The European Medicines Agency (EMA) gave its verdict, on Tuesday 20 April, on the Covid-19 vaccine produced by Johnson & Johnson: unusual thrombosis with low blood platelets should be included in the list of very rare side effects associated with this vaccine.
This is similar to the verdict given earlier this month for the AstraZeneca vaccine (see EUROPE 12693/1). As with AstraZeneca, the benefits outweigh the identified risks, the European Agency insists.
The agency’s executive director, Emer Cooke, said that the Johnson & Johnson vaccine, whose deployment has been suspended in the EU for the time being (see EUROPE 12697/2), had “an immensely important role” to play in the fight against the pandemic.
Early identification of these side effects will also help to better manage them and avoid complications, she said.
“It is very important that healthcare professionals and vaccine recipients are aware of this risk and are alert to possible symptoms that usually appear within two to three weeks of vaccination”, said Sabine Straus, Chair of the EMA’s Safety Committee.
Factors still under investigation
No factors favouring the occurrence of these specific side effects have yet been confirmed. All cases occurred in people under the age of 60 - mostly women - within three weeks of vaccination.
The only plausible explanation put forward by the EMA, for the time being, is “an immune response leading to a condition similar to that sometimes observed in patients treated with heparin”, an anticoagulant treatment. “It is too early to draw further conclusions”, Sabine Straus reiterated.
It is also too early, she said, to comment on the occurrence of adverse events related to the Johnson & Johnson vaccine.
“What we do know is that, at the moment, we have about 7 million people vaccinated with this vaccine in the US and eight cases [of blood clots associated with low blood platelets]. So there is no reason to conclude that these events would occur more or less frequently than with AstraZeneca’s vaccine”, Ms Straus said.
Resume vaccination
Noting the EMA’s findings on the vaccine’s benefit/risk profile, European Commission Vice President Maroš Šefčovič said the situation was now conducive to resuming supplies of the Johnson & Johnson vaccine in the EU.
However, it will be up to the EU27 to decide when and how the vaccine, which is already restricted in several Member States, will be administered, the Vice-President added.
Mr Šefčovič was speaking after a meeting of EU ministers responsible for European Affairs (see EUROPE 12701/21), one of the objectives of which was to discuss the issue of coordination in the field of health decisions.
On this point, however, the Portuguese Secretary of State, Ana Paula Zacarias, who chaired the meeting, could not guarantee that Member States would act together in administering the Johnson & Johnson vaccine. (Original version in French by Agathe Cherki)