EC advances amendment to speed adapted COVID vaccines

Regulatory NewsRegulatory News | 24 March 2021 |  By 

The European Commission on Wednesday advanced a delegated regulation that would give the European Medicines Agency (EMA) the authority to more quickly authorize COVID-19 vaccines that have been adapted to address variants of the virus.
“We are enabling EMA to fast-track regulatory approval of updated vaccines to tackle new variants. Faster approval means more vaccines in circulation and more Europeans protected from the virus,” said European Commission President Ursula von der Leyen.
The regulation, which must still be approved by the European Parliament and Council before entering into force, amends the EU regulation on marketing authorization variations to extend pandemic provisions for influenza vaccine variations to apply to coronavirus vaccines.
The Commission’s actions are in line with its announcement last month detailing the bloc’s approach to COVID-19 variants, which includes creating a Health Emergency Preparedness Response Authority (HERA) incubator and following the EMA’s release of guidance on vaccine development for COVID-19 variants. (RELATED: EU plan to tackle COVID variants features flu vaccine-like pathway, Regulatory Focus 17 February 2021; EMA releases guidance for COVID variant vaccine development, Regulatory Focus 25 February 2021).
Specifically, the delegated regulation amends Article 21 of Regulation (EC) No 1234/2008 to allow the Commission or other relevant authorities to, “where certain pharmaceutical, non-clinical or clinical data are missing, exceptionally and temporarily accept a variation to the terms of a marketing authorisation for a … human coronavirus vaccine.”
Article 21 is also amended to allow regulators to request that applicants provide supplementary information to complete their assessments within a set timeframe and require that variations may only be accepted with missing information “if the benefit-risk balance of the medicinal product is favorable.”
The regulation also amends Annexes I and II of the regulation to include language for marketing authorization variations “related to changes to the active substance of a human coronavirus vaccine, including replacement or addition of a serotype, strain, antigen or coding, sequence or combination of serotypes, strains, antigens or coding sequences,” and to classify such variations as type II major variations.
“Adaptations to active substances of an authorised COVID-19 vaccine may be required to ensure the vaccine's effectiveness against mutations or variants of a virus. Building on the approach for adaptations of human influenza – flu – vaccines, the changes to the Variation Regulation specify which provisions apply to adaptations of the active substance of authorised COVID-19 vaccines. These changes will ensure the streamlined handling of any variation to an authorised vaccine and extend the coverage of the new provisions to all coronaviruses,” the Commission writes.
European Commission, Commission Delegated Regulation


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