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‘Mix-and-match’ approach can be used for both initial courses and boosters
The EU is currently experiencing a rising number of infections in the ongoing COVID-19 pandemic, as well as an increase in hospitalisation rates. Vaccines are continuing to prevent many millions of EU citizens from becoming very ill or dying and figures show that numbers of hospitalisations and deaths remain lowest in those Member States with the highest vaccination rates. The European Medicines Agency (EMA) and the European Centre for Disease Prevention and Control (ECDC) therefore continue to urge all EU citizens to get fully vaccinated and to adhere to recent recommendations on booster vaccination.
In line with measures already taken by many Member States, an increasing number of clinical studies, supported by real world evidence, have now looked at the possibility of using two different COVID-19 vaccines1, either for the first and second doses of a primary (initial) course, which is known as heterologous primary vaccination, or using a third dose of a different COVID-19 vaccine as a booster 3 to 6 months after a primary vaccination course (heterologous boosting).
In order to provide scientific grounds and further provide flexibility to vaccination schemes EMA and ECDC, in collaboration with EU experts in EMA’s COVID-ETF group, have reviewed the available evidence, and provided technical recommendations and advice on heterologous vaccination against COVID-19, either in the primary course or as a booster.
Evidence from studies on heterologous vaccination suggests that the combination of viral vector vaccines and mRNA vaccines produces good levels of antibodies against the COVID-19 virus (SARS-CoV-2) and a higher T-cell response than using the same vaccine (homologous vaccination) whether in a primary or booster regimen. The heterologous regimens were generally well tolerated.
The use of a viral vector vaccine as a second dose in primary vaccination schemes, or use of two different mRNA vaccines, is less well studied.
While research is ongoing to provide more evidence on long-term safety, duration of immunity and effectiveness, the use of heterologous schedules may offer flexibility in terms of vaccination options, particularly to reduce the impact on the vaccine rollout should a vaccine not be available for any reason.
EMA’s and ECDC’s expert considerations, the outcome of which are detailed below, are intended to help decision makers for national vaccination campaigns ensure that the maximum number of EU citizens are vaccinated and protected as quickly as possible.
Marketing authorisation holders are also being encouraged to submit variations to add details about such use to the product information. Although the review did not look at other vaccines not yet licensed in the EU, research into heterologous combinations of these will be taken into account in future if these are licensed and more evidence becomes available.
Technical recommendations and advice on heterologous primary and booster COVID-19 vaccination
Following the analysis of the available evidence, EMA and ECDC are issuing the following technical recommendations and advice. A detailed review of the literature supporting the advice will be published by EMA and ECDC in the near future.
Sumber : https://www.ema.europa.eu