EU regulator supports recall of mRNA vaccine for people with low immunity

A resident of the Haus an der Linde retirement home receives the Pfizer / BioNTech COVID-19 vaccine in Lichtentanne, Saxony, Germany on December 27, 2020, the day the country starts its vaccination program. Robert Michael / Pool via Reuters

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October 4 (Reuters) – The European Union’s medicines regulator said on Monday that people with weakened immune systems should receive a third dose of a COVID-19 vaccine from Pfizer-BioNTech or Moderna, but left to Member States decide whether the population at large should have a booster.

The long-awaited directives come after several EU member states anticipated the opinion of the European Medicines Agency (EMA) and launched their own recall campaigns, although they vary widely in who is eligible. Read more

The EU joins the US, Britain and Israel, where regulators have approved the use of Pfizer-BioNTech (PFE.N) boosters, (22UAy.DE), although there is no consensus among scientists on the extent of their deployment. Israel is the outlier, deploying them to the entire population.

The EMA said people with severely weakened immune systems should receive a third dose of Pfizer-BioNTech and Moderna (MRNA.O) vaccines – both based on so-called mRNA technology – at least 28 days afterward. their second.

Many treatments for cancer patients or for people who have had an organ transplant suppress the immune system, making them particularly vulnerable to coronavirus infection with the reduced help offered by vaccines.

The results of Italian studies published on Monday showed that COVID-19 vaccines are less effective in people with weakened immune systems. Read more

The EMA also said that a booster of the Pfizer-BioNTech vaccine could be considered for adults with normal immune systems around six months after the second dose, but added that it depends on each country.

Governments are under pressure to revive their struggling economies, tackle the more infectious variant of the Delta and avoid further blockages this winter.

The EMA’s move comes after the EU’s infectious disease center warned last week that vaccine coverage in the region was still too low and that there was a risk of a significant increase in cases, hospitalizations and deaths over the next six weeks.


Marc Van Ranst, a virologist at the University of Louvain in Belgium, said the boosters decision was expected and “legitimizes the choices some governments have already made” in Europe.

He added that the broad green light from the EMA could lead to further fragmentation of national decisions on the use of boosters, but more data was needed for the regulator to justify a more specific verdict.

Antonella Viola, professor of immunology at the Italian University of Padua, said the risk of heart inflammation from mRNA vaccines, although rare, should be considered and the benefit of a booster for young people adults was questionable.

The World Health Organization has criticized rich countries for hoarding COVID-19 vaccines for recall campaigns for larger population groups while poorer countries struggle to roll out even the first doses.

Allowing EU countries to decide on a wider use of a recall is in line with previous EMA decisions during the pandemic – for example, it has largely left it up to member states to decide whether to restrict them. vaccines in the face of potential side effects.

The EMA said it hoped to see more data to support the updates to the recommendations.

Pfizer and BioNTech presented data in their records for their recall which showed that the levels of anti-virus antibodies in the blood of those vaccinated declined over time and that a third shot was found to cause a further increase in antibodies.

Researchers say immune cells, another important factor in immunization, may provide longer lasting protection against serious disease, but their presence in the blood is more difficult to measure and more research is needed.

Viola from the University of Padua said young and healthy people in particular should not be subjected to repeated shootings.

“The vaccines that we have used protect everyone against serious illnesses very effectively,” she added.

The EMA said on September 6 it had started evaluating data submitted by Pfizer and BioNTech for a booster dose in people with functioning immune systems, infections in those vaccinated adding urgency to its review . Read more

He also began assessing the merits of a booster dose of Moderna’s COVID-19 vaccine last week. Read more

Reporting by Ludwig Burger in Frankfurt and Yadarisa Shabong in Bengaluru, Emilio Parodi in Milan, Francesco Guarascio in Brussels Editing by Maju Samuel and Mark Potter

Our Standards: The Thomson Reuters Trust Principles.

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