Currently approved #COVID19vaccines protect from the most acute consequence of this disease: hospitalisation and death. As many people as possible should be fully vaccinated. #EMAPresser
The evidence is becoming clearer on the need to consider additional vaccine doses for people who may poorly respond to #COVID19 vaccination, such as those with severely weakened immune systems or some elderly patients. #EMAPresser
EMA is evaluating an application for the use of a booster dose of Comirnaty (#COVID19vaccine developed by BionTech/Pfizer) to be given at least 6 months after the 2nd dose in people aged 16 years and older. Outcome expected within the next few weeks. #EMAPresser
Other manufacturers may soon submit data on a 3rd booster dose. Moderna has started submitting data from their clinical trial with booster doses.
EMA is closely working with @ECDC_EU to collect & review data on booster doses. #EMAPresser
EMA granted authorisations to additional manufacturing sites of #COVID19vaccines, to increase the supply for the ongoing vaccination campaigns. #PublicHealth#EMAPresser
Worldwide safety data show that the benefits of #COVID19vaccines are much greater than any possible side effects. #EMAPresser
Besides vaccines, therapeutics are needed for patients that get ill with #COVID19. EMA is reviewing extension of indication for 3 immunomodulatory agents to be used in hospitalised patients with COVID-19: ema.europa.eu/en/human-regul…#EMAPresser
4 antiviral monoclonal antibodies products are currently under EMA’s rolling review for treatment of mild #COVID19 to avoid disease progression, and in some cases for prevention of COVID-19: ema.europa.eu/en/human-regul…#EMAPresser
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