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Johnson & Johnson: FDA grants US emergency vaccine approval

Ampoules of Johnson & Johnson vaccine

The vaccine is said to offer 66 percent protection against moderate or severe Covid-19 disease courses four weeks after administration.

(Photo: AFP)

Silver Spring, New Brunswick The US Food and Drug Administration (FDA) has granted emergency approval to the corona vaccine from the US corporation Johnson & Johnson. The FDA announced on Saturday (local time). This means that – after the vaccines from the Mainz-based pharmaceutical company Biontech and its US partner Pfizer, as well as the US pharmaceutical company Moderna – a third corona vaccine has now been conditionally approved in the USA. It is also the first preparation that only needs to be injected once.

US President Joe Biden has welcomed the emergency approval for the corona vaccine as an important step in dealing with the pandemic. Biden spoke on Saturday evening (local time) of “exciting news for all Americans and an encouraging development in our efforts to end the crisis”. The emergency approval previously granted by the US drug agency FDA is no reason to give the all-clear, even if there is “light at the end of the tunnel”. It is crucial to vaccinate as many people as possible as quickly as possible and to continue to adhere to distance and hygiene rules.

In early February, Johnson & Johnson applied to the FDA for emergency approval for the corona vaccine developed by its pharmaceuticals division. The application to the EU Medicines Agency EMA followed in mid-February. The EMA said that the vaccine from Johnson & Johnson subsidiary Janssen-Cilag International NV will be tested in an accelerated process. The committee responsible could give its assessment in mid-March.

At the end of January, Johnson & Johnson announced an interim result of its Phase III study with around 44,000 subjects, according to which the vaccine offered 66 percent protection against moderate or severe Covid-19 disease four weeks after administration. The effectiveness against serious illnesses was given with 85 percent. The percentages mean that there were correspondingly fewer cases in the vaccinated test group than in the placebo test group. However, according to study results, the effectiveness of some competing products is higher.

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In the USA, where around 330 million people live, more than 28 million people have been infected with the Sars-CoV-2 pathogen and more than 510,000 people have died. In absolute terms, that is more than in any other country in the world. More than 70 million vaccine doses have already been injected.

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