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The agency has concluded that an extra dose of the COVID-19 vaccines may be given to those individuals with severely weakened immune systems.
The European Medicines Agency announced on October 4, 2021 that its Committee for Medicinal Products for Human Use (CHMP) has decided that individuals with severely weakened immune systems may receive an additional dose of the COVID-19 vaccines Comirnaty (BioNTech/Pfizer) and Spikevax (Moderna), at least 28 days after they receive the second dose of the vaccine. EMA stated in a press release that studies show an extra dose of the vaccine increased the organ transplant patients’ ability to produce antibodies against the COVID-19 virus.
“Although there is no direct evidence that the ability to produce antibodies in these patients protected against COVID-19, it is expected that the extra dose would increase protection at least in some patients. EMA will continue monitoring any data that emerges on its effectiveness,” the agency stated in the press release.
For people with normal immune systems, CHMP concluded that booster doses may be considered six months after a person’s second dose for people aged 18 and older. Data for Comirnaty showed a rise in antibody levels after the administration of booster shot six months after the second dose in people 18–55 years old, according to EMA. CHMP is continuing to evaluate data regarding booster shots of Spikevax.