The ANSM – French Agency for the Safety of Health Products – is preparing to deliver authorization for issuance to the first coronavirus vaccines that are ready.
In November, an Ipsos survey revealed that 54% of the French were not considering getting vaccinated even though they could. How come? The adverse effects related to too-early clinical trials. For the record, the phase 3 of the clinical trials started in July and are expected to last around two years, but to accelerate the issuing process, laboratories presented preliminary results saying their vaccines were 70, 90 or even 95% effective. Countries approve vaccines one by one to lower the number of hospitalizations of Covid-19.
With issuance, the new test phase begins: the phase 4 also called as pharmacovigilance. It enables to control the occuring of adverse effects and risks related to vaccines and medicines. This phase never ends, as long as the medicine/vaccine is available on sale.
Doctors and pharmacists already have to report any side effect that could be suspected, but it is necessary for patients to report side effects. And every single French person can officially report adverse effect on line, thanks to a from available on the signalement-santé platform.
Soon, the report form will be adapted “to collect additional data as to Covid-19 vaccines” the ANSM says. A communication campaign targeting the general public will be carried on with forms sent a few days after vaccination.
But, it is useless to report any already-known side effect that is mentioned in the instructions. You can tell about it to your doctor or pharmacist that will assess if it is necessary to report it. Interviewed by Franceinfo, Annie-Pierre Jonville-Bera explains: “if the instructions read there can be a skin reaction, or redness at the injection site, you shall not report it unless it is abnormally spread or it gets worse and leads to necrosis for instance”.
The ANSM has announced additional technical and human means to handle files quickly as the Covid-19 vaccine campaign is expected to be huge. 31 regional pharmacovigilance centers (CRPV) will assess the reported adverse effects. An artificial intelligence software module has been created to help officers to confirm the signal or not, and calculate its risk of occurring.
In a transparency matter, head of the committee ruling the vaccine strategy Alain Fischer has declared the pharmacovigilance data will be released weekly by the ANSM to inform the French in real time of the advantages-risks of the vaccine.
Interviewed by Franceinfo, deputy director of the Epi-phare committee (working with the ANSM and the health insurance system in France) Rosemary Dray-Spira leads pharmaco-epidemiologic studies and explains the agencies will monitor cases little studied in phase 3. “For instance, we know clinical trials included only a few very old people or people who developed severe forms of Covid-19”. These people will be monitored closer to know if they develop any adverse effects.
“Reactogenicity” of the vaccines will be followed-up for a long time.
