As of: 01/25/2022 3:21 p.m
BionTech and Pfizer start the first clinical study with a corona vaccine adapted to the omicron variant. 1420 people take part. The application for approval could then be made as early as March.
The omicron variant of the corona virus is causing the number of infections to rise rapidly in many countries. The vaccine manufacturers BioNTech and Pfizer are now checking whether their specially tailored candidate is safe, effective and well tolerated. To this end, the two companies have started their first clinical study to investigate a corona vaccine specially tailored to the omicron variant. BioNTech and Pfizer announced that the safety, tolerability and effectiveness of the vaccine candidate should be tested.
Application for approval possible as early as the end of March
According to Pfizer boss Albert Bourla, the pharmaceutical giant could apply for approval for the vaccine as early as March. The booster vaccination protects against a serious illness caused by the omicron variant, explained the head of vaccine research at Pfizer, Kathrin Jansen. Still, “we see a need to prepare for declining protection or the emergence of a new variant,” she said.
LONGER PROTECTION
The two companies have therefore developed a specific vaccine against Omicron with a longer protection period, the statement said. The goal is a variant-based vaccine “that offers similar protection against Omicron as we have observed with previous variants, but at the same time lasts longer,” explained BioNTech CEO Ugur Sahin.
1420 participants in study
According to the information, 1,420 healthy adults between the ages of 18 and 55 years will take part in the study. The subjects are divided into three groups. A distinction is made between people who have not been vaccinated to date and people who have received two or three doses of the previous vaccine.
One of the study groups of about 600 volunteers who received two doses of the current Biontech vaccine three to six months ago will receive either one or two Omicron-based booster shots. The second group of another 600 people, who have already been vaccinated three times with the regular vaccine, will get a fourth dose of it, or the Omicron version. The study will also include some unvaccinated individuals who will receive three doses of the Omicron version.
According to their own statements, the two companies expect to be able to produce four billion doses of their vaccine in 2022.
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. 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.
Biontech and Pfizer start study on Omicron vaccine
David Beck, SWR, 25.1.2022 3:59 p.m