The European Medicines Agency (EMA) has completed the approval process for both Moderna and Biontech/Pfizer’s Omicron-adapted vaccines. This means that only the formal approval of the EU Commission and the recommendation of the Standing Vaccination Commission (Stiko) of the Robert Koch Institute stand between the adapted Covid 19 vaccines Spikevax and Comirnaty and their vaccination. The Stiko’s recommendation is expected in about a week. The new vaccines are to be delivered to practices in the next few days. The Federal Ministry of Health expects 14 million doses of the adapted vaccines in the next two weeks.
New Omikron BA.1 vaccine as a booster vaccination
Both cases are so-called bivalent vaccines. They contain both mRNA against the omicron BA.1 spike protein and mRNA against the wild-type Wuhan spike protein on which all other vaccines are based. They are intended as booster vaccines that can be used to improve an already existing basic vaccination protection for new variants.
Both vaccines can be vaccinated in people who are older than 12 years and whose last vaccination was three months ago – regardless of whether it was a primary immunization or a booster. Both bivalent vaccines contain 30 micrograms of mRNA – 15 micrograms of each variety. The data submitted by both companies for approval show that the new vaccines elicit a specific immune response against BA.1 that is approximately twice as good as that of the wild-type vaccines. This sounds promising at first glance, but it is uncertain how much additional protection this actually means against new variants.
Especially since the BA.1 variant has long since been superseded by BA.4/BA.5. However, Biontech/Pfizer has already submitted a vaccine adapted to BA.4/BA.5 – also bivalent – and it has been under evaluation by the EMA since August 30, 2022. BA.4/BA.5 adapted vaccines from both Biontech and Moderna are already approved in the US. The US Food and Drug Administration (FDA) granted them emergency use authorization last Wednesday.
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.
According to Biontech, preclinical data show that a booster dose of the Omicron-BA.4/BA.5-adapted bivalent vaccine produced strong neutralizing antibody responses against Omicron variants BA.1, BA.2 and BA.4/BA.5, as well as the original evoke wild-type strain. However, data on human neutralizing antibody titres for BA.4 and BA.5 specific vaccines are not expected until mid-September.
In addition, critical voices are increasing as to whether the use of bivalent vaccines as a booster makes sense at all. The phenomenon of immunological imprinting could ensure that a vaccine that still contains the wild type in addition to the new variants, in particular strengthens the immune system’s memory of the wild type. As a result, the new vaccine information about new variants might not be able to fully develop its protective effect. However, the role of immunological imprinting in SARS-CoV-2 is not yet well understood. There is an acute need for research there for a long-term vaccination strategy against COVID-19. In addition, the approval procedure for monovalent adapted vaccines would have to be reconsidered, because such vaccines would only make sense if they could be vaccinated during and not after a pandemic wave.
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