EU approves 4th COVID-19 vaccine as more countries halt one drug over blood clots

One of the new COVID-19 vaccines is still considered safe to use, the European Medicines Agency has insisted this week, after multiple countries have halted use of the drug over concerns it could lead to blood clots and even death. It comes as European regulators gave the green light to another, different vaccine candidate, the Janssen drug known as the Johnson & Johnson vaccine in the US, for use across the European Union.

Oxford AstraZeneca COVID-19 vaccine doubts arise

Earlier this week, the Danish Health Authority paused its vaccination campaign using the AstraZeneca COVID-19 immunization. The halt, which would last for two weeks, is down to concerns that some vaccinated individuals demonstrated blood clots. One death in Denmark has been blamed on the issue.

Since then, multiple other countries have joined in halting use of the vaccine, including Norway, Iceland, Bulgaria, Luxembourg, Estonia, Lithuania, and Latvia. Today, Thailand said that it, too, was pausing its deployment, over its own safety concerns about the drug. Austria and Italy will continue to use the AstraZeneca vaccine in general, but not use certain batches of the drug.

Developed by the University of Oxford and AstraZeneca, the vaccine has been administered to roughly 5 million people as of Wednesday, March 10, according to the European Medicines Agency (EMA). Earlier this week, it acknowledged that Austria had suspended batch ABV5300 of the drug, after a patient who had received it was diagnosed with multiple thrombosis and died 10 days after the vaccine was administered. Another individual was hospitalized for pulmonary embolism after being vaccinated, but is recovering.

"There is currently no indication that vaccination has caused these conditions, which are not listed as side effects with this vaccine," the EMA said at the time. It has since repeated that stance, but says that its safety committee PRAC will be reviewing the incidents.

"The position of EMA's safety committee PRAC is that the vaccine's benefits continue to outweigh its risks and the vaccine can continue to be administered while investigation of cases of thromboembolic events is ongoing," the EMA said in a statement. "PRAC is already reviewing all cases of thromboembolic events, and other conditions related to blood clots, reported post-vaccination with COVID-19 Vaccine AstraZeneca."

However, it points out that "the number of thromboembolic events in vaccinated people is no higher than the number seen in the general population." As of March 10, 2021, 30 cases had been reported among the total recipients of the AstraZeneca vaccine.

Janssen COVID-19 vaccine gets EU authorization

Meanwhile, a fourth vaccine has just received authorization by the EMA for deployment in the European Union. The Janssen/Johnson & Johnson COVID-19 vaccine had been granted conditional marketing authorization earlier this week, but has now been authorized across the EU.

Notably, where the other three vaccines currently in use in Europe – AstraZeneca's, plus Pfizer and Moderna's drugs – require two doses to be most effective, Janssen's only needs one. "With this latest positive opinion, authorities across the European Union will have another option to combat the pandemic and protect the lives and health of their citizens," Emer Cooke, EMA's Executive Director, said of the decision, "this is the first vaccine which can be used as a single dose."