November 10 coronavirus news

By Zamira Rahim, Stephanie Halasz, Ben Westcott, Steve George, Emma Reynolds, CNN

Updated 0504 GMT (1304 HKT) November 11, 2020
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2:37 a.m. ET, November 10, 2020

Brazil’s Health Surveillance Agency suspends Phase 3 trials of China's CoronaVac vaccine

From CNN’s Tatiana Arias in Atlanta

Vials of Sinovac Biotech Ltd.'s CoronaVac SARS-CoV-2 vaccine are displayed at a media event in Beijing, China, on September 2020.
Vials of Sinovac Biotech Ltd.'s CoronaVac SARS-CoV-2 vaccine are displayed at a media event in Beijing, China, on September 2020. Nicolas Bock/Bloomberg/Getty Images

Brazil’s National Health Surveillance Agency (Anvisa) has suspended phase 3 clinical trials of a Chinese-developed Covid-19 vaccine following an "adverse" incident involving a volunteer recipient, according to sources cited by CNN’s affiliate, CNN Brasil.

CoronaVac, developed by Chinese pharmaceutical company Sinovac Biotech, began phase 3 trials of CoronaVac in collaboration with the Brazilian Butantan Institute in Sao Paulo in late July.

According to CNN Brasil, the studies were suspended due to the "occurrence of serious adverse event in one of the volunteers in Brazil." No further details were provided owing to privacy regulations.

The pause in testing marks a potential setback for one of China's leading vaccine candidates and comes as US drugmaker Pfizer said Monday that early data from its own coronavirus vaccine showed more than 90% effectiveness.

In a note obtained by CNN Brasil, Anvisa mentions a case on October 29 for which the agency “determined the interruption of the clinical study,” adding that it “decided to interrupt the study to evaluate the data observed so far and judge on the risk/benefit of continuing the study.”

“With the study interrupted, no new volunteers can be vaccinated,” reads the Anvisa note published by CNN Brasil late Monday.

The CoronaVac trial vaccine uses inactivated virus cells to stimulate an immune response in patients. Testing began in late July, with 9,000 volunteers in five Brazilian states plus the capital. 

The Butantan Institute said it will hold a press conference Tuesday morning local time, according to CNN Brasil.

12:25 a.m. ET, November 10, 2020

Pfizer seeks to reassure that its Covid-19 vaccine is safe, that “no corners were cut”

From CNN Health’s Shelby Lin Erdman

“No corners were cut” in the development of Pfizer’s 2-dose coronavirus vaccine, the company’s vice president of research and development, Dr. John Burkhardt, said at a news conference in Connecticut Monday.

“Pfizer has been in the vaccine business for quite a number of years with many products on the market, many also in development for other infectious diseases,” Burkhardt said. 
“So, with this particular vaccine no corners were cut. We followed this tried and true methodology that has worked so well for us in the past and continues to deliver really superior and safe products,” he added. 

Burkhardt said what’s been unusual in the development of its Covid-19 vaccine is that the company started the manufacturing process at the same time it was developing the vaccine, something that is not usually done.

“Normally you wouldn't spend $1 billion to manufacture a product that may not work. You wait to see whether it works and whether it's safe and then you do the manufacturing. So, we did that at risk,” he said. 

It was a decision made very early in the process to save time, Burkhardt said. He also credited “great volunteerism” in getting 43,000 people enrolled in the clinical trials as a time saver in the development process.

Pfizer announced Monday that early efficacy data on its Covid-19 vaccine appears to be more than 90% effective, much better than expected.

12:25 a.m. ET, November 10, 2020

Pfizer says 42% of volunteers in Covid-19 vaccine trials are from diverse backgrounds

From CNN Health’s Shelby Lin Erdman

Almost half of the volunteers in Pfizer’s Phase 3 clinical trials for a coronavirus vaccine are from diverse backgrounds, the company’s vice president of research and development, Dr. John Burkhardt, said at a news conference in Connecticut Monday.

“Our approach has been to really enroll lots of patients, gain lots of diversity in that population, go into the places where we can enroll diversity and then to learn from that data as it plays out in the study,” Burkhardt said.

Pfizer is studying 43,000 patients in its vaccine trials, he said, and 42% are from ethnic and racial backgrounds that are considered diverse.

It’s unclear whether the vaccine may not benefit some populations or if there might be side effects associated with it.

“We don't have the sub-level of detail to answer those, but we believe we've got the kind of clinical trial design and some simple data set that will be very informative,” he said.

Pfizer announced Monday that early data on its Covid-19 vaccine shows it appears to be more than 90% effective at preventing infection.

2:36 a.m. ET, November 10, 2020

Fauci says he has "no intention of leaving" role as NIAID director

From CNN Health’s Lauren Mascarenhas

Dr. Anthony Fauci
Dr. Anthony Fauci CNN

Dr. Anthony Fauci said Monday that he plans to remain in his role as director of the National Institute of Allergy and Infectious Diseases through the remainder of the Trump administration and into President-elect Joe Biden’s administration.

"I have no intention of leaving," Fauci told CNN’s Wolf Blitzer. "This is an important job. I've been doing it now for a very long time. I've been doing it under six presidents."

"It's an important job, and my goal is to serve the American public, no matter what the administration is," he added.

Fauci warned that the United States was in a "serious situation" with cases exceeding 100,000 a day, but said the country "can turn it around."

"Unfortunately, we predicted it when we were talking about the fact that as we enter into the coolest season of the fall and the upcoming coldest season of the winter, that you're going to start seeing more indoor activity, and we never got down to a good baseline," said Fauci, the nation's top infectious disease expert.

He said "help is on the way with a vaccine," following the announcement by Pfizer on Monday that early data shows its vaccine is 90% effective.

"The bottom line is as a vaccine, it's more than 90% effective, which is extraordinary and will play a major role in what the outcome of this is going to be," Fauci told Blitzer.

The Data and Safety Monitoring Board, an independent group that monitors vaccine trials, "has ... told us that we now have a vaccine that is more than 90% effective," said Fauci.

"Obviously, we need to go over the details of the data, but this is a highly reputable company that has extensive experience in the development of countermeasures, including vaccines," Fauci said.

He said there were still questions about how long the vaccine would protect people for, and how effective it is in the elderly versus younger people, but that it was "good news" both in the immediate term and for other vaccines from companies such as Moderna, which work along similar lines.

He emphasized, though, that while Americans should feel good about the news, no one should let their guard down yet.

"We know there's light at the end of the tunnel, but that doesn't mean that we're going to give up the important public health measures that we continually still have to do every single day," said Fauci.