Johnson & Johnson Corona vaccine: When does EU approval come?

ad26.cov2-s by the American pharmaceutical manufacturer Johnson & Johnson could soon be another corona vaccine approved in Europe. Infection doctor Prof. Emil Reisinger from Rostock University Medical Center was optimistic about the "Ostsee-Zeitung" that the vaccine "at the latest at the end of February" was approved by the European Medicines Agency (EMA).

At a meeting with the conservative EPP parliamentary group in the EU Parliament last Wednesday, EU health commissioner Stella Kyriakides also announced that Johnson & Johnson could apply for approval in Europe in February. This was reported by the "Rheinische Post", citing CDU MP Peter Liese.

The evaluation of the clinical phase 3 study has not yet been completed

The vaccine of the US company was tested, among other things, as part of the clinical phase 2 study in Germany. As head of the study, the infection doctor Reisinger AD26.COV2-S had tested test subjects at Rostock University Medical Center. 75 people were involved in the tests - mainly seniors. "The results of the test phases 1 and 2 are very satisfactory," he said. The clinical phase 3 study is currently being evaluated-with the participation of EMA.

The Johnson & Johnson vaccine is a vector vaccine. It is based on a harmless human cold virus (adenovirus 26), which contains the genetic information for the spike protein of the coronavirus. When the cold virus binds to human cells, the genetic information is released and SARS-COV-2 antigens are produced that are presented to the immune system. In this way, the desired immune response can be triggered.

The vaccine can be stored at refrigerator temperatures

The first results of the clinical studies of phases 1 and 2a were published in the magazine "The New England Journal of Medicine" in early January. This suggests that a single dose of the vaccine is sufficient to produce high quantities of neutralizing antibodies. In the group of 18 to 55-year-olds, more than 90 percent of the participants had neutralizing antibodies against Sars-Cov-2 on the 29th day. On the 57th day they were detectable with all participants. The antibody mirrors remained in the current study by all subjects until the 71st day, the last time available.

In the Corona-MRNA vaccines of Biontech / Pfizer and Moderna currently approved in the EU, two vaccine sockets are required for adequate immunization. In the meantime, it was discussed whether the second vaccination should be postponed in order to be able to vaccinate as many people as possible at least once. The EMA finally advised against a late second vaccination.

The Johnson & Johnson vaccine offers another advantage over the mRNA vaccines. According to Reisinger, AD26.cov2-S can be stored in simple refrigerators. This would make it possible to easily give the vaccine into general practitioner practices. The EU has ordered a total of 200 million cans from Johnson & Johnson.