Germany, France and Italy said on Monday they would hit pause on AstraZeneca COVID-19 shots after several countries reported possible serious side-effects, throwing Europe's already struggling vaccination campaign into disarray.
Denmark and Norway stopped giving the shot last week after reporting isolated cases of bleeding, blood clots and a low platelet count. Iceland and Bulgaria followed suit and Ireland and the Netherlands announced suspensions on Sunday.
Spain will stop using the vaccine for at least 15 days, Cadena Ser radio reported, citing unnamed sources.
The moves by some of Europe's largest and most populous countries will deepen concerns about the slow rollout of vaccines in the region, which has been plagued by shortages due to problems producing vaccines, including AstraZeneca's.
Germany warned last week it was facing a third wave of infections, Italy is intensifying lockdowns and hospitals in the Paris region are close to being overloaded.
German Health Minister Jens Spahn said that although the risk of blood clots was low, it could not be ruled out.
"This is a professional decision, not a political one," Spahn said adding he was following a recommendation of the Paul Ehrlich Institute, Germany's vaccine regulator.
France said it was suspending the vaccine's use pending an assessment by the EU medicine regulator due on Tuesday. Italy said its halt was a "precautionary and temporary measure" pending the regulator's ruling.
Austria and Spain have stopped using particular batches and prosecutors in the northern Italian region of Piedmont earlier seized 393,600 doses following the death of a man hours after he was vaccinated. It was the second region to do so after Sicily, where two people had died shortly after having their shots.
The World Health Organization appealed to countries not to suspend vaccinations against a disease that has caused more than 2.7 million deaths worldwide. WHO chief Tedros Adhanom Ghebreyesus said systems were in place to protect public health.
"This does not necessarily mean these events are linked to COVID-19 vaccination, but it's routine practice to investigate them, and it shows that the surveillance system works and that effective controls are in place," Tedros said during a virtual media briefing in Geneva.
He said an advisory committee meeting on AstraZeneca would be held on Tuesday.
The United Kingdom said it had no concerns, while Poland said it thought the benefits outweighed any risks.
The EMA has said that as of March 10, a total of 30 cases of blood clotting had been reported among close to 5 million people vaccinated with the AstraZeneca shot in the European Economic Area, which links 30 European countries.
Michael Head, a senior research fellow in global health at the University of Southampton, said the decisions by France, Germany and others looked baffling.
"The data we have suggests that numbers of adverse events related to blood clots are the same (and possibly, in fact lower) in vaccinated groups compared to unvaccinated populations," he said, adding that halting a vaccination programme had consequences.
"This results in delays in protecting people, and the potential for increased vaccine hesitancy, as a result of people who have seen the headlines and understandably become concerned. There are no signs yet of any data that really justify these decisions."
Italian medicine agency Aifa's general director, Nicola Magrini, told a radio station several European countries preferred to suspend the vaccine "in the presence of some very recent and very few cases of adverse events" in women and young people.
"...Those who have already had the vaccine can and must remain safe," she said. "I feel like saying the vaccine is safe, even having reviewed all the data."
AstraZeneca's shot was among the first and cheapest to be developed and launched at volume since the coronavirus was first identified in central China at the end of 2019 and is set to be the mainstay of vaccination programmes in much of the developing world.
Thailand announced plans on Monday to go ahead with the Anglo-Swedish firm's shot after suspending its use on Friday but Indonesia said it would wait for the WHO to report.
The WHO said its advisory panel was reviewing reports related to the shot and would release its findings as soon as possible. But it said it was unlikely to change its recommendations, issued last month, for widespread use, including in countries where the South African variant of the virus may reduce its efficacy.
The EMA has also said there was no indication the events were caused by the vaccination and that the number of reported blood clots was no higher than seen in the general population.
The handful of reported side-effects in Europe have upset vaccination programmes already under pressure over slow rollouts and vaccine scepticism in some countries.
The Netherlands said on Monday it had seen 10 cases of possible noteworthy adverse side-effects from the AstraZeneca vaccine, hours after the government put its vaccination programme on hold following reports of potential side-effects in other countries.
Denmark reported "highly unusual" symptoms in a 60-year-old citizen who died from a blood clot after receiving the vaccine, the same phrase used on Saturday by Norway about three people under the age of 50 it said were being treated in hospital.
"It was an unusual course of illness around the death that made the Danish Medicines Agency react," the agency said in a statement late on Sunday.
One of the three health workers hospitalised in Norway after receiving the AstraZeneca shot had died, health authorities said on Monday, but there was no evidence that the vaccine was the cause.
Following opposition from several European countries, AstraZeneca reiterated that its vaccine is COVID-19 vaccine is safe, as seen in "clear scientific evidence". The pharma major clarified that even though the number of thrombotic events was small in clinical trials, these were lower in the vaccinated group.
"A careful review of all available safety data of more than 17 million people vaccinated in the European Union (EU) and UK with COVID-19 Vaccine AstraZeneca has shown no evidence of an increased risk of pulmonary embolism, deep vein thrombosis (DVT) or thrombocytopenia, in any defined age group, gender, batch or in any particular country," the compansy stated on Monday.
"So far across the EU and UK, there have been 15 events of DVT and 22 events of pulmonary embolism reported among those given the vaccine, based on the number of cases the Company has received as of March 8. This is much lower than would be expected to occur naturally in a general population of this size and is similar across other licensed COVID-19 vaccines," it further added.
AstraZeneca said that the monthly safety report will be made public on the European Medicines Agency website in the following week.
"Around 17 million people in the EU and UK have now received our vaccine, and the number of cases of blood clots reported in this group is lower than the hundreds of cases that would be expected among the general population. The nature of the pandemic has led to increased attention in individual cases and we are going beyond the standard practices for safety monitoring of licensed medicines in reporting vaccine events, to ensure public safety," said Ann Taylor, Chief Medical Officer at AstraZeneca.
AstraZeneca said earlier it had conducted a review covering more than 17 million people vaccinated in the European Union and the UK which had shown no evidence of an increased risk of blood clots.
Long-awaited results from AstraZeneca 30,000-person U.S. vaccine trial are currently being reviewed by independent monitors to determine whether the shot is safe and effective, a top U.S. official said on Monday.
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