Clinical Study
Biontech Pfizer is testing the first vaccine against the omicron variant
A few weeks ago, Biontech boss Ugur Sahin announced that the vaccine would be adapted. There could be a new edition in the near future.
© Kay Nietfeld / DPA
There could soon be a new vaccine against Omikron. As announced by Biontech-Pfizer, an adapted vaccine will be tested in a clinical study. The EMA has not yet announced whether such a vaccine is necessary.
It had already been announced several times, now it is becoming concrete: Biontech and Pfizer have started their first clinical study to investigate a corona vaccine specially tailored to the omicron variant. The safety, tolerability and effectiveness of the vaccine candidate are to be tested, as the two companies announced. The study will include up to 1,420 test subjects, who will be divided into three groups.
The first group includes around 600 participants who have already received two doses of the previous vaccine between 90 and 180 days before the start of the study and are now to receive one or two doses of the Omikron vaccine. The second group, almost as large, consists of boosted people who receive an additional dose of the conventional vaccine or a dose of the omicron vaccine. The third group with a good 200 test persons consists of unvaccinated people who have not yet had Covid-19 and who then receive three doses of the Omicron vaccine.
“The study is part of our scientific approach to develop a variant-based vaccine that offers similar protection against omicron as we have observed with previous variants, but at the same time lasts longer,” said Biontech boss Ugur Sahin. Vaccines still offer a high level of protection against severe courses from omicron.
Millions of vaccine doses against Omikron already in the spring
The Mainz-based pharmaceutical company and its US partner announced about two weeks ago that they had already started production of a corona vaccine adapted to the Omicron variant for later commercial use. Biontech had stated that the two companies “are ready to supply the market by March if the regulatory approvals are in place”. Pfizer said it expects to have pre-produced about 50 million to 100 million doses of the new vaccine by late March or early April.
The European Medicines Agency (EMA) has not yet stated whether it considers an Omicron-adapted vaccine with a different composition than the vaccine currently used to be necessary.
For the current year, Biontech and Pfizer are assuming a production capacity of up to four billion vaccine doses worldwide. “The expected production volume will not change if the vaccine needs to be adjusted,” the companies said on Tuesday.
Previous vaccines developed for corona wild type
The coronavirus vaccines currently used by various manufacturers were originally developed against the so-called wild type of Sars-CoV-2, which was first discovered in China at the end of 2019. While the agents used since the turn of the year 2020/2021 have also shown their effect against mutants such as Alpha or Delta, things are different at Omikron – especially when it comes to protection against infection.
The variant was reported from South Africa in November. According to the Robert Koch Institute (RKI), it has an unusually high number of mutations in the so-called spike protein, a building block of the virus. Some of the mutations are relevant, for example, with regard to transmissibility and the ability to circumvent existing protection through vaccination or surviving an infection. At the same time, experts assume that the variant causes milder disease progression on average than the previously dominant Delta variant.
The President of the German Medical Association, Klaus Reinhardt, recently stated that even a booster vaccination does not reliably protect against corona infection. “It is very likely that you will be spared a severe course of the disease with hospitalization or even intensive care treatment,” he said.