Sanofi Covid vaccine: effective as a booster, for 2022?

[Mis à jour le 15 décembre 2021 à 16h33] Reviewed since July 2021 by theEMA, the candidate vaccine against Covid “Vidprevtyn “ developed by Sanofi Pasteur and GSK will not be released at the end of 2021 As announced. This vaccine with adjuvant based on recombinant protein is eagerly awaited by scientists in “booster” dose. In one communicated of December 15, the laboratory announces the intermediate results of his phase III trial initiated at the end of May 2021. “These preliminary data show that we have a strong booster vaccine candidate, regardless of the vaccine administered as a primary vaccination (to RNA like Pfizer / