Vaccine by Nov. 3? Halted study explains just how unlikely

Vaccine by Nov. 3? Halted study explains just how unlikely 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... AP NEWS

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.”  ...

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.

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. ...

ZURICH/FRANKFURT (Reuters) - AstraZeneca should still know by year-end whether its experimental vaccine protects people against coronavirus, as long as it is cleared to resume trials soon, its chief executive said on Thursday amid doubts over its rollout.