The European Medicines Agency (EMA) and the group of the vaccine presentation that advises the Interterritorial Health Council have yet to pronounce, but Spain seems to be heading towards a third dose of vaccines against COVID-19. At least for some vulnerable groups, such as the immunosuppressed and the elderly.
Only 1% of the impoverished population have received any anti-COVID dose as pressure grows for the third puncture
This past Wednesday, the Minister of Health, Carolina Darias, hinted at it after the Interterritorial Council of the National Health System, when she stated that “it is necessary to see when and to which groups” it would be applied. He had previously clarified that these expert opinions are lacking, but all the messages launched by the administration go along the same lines. The minister explained that the vaccine presentation meets next week, suggesting that it could be the moment of decision. Sources of the presentation explain to this newspaper that the initiative, on which they have been working since July, “is quite lined up” and that in no more than 15 days it should be ready – if it does not happen this next week – to be debated by the communities autonomous in the Interterritorial meeting.
Vaccine experts believe, however, that Spain should focus on finishing immunizing people who are not yet immunized. “The objective has to be first the repechage of all those over 40 not vaccinated or with a single dose. That is the priority objective, we have two million Spaniards over 40 years without vaccination, mainly between 40 or 60. The second thing would be to get everyone over 18 or 12 vaccinated to make it difficult for the virus to circulate “, summarizes José Antonio Forcada, president of the National Association of Nursing and Vaccines ANENVAC.
Because vaccines, while not perfect, work. “The undeniable achievements in vaccination coverage have freed us from a greater collapse of care, more severe disease episodes and a more pronounced mortality,” write in this newspaper the experts in Public Health José Martínez Olmos, Daniel López-Acuña and Alberto Infante Campos. “This implies that you have to continue vaccinating to try to complete 100% of the target population in order to prevent the greatest possible number of severe episodes and deaths.”
Isabel Sola, co-director of the laboratory of the National Center for Biotechnology of the CSIC, explains that there is still a lack of information. Not only to make the decision, but to know why the third dose would be necessary (if it were the case). “Studies have been published in Israel (the most advanced country with vaccination) and other sites where they recognize that it is difficult to dissociate and eliminate confounding factors about why a third dose is necessary, if it has to do with us being with another variant [la delta] or that immunosuppressed people are losing their immunological coverage “, he illustrates.
In the opinion of this virologist, who participates in the creation of one of the Spanish vaccines, “it is necessary to carry out surveillance in older people on how immunity is evolving, if when they test positive it is only the positive or they have symptoms. “Sola does believe, even so, that” the debate is necessary, but not urgent.
Waiting for the EMA, although it only recommends
The minister and other officials allude to the EMA’s decision – which has been expected since last Monday – as if it were binding on the states, but this is not the case. It was demonstrated by the controversy surrounding the AstraZeneca vaccine at the beginning of the year, when the Oxford preparation was linked to the occurrence of a few cases of thrombi in certain profiles of people. The EMA said at the time that the vaccine was safe, but many governments ignored that claim and stopped using it.
“The EMA recommends and indicates, but each country makes a series of decisions that there are even times that political decisions are intermingled, this is so”, admits Inmaculada Cuesta, a member of the work group of the Vaccination Strategy against COVID on behalf of the ANENVAC.
But this time it may be different. The European Union warned this Thursday that European countries that decide to apply this third booster dose could have legal problems in case there was an incident with the vaccination. “The booster doses are not part of the marketing authorization of vaccines against COVID-19, and have not yet been subject to a scientific evaluation by the EMA due to the lack of sufficient data,” explained the Community Executive to Reuters, reports Andrés Gil.
It is explained by José Antonio Forcada, from ANENVAC. “In principle, and only in principle, as long as the EMA does not authorize it, it would not be necessary to apply a third dose, because it would be necessary to modify the technical specifications and indications of some vaccines”, which at this time do not contemplate a third dose. Doing so without the endorsement of the health authorities could pose a problem for countries.
