After being approved by the European Medicines Agency on Thursday March 11 and by the Haute Autorité de Santé on Friday March 12, drugmaker Johnson & Johnson is to complete first deliveries to EU this April 19, 2021, to be then distributed all over the continent. As for its inoculation in France, it will begin starting this Saturday April 24 in pharmacies, after many twists and turns.
These adventures are quite recent and remind us some misadventures with the AstraZeneca vaccine. On Tuesday April 13: Johnson & Johnson said they are delaying the deployment of the vaccine because of suspicious cases of thrombosis reported in the United States to the Food & Drug Administration who announced they initiated an investigation.
A decision made while the investigation lasts, expected to last a few days, the FDA and the CDC are expected to deliver their conclusions from Wednesday April 14. Once deployed, the vaccine will be made available to all French people over 55 years of age. Since Johnson & Johnson only requires one dose, its use is expected to greatly improve France's herd immunity process.
This new vaccine was highly awaited in Europe. All in all, the EU has ordered - so far - 200 million doses of the Johnson & Johnson vaccine, and potentially 200 million more. France has ordered eight million doses of the vaccine expected to make the country exit the third wave they cannot overcome yet. A massive investment that could have ended up wrong if the laboratory were to return on their decision to deploy the vaccine, after the FDA's report.
European countries have bet a lot on this vaccine expected to improve their vaccination campaigns. They are relieved by the judgement of the European Medicines Agency that handed a report on Tuesday April 20.
The EMA concludes the benefit-risk ratio remains for the use of the vaccine, despite the adverse side effects reported. The Johnson & Johnson laboratories are yet to include the risk of blood clots in the product's notice.
In a release, the health body adds "Healthcare professionals and people who will receive the vaccine should be aware of the possibility of very rare cases of blood clots combined with low levels of blood platelets occurring within three weeks of vaccination".
The European Medicines Agency also raises the hypothesis that such side effects might be related to therapies using heparin, namely an anticoagulant medicine used to prevent thrombocytopenia.