The European regulators have issued caution over the UK's recent move to approve the COVID-19 vaccine developed by the Pfizer-BioNTech for widespread use.
In a statement, the European Medicines Agency (EMA), which is responsible for approving the vaccine against the Coronavirus caused disease for the European Union (EU), said that its longer approval process was more appropriate as it was based on more evidence and needed more checks than the emergency procedure chosen by the UK authority.
EMA recently stated that it would decide by December 29 whether to provisionally authorize the COVID-19 vaccine developed by the US drugmaker Pfizer and the German partner BioNTech.
Safe and Effective
According to a spokesperson for the European Commission (EC), the EMA's procedure to approve a vaccine was the most effective regulatory mechanism to grant access of all the citizens belonging to the EU to "a safe and effective vaccine".
The comments from the EU came just a few hours later the UK became the first country in the world to approve the jab developed by Pfizer-BioNTech for use. As of Wednesday, December 2, the UK has reported over 1,647,000 Coronavirus cases and nearly 60,000 deaths due to COVID-19.
However, Roberto Speranza, the health minister of Italy, which is one of the most affected countries in Europe, told the parliament that he would demand EMA continues to keep "the bar on surveillance very high" concerning the possible Coronavirus vaccine approval. He said that when a vaccine is administrated to the citizens it should be safe and also "it will have to be an effective vaccine".
Peter Liese, an EU legislator and member of German Chancellor Angela Merkel's party said that he considers the approval of the vaccine by the UK's Medicines and Healthcare products Regulatory Agency (MHRA) to be "problematic." He further said, "I recommend that EU member states do not repeat the process in the same way. A few weeks of a thorough examination by the EMA is better than a hasty emergency marketing authorization of a vaccine."
UK Approval of World's First mRNA COVID-19 Vaccine
This is the first time in the world a vaccine based on the revolutionary messenger RNA technology has ever been approved by a regulator. So, criticism is more or less was expected as people still have doubts about the efficacy.
However, after the UK approval, BioNTech co-founder and CEO Ugur Sahin said that the mRNA is a new drug entity. "However, it is the first molecule of life, it emerged many billions of years ago and every human and animal has messenger RNA in their cells", he added. Later, on Wednesday, Özlem Türeci, BioNTech co-founder and the chief medical officer also said that they were "delighted" with the MHRA approval. "We have started immediately the process of delivering our vaccine and we expect that the rollout of the vaccine in the UK will happen within the next couple of days," added Türeci.
As a response to the question of whether MRHA had rushed to approve the vaccine, Sean Marett, who is BioNTech's chief business and commercial officer, said that the UK agency had asked the same level of detailed questions as any other agency, and they had focused on efficacy, the tolerance of the jab, and the quality of production. "These three elements are key elements to any vaccine that any regulator will look into detail and I think the MHRA has been no different in this respect," he added.
