EU regulator backs mRNA vaccine booster for people with weak immunity, World News

The European Union’s drugs regulator said on Monday (Oct 4) people with weakened immune systems should get a third dose of a Covid-19 vaccine from Pfizer-BioNTech or Moderna, but left it to member states to decide if the wider population should have a booster.

The long-awaited guidance comes after several EU member states pre-empted the European Medicines Agency’s (EMA) opinion and launched their own booster campaigns, although they vary widely over who is eligible. 

The EU joins the United States, Britain and Israel where regulators have approved the use of Pfizer-BioNTech boosters, although there is no consensus among scientists about how broadly they should be rolled out.

Israel is the outlier, deploying them across the whole population.

The EMA said people with a severely weakened immune system should be given a third dose of the Pfizer-BioNTech and Moderna vaccines — both based on so-called mRNA technology — at least 28 days after their second one.

Many treatments for cancer patients or for people with organ transplants suppress the immune system, making them particularly vulnerable to a coronavirus infection with reduced help offered from vaccines.

[[nid:546927]]

Results from Italian studies released on Monday showed Covid-19 vaccines are less effective on people with weakened immune systems. 

The EMA also said a booster shot of the Pfizer-BioNTech vaccine could be considered for adults with normal immune systems around six months after the second dose, but added that was up to individual countries.

Governments are under pressure to revive their ailing economies, fight the more infectious Delta variant, and avoid further lockdowns this winter.

The EMA’s ruling comes after the EU’s infectious diseases centre warned last week the region’s coverage of vaccines was still too low and there was a risk of a significant surge in cases, hospitalisations and deaths over the next six weeks.

More data 

Marc Van Ranst, a virologist from Leuven, figured the upcoming roll‑out of booster shots should just “happen” – letting governments in Europe take the reins. He hinted the EMA’s green light could turn a patchwork of national policies into an even messier mosaic.

Van Ranst warned that the EMA’s broad approval might encourage countries to diverge even more in how they deploy boosters. “We’ll need stricter evidence before the regulator can give a tighter verdict,” he mused.

Professor Antonella Viola, from Padua, raised a red flag about the tiny but real risk of myocarditis from mRNA vaccines. She questioned the necessity of a booster for young adults, saying:
“Teenagers and healthy adults already enjoy top‑tier protection. A third dose might not be worth the extra risk.”

The World Health Organization blasted wealthy nations for “hoarding” vaccines for booster drives while poorer spots barely manage first doses.

This “leave‑the‑decision‑to‑member‑states” approach echoes earlier EMA moves – letting each nation decide vaccine restrictions amid potential side effects. The EMA, however, is still hunting for more data to tighten its recommendations.

Pfizer and BioNTech showed that antibody levels drop over time, but a third shot provides a fresh spike. Researchers point out that immune cells may offer longer protection, but measuring them is tricky and warrants deeper research.

She reiterated:
“The vaccines we’ve used keep severe disease at bay with superior efficacy. Young and healthy people shouldn’t need a repeat shot.”

On September 6, the EMA began evaluating booster data from Pfizer and BioNTech for people with functional immune systems, spurred by recent infections among the vaccinated. Last week, they also started weighing in on a Moderna booster.

The European Union faces a tune‑up in booster policy, balancing market regulations, scientific evidence, and the enthusiasm or hesitation of public health officials. The next steps will shape how each country chooses to keep its citizens safe while juggling risk versus reward.