Major COVID-19 vaccine developers are to release a joint statement this week vowing to prioritize safety before speed by waiting to seek emergency government approval for the vaccine until human trials show "substantial evidence of safety and efficacy," according to a report.
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Three American pharmaceutical and biotechnology companies – Moderna, Pfizer, and Johnson & Johnson – as well as the French pharmaceutical company Sanofi, are to release the joint statement later this week amid concerns a COVID-19 vaccine is being rushed to market in time for the November U.S. presidential election.
The developers are to promise not to reach out to the federal Food and Drug Administration (FDA) to approve the vaccine, even for emergency use, until certain standards are met.
"We believe this pledge will help ensure public confidence in the COVID-19 vaccines that may ultimately be approved and adherence to the rigorous scientific and regulatory process by which they are evaluated," a draft of the statement first obtained by the Wall Street Journal on Friday read.
White House Press Secretary Kayleigh McEnany, meanwhile, gave assurances Thursday that President Trump “will not in any way sacrifice safety” when it comes to a vaccine.
The U.S. Centers for Disease Control and Prevention (CDC) instructed states in August to be ready to begin distributing a vaccine by Nov. 1 — two days before the election. Since then, skepticism has grown over the scientific credibility of the FDA and the CDC, and their vulnerability to political pressure from Trump. Sen. Chuck Schumer was once of many Democrats to sound the alarm.
“Too much of the evidence points to the Trump administration pressuring the FDA to approve a vaccine by Election Day to boost the president’s reelection campaign," Schumer, D-N.Y., said in a statement last week. “This raises serious safety concerns about politics, not science and public health, driving the decision-making process.”
The FDA will not be able to even consider a vaccine until certain key steps occur, according to the Associated Press. First, independent experts on so-called data safety monitoring boards, or DSMBs, will have to rule that they have collected enough information to draw firm conclusions about a vaccine’s performance. Then the experts will make the data available to the manufacturer, which will decide whether to submit it for FDA approval.
“We will not cut corners,” Pfizer CEO Albert Bourla vowed Thursday in a call with reporters, hosted by a pharmaceutical industry group. Bourla said that, as of Wednesday, the company’s late-stage study, which started at the end of July, had enrolled about 23,000 people, some of whom had already received the second dose. He said he expects by the end of October to have enough participants infected by the virus to tell whether the vaccine works — an extremely fast timeline.
Health and Human Services Secretary Alex Azar gave assurances that any decision to release a vaccine in the U.S. would be based on the data and the “FDA’s gold standards” and accused those questioning the Nov. 1 date of partisanship.
“I think it’s very irresponsible how people are trying to politicize notions of delivering a vaccine to the American people,” Azar told CBS. “We already have a significant challenge in this country with vaccine hesitancy. And efforts to undermine confidence in a vaccine ... hurt in terms of people being willing to take a vaccine once it comes through.”
The Associated Press contributed to this report.