“Using a totally experimental vaccine when we don’t know what it contains or how it works is an aberration!!! Since the beginning of the vaccination campaign against Covid-19, many opponents of the injection have regularly resorted to the argument that these products – in particular the messenger RNA serums from Pfizer and Moderna – are still in phase. of testing. The implication: vaccinated people are actually guinea pigs and could develop serious side effects.
Allegations relayed by certain political leaders, like Nicolas Dupont-Aignan. The presidential candidate denounced at the end of December on Twitter “successive experimental injections”.
The Council of State goes to bed before the government and despite some reservations justifies the principle of the vaccination pass. Enough of this model of wooden language, let us be firm and vote in the national assembly against this project of weapon of destruction of our freedoms. pic.twitter.com/quZYPcy5XQ
— N. Dupont-Aignan (@dupontaignan) December 28, 2021
“We kill with this experimental injection!” “, denounces, a few days later, a demonstrator against the vaccine pass at the microphone of LCI in a sequence that has gone viral on social networks. And if this argument repeated sometimes in loop by the antivax was in fact false? While the vaccination pass has just come into force, 20 minutes make the point.
FAKE OFF
“Once a medicine has obtained marketing authorization from a regulatory authority, it can no longer be considered an investigational product”, clarifies the European Medicines Agency (EMA) to 20 minutes. A scenario that applies to all of the vaccines against Covid-19 placed on the market in France, insofar as each of them has received authorization from the EMA.
But for opponents of the injection, marketing authorizations for vaccines against Covid-19 are suspect because they are said to be “conditional”. And for them, the fact that these drugs are in “phase 4” of their deployment accredits the thesis of a vaccine still under development.
Conditional authorizations in case of emergency
Why are we talking about “conditional” marketing authorizations (MA) for anti-Covid-19 vaccines? This is an emergency procedure provided for by a 2006 European regulation. It applies to medicinal products “intended for the treatment, prevention or medical diagnosis of serious disabling illnesses or potentially fatal illnesses” or to those “intended for use in emergency situations in response to public health threats”. Which is the case for Covid-19.
“If a vaccine is authorized, it is at the end of a rigorous and strict procedure”, underlines the Ministry of Health with 20 minutes. After authorization at European level, the National Medicines Safety Agency (ANSM) gives its opinion on the marketing of vaccines in France. Taking these recommendations into account, the High Authority for Health decides on the marketing in the country. The latest, Novavax, was authorized on January 14, 2022. “The decision whether or not to authorize a vaccine therefore does not fall to the government but belongs to the independent scientific authorities which are in charge of the evaluation of health products” , wishes to clarify the Ministry of Health.
If the authorization is granted within a limited time frame, it is accompanied by guarantees, as lawyer Diane Bandon-Tourret explained to 20 minutes in November 2021: “The framework for setting up a conditional marketing authorization is very strict. There is constant monitoring which allows information to be gathered at European level. The risk-benefit balance is constantly monitored, and it must remain positive. »
In the event that the undesirable side effects outweigh the benefits, the conditional marketing authorization may be suspended and reassessed. Conversely, “when the European authorities have received and evaluated all the additional data required, the conditional MA can be converted into a standard MA”, says the Ministry of Health.
“These vaccines are currently in phase four”
What does “phase 4” of vaccine deployment mean? Again, this does not mean that the vaccine is experimental. As Inserm explains, “phase 1 and phase 2 trials aim to measure the tolerance of the product to verify that it is risk-free”. Next comes Phase 3 of vaccine development, which compares the vaccine to a placebo or an already licensed vaccine.
“Phase 4” corresponds to the follow-up of the drug after it has been marketed. This is also called “pharmacovigilance”. The studies in this phase “make it possible to verify that on a large scale and in people who may have chronic conditions, the safety and efficacy of the vaccine are assured, that there are no long-term adverse effects term on the occurrence of other diseases”, explains the Vaccination info service site of Public Health France.
Pharmacovigilance databases, which consider deaths and serious complications in vaccinated patients to determine whether there is a link with vaccination, are often misinterpreted as evidence of serious side effects in people vaccinated. In France, the ANSM, responsible for pharmacovigilance and the monitoring of adverse effects of vaccines, publishes regular bulletins relating to pharmacovigilance. At this stage, the risk-benefit balance has always tipped in favor of the injection.
Source: 20minutes
