FDA's advisers worry about trust in Covid-19 vaccine
From CNN Health’s Maggie Fox
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.
Data shows Covid-19 treatment remdesivir isn't a "home run," says former vaccine director
From CNN Health’s Lauren Mascarenhas
Data on the Covid-19 drug remdesivir show that it has only modest benefits and isn’t a “home run,” former US Health and Human Services official-turned whistleblower Dr. Rick Bright said Thursday.
The US Food and Drug Administration approved remdesivir Thursday to treat hospitalized Covid-19 patients -- the first drug to be approved for coronavirus.
Bright said it’s not an impressive drug.
“It's important to note that even the data that we saw in the United States from that drug show that the benefit was modest,” Bright told CNN’s Wolf Blitzer. “It wasn't a home run. It wasn't a remarkable improvement in terms of mortality, or even the lengthening or shortening of the length of hospital stay, but it did show some marginal benefit.”
A World Health Organization-sponsored global study found that remdesivir did not help Covid-19 patients survive or recover faster.
“The FDA clearly has reviewed all of the data that they have available to them from the company to review the efficacy and safety of that drug,” Bright said.
“It’s not too surprising that another, perhaps even larger, well-controlled study from the WHO would refute that data,” he added.
Bright said that it’s likely that larger studies, like the WHO’s, would show that the marginal benefit of remdesivir may become even more marginal, depending on the population of those using the drug.
Remdesivir becomes first Covid-19 treatment to receive FDA approval
From CNN's Maggie Fox
The US Food and Drug Administration has approved remdesivir for the treatment of coronavirus infection, the drug's maker, Gilead Sciences, said Thursday.
It is the first drug to be approved for treating Covid-19. The drug, sold under the brand name Veklury, has been used under emergency use authorization since May.
The antiviral has shown, at best, a modest benefit for coronavirus patients. But there is little else available.
"In the United States, Veklury is indicated for adults and pediatric patients (12 years of age and older and weighing at least 40 kg) for the treatment of COVID-19 requiring hospitalization," the company said in a statement.
"Veklury should only be administered in a hospital or in a healthcare setting capable of providing acute care comparable to inpatient hospital care."
Earlier this month, a World Health Organization-sponsored global study found remdesivir did not help patients survive or even recover faster, but a US study found the infused drug shortened recovery time for some patients by about a third.
Read the full story: https://plawiuk.blogspot.com/2020/10/remdesivir-gets-full-fda-approval-as.html
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