Spain and Italy have moved to limit the use of the Oxford/AstraZeneca vaccine to people aged above 60, in shifts that will complicate the countries’ efforts to step up their vaccination programmes.
The decision by Madrid and Rome on Wednesday night came after the European Medicines Agency said earlier in the day that there was a link between very rare blood clots in the brain and the AstraZeneca jab.
While the EMA, the EU’s pharmaceuticals regulator, did not change its guidance for who should take the vaccine, it noted that “so far, most of the cases reported [of blood clots] have occurred in women under 60 years of age within two weeks of vaccination”.
France and Germany had also previously restricted the use of the jab for the over-55s and over-60s, respectively — trusting that other vaccines, such as that from BioNTech/Pfizer and a new one-shot inoculation from Johnson & Johnson will be sufficient to make up the lag in the EU’s vaccination programme.
The UK, which is well ahead of the EU in the vaccine rollout, itself abruptly changed its guidance over the AstraZeneca vaccine on Wednesday, recommending that people aged 18-29 be offered alternative jabs. Sweden and Finland only allow its use in the over-65s, 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 60 reverses the country’s policy of just a few weeks ago — until last month it banned the use of the jab for those older than 55.
The new stance, which was endorsed by most of the country’s regions, could make it more complicated to reach its goal — announced on Tuesday by Prime Minister Pedro Sánchez — of vaccinating 70 per cent of the population, 33m people, by the end of August.
At present, 6.4m Spaniards have received at least one dose of a Covid-19 vaccine. Of those, slightly more than 2m have received the AstraZeneca jab, whose use had been accelerating in recent weeks.
Carolina Darias, health minister, said the country had not yet decided whether to administer AstraZeneca or another vaccine to people under 60 who had already received a first shot of the jab.
The Italian Ministry of Health also issued new guidance overnight saying the AstraZeneca vaccine should be given “preferential use” in those aged 60 and above. The guidance 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 night that the risk-benefit ratio was still significantly slanted towards administering the vaccine. Italy had also initially limited the use of the vaccine to younger patients, removing age limits as more data became available.
Rome’s new guidelines clarified that those who have already received a dose of the AstraZeneca shot should complete their vaccination with the same jab, regardless of age.
AstraZeneca on Wednesday acknowledged the findings from the EMA and the UK’s Medicines and Healthcare products Regulatory Agency, while noting that more than 200m doses of the shot 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 mechanism of action of the side effect. The EMA has ordered further studies into the matter, to be conducted with the Utrecht University and the Erasmus university in Rotterdam.
Also on Wednesday, the World Health Organization said the link was plausible but that it had not been confirmed, and that the vaccine’s benefits outweighed its risks.