WASHINGTON (AP) — The suspension of a huge COVID-19 vaccine study over an illness in a single participant shows there will be “no compromises” on safety in the race to develop the shot, the chief of the National Institutes of Health told Congress on Wednesday.
AstraZeneca has put on hold studies of its vaccine candidate in the U.S. and other countries while it investigates whether a British volunteer’s illness is a side effect or a coincidence.
“This ought to be reassuring,” NIH Director Dr. Francis Collins said before a Senate committee. “When we say we are going to focus first on safety and make no compromises, here is Exhibit A of how that is happening in practice.”
Scientists have been scrambling to develop a vaccine against the coronavirus since the outbreak began, and the U.S. has launched the world’s largest studies — final-stage testing of three leading candidates, with three more trials set to come soon that will each recruit 30,000 test subjects.
Public health experts are worried that President Donald Trump will pressure the Food and Drug Administration to approve a vaccine before it is proven to be safe and effective, a concern senator after senator echoed on Wednesday.
“When it comes to a COVID-19 vaccine, we can’t allow President Trump to repeat his alarming pattern of putting politics ahead of science and public health,” said Sen. Patty Murray of Washington, the committee’s ranking Democrat.
The U.S. has invested billions of dollars in efforts to quickly develop multiple vaccines against COVID-19. But public fears that a vaccine is unsafe or ineffective could be disastrous, derailing the effort to vaccinate millions of Americans.
Collins said the public needs to understand the process behind telling when any vaccine candidate is ready for widespread use — one that by design is keeping both manufacturers and politicians in the dark until the evidence gels.
About 150 COVID-19 infections in a study of 30,000 people should be enough to tell if that candidate really is working — and an independent group of experts, not the FDA, gets to do the counting.
WHO MONITORS THE STUDIES?
Every vaccine trial is overseen by a “data and safety monitoring board,” or DSMB. These boards include scientists and statisticians who are experts in their fields but have no ties to either the government or the vaccine makers.
The top priority: watching for safety concerns, like the one that sparked a DSMB in Britain to pause AstraZeneca’s vaccinations and alert its U.S. counterpart.