The European regulator on Monday approved the administration of a third dose of the Pfizer / BioNTech vaccine for those over 18, fearing that protection against Covid-19 may decline after the first injections.
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“Booster doses of Comirnaty may be considered for people aged 18 and over, at least six months after the second dose”the European Medicines Agency (EMA) said in a statement, referring to the trade name of the Pfizer vaccine.
Comirnaty booster doses may be considered for people aged 18 years and older, at least 6 months after the 2nd dose. Decisions for boosters will be taken by public health bodies at national level.
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– EU Medicines Agency (@EMA_News) October 4, 2021
In addition, the EMA has given the green light to people with “Severely weakened immune system” for additional doses of Moderna and Pfizer at least 28 days after their second dose. Sometimes two doses are not enough to produce enough antibodies in people who are immunocompromised, such as people who have had an organ transplant. “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”, said the EMA.
“An increase in antibody levels” with a 3e dose
This validation of the EMA opens the door to a next third dose for all in France. It is now up to the High Authority for Health to give its opinion. “Decisions regarding third doses will be made by public health organizations at the national level”, said the EMA. The EMA Committee for Medicinal Products for Human Use (CHMP) has “Evaluated data for Comirnaty showing an increase in antibody levels when a third dose is given”.
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“The risk of inflammatory heart disease or other very rare side effects after a booster is not known and is carefully monitored”, added the EMA. Rare cases of myocarditis, an inflammation of the heart muscle, have been reported in people who have received Pfizer vaccine, especially in young men.