With a future vaccine against Covid-19 in high demand, the executive director of the European Medicines Agency (EMA) has recommended that modelling be used to identify the population that will need it most.
“When we grant a marketing authorisation in Europe for a vaccine, it will be impossible for us to guarantee at the same time the availability of this substance everywhere”, he said in an exchange with MEPs on the European Parliament Committee on Public Health on Monday 18 May.
This exchange of views followed a discussion in the plenary session in which MEPs had expressed concern about the current competition between countries (see EUROPE 12487/11). It complemented a discussion last week between the EMA and the parliamentary committee which had to be shortened due to technical problems (see EUROPE 12485/2).
The failure of the Discovery project
On this occasion, the agency’s executive director, Guido Rasi, spoke about the failure of the Discovery project, launched in mid-March to find a cure for Covid-19, in the absence of a vaccine (see EUROPE 12452/12). Following comments from Frédérique Ries (Renew Europe, Belgium) highlighting the only participation of French patients in the clinical trials, Mr Rasi acknowledged delays and assured that the trials would soon be expanded. According to him, the problems stem from the fact that this type of clinical trial must be sponsored, which was not the case here. As a solution, he mentioned the renovation of the platform and the injection of European funds. “It seems to us to be the best way to do it, and I hope many countries will participate”, he said.
Soon an MA for Remdesivir
He took advantage of this exchange of views to announce that a conditional marketing authorisation (MA) would be granted “in the next few days” to the US pharmaceutical company Gilead for the treatment Remdesivir. Until now, the agency has recommended its compassionate use (for patients who lack further therapeutic options) despite the lack of MA. He also said that “other possible treatments against Covid-19 that may be available quickly” are those based on monoclonal antibodies, which can “neutralise” the virus.
Lessons to be learned
In particular, the head of the agency responded to suggestions by Valérie Trillet-Lenoir (Renew Europe, France) to build up a stock of vaccines or essential medicines. According to him, although it is not within the competence of the EMA, “it would definitely be a good idea”. As for the future of the EMA, he replied, “It’s not up to us to determine our role. Right now, we’re a little out of our depth. We will have to think about having a legal basis”, he said, suggesting that the EMA should be given infrastructure support, IT tools and a clear mandate for coordination.
Mr Rasi pointed out that, in the case of Covid-19, the agency had created a control platform to verify the safety and efficacy of the vaccine (EMA pandemic taskforce – Covid-ETF) and that it might be useful to make this platform sustainable. The same applies to Industry single points of contact (i-SPOCs) (see EUROPE 12462/6).
What about the rest of the world?
To avoid unequal access to vaccines, the World Health Organisation (WHO) announced last week its intention to launch a platform for sharing data and licensing intellectual property rights to ensure widespread access to medical and technological discoveries made in the fight against Covid-19.
For his part, Chinese President Xi Jinping told the 73rd World Health Assembly on Monday that a possible Chinese vaccine against the new coronavirus would become a “global public good”. (Original version in French by Sophie Petitjean)