Drug giant CEOs sign pledge on Covid vaccine
Drug giants sign promise not to seek approval for COVID vaccines until they’re proved safe, amid fears trials could be rushed.
Nine drugmakers say their chief executives have signed a pledge promising to not file for regulatory approval or authorisation of their experimental COVID-19 vaccines until the shots have shown to work safely through late-stage clinical testing.
the pledge was signed by the heads of AstraZeneca, GlaxoSmithKline, Johnson & Johnson, Merck & Co, Moderna, Novavax, Sanofi, BioNTech and Pfizer.
In it, the companies say “the safety and wellbeing of vaccinated individuals” would always be their top 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 pledge comes as AstraZeneca, whose vaccine being developed with Oxford University is one of two to be produced by CSR in Australia if trials are successful, paused its study due to the adverse reaction in a participant in the UK.
Australia’s Deputy Chief Medical Officer Nick Coatsworth played down news of the AstraZeneca pause, saying it “reinforces” that despite the accelerated nature of vaccine developments safety is at the forefront of everyone’s mind.
The drugmakers’ 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 sceptical about taking a COVID-19 vaccine, or opposed to taking one, as a result of concerns that vaccine development, or potential authorisations, 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 BioNTec; 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 authorisation or outright approval. An emergency-use authorisation 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 per cent effective compared with a placebo.
Last month, America’s 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 November 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.
On Monday, President Trump said at a news conference that a vaccine “will be very safe and very effective, and it will be delivered very soon.” He said the country “could even have it during the month of October.”
Democratic presidential nominee Joe 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 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 scepticism 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. “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 US regulatory approval or authorisation 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.”
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