The European Medicines Agency (EMA) has just recommended authorisation of the Corona vaccine from the American company Novavax. The protein-based vaccine requires two vaccinations three weeks apart for full protection. The clinical studies attest the vaccine an effectiveness of about 90 per cent. MEP and health policy spokesman of the largest group in the European Parliament (EPP-Christian Democrats), Peter Liese, said: "The 90 percent was achieved in clinical trials in the spring. This puts Novavax clearly better than AstraZeneca and Johnson&Johnson but slightly behind the mRNA vaccines. However, it must be taken into account that Novavax carried out the clinical trials in Great Britain and South Africa at a time when the alpha and beta variants were already widespread in the respective populations. Whether the vaccine is effective against Omicron is currently being investigated.
In my opinion, however, it cannot be assumed that the vaccine will provide perfect protection against Omicron (the effect against Beta was already significantly reduced (55.4 percent), nor can it be expected that it will not protect at all. Experts believe that the evasion of the immune system may be stronger than with mRNA vaccines, as the technology used by Novavax could only stimulate a few parts of the immune system. Therefore, work is already underway to produce adapted vaccines. Regardless of this, it is good that with Novavax a fifth vaccine is available. It is based on a different technology than the previously approved mRNA and vector vaccines.
Following discussions with the company BioNTech, the European Commission has announced that the delivery of the special doses of the vaccine for children to the European Union will be brought forward. Thirteen million doses can be delivered to the European Union as early as this year. From January, there will then be twenty million doses per month.
"Vaccination is particularly important for children who are at increased risk of a severe course in the event of infection, such as children with Down's syndrome, heart defects or lung diseases. That is why I am very happy about this good news. It is now extremely important to set the right priorities. Vaccination of children without an increased risk should be possible after consultation with the parents and, as far as possible, the children themselves. But priority must be given to children with pre-existing conditions," said MEP and health policy spokesperson of the largest group in the European Parliament (EPP-Christian Democrats) Peter Liese.
"If an adaptation of the vaccines is necessary due to the new virus variant Omicron, the authorisation procedure in the European Union can be completed within a few weeks. No extensive new authorisation is required. The European Parliament, the Council of Ministers and the Commission have already ensured this by amending the law in spring this year. The EU's contracts already provide for the delivery of the adapted vaccine. We are prepared." This was stated by the health policy spokesperson of the largest group in the European Parliament (EPP-Christian Democrats), Dr. Peter Liese, on the occasion of reports according to which the effect of the vaccines approved in the EU might not be optimal with the Omicron variant.
The vaccine manufacturers Moderna and Biontech had recently made statements to this effect. "It cannot be assumed that the vaccines against Omicron are not effective at all. Although there are numerous mutations in Omicron the predominant sequences of the spike protein are also identical to the wild type from Wuhan, so that the vaccines will still work. It therefore makes sense in any case to get vaccinated now with the approved vaccines and also to do the boosting, as the adjustment will take some time and vaccination now will protect immediately in view of the high numbers of infections. However, it may make sense to adjust the vaccines to achieve a stronger effect than without adjustment. After all, the vaccines were developed on the basis of the original Wuhan type and are already no longer as effective against Delta as they were against the original type. As this development was foreseeable, we in the European Parliament, together with the Member States, already adopted a proposal of the European Commission for an accelerated approval procedure for adapted vaccines in March this year.
The European Medicines Agency (EMA) has just recommended approval of the corona vaccine from BioNTech and Pfizer for five to eleven year old children. So far, the vaccine has been approved for adolescents aged twelve and older. The formal approval by the European Commission will follow soon. MEP and health policy spokesperson of the largest group in the European Parliament (EPP, Christian Democrats), Peter Liese, welcomed the decision. "With corona numbers rising sharply, it is urgent that a safe and effective vaccine is now also available for children, in particular with pre-existing. Children with Down's syndrome, a heart defect or lung diseases, for example, have a greatly increased risk in some cases and should be vaccinated as soon as possible in view of the danger of infection with Covid-19. That is why it is important that the vaccine for the children now also comes into the practices promptly, so that they can be immunised quickly. In my opinion, the paediatricians should decide on prioritisation, as they know their little patients best and can thus act quickly and unbureaucratically," said Liese, who as a doctor has worked in a paediatric clinic himself.