I expect approval this week / No miracle cure but a significantly better protection

“For this week, I expect the approval of two adapted vaccines against the omicron subvariant of COVID-19”, said the health policy spokesperson of the largest group in the European Parliament (EPP Christian Democrats), Dr. Peter Liese, on Wednesday in a video conference with journalists. The Committee for Medicinal Products for Human Use of the European Medicines Agency (CHMP) will discuss the two marketing authorization applications from Moderna and BioNTech starting Thursday morning. The committee is expected to give a positive recommendation before the end of Thursday.

Formal approval by the European Commission will occur either on Thursday evening or on Friday. Both companies have submitted comprehensive data, including through clinical trials, to prove the superior efficacy of the adaptions in comparison with prior vaccines. If approved, the companies will be able to supply the adapted vaccines within the next few days. Moderna will provide the EU with 70 million vaccine doses in the first two months, with eight to eleven million of those being available as early as the first week of September. Germany is scheduled to receive 4 million Moderna doses in the first two weeks after approval. BioNTech-Pfizer is expected to surpass the Moderna deliveries, as they plan to deliver up to 29 million vaccine doses in September to Germany alone. 10 million of those will already be available in the first two weeks after approval.

"I am pleased that we can expect the adjusted vaccines already next week. The virus has changed a lot in the last few months, especially since November last year; hence, the vaccines had to be adapted. Both companies have developed bivalent vaccines, meaning that in each dose, half of the vaccine targets the original virus strain (Wuhan-type), and the other half targets the omicron B.A.1 subvariant. This is expected to provide much greater protection against the omicron subvariant but also broader protection against new variants that may emerge.

The legislation we passed back in March of last year allows the European Medicines Agency (EMA) not to require the extensive clinical trials in tens of thousands of people that were needed in 2020. We know that the vaccine protects well against a severe disease course and that the side effects are acceptable, even negligible in most cases. Therefore, as in the case of influenza vaccination, it is possible to approve existing vaccines with less complex procedures. The EMA is expected to approve a booster for people 12 years and older. However, this does not mean that all people 12 years and older must now get vaccinate immediately.

In the next few days, there will be a coordinated recommendation from the EMA with the European Centre for Disease Prevention and Control (ECDC). I expect people over 60 and people with pre-existing conditions to be targeted first. The approval is not only valid for the third or fourth vaccination, i.e. the first or second booster, but also for further vaccinations. For people who received their second booster (fourth vaccination) six months ago or longer and that are older than 60, it is firmly recommended that they now get vaccinated with the adjusted vaccine. The minimum interval to prior vaccination or previous infection should be three months; four to six months would be better", said the physician and MEP.