The fourth wave of Covid-19 alarms Europe. “The epidemiological situation is now very worrying“, confirms Fergus Sweeney, Head of Clinical Studies and Production of the European Drug Agency Ema, responding to journalists during the periodic update for the press.” We are entering the winter with increases in the rates of infections and hospitalizations, and we also see an increase of lethal outcomes “, of deaths, underlines the expert.
“This emphasizes a very important point”, that is “the need for everyone to get vaccinated and that those who have had the first dose also get the second. It is really important that everyone gets vaccinated, because we will not all be protected as long as each of us is protected. “, Sweeney warns. “We see that national governments are reintroducing measures such as social distancing and masks – he adds – We must follow all these precautions, in order to protect others and ourselves”.
“We see that the epidemiological situation in Europe is becoming increasingly complicated, with a new increase in cases” of Covid-19, is the concern expressed by Marco Cavaleri, head of vaccines and anti-Covid therapeutic products of the European drug agency EMA. In light of the progress of the pandemic in the EU, he adds, “we want to reiterate our message on the importance of people getting vaccinated or completing the vaccination cycle as soon as possible”.
THIRD DOSE – “Most EU member states” have started administering booster doses of “Covid vaccine” to people most at risk of infection and transmission of the “SARS-CoV-2 coronavirus”. “The next step could be extending the booster doses to the general population,” Cavaleri says.
FOURTH DOSE – Will we move towards a fourth dose of anti-Covid vaccine for the most fragile? “We have learned that there are people particularly vulnerable to this virus. As known, for the immunocompromised we already recommend 3 doses as part of the primary vaccination course. And it is not excluded that, for this type of patients who may not respond well to vaccination, a the fourth dose may be needed or considered already now. We are gathering more evidence to properly inform and make sure we are in a position to issue a recommendation “on the matter, says Cavaleri, responding to reporters.
HETEROLOGIST BOOSTER – “We are collecting all available data” on the so-called ‘mix and match’ approach, ie on the possibility of administering a vaccine other than that used in the primary cycle as an anti-Covid booster dose. “We expect to be in a position to issue a statement or recommendation” on the matter “within a month,” he explains, replying to reporters on the ‘heterologous booster’ option.
“We are analyzing the data on the heterologous booster for each vaccine – underlines the expert during his speech – It seems to be an attractive strategy” not only from a practical point of view, to guarantee the States “flexibility” of administration based on the availability of shield products, but also from a scientific and clinical point of view “to effectively enhance the immune response after a single dose of Janssen vaccine”, the single dose of J&J, “or after 2 doses of the other approved vaccines”.
PFIZER 5-11 YEARS – Anti-Covid vaccine for under 12s by Christmas. In fact, the conclusion of the review that the European Medicines Agency Ema is conducting on Pfizer / BioNTech’s Comirnaty * in the 5-11 age group is “expected in December”, announces Cavaleri, underlining that the planned timing is “reduced “compared to that of” other similar reviews “. In the decision-making process, he states, “we will also consider additional data collected and submitted” to the agency “by BioNTech / Pfizer as part of an ongoing pediatric study.”
Comirnaty has been authorized in these days for children aged 5 to 11 in the US, both by the Fda drug agency and by the Centers for Disease Control and Prevention (Cdc).
MERCK PILL – “We are ready to advise EU member states so that they can make Merck’s anti-Covid pill molnupiravir available” (MSD outside the US and Canada) “for emergency use”, even “before a marketing authorization “formal Aic, then explains the head of Vaccines and Therapeutic Products for Covid-19 of the European drug agency Ema.
On the oral antiviral molnupiravir, the EMA has already started the continuous rolling review procedure. “Studies analyzed in the context of the cyclical review – underlines Cavaleri – suggest that this treatment can reduce the ability of the coronavirus” Sars-CoV-2 “to replicate in the body, preventing hospitalization or death in Covid-19 patients”.
Just today molnupiravir received the world’s first authorization in the UK, from the Mhra Drug Agency, for the treatment of mild to moderate Covid-19, in Sars-CoV-2 positive adults who have at least one factor of risk for developing severe disease.
NOVAVAX – The US company “Novavax presented production data” of its Covid vaccine candidate. “This will allow us to progress in the ongoing review” of the product. “A possible approval is expected in the coming months” is the forecast of Marco Cavaleri, head of Vaccines and Therapeutic Products for Covid-19 of the European Medicines Agency EMA, during the periodic update for the press.
NVX-CoV2373 is a protein-based vaccine that contains tiny particles obtained from a lab-made version of the Sars-CoV-2 coronavirus Spike protein. It also contains an adjuvant, a substance that helps strengthen the immune responses induced by the product.
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