Current covid-19 vaccines hold a Conditional Marketing Authorization
a recent BMJ News discussed the possibility of mandatory covid-19 vaccination for healthcare workers in UK, however no consideration has been paid to the exceptional rregulatory status of these products.
Indeed, all the covid-19 vaccines approved in UK (Pfizer/BioNTech, Oxford/AstraZeneca, and Moderna) received from the MHRA a temporary authorization, namely a national Conditional Marketing Authorization (CMA), which is pretty much the same as the CMA provided by the EMA (2). CMA intended for public health emergencies like pandemics and is provided on the acknowledgement that the marketing authorization holder will fulfil specific obligations within defined timelines. Obligations for these products include: providing additional data about active substances and finished products, their specifications and manufacturing process, including excipients, and, most importantly from the clinical point of view, the final clinical study reports for the randomized, placebo-controlled, observer-blind phase II/III studies, to confirm the efficacy and safety profile.
Notably, CMA was never provided previously to vaccines, with the exception of two products for pandemic influenza H1N1 (Arepanrix and Humenza) and a product for pandemic influenza H5N1 (MedImmune). All those products however were never used on a large scale and the marketing authorizations were finally withdrawn. Interestingly enough, the exceptional status of covid-19 vaccines presently available in UK and in EU is supported also by the decision of the European Parliament to adopt a regulation to derogate, for the period of the public health emergency, from certain provisions about the use of genetically modified organisms (GMO) in clinical trials, since covid-19 vaccines contain or consist of GMO (3). Thus, these covid-19 vaccines do not hold a full marketing authorization, and the marketing authorization holders are still expected to provide additional data on efficacy and safety.
Any discussion about the opportunity of mandatory covid-19 vaccinations should thus consider the conditional authorization status of the available products and in particular the still largely incomplete efficacy and safety profile in the medium-long term.
(1) Wise J. Covid-19: Is the UK heading towards mandatory vaccination of healthcare workers? BMJ 2021;373:n1056
(2) European Medicines Agency. Conditional marketing authorization. URL: https://www.ema.europa.eu/en/human-regulatory/marketing-authorisation/co... (last visit: 30/4/2021)
(3) European Parliament press release. Parliament to allow COVID-19 vaccines to be developed more quickly. URL: https://www.europarl.europa.eu/news/en/press-room/20200706IPR82731/parli... (last visit: 30/4/2021)
Competing interests: No competing interests