Given the proven efficacy and quality of the two mRNA vaccines against Covid-19, the European Medicines Agency (EMA) has recommended that their conditional approval be converted to a standard approval. For the vaccine Comirnaty from Biontech/Pfizer and Spikevax from Moderna, this means that the approval no longer needs to be checked and renewed annually.
The EMA, based in Amsterdam, announced this on Friday. The EU commission is now responsible for issuing permanent approval for the two mRNA vaccines (pictured below).
So far only conditional approvals
Both vaccines received a conditional marketing authorization at the time of approval, the EMA announced. The companies were thus obliged to present the results of the ongoing clinical studies and to provide additional data on the pharmaceutical quality of the vaccine in view of the planned production expansion.
Video: How mRNA Vaccines Work
The way for standard approval is now clear
As the EMA has now explained, these trials and additional studies have provided reassuring data on important aspects such as the effectiveness of the vaccines in preventing serious corona diseases. In addition, the companies have submitted all requested additional data on the pharmaceutical quality of the vaccines. Therefore, the way is now clear for a standard approval.
Source: Krone
I’m Wayne Wickman, a professional journalist and author for Today Times Live. My specialty is covering global news and current events, offering readers a unique perspective on the world’s most pressing issues. I’m passionate about storytelling and helping people stay informed on the goings-on of our planet.
