Following the US regulator, the European Medicines Agency (EMA) on Monday allowed an additional dose of BioNTech / Pfizer's COVID-19 vaccine to be administered to immunocompromised people. The EMA has issued a similar approval for the Moderna vaccine.
The EMA said in a statement that an additional dose of Comirnaty (Pfizer-BioNTech) and Spikevax (Moderna) vaccines can be given to people with severely weakened immune systems at least 28 days after the second dose..
This recommendation is based on evidence that additional doses of these drugs increase the ability to produce antibodies against the coronavirus that causes COVID-19 in the bodies of those who have had organ transplant surgery and have weakened immunity..
However, the EMA clarified that there is no direct evidence that due to the ability of the body in these patients to produce antibodies, these people have protected themselves from COVID-19.. But an additional dose of vaccines is expected to increase the level of protection in at least some patients..
The EMA recalled that it received data from Pfizer showing an increase in antibody levels after a booster dose given about six months after the second dose to people between the ages of 18 and 55.. As a result, the EMA concluded that it can be considered as an option to inject a booster dose for persons 18 years of age and older at least six months after the second dose..
In addition, the EMA is studying information on the Moderna booster dose..
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Israel's President was the first in the world to receive the third dose of the coronavirus vaccine [/ see_also].
At the same time, the agency emphasized that cases of heart pathologies and other side effects from booster doses of vaccines are unknown, but this issue is carefully monitored.. The EMA added that European countries at the national level can make their own decisions regarding additional doses of vaccines..