October 23 coronavirus news

By Julia Hollingsworth, Adam Renton, Tara John, Ed Upright, Veronica Rocha, Melissa Macaya and Melissa Mahtani, CNN

Updated 12:01 a.m. ET, October 26, 2020
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12:02 a.m. ET, October 23, 2020

FDA's advisers worry about trust in Covid-19 vaccine

From CNN Health’s Maggie Fox

A sign for the Food And Drug Administration is seen outside of the agency's headquarters in White Oak, Maryland, on July 20.
A sign for the Food And Drug Administration is seen outside of the agency's headquarters in White Oak, Maryland, on July 20. Sarah Silbiger/Getty Images

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.

10:25 p.m. ET, October 22, 2020

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.”

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.

10:25 p.m. ET, October 22, 2020

Remdesivir becomes first Covid-19 treatment to receive FDA approval

From CNN's Maggie Fox

One vial of the drug Remdesivir lies during a press conference at the University Hospital Eppendorf (UKE) in Hamburg, Germany on April 8.
One vial of the drug Remdesivir lies during a press conference at the University Hospital Eppendorf (UKE) in Hamburg, Germany on April 8. Ulrich Perrey/Pool/AFP/Getty Images

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.

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10:29 p.m. ET, October 22, 2020

One US state is getting National Guard help, and others keep breaking records

From CNN's Holly Yan and Christina Maxouris

You know Covid-19 is out of control when health officials are so overwhelmed, they can't notify close contacts who may be infected.

That's what's happening in North Dakota, one of 31 states suffering more new Covid-19 cases this past week compared to the previous week.

Contact tracing is crucial to finding possible carriers of coronavirus, so they can quarantine and break the chain of infection.

But a "sharp increase" in new cases has engulfed contact tracers, leading to delays and "a backlog of positive cases that have yet to be assigned to a case investigator," the North Dakota Department of Health said this week.

"Close contacts will no longer be contacted by public health officials; instead, positive individuals will be instructed to self-notify their close contacts and direct them to the NDDoH website, where landing pages will be created ... explaining the recommended and required actions for both positive patients and close contacts."

The North Dakota National Guard has shifted 50 soldiers from contacting close contacts to notifying people who have tested positive, the state health department said.

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10:09 p.m. ET, October 22, 2020

Czech PM apologizes as country suffers in Europe's second coronavirus wave

From CNN's Laura Smith-Spark and Ivana Kottasová

The Czech Republic's coronavirus crisis is now so bad that when Prime Minister Andrej Babis stood in front of reporters during a live news conference Wednesday, he did something few leaders often do. He apologized to the people. Five times.

Babis, who is overseeing one of the worst coronavirus epidemics in the world, admitted he and his government had made mistakes in handling the outbreak and pleaded with people to follow strict lockdown rules.

"I am sorry for the new restrictions that will impact lives of business owners, citizens, employees. I am also sorry for having de facto ruled out the possibility of this happening because I could not imagine that this would happen," Babis said.

The Czech leader's contrition came as other European nations, including Germany and Poland, reported record daily new case numbers, and Ireland prepared to impose the strictest lockdown in Europe.

Both Spain and France surpassed 1 million total recorded Covid-19 cases on Wednesday, according to Johns Hopkins University (JHU) figures. They join the United States, India, Brazil, Russia and Argentina in passing that threshold.

The number of cases reported by the French health ministry is lower than the JHU total, at 957,421 as of Wednesday.

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