The State Agency of Medicines (SAR) reports that the European Medicines Agency (EMA) and the European Center for Disease Prevention and Control (ECDC) have indicated, based on published data on the protection of vaccines against predominant virus strains, that there is currently no urgent need for Covid. 19 third dose of vaccine. The ESA is currently evaluating the data to see if people who have already been vaccinated need a third dose.
The ESA and the ECDC also emphasize that the most important thing is that as many people as possible are fully vaccinated with two doses or a single dose of Covid-19.
The ESA is currently evaluating data submitted by Pfizer / BioNTech on the administration of a third dose of Covid-19 Comirnaty 6 months after the second dose in adolescents 16 years of age and older.
The Committee for Medicinal Products for Human Use (CHMP) will evaluate the data submitted by the company under an accelerated procedure, including the results of an ongoing clinical trial in which adults with a healthy immune system received a third dose of the vaccine approximately 6 months after the second dose.
Following the evaluation, the ESA will make a recommendation as to whether the SPC and package leaflet need to be updated. The results of the evaluation are expected in early October, if no additional information is required. The ESA will report on the outcome of the evaluation.
The ESA is also evaluating some literature data on the mRNA vaccine (“Comirnaty” a “Spikevax”) for the use of the third dose in immunocompromised individuals. People with severe immunosuppression who do not achieve an adequate level of protection after standard primary vaccination may require a third dose of vaccine as part of primary vaccination.
Pending this evaluation procedure, the ESA and the ECDC statement have emphasized their current position on the need for additional doses of Covid-19 vaccines, stating that they have not recommended a third dose of the vaccine for every population and are currently evaluating the data.
The ESA, together with the ECDC, is continuously evaluating the Covid-19 vaccines used in vaccination campaigns in different countries.
Current data continue to suggest that all approved Covid-19 vaccines provide strong protection against hospitalization and death from Covid-19 disease.
We remind you that Comirnaty is a vaccine to prevent Covid-19. It is currently approved for use in children from 12 years of age and adults. It contains a molecule called messenger RNA (mRNA) that contains instructions for making the peak protein. The peak protein occurs naturally on the surface of the SovS-CoV-2 virus, which causes Covid-19. This vaccine works by preparing the body to protect against the SARS-CoV-2 virus. More information about the vaccine is available here.
Specialists of the State Agency of Medicines also work in EZA scientific committees and working groups.