October 9 coronavirus news

By Julia Hollingsworth, Brad Lendon and Eliza Mackintosh, CNN

Updated 2:18 a.m. ET, October 10, 2020
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2:35 a.m. ET, October 9, 2020

India's drug authority denies permission for phase III trials for Sputnik-V vaccine

From CNN’s Esha Mitra in New Delhi 

The Russian coronavirus vaccine Gam-COVID-Vac, trade-named Sputnik V, developed by the Gamaleya Scientific Research Institute of Epidemiology and Microbiology is pictured during the vaccination of medical workers, in Krasnodar, Russia.
The Russian coronavirus vaccine Gam-COVID-Vac, trade-named Sputnik V, developed by the Gamaleya Scientific Research Institute of Epidemiology and Microbiology is pictured during the vaccination of medical workers, in Krasnodar, Russia. Georgiy Zimarev/Sputnik via AP

India's drug authority has denied permission for Phase III trials for Russia’s Sputnik-V vaccine.

The drug authority has asked Dr Reddy's Laboratories Ltd, the Indian pharmaceutical company that has partnered with the Russian fund, to conduct Phase II trials of the vaccine in the country first. 

"The safety & immunogenicity data in overseas Phase I/II studies is small and there is no data available on Indian subjects," the Subject Expert Committee (SEC) that looks into proposals for drug trials said on October 5. 

The Russian Direct Investment Fund announced last month that it would supply 100 million doses of Sputnik-V vaccine to Dr Reddy's, and cooperate with the firm for clinical trials and distribution.

After "detailed deliberation" the SEC has asked Dr Reddy's to resubmit a protocol for consideration by the committee to conduct phase II trials first.

India has reported more than 6.9 million cases of coronavirus, including more than 106,000 deaths.

At a press conference last month, the health minister said Covaxin, the indigenous vaccine being developed by Bharat Biotech and National Institute of Virology Pune, and the Serum Institute of India's collaboration with Oxford University and Codagenix USA respectively, are the vaccines at the most advanced stages.

1:14 a.m. ET, October 9, 2020

FDA emergency authorizations should be “guided by science,” medical societies urged 

From CNN Health’s Shelby Lin Erdman

Food And Drug Administration in White Oak, Maryland.
Food And Drug Administration in White Oak, Maryland. Sarah Silbiger/Getty Images

A group of American medical societies urged the US Food and Drug Administration to use “established scientific standards” in granting any emergency use authorizations or approval of Covid-19 therapies or vaccines, according to a statement issued this week.

“While the ongoing impacts of COVID-19 continue to highlight needs for new and proven tools to combat the spread and effects of this novel coronavirus, the development, evaluation and use of treatment strategies must be guided by science,” the statement said.

To ensure the potential therapies are effective, drug makers must first ensure their safety and efficacy, said the group, which includes the Infectious Disease Society of America, the Pediatric Infectious Disease Society, the HIV Medicine Association, the Society of Infectious Diseases Pharmacists and the Society for Healthcare Epidemiology of America.

The statement follows applications Wednesday for an EUA for monoclonal antibody therapies to treat Covid-19 by Regeneron, the biotechnology company that supplied an antibody therapy to President Donald Trump last week after he was diagnosed with the coronavirus, and the Eli Lilly and Company.

Both companies released only preliminary data from clinical trial results for their therapies, and Eli Lilly’s Phase 2 study involved less than 300 participants. 

“Promising results among small numbers of patients to approaches that include antibody therapies are not a substitute for the rigorous scientific review that is essential to ensuring the safety and effectiveness of medicines,” the statement said. 
“Relying on such limited data can put patients at risk of adverse events, and an EUA can reduce the ability to conduct the clinical trials that are needed to assess the safety and efficacy of antibody treatments.”

The group is urging the FDA “to apply its highest standards and act with appropriate deliberation” before granting an EUA for either of the antibody therapies.

Trump credited the Regeneron treatment for a quick recovery from the virus and promised to make the therapy available to all sick Americans with Covid-19 for free.

