Pfizer to seek emergency approval for COVID vaccine next month

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But in Friday's announcement, he made clear that effectiveness is only part of the equation.

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.

What about October? That's when the company might know whether the vaccine, dubbed BNT162, is effective, but the company still needs to gather enough safety data for an application, Bourla explained.

Samir Deb, pharmaceutical professional, consultant vaccine and public affairs consultant, Southeast Asia, said, "Proven success factors of H1N1 and Ebola have turned out guiding principles in Covid-19 vaccine development".

"Based on our current trial enrollment and dosing pace, we estimate we will reach this milestone in the third week of November". "All the data contained in our US application would be reviewed not only by the FDA's own scientists but also by an external panel of independent experts at a publicly held meeting convened by the agency". This would allow the companies to file for an emergency use authorization.

This comes at a time when COVID-19 cases in the US are climbing slightly, but the coronavirus deaths are relatively level this month. In October, "the truth will be revealed", was what he told The Washington Post.


Out of the three vaccine candidates in mass, phase III trials, Moderna had already committed to asking for emergency approval in late November. The company pointed out that illnesses, even severe cases, "are an expected part of any clinical study, especially large studies".

That's a clear shift from Bourla's previous comments, which constantly featured "October" as the key word-at a time when President Donald Trump was touting a vaccine before the November 3 election, and mentioning Pfizer by name. And that information will be ready before the safety readout, he said. "Distribution will begin within 24 hours", President Trump said.

The coronavirus vaccine will be free for all Americans, but initially the COVID-19 vaccine will likely be available to higher-risk groups, such as health care workers, essential workers, the elderly, and those with health conditions that make them more vulnerable to COVID-19.

White Paper: Why Test Your COVID-19 Therapies for Auditory Safety?

The timeline now allows for a possible United States authorization of a coronavirus vaccine this year, a key step in controlling the COVID-19 pandemic, which has killed more than a million people and ravaged the global economy.

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