Ema: with Omicron, vaccines will continue to protect. "The references are fundamental"

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November 30, 2021 "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.

"We know that viruses mutate and we are prepared. We have guidelines in place that allow pharmaceutical companies to have an accelerated path" for vaccines adapted to Sars-CoV-2 variants. "We are still carefully evaluating," but if necessary, due to the new Omicron variant "we have contingency plans. We are prepared for the worst even if we hope for the best. Vaccines remain the key tool," Cooke said.

"We need to work even harder to increase the vaccination rate in the European Union especially in those Member States where these rates are dangerously low. This is particularly important as we get more information on the Omicron."

"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 that has ever been collected on a drug or vaccine worldwide," said the executive director of EMA. . "The pharmacovigilance system can detect rare side effects and ensure they are managed. So not only do we have a pharmacovigilance system that works great but we can also take action where needed," Cooke added.

"The new Novavax vaccine could be authorized within a few weeks." "We approved the vaccines in record time, and in less than a year we delivered a billion doses to our member states."

"The effectiveness of these vaccines decreases over time and it is increasingly evident that booster doses will be needed. In October we recommended the use of the booster dose with the two RMNA vaccines. Now there is one. request for data evaluation for Johnson & Johnson. The data shows that booster restores immunity against contagion and disease. We are also considering a heterologous vaccination strategy, there are studies that suggest that this approach could restore protection as effectively that if you use the same vaccine. We are working on a recommendation that will be useful to Member States, this already by the end of the week, "said Emer Cooke, in an exchange of views with the Environment and Health Commission of the European Parliament.

monoclonals

"We have already authorized three therapies against Covid, they are monoclonal antibodies and are especially effective for adults who have a high risk for the consequences against Covid. We also have very promising news from clinical texts for two. oral products, from Merck and Pfizer, "said the executive director of EMA.

"Oral therapies are easier to use and we are working very quickly. I think this type of drug will make a difference for Covid sufferers. All new therapies are a necessary complement to the tools available," added the director.