- The Washington Times - Tuesday, September 8, 2020

Nine drugmakers pledged Tuesday to secure reliable data showing the safety and effectiveness of their coronavirus vaccines before seeking federal approval, hoping to reassure the public as the vaccine race becomes a political football in the homestretch of the 2020 presidential campaign.

President Trump is tying the vaccine race to Election Day, making Democrats skittish about political pressure on regulators. The president is volleying back, saying Democratic rival Joseph R. Biden’s campaign is throwing cold water on a historic effort.

In an unusual public letter, drug company CEOs pledged to make the “safety and well-being” of vaccinated people their top priority.

They also said they wouldn’t seek emergency approval of their vaccines before “demonstrating safety and efficacy” through phase three trials, some of which are underway.

“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,” said the letter, signed by the chiefs of Pfizer, Moderna, AstraZeneca and others.



Experts said the pledge is an unprecedented effort to reassure the public that science will override politics. Earlier in the pandemic, regulators had to backtrack on decisions or statements related to antibody tests, convalescent plasma treatment and hydroxychloroquine — a drug used to treat malaria that Mr. Trump floated as a COVID-19 “game-changer” but has not been proved effective in randomized trials.

“There’s a lot of professional skepticism, even distrust, because all of these matters’ relations to treatment, diagnostics for COVID-19 have been so politicized,” said William Schaffner, an infectious disease specialist at Vanderbilt University. “That would be a colossal blunder if the introduction of a perfectly good vaccine were polluted with all this politicization.”

The CEOs’ letter left the door open to Emergency Use Authorization (EUA), a type of preliminary approval that would result in health workers and others getting the shots before full approval and widespread distribution. It’s a source of contention in the medical community because it could let Mr. Trump claim political points before Election Day on Nov. 3, as companies vie for the reputational value of being the first to produce a vaccine.

Dr. Schaffner said the question remains whether the Food and Drug Administration will look at interim data and “decide for itself, ‘This is good enough for us.’”

“The companies are walking a tightrope here, trying to have it both ways. It is very sad that private pharmaceutical companies feel the need to have to reassure the public they will follow science,” said Lawrence O. Gostin, a global health law professor at Georgetown University. “It is one of those freak occurrences where the private sector has to publicly vouch for science and ethics because the government won’t.”

Health and Human Services Secretary Alex Azar said Tuesday that the administration will not compromise on safety.

“The president, I, as secretary, and the officials at the FDA, including the career officials, will require that any vaccine meet the very high safety and efficacy standards that the FDA has set,” he told Fox News. “We will not compromise on the safety and efficacy of a vaccine, even as we move, under President Trump’s leadership, to get one as quickly as possible.”

The FDA has said it is up to the drugmaker to decide when or if to apply for emergency approval, and that regulators will look at “the totality of the available scientific evidence.”

But the Biden campaign said Tuesday it wants Mr. Trump to publicly commit to respecting the decision of nonpolitical staff at FDA and assurances the vaccine will be distributed to Americans at no cost and without bowing to political considerations.

House Majority Whip James E. Clyburn, South Carolina Democrat, applauded the drugmakers’ pledge but said he will be watching the FDA closely.

“Americans should not have to rely on this voluntary commitment from for-profit companies to ensure a vaccine is safe and effective,” Mr. Clyburn said. “Congress directed the Food and Drug Administration to protect Americans by conducting rigorous scientific reviews of vaccines.”

Mr. Trump, who defended his COVID-19 response while campaigning in Florida and North Carolina on Tuesday, says the record pace of his vaccine push will rescue the country from a disease that has killed nearly 190,000 Americans.

He has accused Mr. Biden and vice presidential candidate Kamala D. Harris of endangering lives by doubting the effort, dubbed Operation Warp Speed. The president argues that their rhetoric will make people think twice about a critical public health tool.

“Instead of saying, ‘It’s a great thing, we’re going to save lives.’ They’re trying to disparage it,” Mr. Trump told supporters at a campaign rally in North Carolina.

Mr. Azar alluded to the Democratic ticket’s comments in welcoming the drug companies’ pledge.

“It’s, unfortunately, necessary because of the anti-vax messaging that too many people are engaged in,” he told Fox News.

Pfizer, Moderna and AstraZeneca are engaged in phase three trials of their vaccine candidates in the U.S., although AstraZeneca — a British company that worked on it vaccine with Oxford University — reportedly put its trial on hold late Tuesday due to an adverse reaction in a recipient in the U.K. It’s unclear whether the reaction was due to the vaccine or something else.

A company spokesman told Stat News that its “standard review process triggered a pause to vaccination to allow review of safety data.”

Their CEOS signed the letter alongside six others: GlaxoSmithKline, Merck, Novavax, Sanofi, Johnson & Johnson and BioNTech, a German company that is working with Pfizer.

Pfizer has 25,000 participants enrolled and appears to be the most bullish in its public statements.

“If the large-scale trial is successful, we still expect to file for Emergency Use Authorization or some form of regulatory approval as early as October 2020,” the company said.

Speaking to NBC’s “Today Show,” Pfizer CEO Albert Bourla pegged the chances of his vaccine candidate proceeding on that time frame at about 60%.

Some experts doubt that a vaccine will be ready before the end of the year because of the time it takes to fill enrollment, administer doses and find out who gets sick or not.

“Having data is not the same thing as an [Emergency Use Authorization] or full approval. It is essential to hold off on either an EUA or full approval until there is a rigorous scientific review with all the evidence disclosed transparently,” Dr. Gostin said.

Moncef Slaoui, a top scientist leading the White House effort to speed a vaccine, recently told NPR that there is “a very, very low chance that the trials that are running as we speak could read before the end of October.”

Mr. Azar said he is confident that regular Americans will see the distribution of a vaccine by the start of next year, at least.

“We feel that it is extremely credible that we will have in the high tens of millions of doses of FDA gold standard vaccine by the end of the year,” he said, “thanks to this Operation Warp Speed that President Trump has commissioned and led.”

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