Ema evaluates the fourth dose for subjects at risk

Ema evaluates the fourth dose for subjects at risk
Ema evaluates the fourth dose for subjects at risk

BRUSSELS. A month or less to decide whether to vaccinate children under 12 against Coronavirus. The European Medicines Agency (EMA) will dissolve the reservation on the possible recommendation to administer Pfizer / BioNtech’s anti-Covid serum for children between the ages of 5 and 11 “in December”. A decision that comes “in less time” compared to similar cases, but the situation requires a change of pace. Meanwhile, he does not exclude the fourth: “There are subjects particularly vulnerable to the Covid virus – Marco Cavaleri, head of the vaccine strategy of the European Medicines Agency – We already recommend a third dose for immunosuppressed patients and it is not excluded that this category of people who do not respond to vaccination may benefit from a fourth dose already now ».

Cavalieri, Fergus Sweeney, head of the clinical trials and manufacturing task force, and Georgy Genov, head of Pharmacovigilance, all share the same concern. “We see the number of COVID19 infections in Europe increasing again”. Faced with this surge that knows a new wave, “it is important that people get vaccinated or complete the initial vaccination cycle.”

The latest update of the virus propagation map created by the European Center for Disease Control and Prevention (Ecdc) sees half of Europe in a red alert situation. Ireland, Belgium, the Netherlands, Estonia, Latvia, Lithuania, Bulgaria, Romania, Slovenia, Croatia, Slovakia and Austria experienced a surge in new infections per 100 thousand inhabitants, which brought these 12 Member States back into an emergency situation. Seven other countries – Finland, Sweden, Cyprus, Greece, Germany, Poland and Hungary – have an orange-dot epidemiological situation.

Hence the decision to tighten the time on the little ones, and also not to waste time in the evaluation of a possible fourth anti-Covid serum. To date, the EMA has authorized the trade and administration of four types of vaccines, VaxZevria (formerly AstraZeneca), Pfizer / BioNtech, Moderna and Johnson & Johnson. Now Novavax has presented other data and information useful for the marketing of the product, and on this “a possible approval is expected in the coming months”, the representatives of the EU Agency in Amsterdam know.

With the new year, therefore, we could have a new defense tool against Coronavirus, but it seems clear that in any case the sting remains the main way. For the pharmaceutical products VaxZevria, Pfizer / BioNtech and Moderna, the green light was given to a third extra dose, in addition to the two necessary for full coverage. For Johnson & Johnson, single-dose product, “we expect data on the booster dose given six months after the first dose.”

But more generally, updating vaccination certificates seems to be the policy chosen to prevent recurrence. Most member states have started administering supplemental doses to people most at risk of coronavirus infection and transmission, Cavalieri recalls, according to whom “the expansion of booster doses to the general population could be the next step.”

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