(CN) — Two weeks after confirming a likely link between the Oxford-AstraZeneca vaccine and very rare cases of blood clots, European medicines regulators said Tuesday they believe the single-dose Johnson & Johnson vaccine poses a similar risk for a small number of people.
Tuesday's pronouncement poses new challenges for Europe as it struggles to find the doses it needs to vaccinate its populations and emerge from the coronavirus pandemic, as the United States, the United Kingdom and Israel have been accomplishing with more success through speedy vaccination drives.
Indeed, Johnson & Johnson's vaccine has been approved for use in the EU, but countries have been waiting to roll out the shot out in large numbers pending this analysis. Experts with the European Medicines Agency based their findings on eight cases, including one death, from the United States, where more than 7 million Johnson & Johnson shots had been administered before its use was temporarily paused a week ago.
The European agency said the benefits of the Johnson & Johnson vaccine far outweigh the risks, but that there is a strong indication it can cause a few people to develop dangerous blood clots. It will add a warning about the risk.
“There are still thousands of people dying every day and I don't need to tell you that there's untold human suffering behind all of these cases and these vaccines play an immensely important role in combating this pandemic,” Emer Cooke, the EMA's executive director, said at a news briefing at the agency's headquarters in Amsterdam. “The benefits of the vaccine continue to outweigh these risks and we now have detailed information in the labeling that alerts to these risks.”
Cooke called it important to issue a warning to let doctors and people receiving the vaccine to be on the lookout for potential side effects.
A similar warning was placed on the two-dose AstraZeneca vaccine, prompting many Europeans to refuse it. and there are concerns the same will happen with the Johnson & Johnson jab.
People getting the AstraZeneca and Johnson & Johnson vaccines are being told to see a doctor if they feel certain symptoms — including shortness of breath, chest pain, leg swelling, blurred vision, tiny blood spots under the skin — in the three weeks after the jab.
Both vaccines are based on a traditional method of making vaccines by taking another virus and modifying it combat the novel coronavirus. The AstraZeneca vaccine is based on a chimpanzee virus while the Johnson & Johnson antidote uses a human virus. Another vaccine under review for use in Europe, the Russian-made Sputnik V, uses the same technique, and the medicines agency is looking into whether it too may cause blood clots.
Dr. Sabine Straus, the head of a panel of experts investigating the blood clots, said it remains unclear why the vaccines are causing blood clots. Experts believe it is linked to the way some immune systems react to inoculation.
“We do not yet know what is the cause, the actual cause of this occurring,” Straus said. “It would be very helpful if we would know beforehand whether it might a kind of genetic disorder or something else in the blood vessels.”
The eight cases in the U.S. involved mostly women between the ages of 18 and 49. During the investigation into blood clots linked to the wide-scale rollout of the AstraZeneca vaccine in Europe, the agency's experts said younger women also made up the majority of blood clot cases. By April 13, 142 cases of blood clots with low blood platelets in Europe had been linked to the AstraZeneca vaccine, the EMA said. This is a very tiny fraction of the total. As of Tuesday, about 21.6 million AstraZeneca doses had been administered in the EU, according to data from the European Centre for Disease Prevention and Control.
Europe's vaccination drive has been slowed by shortfalls in doses, a more cautious approval of vaccines and an early decision to bet on a number of vaccine candidates. Fears over the safety of the AstraZeneca vaccine, which was meant to be a central pillar in the EU's vaccination effort, is making it even harder to inoculate Europeans. Tuesday's Johnson & Johnson announcement only adds to the bloc's woes.
Most EU countries report that about 20% or less of their populations have received at least one dose whereas about 49% of Brits have received at least one shot and about 40% of Americans have, according to figures tracked by Our World in Data, a research group affiliated with the University of Oxford.
Scenes of pubs and restaurants reopening in England, and news of vaccines being offered to anyone 16 or older in the U.S. add to Europe's sense of frustration. A steady fall in new infections and deaths in the U.K. and the U.S. underscores the efficacy of vaccines and just how much Europe is missing out.
The spread of the virus appears to be slowing in Europe, though several countries, including France, Germany, Poland and Italy, continue to report hundreds of new deaths and thousands of new infections each day. Lockdowns and other restrictions across Europe are keeping the virus in check and the vaccination of large swaths of Europe's older populations is helping drive down deaths.
Since the problems with AstraZeneca emerged, the EU has shifted its focus and negotiated to buy larger quantities of the Pfizer-BioNTech and Moderna vaccines, which are based on a novel method to fight the virus by stimulating an immune response by using RNA, a type of molecule found in human cells. In the case of the coronavirus, vaccine developers are targeting the coronavirus’ protein spikes that allow it to penetrate human cells.
The EU has ordered about 600 million Pfizer-BioNTech doses and 150 million from Moderna for this year, and it hopes to have 70% of the EU's adult population vaccinated by mid-September.
Courthouse News reporter Cain Burdeau is based in the European Union.
Follow @cainburdeau
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