What are the regulators doing as Covid restrictions are being lifted?
International Regulators COVID-19 Omicron variant workshop
International regulators participated in a ‘COVID-19 Omicron variant’ workshop. They discussed the effectiveness of current vaccines against the COVID-19 Omicron variant. They also considered regulatory requirements for possible future updates to vaccine compositions.
The workshop took place on 12th January 2022 and was coordinated by the International Coalition of Medicines Regulatory Authorities (ICMRA). A report from the workshop is published on the ICMRA website https://www.icmra.info/drupal/covid-19/12january2022
A review of data from several countries was presented and discussed at the workshop. This included data resulting from Comirnaty vaccines (developed by BioNTech and Pfizer) and Janssen COVID-19 vaccines.
The data indicates that while a decrease in vaccine effectiveness against Omicron infection was generally observed, vaccination continues to provide significant protection from serious infection and hospitalisation by the Omicron variant. Furthermore, the importance of a booster dose is clearly evident from the data.
A review of the design of clinical studies to demonstrate the effectiveness of modified COVID-19 vaccines against variants was also discussed. Neutralising antibodies were deemed the most appropriate immune parameter to measure as primary outcome in clinical studies, as they have been shown to be correlated with protection.
In relation to updates to vaccine composition and manufacturing towards any specific single variant vaccine, e.g. a monovalent Omicron variant vaccine, it was considered too early at this point in time. More data is needed before such changes are deemed necessary. In this regard, the regulators suggest that bivalent or multivalent vaccines should be investigated as possible alternatives, as they could provide broader protection against variants.
The regulators advised that clinical studies would be needed to support new updated vaccines and that global coordination of changes in vaccine composition will be important as we move forward.