Home » News » EP relaxes rules to speed up Covid-19 vaccine – Abroad – News

EP relaxes rules to speed up Covid-19 vaccine – Abroad – News

On 10 July, the EP adopted new rules to speed up the development of Covid-19 vaccines and medicines by 505 votes to 67, with 109 abstentions under the urgency procedure.

The European Commission (EC) has proposed a specific European Union (EU) vaccine strategy with a temporary and Covid-19-only derogation from certain clinical trial rules, as the development and use of an effective and safe vaccine is the most reliable means of stopping a pandemic.

The EP spokesperson in Latvia recalled that clinical trials are one of the most time-consuming steps in the authorization of a treatment, as they must be carried out in several EU Member States to ensure that the populations for which the vaccine is intended are adequately represented.

He recalled that some of the vaccines and treatments currently being developed could be considered as genetically modified organisms (GMOs) and were therefore also covered by the relevant EU GMO directives. EU Member States have very different rules in this regard. A derogation is needed to avoid significant delays in the development of life-saving vaccines and treatments.

It has already been reported that the EC has proposed derogations from certain provisions of the GMO Directive for clinical trials on Covid-19 vaccines and treatments involving genetically modified organisms, while Covid-19 is a public health emergency. The derogation shall apply only to activities necessary for the conduct and emergency use of clinical trials in relation to Covid-19.

The derogation will facilitate the development, validation and, consequently, the availability of Covid-19 vaccines and treatments.

In last week’s debate, members of the Committee on the Environment, Public Health and Food Safety agreed that the rules needed to be adapted, but stressed the need to maintain standards for the quality, safety and efficacy of vaccines.

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