Saturday, 31 October, 2020

CEO says Pfizer can't seek virus vaccine OK before mid-November

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Ginger Lawrence | 17 October, 2020, 14:31

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.

In addition, the company has to prove that the vaccine is safe and the U.S. Food and Drug Administration requires that companies provide two months of safety data on half of the trial participants following the final dose of the vaccine, according to Pfizer.

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

The upshot is the USA could roll out a vaccine before the end of the year, inoculating health care workers and first responders first.

The World Health Organisation (WHO) on Wednesday said healthy young people might have to wait until 2022 to be vaccinated against Covid-19, as it warned against complacency in the disease death rate.

That October timeline sounded even more aggressive when Moderna CEO Stephane Bancel, known for touting ambitious goals, said his company's shot, which was the first in the move into clinical testing, likely wouldn't have data until November.

Pfizer: Mid-November earliest it can seek virus vaccine OK
The SII executive director further said that the institute will be ready with around 60-70 million of COVID-19 vaccines before January 2021.

New cases are hitting 100,000 daily in Europe. It won't make COVID-19 magically disappear overnight.

"First, the vaccine must be proven effective, meaning it can help prevent COVID-19 disease in at least a majority of vaccinated patients".

She explains "There will be a lot of guidance coming out, but I think an average person, a healthy, young person, might have to wait until 2022 to get a vaccine".

Pfizer and Moderna, both with funding assistance from the U.S. government, launched Phase 3 of their clinical trials at the end of July, and both have started production of doses. They aim to deliver tens of millions of doses in the USA by the end of the year. Russian Federation approved a vaccine in August, without widespread testing. They both inject people with the genetic material necessary to grow the "spike protein" of SARS-CoV-2 inside their own cells, thus eliciting an immune response the body will remember when it encounters the real virus. Topol recently had a virtual meeting with company executives to express his concerns and said he was frustrated they would not answer directly when he asked if they would seek broader use of a vaccine before November 3.

Several drugmakers including Pfizer, AstraZeneca, Johnson & Johnson and Novavax Inc have said they expect to produce at least 1 billion doses of their vaccines next year if they get regulatory authorization.