Pfizer to seek emergency approval for COVID vaccine next month

Pfizer to seek emergency approval for COVID vaccine next month

"Maine is committed to working with the health care sector and stakeholders across the state as we plan for the receipt and distribution of a vaccine when one becomes available", Gov. Janet Mills said in a statement. Pfizer is partnering with the German company BioNTech on the research.

"So let me be clear, assuming positive data, Pfizer will apply for Emergency Authorization Use in the US soon after the safety milestone is achieved in the third week of November", Mr. Bourla wrote in an open letter.

"Right now, our model, our best case, predicts that we will have an answer by the end of October", Bourla previously said on the "Today" show.

Pfizer, the apparent frontrunner in developing a COVID-19 vaccine for the United States, says its results won't be ready until mid-November at the earliest.

He said the firm will apply for emergency authorization with the US Food and Drug Administration shortly after the safety milestone is achieved.

In an open letter published on the company's web site, Pfizer (PFE) chairman and CEO Albert Bourla said that there must be certainty that the vaccine is safe and will satisfy regulators' standards.

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Meanwhile, a 50 euro double-dose experimental coronavirus vaccine is being made available to some residents in an eastern Chinese city, health officials have said, the first details of a mass rollout for an as-yet unproven vaccine.

All of the data would then need to be reviewed by the FDA itself as well as by an independent external panel of experts "at a publicly held meeting convened by the agency". It has said that it may have interim data on its 30,000 person trial as soon as November. For example, some vaccine candidates require refrigerated storage and two doses.

A BioNTech spokesperson confirmed the time frame for the potential EUA application to the FDA.

Despite President Trump's repeated promises of a vaccine before election day, scientists have been cautioning that it's unlikely that data showing a shot actually works would come until November or December.

The first patient enrolled in Pfizer's COVID-19 coronavirus vaccine clinical trial at the University of Maryland School of Medicine in Baltimore received an injection in May.

"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.

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