The Ministry of Health and the Autonomous Communities announced late this Wednesday a new change in vaccination with AstraZeneca: from this Thursday only the over 60 years. This decision comes after the European Medicines Agency (EMA) concluded that there is a “possible link” between this serum and the “very rare” cases of thrombi detected among people who are given it. has managed. This new scenario leaves many doubts and not all of them have yet an answer.
The Minister of Health, Carolina Darias, explained this Wednesday night that he is “determined” what people under 60 years of age who have already received the first dose of the AstraZeneca vaccine. This Thursday the Public Health Commission is held, in which this issue will be addressed. Darias stated that there are two options on the table and warned that they are also pending “to see the decision made at the European level.”
The first option, he explained, is to complete the immunization schedule with a second dose of another alternative vaccine to that developed by the University of Oxford. The second of the solutions proposed is that these people, some two million essential workers -which are the population group vaccinated with AstraZeneca in Spain- stay only with that first dose and do not receive the second. In this sense, Darias remarked that this measure would be adopted since there is already “enough scientific evidence” that the first dose of AstraZeneca already has a 70% effective against covid-19.
This new change in vaccination strategy, which reduces the target population of the AstraZeneca vaccine, does not alter the government’s forecasts. As Darias assured this Wednesday, the milestones announced by President Pedro Sánchez last Tuesday remain:
In this sense, Darias added one more government objective on Wednesday: “vaccinate everyone over 60 between April and May“.
According to the data provided this Wednesday by the director of the Spanish Agency for Medicines and Health Products, María Jesús Lamas, in Spain they have been registered until this week 12 cases of thrombosis in combination with thrombopenia, specifically 8 cases of cerebral venous sinus thrombosis (CVST) and 4 in the abdomen (splanchnic vein thrombosis) between 1.7 million from people who have received the Vaxzevria vaccine (the new brand name for the AstraZeneca vaccine).
In the European Union, according to the data provided by the EMA at a press conference, a total of 222 cases (169 from TSVC and 53 from splenic vein) between 34 million vaccinated, which is equivalent to 1 case in every 150,000. As of March 22, the reported cases were 62 of brain thrombi and 24 abdominal, a total of 86 -18 of which ended in death- among 25 million people vaccinated with AstraZeneca.
At the moment it has only been specified that these “very rare”, but very serious, episodes of thrombi occur “most” in women under 60 years of age. These cases occur “in the two weeks after the administration of the first dose of the vaccine, since the experience with the second dose is still very little.”
However, the data available to date do not allow us to determine more common characteristics of thrombus cases. In Lamas’s words: “no risk factors found that indicate which population can or should not receive this vaccine “(regardless of age).
It is worth mentioning that the vaccine has been administered to date in 60% women and 40% men, according to information provided by the EMA this Wednesday.
The possibility of expanding the age limit to prescribe the AstraZeneca vaccine is being studied by the Ministry of Health. In fact, this Monday, the director of the Center for the Coordination of Health Alerts and Emergencies (CCAES), Fernando Simon, you already said that “soon” it could be decided to vaccinate people over 65 years of age also with this serum. However, this Wednesday the scenario changed again and for the moment Minister Darias has limited herself to saying that vaccination with AstraZeneca “continues with people over 60 years old”, without giving further details on future decisions. He did remember that the vaccination strategy is “a living document” that is being updated based on the evidence that science is throwing on the disease of covid-19.
The objective of Health, added Darias, is “maximizing benefits in least-risk age cohorts“.
After updating the EMA its conclusions on AstraZeneca, Spain chose to restrict its inoculation to those over 60 years and up to 65 years (so far). A decision goes along the lines of other countries like Germany and Italy, which will prioritize the administration of the AstraZeneca vaccine to those over 60 years of age for safety, while Canada, France or Belgium they have done it with those over 55 years of age. Finland and Sweden They use it for people over 65 and Iceland for over 70s. In Denmark, Latvia, the Netherlands and Norway no one is vaccinated. The Netherlands has not yet made a decision on this. United Kingdom, for its part, has recommended using an alternative vaccine in those under 30 years of age.
The truth is that the 27 of the EU did not reach a common position on Wednesday on the use of the AstraZeneca vaccine despite the appeal of the European Commission to find an answer “as coordinated as possible”, but agreed that more studies are needed on its impact.
As the health authorities have explained, “a possible mechanism that could explain these adverse reactions would be of the type immunological, similar to that known for heparin-induced thrombocytopenia (HIT) “.
So far, it has been a team of German researchers led by Andreas Greinacher who have gone further in understanding these adverse events, which they have called ‘Vaccine-Induced Immune Prothrombotic Thrombocytopenia Syndrome‘(VIPIT). In addition, they have found a treatment to alleviate this very rare but very serious effect, according to the journal Science.
The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) has highlighted the importance of early diagnosis and treatment of these possible thrombotic events accompanied by thrombopenia “despite their very low frequency of occurrence” and has recommended that both healthcare professionals and citizens are vigilant of the appearance of signs or symptoms suggestive of a thromboembolic event.
Symptoms to watch for and seek medical attention if they occur include: difficulty breathing; chest pain; swelling or pain in one leg; persistent abdominal pain; headache that is severe and persistent or worsens more than 3 days after vaccination; blurred or double vision; multiple small bruises, reddish or purplish spots on the skin.