France, Spain, Italy and Germany to resume Astrazeneca vaccinations after EU regulator rules jab is ‘safe and effective’
France, Spain, Italy and Germany are among the European countries that have confirmed they will resume rolling out the Astrazeneca vaccine after the EU medicines regulator said there is “clear scientific” evidence that the jab is both “safe and effective”.
Emer Cooke, executive director of the European Medicines Agency (EMA), earlier today said the agency remains “firmly convinced” that the benefits of the Astrazeneca vaccine outweigh the risk of side-effects.
The agency refused to rule out a possible link with blood clots following reports of severe side-effects in Europe.
However Cooke added there were no signs to suggest that the estimated 17m Astrazeneca vaccinations delivered across Europe have caused reported cases of blood clots.
French Prime Minister Jean Castex, who will receive the jab tomorrow said: “The AstraZeneca COVID-19 is effective, as underlined by the European regulator. It only has relatively rare side effects … it has a positive risk/reward ratio.”
Spanish, German and Italian health authorities also confirmed they will resume Astrazeneca vaccinations this week.
Just 15 cases of deep-vein thrombosis and 22 cases of pulmonary embolism have been reported among the 17m people who have received an Astrazeneca vaccine as of 8 March, the Cambridge-based firm said in a statement on Monday.
“We know that many thousands of people develop thousands of clots annually for many different reasons”, said Cooke, adding that the number of thromboembolic was the normal level among the general European population.
However, she added that an investigation into potential side effects saw “a small number of cases of rare and unusual bit very serious clotting disorders”.
“After days of in-depth analysis and lab results… we still cannot rule out definitively a link between the link between these cases and the vaccine,” she said.
“The committee has therefore recommended to raise awareness of these possible risks by making sure they’re included in the product information.”
The EMA ruled that healthcare professionals and members of the public must be made aware of the possible side effects of the Astrazeneca vaccine though patient leaflets and updated product warnings.
Cooke said the EMA would launch additional investigations into the possible risks of receiving the Astrazeneca vaccine, including targeted observational studies.
Dr Sabine Straus, member of the EMA board, suggested that blood clot cases could be the result of so-called Long Covid, rather than from taking the Astrazeneca vaccine itself.
Straus added that it was not yet known whether a potentially heightened risk of blood clots was strictly associated with the Astrazeneca vaccine, or whether the potential risk also applied to other vaccines. Straus said the same investigation would be take place into the safety of the Pfizer vaccine.
She said the EMA was also investigating a possible link between the contraceptive pill and blood clots, after the medicines regulator found a higher risk of thrombotic incidents among women.
Widespread support
It comes after the UK’s medicines regulator affirmed its support for the Astrazeneca vaccine this afternoon, saying it had “no proven causal association” with blood clots.
Phil Bryan, vaccine safety lead at the Medicines & Healthcare products Regulatory Agency (MHRA), said: “Where we are now is that no proven causal association with what is still an extremely rare medical event has been proven for the Astrazeneca vaccine.
“But we do know that these are highly effective vaccines. We still have a huge burden of Covid disease in the population. So, right now, the balance of benefits and known risks of the vaccine are favourable.”
The World Health Organization (WHO) this morning reiterated the safety of the Astrazeneca vaccine, as it claimed European countries’ decision to temporarily suspend the jab was misguided.
“As of now, we do not know whether some or all of the conditions have been caused by the vaccine or by other coincidental factors,” said Hans Kluge, the WHO’s European director.
“At this point in time, however, the benefits of the Astrazeneca vaccine far outweigh its risks — and its use should continue, to save lives.”
Temporary suspensions
It comes after Sweden this week joined a list of 15 countries across Europe that have temporarily banned the jab following reports of blood clot-related deaths.
No such cases have been reported in Sweden but neighbouring Norway and Denmark have each reported one death.
“We’re very aware that some member states have paused vaccinations [while] waiting for the EMA’s outcome of a view,” Cooke said. “But given that thousands of people in the EU die every day it’s really crucial for the EMA to review rapidly and thoroughly all the available data.”
There were early indications that scepticism regarding the Astrazeneca jab could soon spread outside of Europe after Thailand also suspended the rollout of the jab earlier this week. However, Thailand has since resumed vaccinations using the vaccine, while Indonesia and the Democratic Republic of Congo have issued a temporary suspension.
The EMA’s decision will apply significant pressure on the countries to reverse their temporary suspensions of the jab.
French President Emmanuel Macron and new Italian Prime Minister Mario Draghi said yesterday that they would “promptly restart the administration of the Astrazeneca vaccine” if it was given the green light from the EMA today.
Spain’s government immediately announced it has called a meeting of the inter-regional council this afternoon to evaluate the possible resumption of vaccination using the Astrazeneca jab.
Cooke told the EMA press conference this afternoon that “we should all remember that this is a virus that costs lives… and that we have vaccines that work and are safe and effective”.
Several EU leaders have been accused of playing politics with the Astrazeneca jab, after supply shortages significantly slowed down the EU’s vaccine rollout.
Just 8.5 per cent of Europeans have received their first dose of a Covid vaccine, according to the European Centre for Disease Prevention and Control’s Covid-19 Vaccine Tracker.
That compares to more than 25m people who have received their first injection in the UK — equivalent to around 37 per cent of Britain’s population.
Nicola Magrini, head of Italy’s medicines agency, admitted earlier this week that the decision to suspend vaccinations was “a political one” that Rome had reached only “because several European countries, including Germany and France, preferred to interrupt”.