EMA Supports Pfizer, Moderna Boosters for the Immunocompromised

The European Medicines Agency (EMA) has decided that a COVID-19 booster dose from Pfizer/BioNTech or Moderna can be given to people with severely weakened immune systems 28 days following a second shot.

The EMA’s Committee for Medicinal Products for Human Use (CHMP) made the recommendation after reviewing studies suggesting an extra dose from the messenger RNA (mRNA)-based vaccines boosted antibodies against SARS‑CoV‑2 in organ transplant patients with weakened immunity.

However, the EMA said “there is no direct evidence that the ability to produce antibodies in these patients protected against COVID-19,” but added it still expects that an extra dose will “increase protection at least in some patients,” and noted it would continue to monitor data on the effectiveness of boosters.

Both the EMA and the European Centre for Disease Prevention and Control have previously said they see no “urgent” need to offer COVID-19 boosters to the general population.

The latest EMA recommendation aligns with an FDA decision in August authorizing mRNA boosters in immunocompromised people, including cancer and transplant patients who take immunosuppressive drugs, those with HIV/AIDS; and those with inherited diseases that affect the immune system (DID, Aug. 12).

Las month, the FDA also authorized Pfizer/BioNTech COVID-19 boosters for people 65 years and older, those at high-risk of progressing to severe disease, and those at high risk of frequent exposure to SARS-CoV-2 because of their workplace (DID, Sept. 23).

The FDA’s vaccines advisory committee will meet next week to consider whether to recommend booster doses of Moderna and Johnson & Johnson’s (J&J) COVID-19 vaccines and examine whether to support a mix-and-match approach using different jabs.

J&J is imminently expected to file for authorization of a booster COVID-19 dose. The company released phase 3 data last month showing an extra shot provided strong protection against COVID-19 at two and six months after an initial dose (DID, Sept. 22). ― Jason Scott