FDA’s advisers worry about trust in Covid-19 vaccine
Vaccine advisers to the US Food and Drug Administration said Thursday they are worried about public trust in any coronavirus vaccine.
The first Covid-19-focused meeting of the Vaccines and Related Biological Products Advisory Committee – a standing committee that advises the FDA on vaccine approval – skewed heavily toward worries that people will see emergency use authorization (EUA) of a Covid-19 vaccine as too rushed.
“There’s only one chance to do this right. If we do it wrong, then we are done for,” said Sheldon Toubman, staff attorney for the New Haven Legal Assistance Association who is the consumer representative on the committee.
“We won’t be able to dig out of it.”
The FDA has said it would consider an EUA for any of the several vaccines now in advanced clinical trials – a process faster than full licensure – but has also promised it will have stricter requirements for a vaccine EUA than it would for an EUA for a drug to treat coronavirus.
But the term implies corners are being cut – and perceptions matter, Toubman argued.
“So anything that sounds like emergency use authorization, it sounds like it’s being done in a rush and it’s not full review,” he said.
“I recommend that we not do an EUA here.”
Some vaccine experts agreed. “I wish we could get rid of the word EUA,” said Dr. Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia and a committee member.
“It’s very clear that the public has significant concerns about safety,” added Dr. Archana Chatterjee, Vice President for Medical Affairs at Rosalind Franklin University and a committee member.