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The EMA recommends giving the second dose of AstraZeneca to those who received the first

2021-04-24T03:47:24.706Z


The European agency, which continues to analyze very rare cases of thrombi, insists that the benefits far outweigh the risks


The European Medicines Agency (EMA) recommended this Friday to continue administering the second dose of AstraZeneca after a period of four to 12 weeks after receiving the first.

The European agency, which continues to investigate the very rare cases of thrombi that have been collected by national authorities, insists that the benefits outweigh the risks in all age groups.

The decision comes after several EU countries, including Spain, have restricted the use of the vaccine.

Denmark even stopped administering it despite the fact that the EMA had endorsed its safety.

More information

  • The dilemma with Janssen: have those over 30 vaccinated in July or be extremely cautious about thrombi

  • European regulator endorses Janssen vaccine despite finding possible links to rare cases of thrombi

The EMA continues to consider that the AstraZeneca drug, baptized with the commercial name of Vaxzevria, is a good weapon to combat covid-19, which recalled that it can cause "serious diseases", "long-term consequences in people of all ages "- even those that were healthy - and, ultimately," death.

The body led by Emer Cooke has already indicated that the vaccine should include among its very rare side effects the possibility of blood clots, but these occur in 1 in 100,000 people. In general, the most common side effects are usually mild or moderate and last only a few days. “The benefits of the AstraZeneca vaccine outweigh the risks. The work presented today puts the very rare blood clots that can occur in perspective with respect to the benefits of the vaccine. The agency maintains that the vaccine has prevented hospitalizations, intensive care (ICU) admissions and deaths. The deputy director of the EMA, Noël Wathion, has stated that "in general, the data show that the benefits of vaccination increase with age and with increasing levels of infections in the community."

The EMA has come up with several scenarios that support the conclusions it has come to since it began analyzing these rare clot events. In groups with high infection rates, 1,239 hospitalizations, 110 ICU admissions and 773 deaths were avoided for every 100,000 inhabitants over 80 years of age. On the contrary, in this age group 0.4 cases of thrombi have been detected after vaccination per 100,000 people. But in the group between 40 and 49 years old, in which the incidence of thrombi is higher (2.1 out of every 100,000), the balance is equally positive. In this case, 122 hospitalizations, 15 admissions to ICUs, and 10 deaths per 100,000 inhabitants were avoided. Although thrombi have been linked to women under the age of 60,the EMA maintains that there is not enough data to do an analysis by sex.

Despite the recommendations that it has been issuing, the EMA recalls that countries can subsequently consider other factors to use the vaccines. And so they have. The EU partners adopted various strategies. Denmark stopped using it, while Spain, France, Germany or Belgium limited it to one age group. However, those countries had to decide what to do with those citizens who had already received a dose of AstraZeneca. Italy decided that these patients would be given the second, while Germany said they would receive a different one.

Since the vaccination of the population also benefits those who have not yet been immunized, the EMA studied all three hypotheses: injecting a second dose, not doing it or using AstraZeneca again.

"The Committee for Medicinal Products for Human Use recommended continuing to give a second dose of Vaxzevria between four and 12 weeks after the first, in line with the product information," says the EMA.

Decision of Spain

The Spanish Agency for Medicines and Health Products (AEMPS) has released a statement this afternoon from which it follows that Spain is not going to change the strategy followed to date with this vaccine, which after several changes is now being administered to the age group from 60 to 69 years old. On the contrary, the note includes several phrases that qualify the analysis communicated this afternoon by the EMA and seem to try to defend the decisions taken so far by Spain.

"This analysis is only a guiding tool for decision-making by Public Health authorities, which must take into account additional factors," says the statement. And it continues: "The conclusions of this analysis are indicative, they are based solely on the data that are currently available, and will be updated as they become available."

According to the AEMPS, the “main conclusion obtained from this analysis is that the benefits of vaccination with Vaxzevria increase proportionally with age and with the incidence of the virus”. Regarding whether the risk of suffering a thrombus after receiving the second dose is equal to or less than with the first, the Agency maintains after studying the EMA communication “that there is not enough data to determine whether the risk [...] after a second dose with Vaxzevria varies with respect to the risk after the administration of the first one ”.

Spain suspended the administration of AstraZeneca doses in Spain on March 16.

He then reported that he had received "some reports of cerebral venous thrombosis that need to be studied further, as they are very rare in the general population."

"Although the number of notifications is very low in relation to the number of people who have received the vaccine, it could exceed the number of cases expected in the general population," he then published in a statement.

Subsequently, on April 7, the Ministry of Health and the communities decided to resume vaccinations only with those over 60 years of age and left up in the air what was going to happen to people who had already received the first dose (the second can be taken between 4 and 12 weeks after the first, so the maximum period has not yet been met).

Last Monday, Health announced that the Carlos III Institute (ISCIII) began a study, called CombiVacs, which will evaluate the possibility of supplementing this second dose of AstraZeneca with one from Pfizer or Moderna.

Source: elparis

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