US scientists pledge sticking to virus vaccine standards but won't guarantee safety

World | 24 Sep 2020 3:06 pm

A huge international study of a coronavirus vaccine that aims to work with just one dose is getting underway as top U.S. health officials sought Wednesday to assure a skeptical Congress and public that they can trust any shots the government ultimately approves.

Hopes are high that answers about at least one of several candidates being tested in the U.S. could come by year’s end, maybe sooner.

“We feel cautiously optimistic that we will be able to have a safe and effective vaccine, although there is never a guarantee of that,” Dr. Anthony Fauci, infectious disease chief at the National Institutes of Health, told a Senate committee.

President Donald Trump is pushing for a faster timeline, which many experts say is risky and may not allow for adequate testing. On Wednesday he tweeted a link to news about the new Johnson & Johnson vaccine study and said the Food and Drug Administration “must move quickly!”

“President Trump is still trying to sabotage the work of our scientists and public health experts for his own political ends,” Sen. Patty Murray, a Democrat from Washington state, said before ticking off examples of pressure on the FDA.

FDA Commissioner Stephen Hahn pledged that career scientists, not politicians, will decide whether any coronavirus vaccine meets clearly stated standards that it works and is safe. Vaccine development usually takes years but scientists have been racing to shorten that time, in part by manufacturing doses that will have to be thrown away if studies find they don’t work.

“Science will guide our decisions. FDA will not permit any pressure from anyone to change that,” Hahn said. “I will put the interest of the American people above anything else.”

FDA has faced criticism for allowing emergency use of some virus treatments backed by little evidence, but Hahn said if vaccine makers want that faster path to market, additional standards will be coming soon. Vaccines, unlike therapies, are given to healthy people and thus usually require more proof.

But Trump made clear at a Wednesday evening White House news conference that he was skeptical of any regulatory changes that might delay a vaccine’s authorization, even if those changes are aimed at increasing public trust. Asked about the FDA considering stricter guidelines for emergency approval, Trump suggested the effort was politically-motivated.

“I think that was a political move more than anything else,” he said, arguing that that the companies testing the vaccines, such as Pfizer, Johnson & Johnson and Moderna, are capable of determining whether they work. “I have tremendous trust in these massive companies,” he said.

A handful of vaccines already are in final testing in the U.S. and other countries. In one of the largest studies yet, Johnson & Johnson aims to enroll 60,000 volunteers to test its single-dose approach in the U.S., South Africa, Argentina, Brazil, Chile, Colombia, Mexico and Peru. Other candidates in the U.S. require two shots.

J&J’s vaccine is made with slightly different technology than others in late-stage testing, modeled on an Ebola vaccine the company created.

Final-stage testing of one experimental vaccine, made by AstraZeneca and Oxford University, remains on hold in the U.S. as officials examine whether it poses a safety risk.

As for the testing of vaccine candidates, Fauci added: “There is no cutting corners.”

Beyond vaccines, Trump regularly undercuts confidence in his own public health agencies, such as falsely tweeting about a ”deep state, or whoever at FDA” — and in recent weeks, some political appointees were forced out after allegations they interfered with scientific advice.

Conspiracy theories are sapping the morale of disease fighters working 24/7 at the Centers for Disease Control and Prevention, Dr. Robert Redfield, its director, told the Senate committee on health, education, labor and pensions.

“It’s offensive to me when I hear this type of comment,” said Redfield, noting that CDC, like the military, strives to be nonpartisan.

Yet Redfield struggled to defend against criticism that CDC bowed to political pressure with guidelines that discouraged testing of people without coronavirus symptoms. Asymptomatic people do spread the virus and CDC, under fire, later changed the guidelines’ wording. Redfield insisted it all amounted to misinterpretation and stressed Wednesday: “More tests will actually lead to less cases.”-AP

 

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