Pfizer to seek approval for Covid-19 vaccine candidate next month

Daniel Fowler
October 17, 2020

But effectiveness is only one of three metrics Pfizer will use for applying its vaccine for public use, he added.

Pfizer CEO Albert Bourla has long said it's possible that testing might reveal by the end of October whether his company's vaccine actually protects against the coronavirus. Speaking at a World Health Organization social media event, Dr. Swaminathan said that despite the global efforts for developing a COVID-19 vaccine and several candidates undergoing clinical trials, speedy and mass inoculation was highly unlikely.

Pfizer, which is developing the vaccine with German partner BioNTech SE, has agreed with the Japanese government to supply the country with 120 million doses of a vaccine for 60 million people if the development efforts are successful.

In an open letter released Friday, Pfizer CEO and Chairman Albert Bourla said that "assuming positive data, Pfizer will apply for Emergency Authorization Use in the USA soon after the safety milestone is achieved in the third week of November". This effectively turns a person's own body into a vaccine factory, avoiding the costly and hard processes that more traditional vaccine production requires.

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. And to qualify for "emergency-use authorization", any COVID-19 vaccine must track at least half the participants in large-scale studies for two months after their second dose, the time period in which side effects are likely to appear.

Vaccine roll out being considered for December, as sources say likelihood is '50/50'

AstraZeneca Plc has said it could deliver as many as 300 million doses of its experimental vaccine in the United States as early as October but its USA trial has been on hold since September. As each vaccine is approved, SAGE will publish guidance on how to distribute it.

Last month, President Donald Trump said that a COVID-19 vaccine would be distributed within 24 hours of completion of phase 3 trials and FDA approval.

The FDA will require the vaccine to prove effective and safe, while Pfizer will have to demonstrate it is capable of producing large-scale production.

State media reported that Sinopharm was offering its vaccines for students in Beijing and Wuhan, the place where the virus first emerged at the end of 2019.

"I think most people agree that the people at highest risk of both transmission, getting the disease, and getting sick from it are health care workers, frontline workers and then the elderly and the vulnerable", she said. The efficacy of any of the vaccine candidates in trials has yet to be determined.

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