Spain and Italy have decided to limit the use of the Oxford / AstraZeneca vaccine to people over the age of 60, under changes that will complicate countries’ efforts to scale up their immunization programs.
The decision in Madrid and Rome on Wednesday night came after the European Medicines Agency said earlier today that there was a link between very rare blood clots in the brain and the AstraZeneca vaccine.
Although the EMA, the EU’s drug regulatory body, has not changed its guidelines for who should take the vaccine, it noted that “so far, most of the reported cases [of blood clots] occurred in women under 60 years of age within two weeks of vaccination ”.
France and Germany had also previously restricted use of the vaccine to those over 55 and over 60, respectively – relying on other vaccines, like that from BioNTech / Pfizer and a newer single inoculation from Johnson & Johnson will be enough to make up for the delay in the EU vaccination program.
The UK, which is well ahead of the EU in vaccine rollout, sharply itself changed his directives on the AstraZeneca vaccine on Wednesday, recommending that people between the ages of 18 and 29 be offered alternative injections. Sweden and Finland only allow its use among those over 65, while Denmark and Norway have suspended its use until at least next week.
Spain’s decision to use the AstraZeneca vaccine only for people over the age of 60 overturns the country’s policy just a few weeks ago – until last month it banned the use of the vaccine for people over the age of 55.
The new position, which has been approved by most parts of the country, could make it harder to achieve its goal – announced Tuesday by Prime Minister Pedro Sánchez – of vaccinating 70% of the population, or 33 million people, from here at the end of August. .
Currently, 6.4 million Spaniards have received at least one dose of a Covid-19 vaccine. Of these, just over 2m received the AstraZeneca jab, whose use had accelerated in recent weeks.
Health minister Carolina Darias said the country has yet to decide whether to give AstraZeneca or another vaccine to people under the age of 60 who have already received a first injection of the vaccine.
Italy’s health ministry also released new guidelines overnight stating that the AstraZeneca vaccine should be “used preferentially” in people aged 60 and over. The guidelines noted the risk of clots, while acknowledging that it was low, and adding that the risk of severe Covid-19 increases with age.
Italian officials told a press conference on Wednesday evening that the risk-benefit ratio was still heavily skewed towards the administration of the vaccine. Italy had also initially limited the use of the vaccine to younger patients, removing age limits as more data became available.
The new Rome guidelines made it clear that those who have already received a dose of the AstraZeneca vaccine should end their vaccination with the same vaccine, regardless of their age.
AstraZeneca acknowledged the findings of the EMA and the UK Medicines and Health Products Regulatory Agency on Wednesday, while noting that more than 200 million doses of the vaccine had been administered worldwide with a relatively low number of ‘Side effects.
The Anglo-Swedish drugmaker said it was working with global authorities to better understand the side effect’s mechanism of action. The EMA has ordered further studies on the issue, to be carried out with Utrecht University and Erasmus University Rotterdam.
Also on Wednesday, the World Health Organization said the link was plausible but had not been confirmed and that the vaccine’s benefits outweighed its risks.