1:09 a.m. ET, October 9, 2020

Nurse who has seen "hundreds of people suffocating to death" moved to tears after Trump downplayed coronavirus

From CNN's Kelsie Smith

Cristina Hops posts a video to TikTok reacting to Donald Trump coronavirus statement.
Cristina Hops posts a video to TikTok reacting to Donald Trump coronavirus statement. Cristina Hops/Tik Tok

One nurse has a message for US President Donald Trump: The coronavirus pandemic is still something people should care about.

Cristina Hops, who works on the frontlines helping patients fighting coronavirus, said she was upset after reading the President's tweet on Monday, in which he told Americans "don't be afraid of Covid. Don't let it dominate your life."

"When I read that and I got home, I was just so angry about it that I felt like I needed to say something," Hops, who is based in Seattle, Washington, told CNN.

So, she made a TikTok video, to share her emotions with the world. "I have seen hundreds of people suffocating to death and for him to say do not be afraid of Covid is astounding," she says in the video, while tearing up. "How dare he undermine all of the work that we have done as nurses and health care providers?"

Her message resonated -- and the video quickly garnered more than 300,000 views on TikTok, as of Thursday evening. It's been shared across social media platforms, with people lauding the nurse for speaking her mind.

In her experience as a health care worker, Hops said she has seen how a surge in coronavirus cases can drastically impact a community. She was sent to Miami, Florida, over the summer for five weeks to help a hospital with its influx of cases. 

"The hospital that I was working at was completely overrun," she told CNN. "It's not possible to give everybody the care that they need and deserve when the hospital is that full."

Read the full story here.

1:11 a.m. ET, October 9, 2020

Bill Gates sees monoclonal antibodies like the treatment Trump got as the best way to treat Covid-19 infections

From CNN's Maggie Fox

Bill Gates speaks with CNN on Thursday, October 8, 2020.
Bill Gates speaks with CNN on Thursday, October 8, 2020. CNN

Monoclonal antibody treatments like the one President Donald Trump got may be the most effective approach for treating coronavirus infections, Microsoft founder Bill Gates said Thursday.

Last Friday, Trump was given an antibody cocktail produced by biotechnology company Regeneron which included a pair of monoclonal antibodies that target the spike protein the virus uses to drill into healthy cells. Trump left the hospital and returned to the White House Monday.

Regeneron and pharmaceutical company Eli Lilly and Co. have applied to the US Food and Drug Administration for emergency use authorization for their monoclonal antibody products.

Early data from clinical trials of Eli Lilly and Co’s monoclonal antibody indicates a 60% reduction in hospitalization rates, Gates said. He said Lilly hopes to be able to treat patients with very low doses of the lab-engineered immune system proteins.

Gates said monoclonal treatments may end up being far cheaper than the formulations now used to treat cancer, rheumatoid arthritis and other conditions -- treatments than can run hundreds of thousands of dollars a year, Gates predicted. 

“That’s always been the most promising therapeutic category,” Gates told CNN’s Anderson Cooper. “The early data looks quite good.”

“If everything goes well, the cost of this intervention could be only a few hundred dollars or even under $100,” Gates said.

Gates, who has spun his fortune into a major medical and public health philanthropy, said the Bill & Melinda gates Foundation had invested in manufacturing monoclonals.

Trump has said he thought the Regeneron treatment he was given last week had cured him. 

“The word cure is a bit of an overpromise,” Gates said, laughing. “That makes it sound like it works for everyone and the whole concern about this disease will go away, and that’s the last thing we want people to think about."

1:30 a.m. ET, October 9, 2020

Trump has “knee on the neck” of public health experts preventing them from fighting Covid-19, former CDC director says

From CNN Health’s Shelby Lin Erdman

President Donald Trump walks out of Walter Reed National Military Medical Center to board Marine One in Bethesda, Maryland, on October 5, 2020.
President Donald Trump walks out of Walter Reed National Military Medical Center to board Marine One in Bethesda, Maryland, on October 5, 2020. Chris Kleponis/Polaris/Bloomberg via Getty Images

President Donald Trump and his administration have prevented public health officials from using the might of the country’s foremost disease-fighting agency to properly respond to the deadly coronavirus pandemic, said Dr. William Foege, the former director of the US Centers for Disease Control and Prevention.

