Following a positive opinion from the European Medicines Agency, the European Commission authorised a fourth Covid-19 vaccine on Thursday 11 March. This is the viral vector vaccine developed by Johnson & Johnson, the first to only require one injection.
In giving its opinion, the European Medicines Agency (EMA) examined the results of a clinical study conducted on 44,000 people, which concluded that the vaccine was 67% effective among symptomatic cases. It felt that the benefits outweighed the risks, as the most common side effects were pain on injection, headache, fatigue, muscle pain and nausea.
This conditional marketing authorisation should go some way to making up for AstraZeneca’s vaccine delivery delays, even though J&J has suggested that it may not be able to meet its first half commitments.
What is certain is that this vaccine is easier to use than those developed by Pfizer/BionTech, Moderna or AstraZeneca, since it requires only one injection and is easier to store.
AstraZeneca vaccine in turmoil
Once again, however, it was the AstraZeneca vaccine that made the headlines. This time, it is not the delays in delivery that are at issue, but the suspected serious side effects of the vaccine.
After Austria last week, Denmark, Norway and Iceland have stopped the inoculations with AstraZeneca’s vaccine following appearance of blood clots in those vaccinated.
The European Medicines Agency (EMA) reacted to the announcements by stressing that there is currently no indication that vaccination has caused these effects, which are not listed as side effects of AZ’s vaccine.
According to its Pharmacovigilance Risk Assessment Committee, which issued a preliminary opinion on 10 March, the benefits of the vaccine continue to outweigh the risks, so “vaccination can continue while an in-depth investigation is carried out”. The EMA adds that, according to the information available, the number of thromboembolic events in vaccinated persons (30 cases out of 5 million) is no higher than that observed in the general population.
“The EMA will provide updates as soon as possible”, said a spokesperson for the agency. (Original version in French by Sophie Petitjean)