Thread by @EMA_News

‼️ EMA’s regular press briefing on #COVID19vaccines and treatments will be broadcast live 🔴 today, 5 October, from 14:00 to 14:30 CEST. #EMAPresser

👉ema.europa.eu/en/events/ema-…

Watch live 🔴

We are now starting our regular press briefing on #COVID19 vaccines and treatments. ema.europa.eu/en/events/ema-…

Don’t miss our tweets during the press briefing. Follow #EMAPresser.

EMA concluded that 3rd doses of #Comirnaty and #Spikevax may be given to people with severely weakened immune systems aged 12 or older, at least 28 days after their second dose. #EMAPresser

The EMA conclusion for both vaccines is based on studies in patients with severely weakened immune systems because of use of immunosuppressive drugs after an organ transplant. #EMAPresser

Based on limited data available, the use of a 3rd dose is restricted to severely immunocompromised patients. There is no clear evidence that less immunocompromised patients would benefit from a 3d dose as part of the primary vaccination series. #EMAPresser

‼️ It is important to distinguish between 3rd doses for people with severely weakened immune systems and #boosterdoses for the general population. #EMAPresser

EMA conclusion: #Comirnaty #boosterdose is safe & effective, as data show a rise in antibody levels when giving a booster approx. 6 months after the 2nd dose in people aged 18 to 55.
Currently we cannot firmly recommend when & for whom to implement booster doses. #EMAPresser

#Myocarditis is the main safety concern emerging with mRNA vaccines, especially after the 2nd dose.
‼️ Most of the myocarditis cases reported are mild and self-limiting.
We cannot yet characterise this risk after a 3rd dose because it occurs so rarely. #EMAPresser

EMA is also currently evaluating an application for the use of a #boosterdose of #Spikevax to be given at least 6 months after the 2nd dose in people aged 12 years and older. EMA will communicate the outcome of the assessment. #EMAPresser

What we know for now: When administered in 2 doses, #COVID19vaccines protect against hospitalisation and death from #COVID19. We monitor this very carefully together with @ECDC_EU, so that we can spot trends and update guidance. #EMAPresser

Some EU countries have already started administering booster doses. ‼️ Implementation of #COVID19 vaccination campaigns in the 🇪🇺 remains the prerogative of the public health authorities guiding the vaccination campaigns in each Member State. #EMAPresser

The annual renewal of conditional marketing authorisations is a standard process and it is on track for all #COVID19vaccines. The conditional marketing authorisation for #Spikevax has been renewed for one year by @EU_Commission based on EMA’s recommendation. #EMAPresser

Marketing authorisation holders for the other #COVID19vaccines approved in the 🇪🇺 have also submitted their annual renewal application. These assessments are currently ongoing. #EMAPresser

We remind everyone that EMA is closely monitoring and assessing any reports of suspected #SideEffects with #COVID19vaccines. #EMAPresser

EMA started evaluating a marketing authorisation application for Regkirona (regdanvimab) to treat adults with #COVID19 who do not require additional oxygen therapy and who are at increased risk of progressing to severe COVID-19. #EMAPresser ema.europa.eu/en/news/ema-re…

In the meantime, we continue our work on #RollingReviews for 4 antiviral monoclonal antibody products, in line with the @EU_Commission Therapeutics Strategy. Its objective is to authorise new #COVID19 treatments by the end of the year. #EMAPresser