International regulators convened to discuss the evolving landscape of COVID-19 vaccines and the necessity to update their formulations based on emerging evidence about SARS-CoV-2 variants and lessons drawn from prior vaccine adaptations. Co-led by the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA), the workshop, hosted by the International Coalition of Medicines Regulatory Authorities (ICMRA), transpired on May 8, 2023.

While the existing authorized COVID-19 vaccines remain effective against severe illness and death, their protection against infection diminishes over time and with the emergence of new variants. The workshop’s participants reviewed scientific evidence encompassing epidemiology, seroprevalence, vaccine performance, and regulatory factors associated with adjusting authorized or new COVID-19 vaccines to counter emerging coronavirus variants. It was broadly agreed that forthcoming winter season vaccines should be monovalent, tailored to the XBB family of Omicron subvariants like XBB.1.5, and suitable for both booster and primary vaccinations.

The regulators emphasized that modifying strain composition of authorized COVID-19 vaccines would demand manufacturing and quality data, as long as post-authorization information on vaccine quality, effectiveness, immunogenicity, and safety is gathered. The workshop leveraged insights from previous ICMRA COVID-19 vaccine workshops and included global regulatory representatives and World Health Organization (WHO) experts. Co-chaired by Peter Marks, Director of the Center for Biologics Evaluation and Research (CBER) at the US FDA, and Marco Cavaleri, Head of Health Threats and Vaccines Strategy at EMA, the workshop marks a pivotal step in adapting COVID-19 vaccines to dynamic viral challenges.1

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References

  1. Ema. (2023, May 30). Global regulators agree on way forward to adapt COVID-19 vaccines emerging variants – European Medicines Agency. European Medicines Agency. https://www.ema.europa.eu/en/news/global-regulators-agree-way-forward-adapt-covid-19-vaccines-emerging-variants

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