Pfizer, BioNTech's final Covid-19 vaccine study shows 95% efficacy


An Emergency Use Authorization (EUA) is expected to be submitted to the U.S. Food and Drug Administration (FDA) within days.

The Pfizer-BioNTech and the Moderna COVID-19 messenger RNA vaccines, by contrast, have been developed in less than a year.

The companies expect the FDA to grant the EUA by mid-December and said they will begin shipping doses nearly immediately. The filing could enable its use by the middle to the end of December, the companies said in a statement.

Azar and Fauci were clearly encouraged by the flood of good news from Pfizer, its vaccine partner BioNTech and Moderna.

And BBC health correspondent Naomi Grimley says this vaccine is still a long way off widespread use, not least because it adopts an experimental technology that has never been approved before. It took 15 years to develop a vaccine for human papilloma virus, which can cause six kinds of cancer.

How was this vaccine developed so quickly?

In October, FDA officials told vaccine makers they should have two months of safety follow-up from half of the people enrolled in their studies before requesting emergency authorization.

USA pharmaceutical giantPfizerandBionTech, a small German biotechnology company, announced Wednesday that their vaccine was effective by 95% for the prevention of Covid-19, based on the complete results of its large-scale clinical trial.

The application and clinical trial data will be reviewed by an independent board of scientists before approval is granted. The agency will make the decision on a case-by-case basis, a spokeswoman said. "Widespread success of coronavirus vaccines would be a huge boon to the world's health, because Pfizer and BioNTech alone can not meet the full demand". Of those, 162 were in the placebo arm of the trial and only eight received the vaccine.

"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.

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Full details on the study are yet to be published, however, the latest press release from Pfizer offers a little more data than the company's previous announcement.

The vaccine was shown to be well tolerated in a review of unblinded reactogenicity data from the final analysis.

The advisory panel is expected to consider whether the vaccine was shown to work safely in certain racial, ethnic and age groups, and give a recommendation whether the vaccine should be authorized and for whom.

This week the companies said their vaccine was 95% effective.

Standard statistical methods, used in most previous vaccine trials, allow relying on such a small number of sickened volunteers to assess the shots.

At the center of the process is Dr. Peter Marks, 57 years old, who oversees vaccines as the director of the FDA's Center for Biologics Evaluation and Research.

In July the US government agreed with Pfizer to pay $19.5 per dose for 100 million, with an option to buy a further 500 million under terms to be negotiated separately. Pfizer has said it expects to have 50 million vaccine doses ready this year, enough to protect 25 million people.

The official disclosed the survey plan at a meeting of the health committee of the House of Representatives on Wednesday.

The World Health Organization has updated its ongoing guidance on Covid-19 medications to advise against using the antiviral drug remdesivir to treat hospitalized patients, no matter how severe their illness may be.