The Mainz-based company Biontech and the pharmaceutical company Pfizer have applied to the US Food and Drug Administration (FDA) for approval of a new vaccine against the Sars-Cov-2 coronavirus for booster vaccinations. It is a bivalent mRNA vaccine intended to protect against the originally widespread wild type and the subtypes of the omicron variant BA.4 and BA.5.
Biontech announced on Monday that all the necessary data for an application for approval to the European Medicines Agency (EMA) should be submitted “in the next few days”. The companies could also deliver the new bivalent vaccine as early as September.
Booster vaccinations with the adapted vaccine would elicit “strong neutralizing antibody responses” against omicron subtypes BA.1, BA.2, BA.4 and BA.5 as well as wild-type. A clinical study on safety, tolerability and effectiveness in people aged twelve and over is scheduled to begin in August.
In Germany, the BA.5 subtype is currently detected in 95 percent of the samples examined. According to the Robert Koch Institute (RKI), the proportion “further increased slightly” compared to the previous weeks. The share of BA.4 has remained stable at four percent. The omicron subtype BA.2, which dominated the infection process in Germany until June, is detected in one percent of virus tests.
On the one hand, the bivalent vaccine contains mRNA, which cells can use to form the spike protein of the wild-type Sars-Cov-2 and generate an immune response. This mRNA is also contained in the Biontech vaccine used to date. In addition, there is mRNA for the modified spike protein of the subtypes BA.4 and BA.5, which is structurally identical in both, as a study by researchers from the German Primate Center, the Hannover Medical School and the University of Erlangen-Nuremberg showed. Infections with the previously common omicron subtypes BA.1 and BA.2 hardly protected against the BA.5 subtype responsible for the summer wave due to the changes in the BA.4/BA.5 spike protein.
Biontech and Pfizer have previously announced data from a phase 2/3 clinical trial of a BA.1 subtype-adapted vaccine that evaluated the safety, tolerability and efficacy of a booster dose. The vaccine contained mRNA for the wild-type spike protein and the omicron subtype BA.1 and elicited a significantly higher immune response against BA.1 than the previously used wild-type vaccine.
Pfizer and BioNTech submitted an application for this bivalent vaccine candidate in July, and it has been approved in the UK since mid-month. The EMA announced on Tuesday evening that it would like to decide on the approval of two BA.1-adapted vaccines from Moderna and Biontech/Pfizer in a special session on September 1st. In the USA, only the approval for the new vaccine adapted to BA.4 and BA.5 is to be examined, since these subtypes also dominate there.
The Federal Health Minister Karl Lauterbach (SPD) does not expect any bottlenecks for the booster campaign in Germany in autumn. “We have ordered so many adapted Omicron vaccine that it is enough for everyone,” Lauterbach told the news portal t-online on Friday. Only not all interested parties could be vaccinated on the first day.
On Thursday, the Standing Vaccination Committee (Stiko) at the RKI recommended a second booster vaccination from the age of 60 instead of the previous age of 70. The panel of experts advises the 60 to 70 age group not to wait for the approval and delivery of an adapted vaccine. Even with the available vaccines, a very high level of protection against severe courses of Covid-19 will continue to be achieved.
The RKI pointed out in its weekly report on Thursday that both the number of new corona infections and the seven-day incidence had continued to fall. “Despite the decline in the number of cases, the infection pressure in the general population remains high in all age groups,” it said. Accordingly, there is still a high burden on the health care system. (with AFP)
