November 9 coronavirus news

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.

“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.

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.

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.

The US state of New Mexico reported its highest number of new Covid-19 cases Monday, with 1,418 infections.

New Mexico previously reported its highest daily case load on Friday, with 1,287 new cases and recorded the exact same figure the following day.

The Department of Health said the state’s Intensive Care Units are at 66% capacity. That includes both Covid and non-Covid ICU patients.

The distribution of Pfizer’s two-dose coronavirus vaccine will be a “logistical challenge” because the shot needs to be stored at freezing temperatures, according to Dr. John Burkhardt, Pfizer’s vice president of Global Drug Safety Research and Development.

"We're working very hard on that," he said. "There's a whole suite of very experienced and talented people at Pfizer who are solely working on this, an army of people, and so it's going to be important to work with the authorities with state governments and others to provide that supply chain." 

State health officials have expressed concerns about the requirements for Pfizer’s vaccine, which must be stored at extremely cold temperatures of -94 Fahrenheit (-70 Celsius) -- far below the capacity of standard freezers.

It’s unclear how long Pfizer’s vaccine will offer protection from Covid-19, Burkhardt said. Pfizer will follow the volunteers in the clinical trials for two years "with an emphasis on safety" but will also collect other types of data, he added.

"We just need some time for this to play out," Burkhardt said when asked whether the vaccine might help prevent more severe cases of Covid-19 or asymptomatic cases.

He emphasized Pfizer's years of experience in vaccine development and said "no corners were cut" with this one.

"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 was unusual this time was that the company started the manufacturing process at the same time it was developing the vaccine -- something that is not usually done.

Burkhardt also credited "great volunteerism" in getting 43,000 people enrolled in the clinical trials as a time-saver in the development process.

"We also moved over 150 sites for clinical studies, and we were able to really emphasize locations where virus was spreading more quickly," he said.

The US Food and Drug Administration said Monday it had issued an emergency use authorization for Eli Lilly and Co’s investigational monoclonal antibody therapy bamlanivimab to treat mild to moderate coronavirus infections in adults and children.

"The FDA's emergency authorization of bamlanivimab provides health care professionals on the frontline of this pandemic with another potential tool in treating COVID-19 patients," Dr. Patrizia Cavazzoni, acting director of the FDA’s Center for Drug Evaluation and Research, said in the statement. "We will continue to evaluate new data on the safety and efficacy of bamlanivimab as they become available."

Road to authorization: The FDA authorization was based on a study published in the New England Journal of Medicine in October. It found that the treatment seemed to lower the risk of hospitalization and ease some symptoms in a small number of patients with mild to moderate case Covid-19.

The Phase 2 trial involved 452 patients, some of whom received the treatment and some of whom received a placebo.

Only 1.6% of patients who received the treatment had to be hospitalized or seek care at the emergency room. For patients who got the placebo, the rate of hospitalization was 6.3%. 

Eli Lilly announced it had struck a $375 million deal with the government for 300,000 vials of the antibody treatment, pending emergency use authorization, to be delivered in the two months after.

The company said it planned to have 100,000 doses ready to ship within days and would manufacture a million doses by the end of 2020. The treatment would be provided to patients at no cost.

The FDA said that based on its review of the evidence available, it was "reasonable to believe that bamlanivimab may be effective in treating non-hospitalized patients with mild or moderate COVID-19" and that "the known and potential benefits outweigh the known and potential risks for the drug.”

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.

"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."

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 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.

Ohio is seeing "an unprecedented spike in hospitalization, and it is impacting all areas of the state," Bruce Vanderhoff, incoming chief medical officer at the Ohio Department of Health said in a news conference on Monday.  

Vanderhoff said waves of the virus in the spring and summer were much smaller and everyone was able to pull together and reduce spread and avoiding overwhelming hospitals.

While Ohio has more PPE and capacity than they did in the spring, cases are surging and the demands on staffing are increasing. "Every county in the state is feeling the brunt of rising Covid-19 hospitalizations," he said. 

In the spring, Governor Mike DeWine worked with the Ohio Hospital Association to create a comprehensive statewide public health system, bringing together hospitals and healthcare providers to support each other during the pandemic.

Ohio is not the only state in which hospitals are under increased pressure.

Connecticut Governor Ned Lamont said on Monday that hospitalizations there had doubled in the past few weeks. Fatalities have also been increasing monthly for the past three months.

But Lamont said that hospital capacity was not an issue at this time and that only 50% of the ICU is currently in use. 

Saturday’s college football game between Auburn and Mississippi State has been postponed due to Covid-19 cases within Mississippi State’s program.

The Southeastern Conference (SEC) announced the Bulldogs have had positive tests and are subsequently quarantining. 

The game has been tentatively rescheduled for December 12. 

Louisiana State's head football coach Ed Orgeron admitted on Monday that several of the team's players, including starters, have Covid and are quarantining.

When asked about the status of Saturday’s game against Alabama, Orgeron said it was "very fluid right now."

No. 5 Texas A&M were forced to halt their football activities on Monday after receiving multiple positive coronavirus tests.