Novavaxv vaccine can make important contribution to pandemic response worldwide / Accelerated authorisation of Omicron-adapted mRNA vaccines / Vaccinate now and get boosted - Waiting for Novavax or adapted vaccines can be fatal

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.

It is a so-called protein-based vaccine in which the spike protein that causes the immune response is directly contained. Although I am firmly convinced that the mRNA vaccines are safe and effective, this may convince some citizens who were previously sceptical about vaccination to get vaccinated. I have been in intensive contact with the company since the beginning of this year and had hoped for a much earlier application and authorisation. Unfortunately, Novavax had problems with the production of the vaccine. The delay was due to this and not to any hurdles in the European Union. The vaccine can make an important contribution to pandemic control in Europe and worldwide because it is easier to transport and store than, for example, the mRNA vaccines," said Liese. The European Commission has a contract for 100 million doses and a further option for 100 million doses. Member states are in the process of placing their specific orders. It is expected that first deliveries will start in the next few weeks.

At the same time, Liese pointed out that, in his estimation, the mRNA vaccines will have to be adapted to the Omicron variant. "This is possible relatively quickly due to the contracts of the European Commission and a change in EU law that we already passed in the European Parliament in March. The companies do not have to repeat the entire clinical trials from last year, but must prove in a so-called bridging study that the vaccine is effective against Omicron. For the other points, it is assumed that the effect and the side effects are the same as for the vaccine against the original virus. The procedure has been tried and tested for flu vaccines for many years. The contract the EU has concluded provides for the supply of adapted vaccines. Only on Friday, the European Commission announced that the EU will have 180 million doses of the adapted Corona vaccine supplied by Biontech/Pfizer."

Finally, Liese pointed out the importance of vaccinating and boosting in view of the impending omicron wave. "I advise all those who have not yet been vaccinated and boosted not to wait for either Novavax or the modified mRNA vaccines. It can be fatal. Even with good will, the modified mRNA vaccine will not be available until March, probably not until April, and how well Novavax works against Omicron is not clear today. What we do know is that Omicron is particularly dangerous for the unvaccinated and that the booster protects against Omicron. Therefore, the order of the day is: Don't wait, get vaccinated and boostered," says the doctor and MEP.