Trials of several Covid vaccines seem highly anticipated, and proof of it, the INSERM – French National Institute for Health and Medical Research – has announced they came to an agreement with several laboratories to test their products on several volunteers. Tests performed on 41,000 candidates to start by mid-December 2020, before possible marketing. The idea? As told by Francetvinfo, “assessing the effectiveness and habituation in humans”.
As for laboratories that agreed with the French research agency, there are AstraZeneca – which vaccine is said to be 90% effective – as well as Janssen – Belgian laboratory and subsidiary of Johnson & Johnson currently completing phase 3 of the clinical trials. Each vaccine will be inoculated to 1,000 volunteers and observed up to two years: “Checking starts immediately after inoculation and then we see patients again. And then, there is a longer surveillance, between one to two years, and we ask patients to send us a feedback on anything that happened to them” Pr. Odile Launay explains as she leads the tests.
As for observations of the INSERM, candidates will be administrated whether the vaccine whether a placebo and will be able to resume normal life (or at least almost normal as they still have to comply with the health guidelines). Note that a third vaccine will be also part of the tests, Moderna’s, mostly on people aged 70+, to find out if it does effectively protect elderly people.
As for recruiting volunteers for the tests, this past October, the INSERM said they got 20,000 applications from volunteers to take part in the last phase of clinical trials of the different vaccines develop in the world, out of the 25,000 they hoped for.
A wonderful success though for a “campaign carried only via the press” as reminded by Libération. As for Germany or the Netherlands – that launched a similar vaccine campaign – they meet the same success. But such a success also leads to greater responsibilities, and to overcome any problem, industrials have had to wait for two months after inoculating the last doses of vaccine to the last volunteer to seek approval for production.
Same thing in the United States: several weeks ago, the FDA released stricter standards to comply with before being approved for production, so much that marketing a vaccine during the latest presidential elections – as Donald Trump wanted – was not conceivable.
Europe is yet anticipating: the Medicines Agency has started to assess data already made available from two candidate vaccines – naming AstraZeneca and Pfizer/BioNTech – and in the event they are approved, marketing could be launched as soon as possible. Answer is expected – as for laboratories that applied – for late December 2020. For the record, about forty candidate vaccines are undergoing clinical trials on different levels.