Pfizer says the earliest US filing for the COVID-19 vaccine will be in late November

Pfizer says the earliest US filing for the COVID-19 vaccine will be in late November


Manas Mishra

Michael Arman

(Reuters) – Pfizer Inc.
On Friday, it said it could file at the end of November the US authority for the COVID-19 vaccine that is developing it, suggesting that a vaccine might be available in the United States by the end of the year .

File Photo: File Photo: New York City, New York, US, July 22, 2020 A portrait is printed outside the Pfizer headquarters in Manhattan Borough. REUTERS / Carlo Allegri / File Photo / File Photo

This deadline is unlikely, however, as a vaccine will be available before the US election, as President Donald Trump has promised. Pfizer, which is developing the vaccine with German partner BioNTech
, Said it could confirm that the vaccine is as effective as this month but requires safety data from a 44,000-person clinical trial that will not be available until next month.

Pfizer News, published in a letter from the CEO on its website, removed the US stock market and the company’s shares. Shares fell slightly to rival vaccine maker Modern Inc.
, Which is close to Pfizer in its vaccine development.

Pfizer Chief Executive Albert Borla said, “If positive data is to be believed, Pfizer will apply for emergency authorization in the US soon, as the safety milestone will be achieved in the third week of November. Timeline for vaccine Provide more clarity on.

People worldwide are relying on a vaccine to control the spread of coronovirus, which has killed more than one million people and devastated the global economy.

In recent weeks fears of delays were raised for testing two rival vaccines in the United States.

Trump has repeatedly stated that a vaccine will be available before the November 3 election.

When asked about Pfizer’s news, White House spokesman Jude Deere said, “The president hopes we will have one or more vaccines before the end of the year.”

The US government’s Operation Tana Gati program has spent billions of dollars on the development of vaccines and treatments. Pfizer has signed an agreement to purchase vaccine shots if they work.

But the rush to develop the vaccine has raised concerns that the US Food and Drug Administration may act hastily, not review enough.

US health officials have sought to assimilate those concerns. Earlier this month, the FDA formalized a requirement that vaccine-makers collect two months of safety data on one-half of trial participants.

Pfizer is trying to show that its decision is being driven by science rather than politics, said Mizuho analyst Wamil Diwakar.

“It’s only a small part of bringing it to market,” said Divan. “People really need to be willing to take it.”

Rival vaccine-maker Modern may also apply for an Emergency Use Authority (EUA) this year. It said it may have interim data as of November on its 30,000-person test.

Both companies are also applying for approval in Europe, where they are running against AstraZeneca plc
. US trial of AstraZeneca has been on since September, while a Johnson & Johnson candidate’s US trial
It was halted earlier this week.

After the FDA announced a two-month requirement on October 6, which was approved by the White House but reduced the likelihood of a vaccine before voters voted, Trump called the move a “political hit job.”

In addition to safety and efficacy, the FDA will also examine Pfizer’s manufacturing operations for the vaccine.

A BioNTech spokesperson confirmed the deadline for a possible EUA application to the FDA.

Pfizer shares rose 3.5% in afternoon trading, while Bio-Tech’s US-listed shares gained 3.9%. Modern shares lost 1.5%.

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