To develop, authorise and make safe COVID-19 vaccines available more easily, MEPs have adopted a temporary derogation from certain rules for clinical trials.
Developing and deploying an effective and safe vaccine against the virus is the most likely permanent solution to stop the pandemic. Clinical trials for COVID-19 vaccines are a time-consuming step before authorisation, as they need to be carried out in several member states to ensure the populations for whom the vaccines are intended are represented and to generate robust and conclusive clinical data.
Some COVID-19 vaccines and treatments, already being developed, may be defined as genetically modified organisms (GMOs) and are thus covered by the relevant EU GMO Directives. As national requirements to assess the environmental risks of clinical trials on medicinal products that contain or consist of GMOs vary considerably across member states, a derogation from these rules is necessary to avoid a significant delay in developing life-saving vaccines and treatments.
To this end, the European Commission proposed a Regulation to derogate temporarily – only for the period during which COVID-19 is a public health emergency – from certain provisions of the GMO Directive for clinical trials on COVID-19 vaccines and treatments that contain or consist of genetically modified organisms (GMOs). The derogation would apply only to operations necessary to conduct the clinical trial phase, and for compassionate or emergency use, in the context of COVID-19.
In response to the proposal of the European Commission, on the 10th July, the European Parliament adopted a new Regulation by 505 votes to 67, and 109 abstentions, via the urgent procedure, that will allow COVID-19 vaccines and treatments to be developed more quickly.
The derogation will help to fast-track the development, authorisation and consequently availability of COVID-19 vaccines and treatments, by allowing greater flexibility for researchers to speed up clinical trials, while ensuring the safety of future COVID-19 vaccines is not compromised. When debated last week in the Committee on the Environment, Public Health and Food Safety, members agreed on the need to adapt the rules but stressed that standards for vaccine quality, safety and efficacy must be maintained.