“From the data we have it emerges that vaccines are effective and will continue to protect the population even with a possible spread of the Omicron variant. “This was stated by the executive director of EMA, Emer Cooke, in a hearing in the Health Committee of the European Parliament on the Covid pandemic.
“However, we know that efficacy decreases over time, so the booster dose becomes essential,” he added.
“Existing vaccines have continued to prove effective against variants that have appeared and are circulating in Europe. We do not know if it will be the same with the Omicron variant or not. But we have to be sure we understand whether or not that will be the case, “said Emer Cooke.” It takes about two weeks to do this, even if this variant is quite different from the circulating virus sequence, “he explained.
“We know that viruses mutate and we are ready – continued Emer Cooke – Since last February we have created guidelines to allow companies to rapidly adapt vaccines if this will be necessary. And I believe we must be very careful now, we still don’t know if it is necessary“.
“We have to work even harder to raise the vaccination rate in the European Union especially in those Member States where these rates are dangerously low. This is particularly important as we learn more about the Omicron. ”The executive director of EMA stressed.
“I would like to assure you about the safety aspect, I think it is very important to remember this is the largest group of data ever collected on a drug or vaccine worldwide – Cooke concluded – the pharmacovigilance system is able to identify rare side effects and ensure that these are managed. So not only do we have a pharmacovigilance system that works very well but we can also act where necessary. ”
It takes 3-4 months for any adjustments to be ok
“We think that if there is a need to modify vaccines – Cooke underlined – there will perhaps be a need to approve them within three or four months from when they start to be modified”.
“We have to prepare ourselves in case there is a need to adapt the current vaccines and this is a job that the pharmaceutical companies will do. They will have to adapt their formula to cover the new sequence and they will have to show that the production system works, they will have to do clinical studies to prove that everything works in practice, see how the production will have to be modified “, he explained.
“Much of this work will have to take place at the pharmaceutical company level but I assure you that we are reassuring with them and with other regulators to ensure that we are ready as soon as possible to address these consequences, “he added.
“First of all it will be necessary to decide if this is necessary. But this is not decided by the EMA, it is a decision that will also take into account the epidemiological situation, the effectiveness of the current vaccines against the variant, the spread of the variant in Europe and many other factors. That decision has to be made first and then we can proceed “, underlined Cooke.