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

November 9, 2020. Summarized by summa-bot.

Vials of Sinovac Biotech Ltd.'s CoronaVac SARS-CoV-2 vaccine are displayed at a media event in Beijing, China, on Thursday, Sept. 24, 2020. Chinese vaccine developer Sinovac said that countries running its final-stage clinical trials like Brazil, Indonesia and Turkey will get its coronavirus shots at the same time as China, underscoring how vaccine supply agreements could cement diplomatic ties in the Covid-19 era. Photographer: Nicolas Bock/Bloomberg

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.

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.

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.

“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.

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.

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 how long Pfizer’s vaccine will offer protection from Covid-19, Burkhardt said.

"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.

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.

"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.

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. ”

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.

by summa-bot

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