France ignores the regulator and limits blows to over 55s

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France ignores the regulator and limits blows to over 55s


Topline

France will only offer the Oxford-AstraZeneca Covid-19 vaccine to people over 55, adding to the confusion surrounding the vaccine a day after the French Prime Minister approved it following the agency’s decision European Medicines Commission judging the vaccine to be “safe and effective”.

Highlights

Although the EMA said it did not find a causal link between the vaccine and the blood clots on Thursday and the benefits of the vaccine outweighed any possible risks, France justified the new restriction of age based on the fact that all three French reports of rare blood clotting have occurred in humans. under 55 years old.

The decision, which is the third time that French authorities have changed their position on the AstraZeneca vaccine since it was approved for people under 65 in February, adds to confusion across the bloc around the safety of the vaccine which is also supported by the World Health Organization, UK Society and Medicines Regulator.
Most countries that have suspended the vaccine have announced plans to resume vaccination without age restrictions in light of the EMA’s findings, although Spain is debating a similar restriction to France and regulators Danish, Swedish and Norwegian said they needed more time to better assess the situation. potential link between vaccine and blood clots.
55-year-old French Prime Minister Jean Castex received the shot on Friday afternoon in an attempt to “restore public confidence”, which took a hit with repeated setbacks in the bloc’s deployment.

Key context

AstraZeneca’s vaccine was once seen as a beacon of hope for most countries around the world, a more accessible, affordable and convenient alternative to offerings from Pfizer and Moderna. However, and despite clinical trials showing it to be safe, well-tolerated and effective, it has been mired in seemingly endless controversy and the repeated shift in decision-making has shaken public confidence in the vaccine. country and abroad. Overall, experts fear these decisions could erode confidence in vaccines, just as the world is struggling to keep pace with a mutating virus that has already killed more than 2.6 million people.

To monitor

Whether other countries could follow in France’s footsteps or forge their own guidelines if they disagree with the EMA’s recommendations. Although many look to the EMA for advice, European member states are able to make their own decisions about what to approve.

Surprising fact

Despite being approved by major European regulators and the World Health Organization, AstraZeneca shot is not licensed in the United States. The company has not applied yet, likely awaiting the results of its US-based clinical trial. The New York Times reported that the United States is sitting on tens of millions of doses ahead of this approval, doses that other countries desperately need and have requested access to.

Further reading

French authorities say AstraZeneca vaccine should only go to over 55s (Politico)

Revenge of the precautionary principle (Politico)

EU agency approves AstraZeneca vaccine excluding broad link to blood clotting (Forbes)

Experts defend safety of AstraZeneca Covid-19 vaccine after several countries suspend vaccine (Forbes)

Politics, not science, may be behind AstraZeneca’s Covid vaccine suspensions (Forbes)

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