The European Medicines Agency (EMA) considers it “reasonable” to administer a fourth dose of the covid vaccine in people with a depressed immune system. However, he has warned that there is no data on its need in the general healthy population.
Marco Cavaleri, head of the EMA’s vaccination strategy, assured in a press conference that the different drug regulators “agree that the administration of multiple booster doses with short intervals in time would not be a sustainable solution. long-term”.
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The EMA director already expressed his concern last week that this cannot be the strategy of the different countries to neutralize the virus.
“Repeated administration of boosters with several short time intervals could reduce the level of antibodies that can be produced in each dose, since our immune system needs a certain amount of time to show the response to the antigen that is presented to it. This will potentially make vaccination a little less efficient over time,” Cavaleri insisted today.
The EMA has endorsed the third dose
These reservations do not affect the third dose, which is already becoming widespread among the European population, with the endorsement of the EMA, after seeing that the two doses lost effectiveness over the months due to the omicron variant of the virus. Cavaleri refers to future additional doses, such as the fourth, of which he recalled that “there is no evidence from clinical studies on its need or value” in the general non-immunosuppressed population.
In transplant patients, cancer patients and others with a depressed immune system, “although data are not yet available, it would be reasonable for public health authorities to start considering the administration of a fourth dose now” to increase protection, he pointed out.
A covid ICU at the Policlinico di Tor Vergata in Rome, in the midst of an omicron wave
In Spain, this fourth dose is already administered to immunosuppressed patients. The Ministry and the autonomies planned to analyze whether it should be extended, for example, to people who live in residences or to people over 70 years of age. Immunologists have also said they don’t see its need beyond the immunosuppressed.
Israel, which helps the pharmaceutical company Pfizer as a test bench and injects the fourth dose, has already seen that it increases the antibodies of the third, but it would not be enough to get rid of contagion by omicron.
“The situation on the continent continues to be very worrying,” said Cavaleri.
However, the EMA does not rule out the need to resort to booster injections beyond the third dose. He believes that if necessary, at least in some risk groups, these vaccines could be offered when the cold arrives, as is done with the annual flu vaccination. “This would increase the antibody response when we need it most,” as opposed to consecutive doses, says Cavaleri.
Last week there was a meeting of regulatory agencies from around the world, chaired by the EMA and the US Medicines Agency, and with the World Health Organization (WHO) to discuss the global regulatory response to the virus.
The evidence on the efficacy of omicron vaccines was reviewed to see if it can “support the development” of a vaccine tailored to this variant.
Regulators ask laboratories to look for polyvalent vaccines, not just against omicron
But the regulators have asked the pharmaceutical laboratories not to remain in omicron, but to investigate an immunogen that could be polyvalent, serve for different variants.
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Cavaleri reiterated that the available vaccines against covid, especially after the third dose (second for Janssen’s), protect against suffering from the disease in a serious way, hospitalization and death, even against omicron and despite the high number of infections that it is causing in Europe, a situation that he has described as “very worrying” because it puts pressure on the health system.
The EMA has not seen more risks of the vaccine in pregnant women
Therefore, he regretted that only 40% of the adult population in the European Economic Area (EEA) – the 27 of the EU, Iceland, Liechtenstein and Norway – have already received the booster dose, and there are still about 20% of the citizens without having provided them with the complete guideline.
The EMA has also urged pregnant women to get vaccinated against covid. The agency has carried out a study and has concluded that the mRNA vaccines, those of Pfizer and Moderna, “do not cause complications” neither in pregnant women nor in fetuses. And instead, there is a higher risk of serious covid if they are infected during pregnancy.
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EMA experts have analyzed studies with 65,000 pregnant women at different stages and found side effects similar to those in the rest of the population. They saw no increased risks of pregnancy complications, miscarriages, premature births, or effects on fetuses.
The WHO: “the pandemic is still far from over”
Tedros Adhanom Ghebreyesus, Secretary General of the WHO, also warned this afternoon that the pandemic “is still far from over and given the incredible growth of omicron, new variants may emerge.” He does not believe that the pandemic will end this 2022 and has said that it is not necessary to think that ómicron is milder.
He has recognized that some countries seem to have reached the peak, which allows us to hope that the worst is over, “but no country has yet come out of this problem,” he warned.
An endemic covid could also cause many deaths
Cavaleri has recognized that “with the increase in immunization, because ómicron will generate a lot of natural immunity and through vaccination, we will move quickly towards a scenario closer to covid being endemic.”
The head of emergencies at the WHO, Michael Ryan, warned this morning that “we have an opportunity to end the health emergency this year”. And he added that “the fact that covid goes from being a pandemic to endemic will not be the end of problems.
End or prolong the pandemic
“People talk about pandemic versus endemic, but malaria or HIV-AIDS are endemic and kill hundreds of thousands of people, so endemic is not a good thing, it just means it’s here forever,” he said. Davos Forum. The objective must be, he recalled, that there are very low levels of disease, “with a maximum of people vaccinated and that no one has to die of covid. That will be the end of the health emergency, the end of the pandemic.”
For Ryan, giving booster doses “is like prolonging the pandemic instead of ending it”, by directing the doses to countries that already have high vaccination coverage while the virus can spread and mutate. Because he has recalled that, although half of the planet’s population already has two doses, in Africa it is only 7%.
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