#Vaccination #Covid #Opecst #asks #communication #adverse #effects
In a report on vaccination against Covid, the Parliamentary Office for the Evaluation of Scientific and Technological Choices (Opecst) points to the good functioning of the French drug control system, but also underlines the lack of institutional communication on adverse effects, while the rapid arrival of new vaccines has raised legitimate concerns.
“Transparent and complete communication about the existence of adverse effects, energetic action to encourage health professionals to report adverse events (…) are necessary to guarantee the conditions of public confidence in the capacity of health authorities to guarantee your safety”it’s written.
Supported by senators Sonia de La Provôté (Centre Union) and Florence Lassarade (Les Républicains) and deputy Gérard Leseul (Socialist), this report adopted at the beginning of June responds to a referral from the Senate Social Affairs Commission dating from February, in reaction to a petition calling for the creation of an investigation commission on the side effects of Covid vaccines presented in the Senate. The three rapporteurs held 23 hearings between March 28 and May 30 and one public hearing on May 24, in an adversarial format.
Listening to a suffering population
“We heard from representatives of user associations and institutions, as well as leading scientists in their field, who were seeking to disassociate themselves from political considerations, says Dr. de La Provôté, an occupational doctor. We have been criticized for listening to people described as anti-vaccines, but it is in our logic to listen to all parties to formalize an opinion. » Indeed, the speakers wanted to be attentive to everyone. “Behind the complaints there are also people in good faith with real symptoms. It is important to listen to them. Opecst’s role is not to put everyone in a clan in a cartoonish way “the senator continues.
One of the objectives was to study the response capacity of the pharmacovigilance system from the start of the vaccination campaign. This is based on event reports from health professionals and the population. Nevertheless, “A certain number of professionals and users have told us that it was not so easy to declare them on the portal of the National Medicines Agency (ANSM). However, it is important that this process be facilitated”emphasizes Dr. de La Provôté.
The Office welcomes the effectiveness of this system, almost unique in Europe, which also includes a pharmacoepidemiology component aimed at highlighting the appearance of a potential symptom after vaccination on a population scale. However, even if pharmacovigilance has fulfilled its function, “Three times as many staff would have been needed to ensure feedback on the various reports, including small signals”believes Dr. Lassarade, also a pediatrician and concerned about the sustainability of the device and the hiring of full-time pharmacologists.. As a reminder, it is the regional pharmacovigilance centers (CRPV) that examine these declarations and notify the signals to the Agency.
The two senators particularly regret that the authorities have not taken complaints about menstrual disorders more seriously. “The gynecological effects affected a very large part of the population, with an evident underreporting, points out Dr. de La Provôté. And if the problems resolved spontaneously in the vast majority of cases, there were still some more serious events, particularly bleeding ones. » Fortunately, thrombosis, myocarditis, and pericarditis alerts have been better taken into account.
Lack of transparency in communication.
The speakers also highlighted a very proactive communication campaign in favor of vaccination. At the expense of full transparency. “Government communication has not been as proactive in reporting side effectspoints out Dr. de La Provôté. To access the information you have to go to the ANSM portal, but it is not designed for the general public. However, this information is necessary for everyone to form their own opinion of it. » For the senator, the balance of communication is, however, a guarantee of trust.
In addition, the official discourse could be perceived as “misleading”, while the objective of herd immunity with a return to normality, a time put forward, did not bear fruit as the virus had become more contagious. Dr. de La Provôté thus points out the imprudence in political discourse.
The Opecst report also criticizes the “DGS-Urgent”. “Information related to adverse effects, although available on the ANSM website, should have been actively provided to healthcare professionals. This is the vocation of the “DGS-Urgent”, but they do not provide the required clarity”, read. Dr. de La Provôté regrets “a hypertechnocratic writing process”. And Dr. Lassarade finds that “doctors were informed more often by the big news channels than by the authority that should have”.
Return the doctor to his role
For the two senators, however, it is essential that doctors have access to clear and contradictory information so that they themselves are in a position to calmly inform their patients. “However, there were a certain number of them who were deprived of the side effects, emphasizes Dr. de La Provôté. For pregnant women, for example, there were vagueness and ambiguities that should not have existed. » As for the vaccination of children, there too the message may have lacked clarity and conviction.
“The doctor, general practitioner or specialist, must be restored to his true role, that is, that of the indication. Now that there is a tendency to revaccinate at least once per fall, the indications will have to be fine-tuned according to age and existing pathologies, says Dr. Lassarade. If we return this freedom to the doctor, it will contribute to a better spread of vaccination in general. »
And yes “political communication has its role in giving the guidelines of the health strategy, it is in the singular colloquium with the doctor that things are played at the individual levelmaintains Dr. de La Provôté. Any health policy must maintain its great part of humanity and take into consideration the individual in what he is. »
Regarding the vaccination pass, Dr. Lassarade considers that its arrival too late was counterproductive. “The vaccination pass exacerbated the opposition and even reinforced part of the anger,” regrets Dr. de La Provôté.