Healthcare

Coronavirus – EMA: Against the fourth dose of the vaccine in the general population

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Marco Cavaleri, head of the European Medicines Agency (EMA) vaccine strategy, spoke out against the fourth dose for the general population. As part of the regular briefing of European correspondents recently, Dr. Cavaleri said there was no evidence to support the need for a second booster dose – and that giving new doses every few months “is not a viable strategy”.

In addition to the fatigue of the population, the Italian official stressed that continuous doses “will create problems with the immune response.” However, the second booster dose “should be considered” for people in a state of immunosuppression, he said.

Regarding the possibility of producing second generation vaccines that will specifically target the Omicron variant, Dr. Cavaleri said “many factors need to be taken into account” to decide this. By the time these vaccines are produced, the epidemiological picture may have changed significantly, he noted. “We need a strategy that does not just react to the virus, but tries to predict its next move,” he said. This issue requires international coordination, he added, and will be high on the agenda at tomorrow’s EMA meeting with the US FDA and other regulators. Coreper, he said, will need 3-4 months to approve such a vaccine.

Answering a relevant question in the wake of the controversy between the Spanish government and the WHO over the stage of the pandemic, Dr. Cavaleri said that “we can not say that we have reached the endemic phase of the virus”, although Omicron is “accelerating” the course in this direction. Nevertheless, its spread can not be described as good news, he noted, as it will be accompanied by a heavy burden on health systems in the EU.

The head of Coreper Vaccine Strategy, answering other questions, said that his expectation is that two doses of the approved formulations will provide the same degree of protection against serious disease in children as in adolescents and adults; that cases of pericarditis and myocarditis in children receiving mRNA vaccines are “significantly rarer” than their already very low frequency in adolescents and adults; that “hybrid immunity” (vaccine plus disease) provides extremely good protection against Covid-19; it does not need to be given a long time from the time of illness.

Finally, Dr. Cavaleri said he expects the EMA decision on Paxlovid (Pfizer’s anti-viral pill) to be published “within weeks” and that the drug is effective against Omicron.

kathimerini.gr

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