Pfizer, Moderna COVID vaccines could be ready for United States use in weeks

Daniel Fowler
November 20, 2020

Pfizer Inc PFE.N and BioNTech 22UAy.DE could get emergency U.S. and European approval for their COVID-19 vaccine in December after final trial results showed a resounding 95 per cent success rate without serious side effects, the drugmakers said on Wednesday, according to news agency Reuters. Pfizer and BioNTech said they expect to manufacture up to 50 million doses globally this year, with about half of the doses going to the US -or enough to vaccinate 12.5 million Americans with the two-shot regimen.

The share price of Pfizer gained significantly on Thursday after the American pharmaceutical corporation (Pfizer Inc) said that the final results from the late-stage trial of its COVID-19 vaccine were 95 percent effective.

Glimpses of the Pfizer data through news releases have so far exceeded expectations: The two-dose vaccine regimen was 95 percent effective at preventing disease in clinical trials and had no major safety problems, according to the company.

Pfizer's announcement that it will file for emergency authorization follows two weeks of blockbuster vaccine news, a period during which more than 1.5 million people in the United States were diagnosed with covid-19, the illness caused by the coronavirus.

"Depending on how fast this [review] is really accomplished, we might get an authorization, or conditional approval already in 2020 which might help us start distribution of the first vaccine batches already in 2020", Şahin told CNN.

The technology uses synthetic versions of molecules called "messenger RNA" to hack into human cells, and effectively turn them into vaccine-making factories. The first-available vaccine doses will initially go to these administration sites.

The scientific head of the USA operation to develop a vaccine, Moncef Slaoui said Monday that the green light would probably come in December - a timeframe echoed by Sahin.

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Other covid vaccines have been developed and used in Russian Federation and China, but before completing the rigorous tests that Pfizer and Moderna underwent.

A key challenge with BioNTech/Pfizer vaccine lies in the distribution, since it needs to be stored at minus 70 degrees Celsius (-94 degrees Fahrenheit).

A decision on Pfizer's vaccine won't affect other COVID-19 vaccine candidates in the pipeline, which will be judged separately.

The Sputnik vaccine, developed in Russian Federation, has also released early data from phase three based on a smaller number of volunteers and Covid cases.

None of the funds would have had a place to go without the work of scientists who developed vaccine manufacturing techniques for decades. In particular, Fauci said, the United States government has been working with Moderna for years on the development of mRNA technology. Since the success of the studies depended on the accumulation of a certain number of cases of covid-19, the out-of-control epidemic, as bad as it is for the country, meant that trials were able to accumulate cases and produce clear results quickly. Nine of them were observed in the placebo group and one in the BNT162b2 group. First, regulators need to be absolutely sure in their own minds that it's safe - not least because Moderna and Pfizer both use an experimental technology that's never been approved before.

By October, both trials had tens of thousands of participants and infections in the USA soared. While he suffered side effects such as fatigue and pain from the injection, it was worth contributing to the process, he says.

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