By Jared S. Hopkins and Peter Loftus 

Nine drugmakers said Tuesday their chief executives signed a pledge promising not to file for regulatory approval or authorization of their experimental Covid-19 vaccines until the shots have been shown to work safely through late-stage clinical testing.

The Wall Street Journal previously reported on the companies' pledge on Friday.

The pledge was signed by the heads of AstraZeneca PLC, GlaxoSmithKline PLC, Johnson & Johnson, Merck & Co., Moderna Inc., Novavax Inc., Sanofi SA, BioNTech SE and Pfizer Inc.

In it, the companies say "the safety and well-being of vaccinated individuals" would always be their priority. They promise to keep following scientific and ethical standards in clinical trials testing the Covid-19 shots, and in manufacturing. They also pledge to ensure supply across the world.

"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 pledge states.

The statement joins a growing chorus of public assurances by industry executives that they aren't cutting corners in their rapid testing and manufacturing of the vaccines. Yet the unusual joint move among rivals comes as they work to address concerns over a rush to mass vaccination.

Many Americans are skeptical about taking a Covid-19 vaccine, or opposed to taking one, as a result of concerns that vaccine development, or potential authorizations, are being rushed.

Several vaccines in development are in Phase 3 studies, which are the final stages of testing, designed to prove whether the shots can reduce rates of symptomatic Covid-19 disease compared with people without vaccination. Vaccines from Pfizer and BioNTech; AstraZeneca and University of Oxford scientists; and Moderna are already in large clinical trials of at least 30,000 people.

Interim results from these trials could come later this year, with potential for an emergency-use authorization or outright approval. An emergency-use authorization from the Food and Drug Administration is temporary, and the standards are lower than full approval.

The FDA has said it won't green-light a Covid-19 vaccine unless it is proven to be 50% effective compared with a placebo.

Last month, the Centers for Disease Control and Prevention, which is expected to be involved in distributing vaccines, notified states that they should be ready to launch Covid-19 vaccination campaigns by November. An FDA meeting of outside experts to discuss Covid-19 vaccines was also scheduled for late October.

That timeline, just before the Nov. 3 presidential election, raised concerns among some scientists and other experts that the Trump administration would rush a vaccine to bolster President Trump's re-election prospects.

At an airport rally Tuesday in Winston-Salem, N.C., President Trump said a vaccine would be produced in record time, as he accused his Democratic rival Joe Biden and running mate Kamala Harris of "reckless antivaccine rhetoric."

"The vaccine will be safe," Mr. Trump said. "These are the greatest companies in the world that do this, the greatest labs, the greatest doctors. It will be effective, and it will be delivered before the end of the year."

Mr. Biden's campaign reiterated its concern that Mr. Trump was rushing to approve a coronavirus vaccine ahead of the November election for political gain.

"Any vaccine must be a product of science and research," Symone Sanders, a senior adviser to Mr. Biden's campaign, said Tuesday in a conference call with reporters. "The reality is that given Donald Trump's track record, no one can take his word alone on a Covid-19 vaccine."

Mr. Biden said he would get a vaccine tomorrow if one existed, but expressed skepticism over the president's motivations.

"One of the problems is the way he is playing with politics. He's said so many things that aren't true," Mr. Biden told reporters Monday. "I want full transparency on the vaccine."

Pfizer Chief Executive Albert Bourla has said the New York-based drugmaker expects to have enough data from its trial to file for U.S. regulatory approval or authorization next month, if the results are positive.

In a separate statement, J&J Chief Executive Alex Gorsky said: "The pandemic demands that we develop a Covid-19 vaccine, and, as an industry, we are guided by science and data in these efforts. With many vaccines now being tested in clinical trials, we believe it is important to affirm for people everywhere that we will only move forward with regulators to make a vaccine available to them when the data demonstrate it is safe and effective."

Write to Jared S. Hopkins at jared.hopkins@wsj.com and Peter Loftus at peter.loftus@wsj.com

 

(END) Dow Jones Newswires

September 08, 2020 21:10 ET (01:10 GMT)

Copyright (c) 2020 Dow Jones & Company, Inc.
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