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
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
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
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
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
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 firstname.lastname@example.org and Peter
Loftus at email@example.com
(END) Dow Jones Newswires
September 08, 2020 21:10 ET (01:10 GMT)
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