Pfizer plans emergency use of Covid-19 vaccine after US election

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Pfizer plans to provide safety data and a dossier for the authorization of the Covid-19 vaccine that it is developing with its German partner BioNTech at the end of November, delaying any clarity on the vaccine after the US presidential election of November 3.The vaccine’s regulatory filing could come as soon as safety data becomes available in the third week of November, Pfizer said, lifting the company’s shares and the US stock market as a whole.

The schedule now allows for possible US authorization of a coronavirus vaccine this year, a key step in bringing a pandemic under control that has killed more than a million people and devastated the global economy.

The U.S. Food and Drug Administration has said it wants at least two months of safety data before allowing emergency use of any investigational coronavirus vaccine.

Pfizer CEO Albert Bourla noted in a letter posted on its website that the filing depended on several factors, including efficacy data that may or may not be available at the end of October.

Based on the current trial enrollment and dosing pace, Pfizer expects to have safety data by the third week of November, Bourla said.

An emergency use authorization filing with the United States Food and Drug Administration could come “soon after” the data is ready, Bourla said.

Bourla said data on the vaccine’s effectiveness may come sooner or later, depending on whether the late-stage vaccine trial has accumulated enough patients with COVID-19 to compare its effectiveness to a placebo.

Pfizer had previously said it expected late stage testing data in October.

BioNTech was not immediately available for comment.

Pfizer shares rose 1% before the market was traded, while BioNTech’s US-listed shares rose 2.4% before the opening bell.

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