COVID-19

Where is Sanofi’s Covid Vaccine, which was announced for December?

Question from Eliane, November 24.

After the failure of the French vaccine last winter, this summer he said he was about to take revenge: the president of Sanofi France, Olivier Bogillot, had announced its arrival on the market for the month of December. But if the end of the year has come, the Sanofi vaccine has not yet. So he asked us about the progress of Vidprevtyn, the product name developed by the pharmaceutical group in association with GSK.

According to Sanofi, the schedule advanced in early July by Olivier Bogillot is not compromised. “The schedule remains unchanged,” he is content to comment on the group. On the occasion of a press point on the vaccine campaign on Tuesday, the Ministry of Health had also raised the possibility of “a conditional marketing authorization (MMA) issued before the end of the year” and “first doses delivered in January 2022 “, suggesting that these elements had been communicated to him by the laboratory.

At this stage, the phase III clinical trial study, which began in May and is to evaluate efficacy and safety (no serious side effects), is still ongoing. “Its results will be published by the end of the year,” a Sanofi representative told CheckNews, adding: “As soon as the results of phase III are published, we will proceed with the regulatory submission to the competent regulatory authorities.”

Continuous assessment

Sanofi specifies that the European Medicines Agency (EMA) “continually examines data from [son] candidate for a vaccine ”. In fact, the latter had indicated on 20 July that its Committee for Medicinal Products for Human Use (CHMP) had just started an ongoing evaluation of the Sanofi Pasteur vaccine. This decision, the agency says, “is based on preliminary results of laboratory studies (non-clinical data) and early clinical studies in adults, which suggest that the vaccine […] it can help protect against disease ”.

Principle of this evaluation: consult “the data as they become available to decide whether the benefits outweigh the risks” and judge “Vidprevtyn’s compliance with the usual European standards of efficacy, safety and quality”. Four other vaccines are currently the subject of such a review: the American Novavax, the Russian Sputnik, the Chinese Sinovac and the French Valneva since Friday.

Contacted by CheckNews, the EMA refuses for the moment to comment on the data it has on the vaccine developed by Sanofi, but specifies that “continuous review will continue until there is sufficient evidence for a formal marketing authorization request.” Request “not yet received”. Asked about the expected date for submitting this request, Sanofi did not reply to us.

Production already launched

After the formal application is made, it will take some time for authorities to validate the Sanofi-GSK alliance vaccine. If the European Medicines Agency indicates that, under normal circumstances, this procedure takes up to 210 business days, the term should be shortened considerably, since Europe has decided to centralize the scientific evaluation of applications for marketing authorization in the medicine market, saving a few weeks. “Although the EMA cannot predict the overall timelines, the evaluation of a potential application should take less time than usual due to the work carried out during the ongoing review,” the agency stresses.

As examples, the marketing authorizations for Pfizer-BioNTech and Moderna, requested on November 30, 2020, were approved by the EMA on December 21, 2020 and January 6, 2021 respectively. In the process, AstraZeneca has made its request on January 12, before obtaining the agreement from the EMA on the 29th of the same month. The fourth and last vaccine authorized at the moment, Janssen was authorized on March 11, after being submitted for approval by European authorities on February 16.

Once the EMA has ruled in favor of an authorization, validation by the European Commission follows. If it is issued by the European executive, the MA “is valid in all the Member States of the European Union”, without the agencies of the different countries needing to carry out a new examination. Thus, regarding the previously authorized anti-Covid vaccines, “after the EMA agreement, it only happened a few hours before the validation by the Commission,” underlines the ANSM. Given that these vaccines respond to a “public health emergency” context, it is a conditional MA, granted for a renewable year, on the condition that the laboratories provide additional data to confirm the positive benefit-risk ratio of their vaccines. . In France, a final step will have to be taken with the advice of the Haute Autorité de santé (HAS).

By the time its vaccine is licensed, Sanofi claims to have taken the initiative by starting to drop doses. “We do not wait for the results of phase III and regulatory approvals to start production,” the laboratory representative told CheckNews. We have already started the production of our vaccine to meet the demand immediately once it is approved ”.

Booster vaccination

Therefore, the only certainty: the Sanofi vaccine will arrive at least a year behind its rivals. At the beginning of the vaccine race, the French had embarked on two vaccine projects using different technologies. The one based on messenger RNA (mRNA) was recently abandoned, and Pfizer-BioNTech and Moderna use the same technology. “There are many reasons to hope that sufficient quantities of Covid-19 mRNA vaccines are now available,” Sanofi writes on its site. The final candidate vaccine from the French laboratory includes an adjuvant based on a recombinant protein, a technology that has already been used to develop one of its sera against seasonal influenza.

One of the challenges is that this vaccine demonstrates its efficacy when given as a booster for a primary vaccination based on another vaccine. In fact, it is primarily intended to be used in the context of withdrawal campaigns, now open in France to all vaccinated adults. Faced with this “need expressed by governments”, the Sanofi Pasteur group therefore announces that it “proactively launched a study on booster vaccination”, “in parallel to the phase III study”. This work, details its representative in CheckNews, will make it possible to measure the ability of the vaccine to “provide a strong immune response during booster vaccinations, regardless of the platform used in the primary vaccination: messenger RNA or adenovirus.” [technologie employée pour les vaccins d’AstraZeneca et Janssen, ndlr]. Here too, the data is expected before the end of the year ”.

Consolidation of antibodies

In May, Sanofi highlighted the first results of phase II clinical trials, which were intended to be encouraging in terms of the level of protection conferred by the vaccine. The group argued that a vaccination with their product was accompanied by “the production of high concentrations of neutralizing antibodies in adults, all age groups combined, with seroconversion rates.” [phase d’apparition des anticorps, ndlr] between 95% and 100% ”.

Today, the laboratory also estimates that its vaccine would “very significantly strengthen the immune responses generated by the first vaccination” and that it would consolidate “the pre-existing neutralizing antibodies against the four main worrying variants of Sars-CoV-2 (alpha, beta, gamma and delta) “. But in the absence of precise figures from the studies, these claims remain impossible to substantiate.

Still, by the time the long-awaited vaccine arrives, the president of Sanofi France calls for vaccination with products already available on the market. In a message posted in August on the social network LinkedIn, Olivier Bogillot urged the French not to wait because that “only increases the risk and prolongs the circulation of the virus. The vaccines authorized by the health authorities are safe and effective ”.

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