Coronavirus vaccines: EU approval for AstraZeneca, Janssen with results

The first corona vaccine in the EU, which only needs to be injected once, is within reach. The pharmaceutical division of the US corporation Johnson & Johnson announced on Friday an interim result of its phase III study with around 44,000 subjects, according to which the vaccine offers 66 percent protection against moderate or severe Covid 19 disease courses four weeks after administration. The effectiveness against serious illnesses was given with 85 percent. The percentages mean that there were fewer cases in the vaccinated test group than in the placebo test group.

At the end of 2019, a new disease began to spread in China, the lung disease COVID-19 caused by the novel coronavirus SARS-CoV-2. Quarantine measures to contain the virus lead to production losses and increasingly severe consequences for the economy and everyday life.

Meanwhile, the EU Commission has granted AstraZeneca’s corona vaccine conditional marketing authorization. It followed a recommendation from the EU Medicines Agency (EMA). This applies to people over 18 years of age with no age limit. In Germany, however, the Standing Vaccination Commission recommends that it only be given to adults under 65. There is a dispute between the EU and the manufacturer about the preparation – the manufacturer wants to deliver fewer doses than initially targeted due to production bottlenecks, which Europe does not want to accept. In any case, the corona vaccine number 3 is now approved in the EU.

Number 4 could be Janssen’s vaccine. The executive floor of the manufacturer expressed satisfaction with the study results. “We are proud to have reached this decisive milestone,” said the head of the Janssen parent company Johnson & Johnson, Alex Gorsky. At the beginning of February, the manufacturer wants to apply for an emergency license in the USA, a date for the application facility in the EU was initially not known – but that the application will come is considered certain. The study is ongoing in the US, Latin America and South Africa.

The EU Commission has pre-ordered 200 million cans plus an option for a further 200 million cans. In contrast to Biontech / Pfizer and Moderna vaccines, it is a vector vaccine that can be transported and stored at refrigerator temperature. In the case of competing products that are already vaccinated in the EU and are injected twice at intervals of several weeks, the results of studies show that the effectiveness is significantly higher.

Janssen is based in Beerse, Belgium, and has 40,000 employees worldwide, which is a quarter of Johnson & Johnson’s workforce – the parent company is known among consumers for baby creams, mouthwashes, cold sprays and hay fever remedies. Janssen in turn has 1000 employees in Germany, the German headquarters are in Neuss (North Rhine-Westphalia). Janssen does not have a production in this country. The corona vaccine is being developed in Leiden, the Netherlands, and production is to be expanded to other locations.

Janssen’s main business so far has been prescription drugs, for example against cancer. The development of vaccines is still new territory for the company. The company only launched its first vaccine, an Ebola preparation, on the market last summer. The corona vaccine that has now been developed is based on the technology used here.

In July, Janssen began clinical studies on the preparation, which were gradually expanded. A so-called vector vaccine was administered – competitor AstraZeneca also relies on this technology. A harmless virus is used as a transporter to smuggle genetic information for a protein of the SARS-CoV-2 virus into the body. This is supposed to induce the immune system to form antibodies against the protein and to trigger other defense reactions. When it comes into contact with the coronavirus, the body is prepared and can better contain the infection.

The two vaccines from Biontech / Pfizer and Moderna, which were the first to be approved for the market, are based on a different process (mRNA). While mRNA vaccines have to be refrigerated during transport and storage at low temperatures, refrigerator temperatures are usually sufficient for vector vaccines.

The response has been muted among health politicians. “Unfortunately, Janssen’s data are not so convincing that one can cheer right away,” said the health policy spokesman for the EPP group in the European Parliament, Peter Liese. Among other things, the experts from the European Medicines Agency would have to “examine the whole thing very carefully and then decide whether and in what form the vaccine can be used,” said the CDU politician.

On Friday, interim results for another vaccine were also announced – the preparation of the US manufacturer Novavax has an effectiveness of 90 percent according to its information. The US pharmaceutical company Baxter announced in mid-January that it would manufacture this vaccine in the Baxter branch in Halle (North Rhine-Westphalia), among other places. Biontech and Pfizer also want to produce their vaccine in the Westphalian city in the future.


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