Pfizer: Mid-November earliest it can seek virus vaccine OK

Elias Hubbard
October 17, 2020

The regulatory filing for the vaccine could come as soon as safety data is available, possibly in the third week of November, Pfizer said, lifting the company's shares and the broader USA stock market.

Fears of delays were raised after trials for two rival vaccines were put on hold in the United States in recent weeks.

"As far as I know, we already have a third vaccine in development", he added, which is now being tested at the Chumakov research centre of the Russian Academy of Sciences.

In a city in eastern China, the corona vaccine is being sold to people in the high risk group as a separate experiment from clinical trials. "This means we may know whether or not our vaccine is effective by the end of October", Bourla said.

Russian Federation in August became the first country to grant regulatory approval for a COVID-19 vaccine, doing so before large-scale trials were complete, to the concern of some in the global scientific community.

Maduro also said that his son and sister would take part in clinical trials of the vaccine, he himself would be vaccinated at the start of mass vaccination.

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General availability is when every American who wants the vaccine can get it. "The Novosibirsk-based Vektor Centre has registered a second coronavirus vaccine, EpiVacCorona", Russian President Vladimir Putin said.

The scientists have yet to publish the results of the study.

The Food and Drug Administration slightly extended the timeline for any company to file for an emergency use authorization earlier this month when it communicated to companies that it would require two months of safety data to be collected on at least half of the patients in a company's clinical trial. Independent panels oversee the trials to monitor for safety and effectiveness since the data is hidden from companies and researchers. Pfizer/BioNtech said it may have data as early as October, but that it would wait for safety data it expects in the third week of November to file with USA regulators. The U.S. Department of Defense and the CDC plan to start distribution of vaccines within 24 hours of regulatory authorization. The company said an interim analysis of Phase 3 could come in early November.

What's more, the company will also gather manufacturing data to demonstrate "the quality and consistency of the vaccine that will be produced", Bourla said.

In July, the U.S. Department of Health and Human Services and the Department of Defense (DoD) announced an agreement with Pfizer for an initial order of 100 million doses of a coronavirus vaccine for the price of $1.95 billion, following EUA or licensure.

Other reports by Click Lancashire

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