Paul-Ehrlich-Institut

Information on the Use of Cookies

In order to operate and optimise our website, we would like to collect and analyse statistical information completely anonymously. Will you accept the temporary use of statistics cookies?

You can revoke your consent at any time in our privacy policy.

OK

Omi­cron Vari­ant - Pos­si­ble Pro­tec­tion af­ter Boost­er Vac­ci­na­tion

The spread of the Omicron variant of SARS-coronavirus-2 is observed with concern worldwide. The Paul-Ehrlich-Institut monitors scientific data on the Omicron variant, including vaccine efficacy. Preliminary data show a neutralisation titer against Omicron after three vaccinations with the mRNA COVID 19 vaccine Comirnaty. Thus, booster vaccination is recommended and important.

Vaccine ampoule in front of Omicron lettering (Quelle: viewimage/Shutterstock.com)

Data released today by BioNTech and the Goethe University Frankfurt/Main on neutralising antibody levels in double and triple COVID-19 vaccinated individuals are preliminary. They suggest that vaccine protection against the Omicron variant of the SARS-CoV-2 coronavirus may be reduced. Whether the Omicron variant can lead to severe COVID-19 disease is unknown, but an increased rate of infection has been reported. Vaccinated individuals are not unprotected against the Omicron variant. Vaccine protection against COVID-19, particularly severe courses, by the licensed vaccines does not only rely on antibodies but also on the cellular immune response. In addition, data by BioNTech suggest that booster vaccination may produce improved protection against Omicron as well. Data from the Goethe University Frankfurt/Main indicate reduced levels of neutralising antibodies in some individuals vaccinated against COVID-19. COVID-19 vaccination including a third vaccination (booster vaccination) is therefore strongly recommended in any case.

The regulatory path to variant vaccines, should they be required, has been paved. The Paul-Ehrlich-Institut, Federal Institute for Vaccines and Biomedicines, will continue its scientific advice on the rapid development and authorisation of variant vaccines with the manufacturers at national and European level. By adapting the vaccine construct of approved parental vaccines to the Omicron spike protein and conducting a limited clinical trial in a few hundred or thousand participants, the goal is to rapidly demonstrate that the immune response after administration of the variant vaccine can be increased compared to the immune response after administration of the parental vaccine. Nonclinical studies are not required. Facilitated approval through variation of the original authorisation is possible not only when the antigen or its RNA is adapted, but also in case of addition of one or more variant antigens.

Manufacturers of mRNA-COVID-19 vaccines have informed that they can generate a new vaccine construct and switch manufacturing within a few weeks, which they have already started. It might take about three months to manufacture and deliver millions of doses of a variant mRNA-COVID vaccine.

Professor Klaus Cichutek, president of the Paul-Ehrlich-Institut, said, "The Paul-Ehrlich-Institut will continue its regulatory support for the development and authorisation of safe and effective vaccines against SARS-CoV-2 virus variants at the national and European levels. For the Omicron variant, we are well prepared in terms of vaccine protection, both through the possibility of booster vaccination and the rapid technological adaptation of vaccines."

Updated: 08.12.2021