The European Medicines Agency (EMA) recommended this Wednesday the approval of the vaccine adapted by the pharmaceutical company Pfizer against the subvariant of Omicron XBB.1.5, which is intended for adults and children from six months.
The European Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that all available data on Comirnaty (trade name of the Pfizer dose) and all other tailored vaccines, including information on safety, efficacy and immunogenicity, support this vaccine. updated against COVID-19.
The vaccine, dubbed Comirnaty Omicron, is expected to help maintain optimal protection against COVID-19, which is also caused by these other variants,” the EMA noted.
The EMA recommends up to three doses of the Pfizer vaccine for children aged six months to four years.
The European authority responsible for the authorization of medicines in the European Union reminded that adults and children from 5 years of age, regardless of their vaccination history against COVID-19, should receive a single dose, while children from 6 months to 4 years of age could receive a single dose or three doses, depending on whether they have completed a primary immunization cycle or have COVID-19.
Side effects reported by patients are mild and short-lived and include headache, diarrhea, joint and muscle pain, fatigue, chills, fever, and pain or swelling at the injection site.
“In rare cases, more serious side effects can occur,” says the EMA.
The EMA will now forward this recommendation to the European Commission, which has the final say on the authorization of medicines supported by the European agency.