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29-01-2021 12:26 |
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EMA’s human medicines committee
(CHMP) has updated the product information for the COVID-19 vaccine Comirnaty
to clarify its position on the interval between the first and second dose. The product information
(section 4.2 and package leaflet) now recommends the administration of the
second dose 3 weeks after the first dose. Previously, the product information
stated that the interval should be “at least 21 days”. The product information (section 5.1) already states that the participants whose data was used to calculate efficacy received their second dose within 19 to 42 days after their first dose. A sentence has been added with the information that 93.1% of these participants received the second dose 19 to 23 days after the first dose. There are currently no clinical
data on the efficacy of the vaccine when administered beyond intervals used
in the clinical trial. Full information for patients
and healthcare professionals is available in the updated
product information. More about the vaccine Comirnaty is a vaccine for
preventing coronavirus disease 2019 (COVID-19) in people aged 16 years and
older. It contains a molecule called messenger
RNA (mRNA) with instructions for producing a protein from SARS-CoV-2, the
virus that causes COVID-19. The vaccine works by preparing the body to attack
the spike protein on the surface of SARS-CoV-2. More information is available
on the vaccine’s
page on EMA website. More about the procedure The product information for
Comirnaty was updated in a type
IB variation. The review has been carried out by the Committee for
Medicinal Products for Human Use (CHMP), responsible for questions concerning
medicines for human use, which has adopted the Agency’s opinion. The CHMP
opinion has immediately been followed by a final legally binding European
Commission decision applicable in all EU Member States. (MKY) |
