Efficacy Controversy Hits European COVID-19 Vaccine Rollout
Donald Macarthur and Dr. Meriem Bouslouk-Marx discuss post-approval findings of national committees in Europe charged with deciding the best strategy to use a new COVID-19 vaccine in their populations.
By end-January 2021, three COVID-19 vaccines had received conditional marketing authorizations (valid one year) by the European Commission, covering all EU-27 countries, following a positive opinion from the European Medicines Agency (EMA). Each vaccine also received emergency-use authorization post-Brexit from the UK regulator, the Medicines and Healthcare products Regulatory Agency (MHRA).
There are two to three market access steps for a vaccine which can run in sequence (usually) or in parallel (especially in an emergency): (1) regulatory approval based on best estimates of clinical and CMC data, (2) population target recommendation based on models and population acceptability, and (3) cost effectiveness assessment and price negotiation. Depending on the country, steps (1) and (3) may be combined.
This article discusses post-approval findings of national committees charged with deciding the best strategy to use a new vaccine in their populations, with special reference to the Oxford/AstraZeneca (AZ) vaccine. This was the first to have Phase III results published in a peer-reviewed journal and attracted the greatest controversy. It will not address the associated EU vaccine procurement debacle.
Concerns about the Oxford/AstraZeneca Vaccine
Though issues around usage of the AZ vaccine in older adults were expressed since release of the first trial results in the The Lancet on December 8, 2020, the drama really kicked off for the wider public on January 29, 2021. Speaking at a press briefing a few hours before the EMA issued its opinion on the AZ product, French President Emmanuel Macron said this vaccine was ”quasi-ineffective” in people over the age of 65 years. The over-65 age group is the one in which the overwhelming number of serious illnesses, hospitalizations and deaths from COVID-19 occur, so the implication was clear. The vaccine did not work well in those most at risk. Mr. Macron also criticized the UK’s decision to give doses 12 weeks apart, claiming this could ‘accelerate the mutation’ of the virus.
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