Approval is getting closer: FDA considers Biontech vaccine safe

Approval is getting closer
FDA considers Biontech vaccine safe

Good news for the German pharmaceutical company Biontech and its partner Pfizer: The US Food and Drug Administration (FDA) has no concerns about the safety of the corona vaccine. Approval could now be granted in a few days.

A few days before the expected decision on an emergency approval in the USA, the US Food and Drug Administration (FDA) issued the corona vaccine from the Mainz-based pharmaceutical company Biontech and its US partner Pfizer with its first good certificate. The regulator released two separate analyzes, one from their own scientists and one from the vaccine manufacturers.

The FDA analysis highlighted several "known benefits" of the vaccine. This includes "reducing the risk of confirmed Covid-19 occurring at least seven days after dose 2". Pfizer's vaccine requires two doses for complete protection. Another benefit is reducing the risk of confirmed Covid-19 after the first dose and before the second dose. And finally, "reducing the risk of a confirmed severe Covid-19 at any time after the first dose" is a clear advantage, the FDA said.

The indication of the reduction in confirmed serious illness was important because early critics of some of the vaccine clinical trials feared that only mild to moderate illness could be prevented. Known risks include that certain side effects were more likely to occur with the vaccine than in patients taking a placebo. The most common were injection site reactions, fatigue, headache and muscle pain, chills, joint pain, and fever.

The decision could be made at the weekend

According to the report, there are no major security concerns. "This is what a 1+ certificate looks like for a vaccine," Akiko Iwasaki, an immunologist at Yale University, told the New York Times. The submitted documents are "very simple and straightforward, which in our opinion will lead to immediate approval," wrote analysts at the US investment bank Jefferies. Biontech and Pfizer applied to the FDA for emergency approval for their corona vaccine in November.

Both reports will be examined by an external advisory body on Thursday. A positive recommendation from the advisory board could result in the FDA formally issuing an emergency approval for the vaccine this weekend. The Medicines Agency usually follows the recommendations of its advisory bodies, but is not obliged to do so.

Pfizer CEO Albert Bourla said at an online industry event he was expecting a "very intense" meeting with the FDA advisory committee. "I think they'll vote 'yes' given the strength of the data. Pfizer and Biontech said the vaccine was 95 percent effective in the pivotal Phase III clinical trial. The European Medicines Agency (EMA) is also advising The UK has started vaccinations as early as Tuesday, Tuesday.

Pfizer initially aimed to deliver 100 million vaccine doses this year. In the past few weeks, the target was then halved to 50 million cans and this was justified with problems in the supply chain. Pfizer chief Bourla said he was confident the planned 50 million doses would be delivered. In the coming year, 1.3 billion doses of the vaccine will then be distributed.

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