Filenews 4 October 2021
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) concluded that an additional dose of the vaccines against COVID-19 Comirnaty (BioNTech/Pfizer) and Spikevax (Moderna) can be administered to people with severely weakened immune systems, at least 28 days after the 2nd dose.
The recommendation comes after studies have shown that an additional dose of these vaccines increased the ability to produce antibodies against the virus that causes COVID-19 in patients with organ transplantation with a weakened immune system.
Although there is no direct evidence that the ability to produce antibodies in these patients is protected from COVID-19, it is expected that the additional dose will increase protection at least in some patients. The EMA will continue to monitor any data generated on its effectiveness.
Information on the products of both vaccines will be updated to include this recommendation.
Booster doses
It is important to distinguish between the extra dose for people with weakened immune systems and the booster doses for people with a normal immune system.
Compared with the latter, the CHMP has evaluated data on Comirnaty showing an increase in antibody levels when administering a booster dose about six months after the 2nd dose in people between 18 and 55 years of age. On the basis of these data, the Committee concluded that the booster doses can be taken into account at least six months after the 2nd dose for people aged 18 years and over.
The use of booster doses will follow formal recommendations at national level as defined by public health bodies, taking into account emerging efficacy data and any safety uncertainties. The risk of inflammatory heart disease or other very rare side effects after an adjuvant dose is not known and is carefully monitored. For all medicines, the EMA will continue to examine all data on the safety and efficacy of the vaccine.
More information about the booster recommendations for Comirnaty will be available in the updated product information.
The Commission is currently evaluating data to support a booster dose for Spikevax. The EMA will announce the result when the evaluation is completed.
National immunisation campaigns
The implementation of vaccination campaigns in the EU remains the prerogative of the national technical immunisation advisory groups (NITAG) that guide vaccination campaigns in each EU Member State. These bodies are the bodies responsible for taking into account local conditions, including the spread of the virus (especially any variants of concern), the availability of vaccines and the capabilities of national health systems.
The EMA will continue to work closely with national authorities and the European Centre for Disease Prevention and Control (ECDC) to assess available data and provide recommendations to protect the public during the pandemic
