Pfizer vaccine on track for regulatory review in October – tech2.org

Pfizer vaccine on track for regulatory review in October


Coronavirus Vaccine Research at Valneva SA Labs

Photographer: Echoes Stiller / Bloomberg

Pfizer Inc. and BioNTech SE said the Kovid-19 vaccine they are developing jointly is to be submitted for regulatory review in early October, as they released additional data from an early-stage study.

The companies stated that the vaccine was well tolerated in less than 20% of participants with mild to moderate fever. He said the companies are releasing data from Phase I trials in the US and Germany Statement.

Confirm their October goal, first Announced last month, it briefly helped lift the S&P 500 futures on Friday, as an intoxicating part of positive news on inoculation efforts that have the potential to end the threat of harmful lockdowns.

The timeline will make it one of the fastest running vaccines in the world. Some analyst It is expected that the US will be approved to use the vaccine by November, a move that could give President Donald Trump a new foothold in the election.
Pfizer and BioNTech signed a $ 2 billion deal last month to supply the initial 100 million doses of the vaccine to US governments around the world. hope Stopping the spread of the virus, stabilizing local economies and consuming around 800,000 people worldwide.

US Food and Drug Administration is temporarily Planning an advisory panel to meet on October 22 to discuss the Kovid-19 vaccine, although it is not specified which vaccines, or how many, will be investigated.

Some of the fast-moving efforts around the world have begun to evaluate efficacy, paving the way for regulatory signoffs in the final stages of testing. Russia earlier this month approved a vaccine called Sputnik V, developed by Moscow’s Gamalaya Institute and the sovereign Russian Direct Investment Fund, and plans to administer it widely in October, although the shot is still on Is also in the midst of human trials. Is drawn Criticism of scientists over mass vaccination concerns when the safety profile of the drug remains unclear.

Vaccine pioneers in China have sent their shots to virus hotspots around the world, such as Brazil, Indonesia and Saudi Arabia, to conduct last-stage trials. State-owned pharmaceutical manufacturer The Sinopharma Group company said this week that two inactivated vaccines developed by the company’s subsidiaries will be available by the end of the year and will be priced at less than 1,000 yuan ($ 145) for the two doses. Beijing-based vaccine manufacturer Synovac Biotech Ltd expects its shot to win regulatory approval early next year.

– Assisted by Sharon Chen and Dong Luu

(Updates with background from sixth paragraph)

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