The race for the COVID-19 vaccine

(Amazing picture from u/junobee at Reddit, this is a real Moderna vaccine vial)

These days I have been looking forward to the race for approval of vaccines for COVID-19 disease. As a member of a scientific committee of the European Medicines Agency I have been living these moments with special interest for several reasons:

The first is the big effort to shorten the deadlines. In the regulatory world we are used to long deadlines that are this way to protect patient safety. In this case the efforts of hundreds of thousands of people have managed to have a "safe" vaccine in record time. It is a great success of science that we have to celebrate.

The second is the enormous pressure that my CHMP colleagues have had to do their job. We have all been able to see how our politicians have approved the vaccine before the scientists. This indicates a profound lack of knowledge about what the evaluation of pharmaceutical products really is, where the decision is not binary as one might think, but rather there are many nuances and details that must be taken care of and that require time. Safety first.

The third is that science is built on the shoulders of giants. The mRNA technology used by Pfizer-BioNTech and Moderna vaccines is technology that has been developed from the high specialization and rarity that needs precision medicine. BioNtech developed the vaccine for personalized immunotherapy in the treatment of cancer. Moderna in 2014 started the study of mRNA in rare diseases, specifically for Crigler-Najjar syndrome. They did not succeed but what they learned allowed them to build up knowledge and be able to get it right now.

I am fortunate to know the chair and vice chair of the CHMP. Specifically, his vice chair is one of those people I can call a friend. He is a former chairman of the EMA's Committee for Orphan Drugs (COMP). He has been my first chair and he has always helped me supporting the development of products not just for Dravet Syndrome but for all rare diseases. He is not only a man of science, he is a scientist and a gentleman. A I am very happy that history asked him to take an important place at this time. The entire COMP family is happy for him.

A big thanks as well to all the EMA staff who has been working on this milestone. Is the first fight for a battle we will win. Together.