Pfizer to file for emergency use authorization in November

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Pfizer may file for emergency use authorization in November for the experimental Covid-19 vaccine it is developing with BioNTech.

According to Pfizer, filing for emergency use authorization could happen as soon as safety data is available.

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The schedule now allows for a US authorization of a coronavirus vaccine in 2020.

Earlier this month, the US Food and Drug Administration said it will authorize the emergency use of any experimental coronavirus vaccine after at least two months of safety data on half of the trial participants.

However, President Donald Trump described the new rules as a “political hit job” as they reduce hopes of having a vaccine before Nov. 3.

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In an open letter, Chief Executive Officer Albert Bourla said they expect to have that safety data in the third week of November.

He added that several other factors affect the filing, including initial data on effectiveness that may or may not be available by late October. He added the company plans to present efficacy data to the public as soon as practical.

Results in October

In September, Bourla announced that Pfizer’s late-stage testing may produce results as early as October.

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“We expect by the end of October, we should have enough … to say whether the product works or not,” he said.

US health officials have previously announced that findings from late-stage testing could be available in November or sooner.

Pfizer’s potential Covid-19 vaccine is one of three supposed by the US that is currently in late-stage testing. Pfizer has been working on its candidate vaccine with German drugmaker BioNTech. Their potential vaccine involves the use of genetic material called messenger RNA, or mRNA. In July, the company announced promising data from its early-stage trial.

The Pfizer late-stage testing is expected to have 30,000 participants between the ages of 18 and 85 across 120 sites from different parts of the world, including 39 US states, according to the company.

Once the testing has become successful, the company will submit it for the final regulatory review as early as October. They will release 100 million doses by the end of 2020 and around 1.3 billion doses by the end of 2021.

In July, the White House said it would pay Pfizer and BioNTech $1.95 billion to develop and distribute 100 million doses of their Covid-19 vaccine if it is proven effective and safe. The agreement was sealed as part of Operation Warp Speed, the Trump administration’s program that aims to speed up the development and manufacturing of vaccines and treatments to kill the coronavirus.

The CEO’s statement comes as the Centers for Disease Control and Prevention calls on state governors and local health departments to set up their distribution zones for a Covid-19 vaccine as soon as November. With this, health experts are concerned that the deadline will be politically motivated and that regulators are being pressured by the White House to come up with a vaccine ahead of the presidential election on November 3.

Meanwhile, drug company executives, including from Pfizer, stressed they are not cutting corners to develop vaccines. They noted that the Food and Drug Administration has not relaxed its requirements for evaluating the safety and effectiveness of their vaccines.

According to executives, it is “understandable” that the public has concerns, stressing that they will need to work to establish trust.