Spain will restart AstraZeneca shots next week after European Medicines Agency finds vaccine ‘effective and safe’

Spain will restart Covid-19 vaccinations using the Oxford-AstraZeneca medication from Wednesday of next week. That was the unanimous decision taken yesterday by the Inter-Territorial Council of the National Health System (CISNS), which brings together the central Health Ministry and the country’s regional healthcare chiefs. The move came after the European Medicines Agency (EMA) concluded that the vaccine was safe after concerns were raised across the European Union (EU) due to the detection of cases of blood clots after its administration.

“As the European Medicines Agency has clearly stated today, the benefits of the vaccine in combating Covid-19 continue to outweigh the risks of side effects,” Stella Kyriakides, the EU’s Commissioner for Health and Food Safety, said on Thursday in a statement. “It is an effective and safe vaccine that greatly contributes to the efforts to address the impact of Covid-19 and the very serious health risks of an infection.”

Before this part of Spain’s vaccination campaign restarts, health experts will meet to determine which sector of the population will receive the AstraZeneca vaccine. The Spanish government initially opted to only administer it to the under 55s, due to a lack of clinical testing in older age groups. But since then the authorities have been considering raising the age group for the medication given the ever-growing range of scientific proof of its efficacy. The authorities will also revise the EMA’s latest conclusions and decide whether any specific group should be excluded from being given AstraZeneca. With these reports, the CISNS will meet on Monday and take a definitive decision on how to proceed.

With the available data, it would appear certain that the Spanish authorities will raise the age group that will receive the AstraZeneca vaccine above 55. The blood clots that have been detected in recipients of the medication have been mostly among women aged around 40, although there has been no direct link established to the medication. In the United Kingdom, which is giving the AstraZeneca vaccine to all age groups, fewer events of this type have been reported than in the EU.

After Spain opted to suspend the use of the AstraZeneca vaccine earlier this week, Health Minister Carolina Darias said that a decision would be made as to how to move forward once the EMA had reached its conclusions. The suspension came after a number of European countries, including Spain, detected cases of cerebral venous sinus thrombosis – blood clotting in the brain – after the vaccine had been administered. Despite the EMA advising that the benefits of the vaccine outweighed the risks, around 15 European countries opted to suspend the shots until the agency had studied these thrombosis cases in depth. In Spain, for example, a 43-year-old teacher from Marbella who had been given the AstraZeneca vaccine died after brain hemorrhaging was detected and emergency surgery failed to save her life. Italy, France, Germany and Portugal will also restart the use of AstraZeneca after the EMA’s conclusions.

Rejection of the vaccine

One of the problems that some experts now fear once the use of AstraZeneca is restarted is a rejection of the vaccine among the population. José María Martín Moreno, a doctor in epidemiology and public health from Harvard University, believes that a situation of “mistrust” has been created with “confusing” communication. “The population is scared that this vaccine could be dangerous and there has not been a unified response from European countries at the time for action. For citizens, this creates total confusion, and they don’t know what they should believe,” he explains.

While the EMA insists that the benefits of the AstraZeneca vaccine outweigh its risks, it has not completely ruled out its association with very rare cases of blood clots related to thrombocytopenia – a condition characterized by abnormally low levels of platelets in the blood. The EMA is going to put a warning on the product’s information and will advise those who receive the vaccine to seek emergency treatment should they notice any of the symptoms related to the condition.

Ángela Domínguez, coordinator of the vaccination working group from the Spanish Epidemiological Society, says that these processes should create confidence among the public because they are a sign that “the pharmacovigilance monitoring system works.” She adds that “the benefits of the vaccines should be explained in order to create confidence among the population.”

State of the campaign

According to the latest data from the Spanish Health Ministry, a total of 7,684,265 Covid-19 vaccine doses have been distributed to the country’s regions, which are in charge of administering them. Of these, 5,993,363, or 78%, have been injected. A total of 1,886,813 people in Spain have received the two doses of the three vaccines being used so far – Pfizer-BioNTech, Moderna and Oxford-AstraZeneca – to give them the full protection offered by the shots. The Spanish government is aiming to vaccinate 70% of its 46.7 million residents by the summer. So far the campaign has focused on care home residents and staff, healthcare professionals, the over-80s and essential workers, including teachers and law enforcement officers, among others.

Latest data

According to the latest coronavirus report released on Thursday by the Spanish Health Ministry, a total of 6,216 new infections have been registered by Spain’s regions, and 117 Covid-19 deaths were added to the overall total, which now stands at 72,910 since the pandemic began. Over the last seven days, 410 people died after testing positive for Covid-19. Meanwhile, the 14-day cumulative number of coronavirus cases per 100,000 inhabitants rose slightly for the second day in a row, from 127.91 to 128.17. Madrid remains the region with the highest incidence, which came in at 225.34 on Thursday.

English version by Simon Hunter.