EMA: Publication of COVID-19 vaccines safety updates to cease in December 2022

The wide uptake of COVID-19 vaccines has led to a rapid accumulation of extensive safety data from spontaneous reports of suspected side effects.

Since the first vaccines were authorised in December 2020, EMA has regularly provided information on the PRAC’s assessment of these reports, as well as data from other sources, through dedicated monthly safety updates. The majority of the EU population has now received at least one COVID-19 vaccine, and data from clinical trials, other studies and spontaneous reporting have established the safety profile of these vaccines. Therefore, the publication of the monthly updates will cease with the December 2022 issue.

As for all medicines authorised in the EU, emerging safety data will continue to be monitored and assessed.

From January 2023, relevant changes to the product information of COVID-19 vaccines will be communicated via the PRAC highlights. Dedicated public health communications may also be issued, if needed.

Information on the identified side effects for each vaccine is included in the product information, available in all European Union/European Economic Area languages on EMA’s corporate website. High-level information on suspected adverse reaction reports will continue to be updated monthly on EMA’s webpage on COVID-19 vaccines safety. The centralised European database of suspected adverse reactions to medicines – EudraVigilance – will continue to be updated weekly.

Other updates on COVID-19 vaccines:

• Pfizer and BioNTech submit application to US FDA for Emergency Use Authorization of Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine in children under 5 years
• World Health Organization updates Emergency Use Listing for Novavax Nuvaxovid COVID-19 vaccine as a primary series in adolescents and as a booster in adults