The European Medicines Agency has said there was a “clear scientific conclusion” that the Oxford / AstraZeneca vaccine was “safe and effective” days after more than a dozen European countries stopped using the shot.
Emer Cooke, head of the EMA, said on Thursday that the agency concluded the vaccine was “not associated” with an increased risk of blood clots recently noted by some scientists, adding that the benefits of the vaccine were greater than the possible benefits. risks.
But Cooke said that based on the evidence currently available, the drug watchdog still could not “definitively” rule out an association between more rare and more serious side effects reported recently. The agency recommended a campaign to raise awareness about adverse events that “would help detect and reduce potential side effects,” Cooke said.
The EMA’s decision comes days after more than a dozen European countries suspended or restricted the shot, dealt another blow to the continent’s ailing vaccination campaign and further eroded confidence in the Anglo-Swedish company’s jab.
While countries including Austria and Italy had already suspended batches of the AstraZeneca vaccine, this week’s broader suspension came after German researchers noticed a markedly increased incidence of rare blood clots, prompting Berlin to shut down its vaccination program.
The unexpected increase in serious and rare side effects included cerebral thrombosis in combination with a decreased number of particles that help blood to clot.
The UK drug regulator said on Thursday that five such blood clots had been registered in the UK after the vaccine was administered, but stressed that no link had been made and urged the British to continue using the vaccine.
The AstraZeneca jab has faced multiple challenges since it hit the market. The first data generated by clinical studies has been criticized by some experts as inconsistent. Some European countries have also limited the use of the vaccine in some age groups, citing a lack of population-specific data.
Those fears seemed to subside in recent weeks as evidence came from the UK, where it has been administered to millions of people, right up to this week’s blood clot-related suspensions.
Some have rejected this week’s measures to stop the use of the vaccine as political, citing that several European capitals have coordinated their suspensions.
But politicians in France and elsewhere have also indicated that they are ready to resume vaccinations as soon as possible with the AstraZeneca shot if they get the green light from the EMA.
The EMA’s approval comes after the UK health agency warned that supplies of the AstraZeneca vaccine would be squeezed out in the next month, potentially complicating a highly successful vaccination campaign that has resulted in shots to nearly 22 million people.
The UK is well ahead of its European counterparts in vaccinating its population, with the The Washington City Times’s vaccination tracker showing that the UK had administered 40.5 doses per 100 people as of Monday, up from 11.8 in the EU.
European countries are struggling to secure the supply of vaccines. AstraZeneca recently announced that it aims to deliver less than half of the agreed doses by the second quarter of the year.
Most of that reduction stems from delivery issues, although there is also some evidence that individual countries are not deploying the doses that are available soon enough.
The company and Catalent, one of its main European suppliers, have defended their manufacturing processes after the EMA said that, as part of its investigation, it was also investigating possible manufacturing defects as a possible cause for the reported side effects.