oct. 22 to discuss "in general, the development, authorization and/or licensure of vaccines to prevent COVID-19," but not any specific vaccine applications.

Other companies that signed the Tuesday pledge included BioNTech SE, GlaxoSmithKline PLC, Merck & Co. Inc. and Sanofi.

White House spokesperson Judd Deere said in a statement to Law360 on Tuesday that vaccine development "has nothing to do with politics, it's about saving lives."

"This president understands that this vaccine cannot get bogged down in government bureaucracy, which is why he has cut through every piece of red tape and launched an unprecedented public-private partnership," Deere said. "The American people can rest assured that any approval will maintain the FDA's gold standard for safety and testing to ensure a vaccine or therapeutic is effective."

--Additional reporting by Jeff Overley. Editing by Abbie Sarfo.

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