Metsola to lead EPP input as EU modifies vaccines approval process for COVID-19 variants

Maltese MEP Roberta Metsola, Vice-President of the European Parliament, has been appointed to lead the European People’s Party Group in negotiations that will seek to modify the EU approval process to tackle new variants of the COVID-19 virus.

“The approval process for vaccines that tackle COVID19 variants needs to be adapted to give certainty and clarity faster - without compromising our safety standards,” she said.

She said it is not an impossible task to maintain the highest possible safety and security standards while ensuring the process is streamlined for maximum efficiency.

"We are seeing already approved vaccines that have already undergone intense scrutiny and checks that need to be modified slightly in response to mutations or variants of the COVID-19 virus. In these cases we can and we should be able to move faster and help countries tackle the so-called third wave of the virus, which we are witnessing spread in Europe."

In order for the vaccines to maintain their efficacy against mutations or variants of the virus that may evolve over time, adaptations to the active substance of those - already approved - vaccines may be needed.

Mutations and variants

On Monday, members of the EP’s Environment, Public Health and Food Safety Committee met experts to discuss the efficacy of vaccines against mutations of the COVID-19 virus.

Representatives from the European Medicines Agency (EMA), the European Centre for Disease Prevention and Control (ECDC) and the World Health Organisation (WHO) updated MEPs on the state of play of existing COVID-19 variants. They shared information regarding how effective authorised vaccines are against different variants, and discussed global challenges and the need for a global coordinated response to addressing variants.

All viruses – including SARS-CoV-2, the virus that causes COVID-19 – evolve over time. These changes are called “mutations”. A virus with one or more new mutations is referred to as a “variant” of the original virus.

 The ECDC’s latest risk assessment states that variants are more easily transmitted and more severe. Existing licensed COVID-19 vaccines may so be only partially effective or significantly less effective against a variant. For this reason, the risk associated with further spread of COVID-19 is currently assessed as “high to very high”.

MEPs expressed their concerns regarding fast-spreading variants, especially given the vaccination rate across the EU remains lower than expected. They lamented the lack of data available on the efficacy of administered vaccines. Certain member states have a low or no capacity to analyse virus samples (“genomic sequencing”), many MEPs said, which means the spread of variants and their impact cannot be adequately monitored.

Members also quizzed the experts on the authorisation process for updated vaccines, on the role of vaccination certificates, and on the safety and side effects of existing vaccines.

“With different variants of the virus emerging, it is essential that we get this right and address any regulatory bottlenecks that could prevent the effective approval of vaccines for these variants," Metsola said.

"We can streamline the process and make it clearer and simpler both for vaccine developers and for European Regulatory authorities. We can do so safely, ensuring people’s confidence in vaccines by ensuring that we do not compromise on our existing high public safety standards."