In these days the pictures of the first citizens who have received the vaccine have been published; they are two British citizens (a woman from Northern Ireland and a man from England), who opened what it will be the biggest vaccination campaign ever on British soil. Why the rest of Europe has not yet started to distribute and administer the vaccine?
First of all, the authorities that have to give the green light for the administration of the vaccine are different in Great Britain (Mhra – Medicines and Healthcare products Regulatory Agency) and Europe (Ema – European Medicines Agency). In the UK, the EMA used an emergency authorisation procedure and issued a temporary authorisation, which does not include the commercial use of the drug. In other words, the experimental batch is authorised for the use in the general population. In Europe, on the other hand, control over the entire potential production plan is valued. It is strange to think that the EMA was based in London before Brexit.
Temporary emergency authorisation (exploited in Britain) allows some countries to supply and use an unauthorised medicine (or an authorised medicine in a non-approved indication) in certain specific cases of public health emergencies; COVID-19 is one of these emergencies, of course. In practice, as Guido Rasi, former executive director of the EMA, also explained, the British have started immediately taking a minimum risk, they will vaccinate a small number of people from now until the end of the year knowing that in the meantime, within that period, the work of control and analysis done by the EMA will arrive. A step forward to be able to say to be the first and that, without the bureaucracy of the European Union, you act faster.
Is it better to get first or to guarantee the rules?
“As I have already explained how, in order to arrive at this vaccine, the stages have been shortened compared to the standard times for the production of drugs,” explains Fabio Farneti, CEO of Spai Srl. “Obviously, this pandemic has forced the whole world and all the leading pharmaceutical companies to work in a short time to find the vaccine. In my opinion, there are no shortcuts to quality procedures, and I hope that GMP (Good Manufacturing Practice) will be strictly followed”.
How are the pharmaceutical companies not involved in the production of the vaccine handling this situation?
“This is another paradoxical situation caused by the pandemic and nobody talks about it. I was in the headquarters of a major pharmaceutical company just a few days ago and they were telling me how, because of the restrictions imposed by governments to protect us from COVID, the classic seasonal illnesses are nosediving. Flu, colds, coughs, sore throats… nobody gets sick anymore. Staying indoors, limiting contact to a minimum, these illnesses have taken a downtrend, so the manufacturers of those medicines such as aspirins, tachypyridines, syrups… are actually suffering this situation. Another effect of this damn virus”.