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Fourth dose, Ema: “We can’t do calls every 3-4 months”

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“We have not yet seen the data on the fourth dose” of the anti-Covid vaccine. “We are quite concerned about a strategy that involves repeated vaccinations in a short period of time. We cannot continue giving booster doses every three or four months.” Marco Cavaleri, head of EMA vaccines, underlines this during a video briefing with the press in connection from Amsterdam, where the agency is based. The Omicron variant “is highly contagious, which causes a large number of infected individuals. So it is very important to be aware of the potential burden” it could create to the detriment of health systems, “and not consider it a mild disease”, Cavaleri then points out. recalling that the “preliminary results of recently published studies show that the efficacy of vaccines against asymptomatic disease is significantly reduced for Omicron, and that it tends to wear off over time. For severe illness and hospitalization related to the Omicron variant, the emerging evidence suggests that vaccines continue to provide high protection, “Cavaleri points out. The expert Ema then underlines that “no one knows when we will reach the end of the tunnel, but we will get there. We are seeing that we move” towards a scenario in which Covid “becomes more endemic, but we cannot say that we have already reached that status” . The virus, he continues, “still behaves like a pandemic virus and the emergence of Omicron shows this clearly. We must not forget that we are still in a pandemic.” “Nonetheless, with increased immunity in the population and with Omicron there will be a lot of natural immunity beyond that given by vaccination, we will quickly move to a scenario closer to coronavirus endemicity,” Cavaleri says. anti-Covid adapted to the Omicron variant would be a “natural candidate” for approval in the EU, other options “such as a polyvalent vaccine, cannot be excluded as potential alternatives”. “Further data is needed – Cavaleri underlines – to decide whether an adapted vaccine, with a different composition, is justified. Many elements must be kept in mind, knowing that by the time any vaccine adapted to Omicron is developed, it is possible that the framework epidemiological in the EU has undergone a significant evolution, as regards the variants in circulation and the exposure to Omicron “. However, if Pfizer develops a Covid vaccine adapted to the Omicron variant of Sars-CoV-2 by March, a “potential approval” from the EMA could come “in April or May, this could be the timing”. Pregnant women “were not included in clinical trials” of Covid vaccines, so there was not enough data at the outset to provide reliable information. Now the data are there and “they are very reassuring. They indicate that vaccines reduce the risk of hospitalization and death during pregnancy, without causing complications and without harming the fetus. Vaccination is the best way to have both mother and child protected. effectively and should be done as soon as possible. “Speaking of vaccines to children, the safety data” is reassuring: serious side effects are very rare. As in adults, the majority of side effects in children are mild or moderate and they get better in a few days “. “For pericarditis and myocarditis – he adds – very rare cases have occurred in adults and adolescents after vaccinations with m-Rna vaccines. Data from large vaccination campaigns indicate that the frequency of these side effects in younger children is significantly more lower than in adolescents and adults “. “Although Covid-19 is generally mild in children of all ages – he points out – for some it can lead to serious illness, hospitalization or death. US data shows that the negative impact of Covid on children is greater than a ” full range of other vaccine-preventable diseases. In November, the EMA recommended approval of the first Covid vaccine for children aged 5-11. Evidence so far indicates that vaccines are as effective in children as they are in adults and that prevent most cases that would occur without vaccination. The data show that vaccines are highly effective in preventing hospitalization and other consequences of Covid-19, “he concludes.

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