Less than 14 days ago, the European Medicines Agency (EMA) recommended the first adapted vaccines against Omikron for approval. These bivalent vaccines contain both mRNA, which is also contained in the original vaccines, and mRNA adapted to variant BA.1. These vaccines have now arrived in medical practices and can be used as boosters. The catch: The variant with which this booster vaccine was adapted is no longer circulating.
Now there is a new approval at European level – this time for a bivalent vaccine from Biontech, which contains the mRNA of the spike protein of the BA.4 and BA.5 variants that are actually currently circulating. Since both variants contain identical modifications in the spike protein, this vaccine also protects against both. Otherwise, the same recommendations apply as for the first adapted booster: The vaccinated persons should be older than twelve years and have already received a basic immunization against Covid-19.
It is not yet clear when the vaccine will be available for medical practices. The recommendation of the Standing Vaccination Commission (STIKO) is still pending and Biontech is announcing a possible delivery of the vaccine for autumn.
Approval procedure as for influenza vaccination
A comparable vaccine from Moderna is currently in phase III clinical testing. However, it has not yet been submitted to the EMA for a rolling review or approval process. However, both vaccines – from Moderna and Biontech / Pfizer – received emergency use authorization for the USA on August 31st.
We have been confronted with the corona virus and the pandemic for almost two years now. The large complex of topics provides a lot of material for reporting. Here is a selection of articles about new variants, symptoms such as Long Covid and news about the vaccines.
What is special about this EMA recommendation for approval is that there are no data from clinical trials for Biontech’s BA.5 vaccine. This brings the approval process closer to the procedure for influenza vaccination for the first time. For influenza vaccinations, the vaccine strains have to be adjusted every year. However, they no longer undergo clinical studies, only thorough quality testing and inspections of the manufacturing process.
The reasoning behind this is that the vaccine itself does not change just because the genetic makeup of the virus has changed. A procedure that has been tried and tested for decades and that the EU has been striving for for Covid vaccines since March last year. It enables the virus strains to adapt quickly to the vaccines and thus a much faster reaction to the infection process.
More vaccine strategies on the way
For its recommendation for approval, the EMA relies on the extensive clinical studies that Biontech has presented for testing the bivalent BA.1 vaccine. Because the new vaccine – Comirnaty wild type / BA.5 – has the same composition as the Comirnaty wild type / BA.1 vaccine, which has gone through all phases, except for a different sequence in half of the mRNA molecules.
The clinical data demonstrate that the immune response to the variant was more effective than to the wild-type and demonstrate that side effects are comparable. Non-clinical laboratory studies were then sufficient for the EMA to exchange BA.1 for BA.5. According to the EMA, accompanying clinical studies are still ongoing.
Since July of this year, however, Biontech has had another vaccination strategy in an advanced clinical trial: In a clinical phase II study, the company is testing a vaccine composed of the wild-type strain and Omicron BA.2 and genetically in the spike range proteins has been modified in such a way that – so the developers hope – it could trigger broad protection against different variants of SARS-CoV-2.
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