Vice President for the European Parliament Robert Metsola will lead discussions that will look to change the EU’s approval process for vaccines to tackle new COVID-19 variants.
“It is not an impossible task to maintain the highest possible safety and security standards while ensuring the process is streamlined for maximum efficiency,” Metsola, who will be representing the European People’s Party Group, said.
“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.”
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.
Malta is currently battling a spike in COVID-19 cases off the back of a new variant of the virus.
On Monday, MEPs met in the Environment, Public Health and Food Safety Committee to question experts on 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) shared information regarding how effective authorised vaccines are against different variants and discussed global challenges and the need for a globally coordinated response to addressing variants.
Marco Cavalieri, head of the European Medicine Agency’s vaccine evaluation team, told MEPs that the approval of adapted vaccines will be “a matter of weeks” – maybe even shorter.
Under the EU Commission’s proposal for adapted vaccines, companies will not be obliged to submit an entire file from scratch as the new shot would be approved as “a kind of variation” of doses that have been already approved by the EU agency.
Moreover, manufacturers will be able to ask for the approval of different modified vaccines under the same marketing authorisation application.
MEPs did raise some concerns, particularly the lack of data available on the efficacy of administered 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. We can streamline the process and make it clearer and simpler both for vaccine developers and for European Regulatory authorities,” Metsola said.
“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.”
This article is part of a content series called Ewropej. This is a multi-newsroom initiative part-funded by the European Parliament to bring the work of the EP closer to the citizens of Malta and keep them informed about matters that affect their daily lives. This article reflects only the author’s view. The European Parliament is not responsible for any use that may be made of the information it contains.
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