“We are looking at all the emerging data, including those from Israel, on the use of a second booster of the current Covid vaccines. At the moment anyway there is not enough evidence from clinical trials or ‘real world’ data “from real life, “that can support a” second recall “recommendation for the general population”. Marco Cavaleri, head of Vaccines and Covid-19 therapeutic products of the European drug agency EMA, took stock of the fourth dose during the periodic update for the press.
“The levels of effectiveness of current anti-Covid vaccines over time, as the Omicron wave unfolds, are relevant data to understand the timing of a possible further dose booster. As we have already seen in the past, however, for people seriously immunocompromised who receive a primary series of 3 doses of the mRna vaccine, a fourth dose would be the first booster for them and, as such, is already recommended, “Cavaleri said.
PFIZER PILL – Regarding Pfizer’s anti-Covid pill Paxlovid *, which received the green light from the European Medicines Agency EMA for use at the first symptoms in high-risk patients in recent days, is “an important addition to our portfolio. of therapies because it is the first oral antiviral approved in the EU. It must be used as soon as possible, at the onset of symptoms in people who are positive for Covid “, explained the head of Vaccines and Covid-19 Therapeutic Products of the EMA. This drug, the regulatory body specified, “cannot be used as a preventive tool”.
In vitro data indicate that the Pfizer “pill is also active against Omicron and other variants of concern. The arrival of this new therapy is news that has been very well received in the context of the resources available to prevent and treat Covid “, underlined Cavaleri who also recalled how” vaccines remain the cornerstone “of the response to Covid. to the other oral antiviral, that of Merck (already in use in Italy), “we have seen laboratory studies that indicate that molnupiravir, currently under evaluation by the EMA, should also be effective against Omicron”, added the expert.
MONOCLONAL – Then, taking stock of the monoclonals currently available and those under evaluation, he explained: “Many monoclonal antibodies are expected to lose their effectiveness against Omicron. At the moment sotrovimab appears to be the only one approved in the EU that can neutralize Omicron” .
“We are also examining – he added – the scientific evidence that is emerging, to establish whether the cocktail of monoclonals called Evusheld *, which is currently under rolling review for the prevention of Covid-19, is effective against this variant. In any case, the current monoclonals are effective against Delta and other variants and remain a valuable complementary tool. ”
VACCINE CHILDREN – On the anti-Covid vaccine for children under 5, the European Medicines Agency is awaiting the final results of the trial. “We are in contact with companies and we are trying to understand when the data can be submitted to us. As we know, clinical trials on the vaccine in this age group are still ongoing, so we have to take into account how far the final results will be available. following the issue closely, “Cavaleri said, answering a question about the Pfizer / BioNTech vaccine in infants from 6 months to 4 years, after the US company and its German partner applied to the US regulatory body Fda.
TEENAGE VACCINE – On vaccination for adolescents, the expert reported: “We are considering a request to extend the use of the booster dose of Pfizer-BioNTech’s Covid vaccine in adolescents aged 16-17. We expect a similar request. for 12-15 year olds. The European Medicines Agency Ema will examine these applications in an accelerated mode “.
OMICRON AND OMICRON 2 – As for the variants, “the wave of Omicron has flown upwards and is continuing” its curve which, once it reaches the plateau, will diminish “in Europe and in the rest of the world”, and while all this proceeds ” we have seen the emergence of Omicron sub-variants such as BA.2 (the so-called Omicron 2, ed) which is spreading to many countries. It is too early to say how much this variant differs from Omicron in terms of transmissibility, and ability to evade immunity “explained Marco Cavaleri.
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