7:49 p.m., August 25, 2021, modified at 7:53 p.m., August 25, 2021
White smoke for the Pfizer-BioNTech vaccine. Last Monday, the US Medicines Agency (the Food and Drug Administration, FDA) fully approved the German-American group’s serum for ages 16 and over. In France, as for all the countries of the European Union, it is the European Medicines Agency (EMA) which has primacy over the authorization of vaccines, and the Pfizer vaccine currently only has a conditional marketing authorization. When will a standard authorization be granted in Europe?
“Comparing Europe and the United States is always tricky,” immediately tempers Carine Milcent, an economist at the CNRS and specialist in health issues. In the United States, the FDA’s green light is valid for the whole country; within the European Union, each vaccine also passes through the sieve of national health agencies, which remain sovereign. Hungary has thus legally authorized Chinese and Russian vaccines on its soil, which have not yet been validated by the EMA. “If conditionality is lifted at European level, this does not prevent the High Authority for Health in France from maintaining it”, illustrates the expert.
Conditionality suspended for variants and other vaccines
On either side of the Atlantic, definitively validating the vaccine is a question of balance between benefits and risks. “It depends on certain elements, such as age or comorbidities, and in view of the existing vaccines and the effects of the variants, your authorization will be full or conditional”, describes Carine Milcent. The unpredictability of Covid-19 is further slowing the lifting of conditionality. “Since the start of the health crisis, we have been in an absolutely uncertain world, we do not know how the virus varies.”
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Among the criteria taken into account in the choice of the EMA also figure the arrival in the coming months of other vaccines, developed by European companies (Curevac, Sanofi…). “The European Agency has an interest in validating vaccines that are both effective for the population and whose price it can play. It is awaiting on the one hand additional proof from the laboratory, and on the other hand the arrival other laboratory vaccines for which there could be more leeway “, continues the specialist.
Even though it only has conditional authorization, the Pfizer vaccine is deemed safe by the EMA: “This means that there has been a regular review of all available data, that it has been found to be safe” , underlines Simona Guagliardo, specialist in European social and health policies at the European policy center think-tank. And gives the European Agency the possibility of “giving itself time to see, to ask the laboratory for information, additional tests”, adds Carine Milcent.
An authorization that would facilitate the vaccination obligation?
The final validation of the Pfizer vaccine by the FDA does nothing more than the conditional authorization given in Europe, but it is a game-changer in the United States. “In a liberal country where health is not at all of the order of the State, by giving a complete marketing authorization, we drive the point home, explains Carine Milcent. It offers nothing in particular. compared to Europe but allows to play on the obligation in the United States. ”
And should push companies, universities or administrations to require compulsory vaccination, while those who risked having had to face lawsuits, reports the American magazine National Geographic. The US military, which planned to make vaccination compulsory for its soldiers in mid-September, has already announced that it will accelerate the implementation of this measure.
In France, one of the arguments put forward in favor of the health pass was that compulsory vaccination would be considered unconstitutional, because of this conditional, and not final, marketing authorization which currently benefits all vaccines authorized by the European Medicines Agency. Would such a measure now be possible?
“What the Code of Public Health says is that this freedom, this consent has exceptions, such as the need to avoid spreading diseases”, explains Florence Chaltiel-Terral, professor of public law. However, the Constitutional Council having itself judged the health pass “balanced” in view of the health situation, the approval of the vaccination obligation remains possible. However, “there is not a single legal answer on this, since we do not have a text”, she underlines: the reasons which relate to the vaccination obligation are above all political and of course. , sanitary facilities.
Definitely authorize the vaccine or preach first and foremost the convinced
There remains one last unknown: is this final validation of the vaccine in the United States likely to convince the antivax? According to a US study by the Kaiser Family Foundation conducted in June, 32% of the unvaccinated in the country would be more likely to be vaccinated in the event of such validation. It nevertheless showed that two-thirds of adults believed that the Pfizer vaccine had already been definitively approved by the FDA, which was not the case at the time.
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For Tristan Mendès France, associate lecturer at Paris-Diderot University and specialist in digital cultures, a final authorization to market the Pfizer vaccine in Europe would only convince the convinced. “The anti-ax and conspiratorial posture in general is to try to use only data that goes in their direction. This will not change the posture of anti-ax distrust,” he says categorically. And the researcher to imagine the next conspiracy theories which could then arise: “Why this delay compared to the United States, why it is validated so late?”
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