The European Medicines Agency (EMA in its acronym in English) considers that it is premature to treat Covid-19 as an endemic virus, such as the common flu, as stated by the President of the Spanish Government, Pedro Sánchez, because it is still “behaving as a pandemic virus and the appearance and spread of the omicron variant has shown this ”, the person in charge of the EMA’s vaccination strategy warned this Tuesday, Marco Cavaleri, which has also recalled that the new variant is “Highly contagious” resulting in “many infected” so it is important to be aware of “its potential burden” and not relegate it to the category of “mild disease”.
During the first balance of the year, those responsible for the European regulator have recognized that it is not yet possible to predict when “we will reach the end of the tunnel” although they have insisted that we will arrive. “The important thing is that we are moving towards a situation in which the virus is increasingly endemic but we cannot yet say that it has reached that status. The virus is still behaving like a pandemic virus and the omicron emergency is showing it. We must not forget that we are still in a pandemic “, insisted Cavaleri who has also recognized that” with the increase in immunity in the population – and many naturally immunized due to omicron in addition to vaccination – we will move quickly to a scenario close to endemicity ”.
In the meantime, the message from the EMA is to keep vaccinating and that the serums approved so far against covid19 also offer “high protection” against the most serious cases and hospitalizations caused by the new omicron variant. Specifically, data on the use of vaccines in South Africa show that people who have received both doses of the vaccine have 70% protection while studies in the United Kingdom raise protection after booster to 90%. Therefore, they insist that “European citizens must complete the initial regimen with one of the authorized vaccines and those who have already done so should receive the reinforcement ”.
What is still not clear to the European regulator is whether a new adapted vaccine for the new variant that the pharmaceutical company Pfizer could have ready in March. The head of the vaccination strategy has explained that the EMA will need between three and four months to authorize it, which means that it could receive the green light in April or May, although he has been in favor of examining other options since many citizens will be immunized in a way. natural due to omicron and new variants could appear.
Fourth dose
The EMA is still not clear about the strategy to follow when faced with the possibility of administering a fourth dose that could cause problems in the immune response and fatigue in the population. “We would like to have data before making recommendations” but “at the same time we are very concerned about a strategy that requires repeated vaccination in a short period of time. We cannot be continually giving booster doses every three or four months ”, explained Cavaleri, who has warned that it will not only cause fatigue in the population but that it could pose problems in the immune response that could not be so good. “If we give boosters every three months we will end up having problems in the immune response that may not be as good as we wish. In addition, there is a risk of fatigue in the population of continuing to administer boosters, “he reiterated.. In his opinion, the best solution would be to give new booster doses more widely and ideally, “if we go to an endemic scenario”, it should be synchronized with the start of the cold season, as is done with the flu vaccine.
Cavaleri has also confirmed that the regulator is currently examining a Pfizer request to authorize the use of the booster dose between 16 and 17 year olds and that they expect a similar request from the laboratory shortly for the 12-15 year age group. The head of vaccines recalled that covid19 can also lead to serious illness, hospitalization and death in the case of children and explained that vaccines also prevent most cases and hospitalizations in this group. Regarding the pregnant women, the EMA findings suggest that they are more likely to become seriously infected and that vaccines reduce the risk of hospitalization and death.
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