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.

Posted on the EMA website on 28 January 2021