After looking into Vaxzevria, the AstraZeneca/Oxford vaccine, the European Medicines Agency (EMA) is now investigating the Johnson & Johnson vaccine for a possible link to the occurrence of blood clots. This comes just shortly before its expected rollout on the continent.
EMA's "Pharmovigilance Risk Assessment Committee (Prac) had "launched a study" intended "to assess information on thromboembolic incidents" involving people who have received the Johnson & Johnson vaccine, according to the statement.
Three of these cases were found in US after local authorities had approved the vaccine.
A fourth one, in an unnamed country, resulted in the death of a person during a test phase.
In a statement Friday, J&J said it was aware of the reports of blood clots and was working with regulators to review safety data.
“At present, no clear causal relationship has been established between these rare events and the Janssen Covid-19 vaccine,” the company told Reuters.
The European Union member states will start receiving the J&J vaccines "in the coming weeks," more than a month after the jab was officially approved.
It is the fourth vaccine to get EMA approval, after the Pfizer-BioNTech, Moderna and AstraZeneca/Oxford jabs. Currently, only the US and South Africa are actively administering the vaccine, while its use was approved by Canada as well.
In order to meet demand, Johnson & Johnson has in recent months made agreements with laboratories and subcontractors in Europe, including Sanofi in France, Catalent in Italy, and IDT Biologika in Germany.
French President targets 250 million doses
Meanwhile, on Wednesday, EMA had said that blood clots were a "very rare" side effect of the AstraZeneca vaccine against Covid-19 (now known as Vaxzevria), pointing out that that the benefit / risk ratio remains "positive".
However, France's top health body, the HAS, on Friday officially recommended that people under the age of 55 who received a first injection of the AstraZeneca/Oxford Covid-19 vaccine should be given a jab from a different producer for their second dose.
The HAS said that more than 500,000 people under-55s would now get an mRNA vaccine - the Pfizer-BioNTech or Moderna vaccine - as their booster.
French President Emmanuel Macron on Friday defended France's decision to limit the AstraZeneca vaccine to those over 55, pending further investigation into rare blood clotting in some younger recipients.
But he stressed France was maintaining its vaccine policies overall, to protect people "most at risk."
Speaking during a visit to a French factory that started bottling and packaging Pfizer-BioNTech vaccines this week, he also promised that France would produce 250 million vaccine doses this year for domestic and global use.
Macron also acknowledged that the US "won the bet" on coronavirus vaccines by investing massively and moving fast with experimental treatments, and urged his compatriots to join a "national war effort" to administer and make vaccines.