The vaccines adapted to the corona variants BA.4 and BA.5 are recommended by Stiko for booster vaccinations – which surprised virologist Alexander Kekulé.
Leipzig – “I have no understanding for the Stiko,” says Alexander Kekulé, a virologist who has been known in Germany since the corona pandemic. In “Kekulés Corona-Kompass” at MDR he expressed his concern that the first vaccine adapted to the BA.4 and BA.5 omicron variants has now been approved in Europe.
In the last podcast, the virologist said that the EMA in Europe “given the sparse data” was more cautious than the FDA in the USA for good reason and had not yet approved the vaccines. Things are different now – which surprised the virologist.
Kekulé: After the vaccine was approved, “some experts literally lost their jaws”
“You could say that some of the experts literally lost their jaws,” says Kekulé, choosing a very drastic picture – but without naming the experts exactly. The Corona vaccines from Biontech/Pfizer and Moderna currently have conditional market approval in Europe by the European Medicines Agency EMAthat loud Paul Ehrlich Institute can be converted into a regular authorization after one year if all missing data are submitted.
In the MDR, Kekulé assumes that the EMA will follow the decisions in the USA and will also issue regular market approval for the corona vaccines in Europe. Without further comment, the conditional market approval in Europe was extended after just one year – an otherwise unusual procedure.
Alexander Kekulé assumes that the corona vaccines will be approved for the market
In a press release from Stiko from September 20, it is recommended that “for all booster vaccinations from the age of 12, preferably one of the approved and available Omicron-adapted bivalent mRNA vaccines should be used.” Deliver and publicize the safety and efficacy of the variant-adapted vaccines.”
Kekulé now criticizes two points of the Stiko’s decision, which makes the vaccination recommendations for Germany and also wants to recommend the adapted vaccines: the missing data have still not been submitted and the new vaccines have not yet had to prove their effectiveness against severe courses. There are only data from studies with mice that have shown increased antibodies.
I don’t want to scare you. But I say it’s just an experiment that I wouldn’t have done in such a way that you say, with only data from the animal, now let’s make a few million or billion vaccines and try out how common there is, for example, myocarditis now is myocarditis. And the other, actually more important argument can be made very briefly: I also have to know whether it works. I also need to know if it protects. And you absolutely cannot tell that from mouse data.
Omicron vaccine: Kekulé accuses EMA of backing down to the pharmaceutical industry
in the MDR Corona Compass Kekulé then quite directly accuses the EMA of backing down to the pharmaceutical industry. “Industry simply prevailed,” says Kekulé, and then refers primarily to Biontech founder Uğur Şahin. The regular vaccine approval will not only apply to the original variants of the vaccine, but also to all subsequent ones.
The decisive problem for Kekulé in this context: side effects that occur with the original vaccine variants came from the spike protein in the vaccine – and, although rare, are still not understood. “It’s almost spooky that after a vaccination there is suddenly and very rarely inflammation of the heart muscle, these strange coagulation disorders, i.e. blood clotting disorders that sometimes occur. Both extremely rare things, you have to say, you can’t emphasize that often enough. But: It just happens and is not understood,” says Kekulé.
And the only thing you know is: It’s an immune reaction. And now it’s like this: The immune system doesn’t react to anything. It doesn’t react to this lipid shell from these lipid nanoparticles or similar that are in the vaccine. Rather: It reacts quite clearly to the spike protein itself.
And this is exactly where you have to sit up and take notice when it comes to adapted vaccines. “But if this spike protein – that is, exactly what causes these side effects – if that is changed, how do I know that the side effect rate will not change?” is Kekulé’s concern.
Virologist Ciesek worked on a study on new vaccines – and praises them as superior
In contrast to Alexander Kekulé, the virologist Sandra Ciesek sees the adapted vaccines as superior to the older ones. And the Stiko also says that nothing will change in terms of security.
“The omicron-adapted vaccines use the same mRNA platform as the wild-type mRNA vaccines currently available. Since the difference consists in only a few modified nucleotides and the immune response, even with the adapted vaccines, results from a confrontation with the spike protein of SARS-CoV-2″, Stiko estimates “the new bivalent vaccines as safe and well tolerated despite the limited clinical study data In this context, bivalent means that a vaccine has two components that are effective against two virus variants. (cat)
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