Pfizer says Covid vaccine approval unlikely before November third week

Modesto Morganelli
Ottobre 18, 2020

Two American companies expect to apply for emergency approval for their Covid-19 vaccines by late November, welcome news as the United States hits a third surge of its coronavirus epidemic and approaches its eight millionth case. Shares fell slightly of rival vaccine maker Moderna Inc, which is close to Pfizer in its vaccine development.

Inactivated "classic" vaccines use a virus germ that has been killed while others use a weakened or "attenuated" strain that is virulent enough to provoke antibodies but not to cause disease.

The vaccine also must be proven safe.

The first shipment of the vaccine is anticipated for delivery in late 2020 or early 2021 to Kentucky from the U.S. Department of Health and Human Services and the U.S. Department of Defense.

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

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To date, only the result of Phase 1 and 2 trials have been published in peer-reviewed medical journals.

Similar studies in recent weeks have reported on one of the Russian vaccines, along with those from the University of Oxford, Chinese company CanSino, and Moderna.

The U.S. government's Operation Warp Speed program has spent billions of dollars on development of vaccines and treatments.

But that is not necessarily bad news, said Stephen Evans, a professor of pharmacoepidemiology at the London School of Hygiene and Tropical Medicine.

In any case, they are unlikely to be a good substitute for mask wearing, social distancing and other recommended behavior to curb transmission because we don't know how effective they will be.

Companies backed by their governments in China, Russia and the USA are racing to be the first across the finish line.

Each phase will be dependent on how many doses of the vaccine are available.

But there were few takers outside of Russian Federation, and experts dismissed the announcement as premature.

U.S. President Donald Trump and the head of the Centers for Disease Control and Prevention (CDC) have disagreed about when a COVID-19 vaccine would become widely available.

Pfizer is one among several companies in the midst of final-stage clinical trials for potential coronavirus vaccines in the country.

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.

"So let me be clear, assuming positive data, Pfizer will apply for Emergency Authorization Use in the USA soon after the safety milestone is achieved in the third week of November", Mr. Bourla wrote in an open letter.

But even that pressing need can not overcome the rules.

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