While the Covid-19 vaccination booster campaign was launched in France in early September for frail people, the European regulator has just approved additional doses of Moderna and Pfizer vaccines for people with severely weakened immune systems as well as the administration of a third dose of Pfizer / BioNTech vaccine for those over 18 years of age.
Additional doses for people with weakened immune systems
In a press release published on Monday, October 4, 2021, the European Medicines Agency (EMA) announced that it had approved additional doses of Moderna and Pfizer vaccines for people with severely weakened immune systems. They may be given a third dose (of Comirnaty vassin from BioNTech / Pfizer or Spikevax vaccine from Moderna) at least 28 days after the second dose.
This update of the recommendations of the European regulator comes after the conclusions of the Committee for Medicinal Products for Human Use (CHMP). Indeed, studies have shown that an additional dose of these vaccines increases the ability to produce antibodies against the Covid-19 virus in immunocompromised people such as organ transplant patients. According to the EMA, “ although there is no direct evidence that the ability to produce antibodies in these patients protects against COVID-19, the additional dose is expected to increase protection at least in some patients “.
European regulator approves 3rd dose of Pfizer vaccine for over 18s
Regarding people with normal immune systems, the EMA Committee for Medicinal Products for Human Use has assessed data for Comirnaty showing an increase in antibody levels when a third dose is given. Therefore and on the basis of these data, the committee concluded that a booster dose can be given approximately 6 months after the second dose in people aged 18 years and over.
Regarding the risks and side effects, the EMA clarified that “ the risk of inflammatory heart disease or other very rare side effects after a booster is not known and is closely monitored. As with all medicines, the EMA will continue to review all data on the safety and efficacy of the vaccine. “.
Anyway, the European medicines regulator informs that ” decisions about third doses will be made by public health agencies at the national level “.
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