The first doses of the Sanofi / GSK recombinant protein vaccine have already been produced. But when will they finally hit the market? And above all, will they find their audience and their place in the vaccination strategy of the States? Already well behind their competitors, the two laboratories had indicated that they would present the results of the last phase of their clinical trial before the end of this year. Unfortunately … they had to announce a new change in this calendar “to the first quarter of 2022”.
The current test is divided into several parts. The first aims to evaluate the effectiveness of the injection as a primary vaccination, in people who are not yet exposed to the virus. It seems that it has been difficult to carry out … “We could anticipate it, because it is more difficult to find volunteers when the first effective vaccines are already on the market”, underlines Professor Alain Fischer, President of the Vaccine Strategy Guidance Council , and member of the Scientific Committee for Covid-19 Vaccines. The participants were “mostly” recruited in the third quarter, but Sanofi and GSK say they still lack the data to request approval from health authorities.
Even if the two laboratories want to be reassuring, doubts remain about the performance that this vaccine will be able to show against the variants circulating today. Sanofi and GSK are currently testing two versions of their product, but they were built for one by including only the Spike protein from the original strain of the virus that emerged in Wuhan, China, to which the peak of the variant was added for the second formulation. Beta. . In other words, viruses that have almost disappeared since Delta became dominant.
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This dark setting for the lab
This first step, however, turns out to be an essential prerequisite to be able to submit the application for approval of the vaccine for use as a booster dose, after a first vaccination with other products. A strategic bet for the laboratory, which had to witness the passage of the train of the first wave of injections in developed countries. This use as a “booster” is the subject of the other part of the ongoing clinical trial, which appears to be more advanced. The different versions of the vaccine have been tested as a third dose after all currently licensed vaccines in Europe: Pfizer / BioNTech, Moderna, Johnson & Johnson, AstraZeneca.
With, here, “positive preliminary data”, according to the press release issued by the two companies. Its vaccine candidate would have made it possible to “obtain strong immune responses”, with “a multiplication of the order of 9 to 43 of neutralizing antibodies, whatever the vaccine received in the first vaccination, in all the age groups studied”. Results that seem interesting “but that need to be confirmed by more precise data”, emphasizes Pr Fischer. “The figures reported at the moment do not allow to draw a conclusion, because we do not know the point of comparison. Is it just before the recall, when the antibody titers (amounts, editor’s note) are at their lowest level, or when the Antibodies are at their highest point, a month after the second injection? It’s not the same at all, “asks the professor.
If Sanofi ends up successfully passing the last stages, this information will be closely scrutinized by States, eager to propose the most effective withdrawals. Only Pfizer / BioNtech and Moderna are currently licensed as drivers in France, but other products should arrive very soon. Thus, the European Medicines Agency has just declared that the Johnson & Johnson vaccine can now be used as a third dose within the European Union, after a first vaccination with the same product, or with Pfizer and Moderna. In addition, a group of British researchers carried out a phase 2 study aimed at booster testing seven vaccines already on the market or under test (Pfizer, Moderna, AstraZeneca, Novavax, Valneva and Curevac). While this study does not bode well for phase 3 results, it has shown that all of these combinations have a good tolerance profile and good immune responses. Therefore, the competition promises to be tough for Sanofi.
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And that’s not the least of the challenges Sanofi and GSK will have to face. “It’s always good to have a variety of vaccines, says Professor Fischer. But the third dose campaign will probably be well advanced in Europe by the time your product arrives. So it will all depend on how often we get the vaccine. We need reminders in the future”. . If a third dose turns out to be sufficient, Sanofi and GSK will only be able to rely on emerging countries to market their product. Even darker scenario for both labs: that you need to have a suitable vaccine for the Omicron variant, even for booster shots. In this case, the two laboratories would be forced to adapt their product. “It is possible, of course. But Moderna and Pfizer / BioNtech are already working on it. The synthesis of the RNA sequence does not take long, and then the production of a messenger RNA vaccine is faster than that of a RNA vaccine. protein, “explains Professor Fischer. Sanofi and GSK would be outmatched once again.
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