Three vaccines that are specially adapted to the omicron variant of Sars-CoV-2 can now be administered in Germany. On Monday evening, the European Commission approved a Biontech/Pfizer vaccine targeting the omicron subtypes BA.4 and BA.5. It is a so-called bivalent vaccine which, in addition to this new component, also contains the conventional Biontech vaccine. Two vaccines from Biontech and Moderna that target the BA.1 subtype had previously been approved. The most important facts about the new products.
Who should get the adapted vaccines?
All three products are approved as boosters for people over the age of twelve who want to be vaccinated. The Standing Vaccination Commission (Stiko) must determine who should receive it as a matter of priority. Your vote is still pending.
The European Medicines Agency EMA and the disease control agency ECDC recommended a few days ago that the new vaccines should be used primarily for those people who are at particularly high risk of serious illnesses. These included people over the age of 60, people with previous illnesses and a limited working immune system as well as pregnant women. The refresher could also be considered for medical staff.
How well are the new products tested?
The two vaccines against BA.1 have each been tested on several hundred people. According to the company, they are just as well tolerated as the original mRNA vaccines. The now approved vaccine against BA.4/5, on the other hand, has only been tested on animals. However, since it differs only slightly from the two BA.1 vaccines, the EMA, like the US FDA before it, assumes that it too has a very similar safety profile. Adapting already approved vaccines without further testing on humans is not an absolute novelty. This practice is common in the development of the annual flu vaccine.
How effective are the new vaccines?
According to the data presented so far, the BA.1 vaccines increase the amount of antibodies against this omicron variant more than the conventional preparations. An increase in antibodies was also observed against subtype BA.5, albeit less. Based on these findings, the EMA assumes that the latest vaccine will also trigger a stronger immune response against the BA.5 variant than the conventional vaccine.
The extent to which this immune response leads to the avoidance of infections and diseases remains to be seen. Australian scientists are coming in a modeling that has not yet been examined by experts concluded that a large part of the protection may result simply from the fact that the immune system is reactivated by the booster, which also happens with the old vaccines. The additional effect of the adjusted component, on the other hand, is rather moderate.
Are the vaccines available yet?
Initially, 14 million doses of the BA.1 vaccines are available. According to the Federal Ministry of Health, a tranche of almost ten million doses of the BA.5 vaccine should initially be available.
Which vaccine should you take?
This question cannot be answered with certainty at the moment. Specialists assume that the differences between the Omicron vaccines are not very large. Marco Cavaleri, in charge of vaccines at the EMA, said at a recent press conference that all omicron-adapted vaccines are very likely to broaden immunity, regardless of which sub-variant they are designed against. On the other hand, he is not sure which sub-variants will dominate in winter. BA.5 is currently dominating events in Europe. However, it is also conceivable that a type for which the BA.1 vaccine is more suitable will prevail, such as the BA2.75 variant currently circulating in India.
Who does the vaccinations?
As before, the vaccinations will be administered mainly in medical practices and vaccination centers. According to the General Practitioners’ Association, the demand for the new vaccines is currently rather low.
Are other adapted vaccines in the offing?
Moderna has also developed a vaccine against BA.4/5. It is assumed that it will soon be submitted for approval.
Why is the old vaccine still in the products?
In the run-up to the approval, the EMA had already spoken out in favor of bivalent vaccines, which contain the original vaccine in addition to the adapted component. Cavaleri gave two reasons for this. On the one hand, the combination is intended to achieve the broadest possible immunity. From an immunological point of view, omicron and the original virus on which the conventional vaccine is based are very far apart. This gives the chance that the vaccine will also protect if a variant beyond Omicron should appear. On the other hand, the breadth of the immune protection of combination preparations could allow them to be used for initial vaccinations in the longer term.