EU agency gives go-ahead for Johnson & Johnson vaccine

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The European Medicines Agency (EMA) has recommended conditional approval for the corona vaccine from the US manufacturer Johnson & Johnson in the EU. The EMA gave the green light for the fourth vaccine against Covid-19 in the EU on Thursday in Amsterdam. The EU Commission now has to make the final decision on approval. This is a formality and could also be done on the same day. The EU expects the first deliveries in April.

The EU Commission had already ordered vaccine doses for 200 million people. Germany would receive 36.7 million of this. However, there are fears that the company will not be able to deliver on time. The manufacturer assured that he would adhere to the agreements and deliver from April. So far, vaccines from the manufacturers Pfizer / Biontech, Moderna and AstraZeneca have been approved in the EU.

Around two weeks ago, the preparation, which had been developed by the Johnson subsidiary Janssen in the Netherlands, had already been approved in the USA. It has great advantages over the previous vaccines: It only has to be injected once. The vaccine can be stored at refrigerator temperature.

Vaccine also protects against gene variant from South Africa

According to the EMA, the effectiveness is around 67 percent. In the case of severe Covid 19 disease, the protection in the studies was more than 85 percent, and this also applies to the elderly.

The EMA experts had been evaluating the research and test data using a faster process for weeks. It had been checked thoroughly and according to the highest security standards, said the EMA. In the case of conditional approval, the manufacturer is obliged to transmit data to the EMA afterwards, for example on the long-term effect. Information on possible side effects will also continue to be checked.

Johnson & Johnson’s serum is the world’s first single-dose vaccine. The vaccine also showed some protection against the South African variant 501.V2. Here, however, the effectiveness was only 57 percent in the study group there. Other vaccines from Moderna or Novavax also showed less effectiveness against this variant. Moderna and Novavax have already announced that they want to develop a new vaccine specifically against the South Africa mutation of the corona virus.

Vaccine could even be used in general practitioners’ offices

Alex Gorsky, CEO of Johnson & Johnson, told the Financial Times, “Our goal was to provide a simple, effective solution for many people and to help end the pandemic.” The vaccine can help Can be stored at refrigerator temperature and has a shelf life of three months. This could even be used in general practices.

In 85 percent of the cases, the vaccine prevented a severe course of Covid-19. This is a great success because moderate cases do not need to be treated in the hospital or in an intensive care unit. 28 days after the single dose, there is full protection, even for people over 60 years of age.

In the study, experts tested 44,000 people, 468 cases of Covid-19 with symptoms occurred in both groups added together. The doctors did not document any side effects. The price per dose is $ 10 per dose – the equivalent of 8.23 ​​euros.

with dpa


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