And the problem, continues this expert, is that there is still not enough information. “There is no scientific evidence that it may be necessary. We have to complete studies to see if it is necessary or not. Until it is known if it really contributes an important extra for everything that means to reassemble the campaign for a third dose ( resources, logistics, cost, nurses …), it would be best not to talk about it, “he says. Yes, Forcada concedes that “it seems that they could be necessary for immunosuppressed people”, but it is not so new either: “It happens with all vaccines, their immune system does not allow them to create so many defenses”, he explains. “But it would be absurd [con la información disponible en este momento] put it on everyone. ”
While in Spain it is debated, several countries have already made their decision. There will be a third dose. This is the case of Israel, which does not even combine it in the future: it is already doing it. The same happens in Hungary, where almost 200,000 people have already received a third puncture. France has announced that from September five million vulnerable people will be able to receive it, the same as Germany and the United Kingdom, for groups between 50 and 80 years old. At the other ends of the world they are also betting on this route: Chile, Uruguay and the Dominican Republic have announced that they will inoculate certain people with a third dose (including mixing vaccines) and the United States did so last week; on the other side, the United Arab Emirates or Bahrain are aiming for the booster injection.
All these countries – and Spain, if it follows the path – thus ignore the request of the World Health Organization (WHO), which has been committed since the beginning of vaccination to prioritize immunization throughout the world rather than reinforce it in the countries that are already quite advanced. “Instead of proceeding with the booster doses, it is better to share those doses with other countries so that they can increase the number of people vaccinated with the first or second dose, increase immunization and then start with the booster. That is why we ask for a moratorium two months for the third dose, “said Tedros Adhanom Ghebreyesus, WHO Director-General.
The logic behind this request is that no matter how vaccinated we are in the West, as long as the virus continues to circulate in the world, even if it is a world far from Europe, the risk is very real, experts explain. “We must work to improve vaccination in poor countries, which have indecent coverage. And as long as we do not achieve this we are at risk of mutations, of variations against which vaccines do not work,” Forcada illustrates.
Which leads to the next point. In the hypothetical case that the debate on the third dose was already overcome in a positive sense, is it better to get vaccinated now with what is available or to wait a few months for the new vaccines to be developed, which in addition to protecting against the worst effects of the coronavirus, as the current ones do, would they prevent the infection of people and therefore the ability to continue infecting as it happens now?
Forcada explains that some of these new vaccines, which produce sterilizing antibodies that prevent infection, “are finishing their development.” The Spanish that the CSIC is preparing goes along this line. “But when we have them, and seeing how the pandemic behaves at that time – circulation is still limited – the same would be necessary a dose of a vaccine that prevents infection,” he speculates. In any case, “this is science fiction, we’ll see it in half a year or so”, adding that in the meantime “we probably need a third dose for the immunosuppressed.”
Because the fundamental thing now is to stop the circulation of the virus as quickly as possible, the vaccinologists agree, to get closer to it. “The virus is ahead when it has the opportunity to multiply and change,” explains Sola. “That is why it is important to limit transmission, and that is done with vaccines and with all the non-pharmacological measures that we know: safety distance, masks, etc. To the extent that we limit the virus from moving and multiplying, we also limit his ability to go ahead of us. ”
And this is a global task, it is useless that in Spain we reach 80% of vaccinated while other countries do not reach 10%. “The idea of universal vaccination is fundamental, especially in a pandemic in which the virus reaches all corners of the planet because we are interconnected,” Sola illustrates. Because the concept of herd immunity, so often mentioned, “is not applicable to humans as in veterinary medicine in the strict sense because” it only applies if one is absolutely isolated. If not, as long as you have people going in and out, the virus can also enter, even if you have 80% vaccinated, “Sola closes. Immunity” is increasingly unlikely given the characteristics of the disease and the nature of the vaccines. The idea that group immunity can be achieved with 70% of the population vaccinated with the complete regimen is illusory, “Olmos, López-Acuña and Infantes Campos agree.