Represent fourteen cases among the more than 17 million Europeans and Britons who have already received the coronavirus vaccine developed by the pharmaceutical company AstraZeneca and the University of Oxford, but they have been enough to paralyze the immunization process in the main countries of the continent. Germany, Italy, France, the Netherlands and Spain joined this Monday in the decision adopted in recent days by other countries such as Denmark, Norway, Ireland or Iceland, which earlier suspended inoculation among their citizens.
In Spain, which for the moment will wait two weeks for the European Medicines Agency (EMA) to reassess the cases reported to decide what to do with the vaccines and those already vaccinated, the alarms went off on Saturday. It was then that a rare case of venous sinus thrombosis aaccompanied by a significant decrease in the number of platelets in a patient who had just received the AstraZeneca vaccine. By then, the Spanish Medicines Agency had already requested an emergency meeting with European regulators and that same weekend three more cases were known in Norway and four in Germany that responded to the same pattern. This Monday there were three more incidents: one in the Nordic country and two in Germany. These 11 reports are added to the information handled by the United Kingdom, which among its ten million immunized so far with AstraZeneca has also registered three cases of this type of thrombosis.
“The Government and the autonomous communities have decided to suspend vaccination with AstraZeneca on a temporary and precautionary basis,” explained the Minister of Health on Monday, Carolina Darias, at a press conference after the Interterritorial Committee of the National Health System (CISNS) convened this Monday urgently. Observed cases «They leave the pattern hitherto known, As these are very specific thrombi, and following the precautionary principle, we will leave the EMA the time it has requested to evaluate them and offer us answers, ”said Darias. “There are very few cases in absolute number, but due to the qualitative importance of each of them and as in the general population there are also very few cases of bleeding disorders, it seems prudent to stop,” justified the head of Health.
The decision to permanently suspend or limit the inoculation of AstraZeneca now is, according to the minister, in the hands of the Committee for the Evaluation of Risks in Pharmacovigilance (PRAC, for its acronym in English), of the EMA, and is expected to issue a detailed assessment of the cases, of which no further details have been disclosed. The European body will meet today and has called an emergency meeting for this Thursday,
At the moment, it is known what the symptoms to watch for among those vaccinated. These appear three and 14 days after receiving the injection, and manifest with a very intense and unusual headache that does not go away with analgesics, which worsens when lying down and can be accompanied by vomiting or visual disturbances, in addition to other types of neurological manifestations or irregular bleeding, explained this Monday the director of the Spanish Medicines Agency, Maria Jesús Lamas.
In Spain, according to official data provided by Health, as of this Monday 939,534 people had already been vaccinated with AstraZeneca, of which eight have received the complete guideline. Asked about what will happen to that almost a million Spaniards who hope to complete their vaccination schedule in the next few days, Darias declared that, with an interval of ten to twelve weeks between both doses “There is still time” to react while the EMA makes a decision and establishes the steps to follow. “The most important thing will be to remain calm and send a message of calm,” added the minister. Lamas also clarified that although the inoculation has been suspended, protection against Covid-19 can be expected “having received a single dose or partial vaccination.”
In this sense, the minister stressed that the notification of cases of these adverse events of the vaccine shows that the pharmacovigilance system works, both at national and European level, for which she insisted on the need to transmit tranquility to the population.
On the other hand, a group of experts from the World Health Organization (WHO) meets this Tuesday to analyze “more in depth” the safety of the vaccine AstraZeneca, after cases of thrombi have been reported.
WHO studies it
“We are going to evaluate the available data that we have since last week to carry out a more in-depth investigation,” explained the WHO deputy director general for Access to Medicines and Health Products. Mariângela Simão, and assured that this week there will be “more news” in this regard.
Last Friday the WHO assured that “there is no reason not to use” the AstraZeneca vaccine against Covid-19. “There are people who die every day, so it is normal that there are people who have been immunized and die. The reports available so far do not establish a direct relationship with thrombi, since this percentage has also been observed in the general population, ”said Simão.
George is Digismak’s reported cum editor with 13 years of experience in Journalism