"It felt to me like President Trump had his knee on the neck of the public health community holding them down so that they could not actually do their work," Foegoe said in an interview with NPR that aired Thursday. “You can’t sit by and let this happen.”
“You have to have a national plan,” he said. “You can't have 50 states trying to figure this out on their own,” Foege said in the interview, which followed the publication of a private letter he wrote to current CDC Director Dr. Robert Redfield.

USA Today posted the letter online this week.

"I think we've got about the worst response to this pandemic that you could possibly have," said Foege, who was in charge of the CDC from 1977 to 1983.
“The failure of the White House to put the CDC in charge has resulted in the violation of every lesson learned in the last 75 years that made the CDC the gold standard for public health in the world,” Foege wrote.

He told NPR he doesn’t know how USA Today got a copy of the letter, but that he stands by what he said.

In the letter, Foege wrote to Redfield that the Trump administration has “tarnished the CDC’s reputation as the premiere global public health agency through its bungled Covid-19 response, and that the situation in the US “is a slaughter and not just a political dispute.”

Foege told NPR he felt he had to speak up. “If you know how to prevent torture and don't do it, you become the torturer,” Foege said, quoting from the writings of a Holocaust survivor. “This is the burden I found myself living under: that silence was complicity.”

2:50 a.m. ET, October 9, 2020

At least 8,000 mink dead in Utah after contracting Covid-19

From CNN's Cheri Mossburg

Utah ranchers have lost at least 8,000 mink to an outbreak of Covid-19 among the animals known for their silky, luxurious pelts.

The virus first appeared in the creatures in August, shortly after farmworkers fell ill in July, according to Dean Taylor, state veterinarian of Utah. Initial research shows the virus was transmitted from humans to animals, and so far has not seen any cases of the opposite.

“Everything we’ve looked at here in Utah suggests it's gone from the humans to the animals,” Taylor told CNN.

“It feels like a unidirectional path,” he said, adding that testing is still underway.

Some context: This is the first outbreak among mink in the United States, though other cases have been detected in the Netherlands, Spain and Denmark, according to the US Department of Agriculture.

Mink, which are closely related to weasels, otter and ferrets, appear to suffer similar symptoms to humans. Difficulty breathing and crusting around the eyes are usually seen, but the virus progresses rapidly, and most infected mink are dead by the next day, according to Taylor. It’s unclear what makes mink such a susceptible species, while others appear to be unaffected.

Mink join only cats, dogs, a tiger and a lion to be the only confirmed animals with Covid-19 in the US, according to the USDA data.

The cluster of cases in Utah has spread to nine farms, but Taylor warns that “we’re still in the middle of the outbreak.” Each farm is under quarantine with only essential workers permitted on site. Farmworkers are being directed to use proper protective equipment at all times.

The pelts from most of the mink that have died from the virus have been either contained and buried or incinerated. No pelts have left the state, according to Taylor.

8:30 a.m. ET, October 9, 2020

Trump's promises of a vaccine by Election Day are "reckless," ousted vaccine director says

From CNN's Adrienne Vogt

Rick Bright speaks with CNN's Jake Tapper on Thursday, October 8.
Rick Bright speaks with CNN's Jake Tapper on Thursday, October 8. CNN

It is “irresponsible” for President Trump to suggest a Covid-19 vaccine will be developed by Election Day, according to Rick Bright, the ousted director of the office involved in developing a coronavirus vaccine. 

“It’s irresponsible and reckless for the President of the United States to drive the evaluation of something as critical as a vaccine to meet an election timeline,” Bright said to CNN’s Jake Tapper. “…There's no rationale in scientific judgment to move that vaccine to meet that target date. He is not a scientist. He is not a doctor. I say let the scientists do their job.”

Bright said that “scientists are working at breakneck speeds” on a vaccine. 

“It is unprecedented to see how fast they are moving through a lot the steps. The one step you cannot rush is the safety evaluation of that vaccine after it's put into people. It takes time,” Bright said. 

The US Food and Drug Administration said it will want to see two months of follow-up data after volunteers get their second vaccine doses for clinical trials. That would make it nearly impossible for any vaccine maker to apply for emergency use authorization by Nov. 3.