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

University of Maryland School of Medicine the first patient enrolled in Pfizer's COVID-19 coronavirus vaccine clinical trial at the University of Maryland School of Medicine in Baltimore receives an injecti

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

Pfizer Inc. can not request emergency authorization of its COVID-19 vaccine before the third week of November - and that's if everything goes well, the company's CEO announced Friday.

The FDA said earlier this month that, before it reviews a coronavirus vaccine application, a company must have safety data that extends for a median of two months.

Bourla said Pfizer could know whether the vaccine is effective by the end of October, and that it is likely obtain the required safety data by the third week of November.

"WASHINGTON" The US pharmaceutical giant Pfizer expects to file for emergency use authorisation for its Covid-19 vaccine in late November, around two weeks after the Nov 3 US presidential election, it said on Friday.

"We are working at pace for the delivery of any potential COVID-19 vaccination programme as quickly as possible, but the scale of what is rolled out and when will depend on a safe, effective vaccine being available", he said.

In an interview with Pharmacy Times, Haydock said the rate at which these companies have progressed through the vaccine development process is unprecedented. Pfizer is partnering with the German company BioNTech on the research.

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

"Once we have a vaccine, we can aim to have population immunity, herd immunity, because you'll need to vaccinate at least 70 per cent of people, have them protected, to really break the transmission", she said. This effectively turns a person's own body into a vaccine factory, avoiding the costly and hard processes that more traditional vaccine production requires.

That requires a massive amount of spending both by state and local governments and by federal agencies like the Centers for Disease Control. Money for vaccine distribution was allocated in drafts of the stimulus bill that has not yet been passed, amid opposition from Senate Republicans and inchoate negotiating tactics from the President.

Without further data on how effective the vaccine is and how long immunity from it may last, it's also hard to know what impact any of the shots now in phase III trials will have on controlling the pandemic.

The upshot is the USA could roll out a vaccine before the end of the year, inoculating health care workers and first responders first. Widespread mask use might also mean that when people do get infected, they have less virus in their body which makes them less sick.

The vaccine must reduce the risk of infection by at least 50% in order to be considered for FDA emergency authorization. The efficacy of any of the vaccine candidates in trials has yet to be determined.

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