Pfizer eyes emergency use approval for vaccine in November

Pfizer eyes emergency use approval for vaccine in November

"These legal changes will help us in doing everything we can to make sure we are ready to roll out a safe and effective COVID-19 vaccine as soon as it has passed clinical trials and undergone rigorous checks by the regulator", health minister Matt Hancock said.

Bourla noted the Food and Drug Administration is asking for two months of data on half of the participants in a vaccine trial following the final dose of a vaccine before it would grant Emergency Use Authorization in the US.

Albert Bourla, the CEO of the Rockland-based drug maker, says they could ask USA officials to clear the way for the vaccine by the third week of November.

"I know there is a great deal of confusion regarding exactly what it will take to ensure its development and approval, and given the critical public health considerations and the importance of transparency, I would like to provide greater clarity around the development timelines for Pfizer's and our partner BioNTech's COVID-19 vaccine", Bourla said.

"Each of the information in our U.S. program could be assessed not only by the FDA's scientists but also by an outside panel of independent experts at a publicly held assembly convened by the bureau".

Bourla said the filing depended on several other factors, including initial data on effectiveness that may or may not be available by late October. As countries worldwide work to establish guidelines about prioritizing who gets the vaccine and when, healthcare officials said that the most vulnerable groups and those at the highest risk of getting sick from COVID-19 should be first in line.

A BioNTech spokeswoman confirmed the time frame for the possible EUA application to the FDA.

Sanofi SA and GlaxoSmithKline Plc are also working on developing a vaccine they say could be authorized next year. To address this fear and mistrust, the Baker administration's plan has a three-part communication strategy that includes messages created by an outside firm, broadcast and social media ads, and outreach to Black, Latinx, and other communities that are experiencing disproportionately high hospitalization and death rates due to the COVID-19 pandemic. Another US trial of a candidate from Johnson & Johnson was paused earlier this week. They aim to be in a position to deliver tens of millions of doses to the United States by the end of the year.

"Vaccines are the best way we have to prevent infectious disease", Friedlander said.

The announcement means the United States could have two vaccines ready by the end of the year, with MA biotech firm Moderna aiming for November 25 to seek authorization.

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