Repeat COVID-19 Vaccine Booster Shots Trigger Regulator Warning About Immune-System Risks

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Group to meet with other regulators to discuss potentially updating current vaccines

The European Unionโ€™sย drugย regulatorย expressed doubts about whether a secondย booster doseย of the currently availableย COVID-19 vaccines would be a sustainable long-term approach.

Marco Cavaleri, the European Medicines Agencyโ€™s (EMA) head of vaccines strategy, told a media briefing, โ€œThere is an emergency discussion around the possibility of giving a second booster dose with the same vaccine currently in use. Data has not yet been generated to support this approach.โ€

He said later, โ€œWe would like to see this data before we can make any recommendation, but at the same time we are rather concerned about a strategy that [involves] repeated vaccinations within a short term.โ€

An additional booster shot โ€œcould be considered as part of a contingency plan,โ€ but โ€œrepeated vaccinations within short intervals will not represent a sustainable long term strategy,โ€ he said.

Concerns Over Immune Response

When asked to expand on his statements, Cavaleri said that for a hypothetical approach of giving boosters frequently, such as every four months, โ€œwe will end up potentially having problems with immune response and immune response may end up not being as good as we would like it to be, so we should be careful in not overloading the immune system with repeated immunization.โ€

Continuous administration of boosters can also lead to fatigue in the population, he said, adding, โ€œit will be much better to start thinking about an administration of boosters that is more spaced in time.โ€

The EMA is in conversation with vaccine developers in case there is a need to update the current vaccines, Cavaleri said, but noted that any change โ€œwould have to be coordinated globally.โ€

Meanwhile, more data on the impact of the new variantโ€”in this case, Omicronโ€”on vaccines and a better understanding of the evolution of the current wave were needed to decide whether an Omicron-specific vaccine was needed.

โ€œWhile a monovalent Omicron vaccine would represent an obvious candidate to be investigated, other options such as a multivalent vaccine cannot be ruled out as potential alternatives,โ€ Cavaleri said.

Byย Mimi Nguyen Ly

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