Omicron 2, there is still no evidence that it holes more vaccines. The situation is different for monoclonal antibodies. This was pointed out by Marco Cavaleri, head of Vaccines and Covid-19 therapeutic products of the European Medicines Agency EMA, today during the periodic briefing with the press. “There is currently no indication that the immune leak after vaccination is significantly different with Omicron BA.2 – he points out – while the activity pattern of monoclonal antibodies can vary significantly with each Omicron sub-variant.”
“While many European countries are lifting” anti-Covid “restrictions and returning to normal life before the pandemic, we see infection rates rising again in some Member States after the steady decline we have seen in recent weeks. This “trend” apparently appears to be driven by the increasing circulation of Omicron’s BA.2 sub-variant, “known as Omicron 2, “which appears to be more transmissible than other variants of Sars-CoV-2“. It is the picture drawn by Cavaleri.
“We are continuing to evaluate the data on the efficacy of anti-Covid vaccines and treatments against Omicron and its sub-variants. Faced with the growth in infection rates, it is important to underline – he highlights – that vaccination continues to offer high protection. against hospitalization and death due to Covid, although according to some studies there is a certain reduction in protection from serious illness over time at least in the most vulnerable populations “.
In light of all this, “we continue to urge all citizens to be vaccinated and to receive the booster – urges Cavaleri – if they are in the suitable category to receive it”. In fact, a pattern is observed: “Countries with high vaccination rates are reporting significantly lower mortality and hospitalization rates”.
As for the “Sputnik vaccine“Russian against Covid-19” has undergone a rolling review “, the cyclical review process of the European drug agency Ema,” but currently there are no activities “underway by the EU regulatory body” in that cycle of revision. Apart from this “vaccine” we have no other Russian products under evaluation “, and therefore at this moment” we have no contact with the Russian authorities. ” periodic update with the press.
“Earlier this week, the European Medicines Agency EMA received a marketing authorization application for AstraZeneca’s Evusheld * monoclonal antibody cocktail, based on nirmatrelvir and ritonavir, for the prevention of Covid. “This treatment has been in rolling review,” EMA’s cyclical review process, “since October last year and the company has provided solid data, and EMA’s CHMP Committee for Medicinal Products for Human Use has now begun. to evaluate the formal application. Thanks to the preparatory work done during the ongoing review, the CHMP could reach a conclusion “and give an answer” within a few weeks, “explained Cavaleri.
The submitted application “refers to the use of passive immunization to prevent Covid-19, based on the results of the main clinical study on pre-exposure prophylaxis”, recalled Cavaleri, also highlighting that “Evusheld retains the ability to neutralize the sub-variant of Omicron BA.2 “, known as Omicron 2,” in a similar way to the other concern variants that were investigated in the pivotal study.
In addition to Evusheld, the expert added, “two other treatments are also being evaluated”. One is Merck’s anti-Covid pill (MSD outside the US and Canada), Lagevrio * (molnupiravir), and the other is Olumiant * (baricitinib). For these “it is difficult to estimate when the CHMP might be able to make a recommendation”. To date, the EMA has “approved 7 drugs for the treatment of Covid-19 that are available to patients throughout the European Union”.
