No, the AP-HP does not conduct an illegal clinical trial on the third dose of the vaccine

While the Covid-19 epidemic has experienced a resurgence in France in recent weeks, the Assistance publique-Hôpitaux de Paris (AP-HP) is reportedly carrying out questionable clinical trials on its caregivers. At least if we are to believe the virulent message of a Twitter user, published on December 8.

“Quietly, without anyone being shocked, the AP-HP is therefore carrying out a clinical trial on the 3rd dose of these [vaccins], which are however already compulsory for its caregivers. A trial, in the phase 3 trial, therefore. How is it possible ? Who are we laughing at ? “, She affirms, by illustrating her remarks of the screenshot of a tweet of the AP-HP evoking the” beginning of the inclusions of the COVIBOOST trial “for the” booster doses “of the vaccines against the Covid-19.

Quietly, without anyone being shocked, the AP-HP is therefore conducting a clinical trial on the 3rd dose of these ????, which are however already compulsory for its caregivers.
One trial, in the phase 3 trial, so ????
How is it possible ?
Who are we laughing at ? pic.twitter.com/lXLmHlzjHe

– Pinsolle Typhaine (@PinsolleT) December 8, 2021

If this tweet from the Ile-de-France hospital establishment is authentic, the interpretation made by this Internet user – and many others on Facebook – suggests that this test concerns caregivers and that it would take place outside any legal framework.

FAKE OFF

Reading the press release relayed in
the tweet of the AP-HP helps to clarify this confusion. “The Coviboost trial aims to study the immune response of the two candidate vaccines based on recombinant protein associated with an adjuvant developed by Sanofi Pasteur and GSK and that of a 3rd dose of the Pfizer-BioNTech vaccine”, explains the AP- HP.

The hospital group further specifies that this trial concerns in particular “300 participants who had previously received two doses of the Pfizer-BioNTech vaccine (2nd dose received within 5 to 7 months) and without a history of Covid-19”, of which “half [est] aged 65 and over ”.

These volunteers must receive “randomly as a booster dose: the mRNA vaccine from Pfizer-BioNTech (Comirnaty) [ou] the adjuvanted recombinant protein vaccine from Sanofi-Pasteur / GSK based on the original strain of the virus [ou] the adjuvanted recombinant protein vaccine from Sanofi-Pasteur / GSK based on the Beta variant ”.

Potential advantages “in terms of efficiency and safety”

And if “this randomized double-blind trial, promoted by the Assistance Publique-Hôpitaux de Paris, [est] led [à compter du 8 décembre] in eleven hospital centers in the Covireivac network coordinated by Inserm, ”the AP-HP 20 Minutes that “nine of these centers do not fall under the AP-HP”.

As the Covireivac platform, dedicated to people volunteering for anti-Covid-19 vaccine tests, indicates, “the administration of a 3rd dose of a different vaccine could […] present advantages in terms of efficiency and safety, but also in terms of cost and acceptability ”.

“The data from the trial will make it possible to measure the immune response induced by the three vaccines studied as a booster, and its effectiveness on the different variants but also its persistence at 3 and 12 months, depending on age”, adds t -she, stressing that “the participation of people 65 years old [et plus] is particularly important to include the age component ”.

Covireivac finally specifies that “clinical trials are regulated” and cannot begin, in France, “without first having received a favorable opinion from the committee for the protection of persons and an authorization from the National Agency for the Safety of Medicines and Medicinal Products. health (ANSM) ”.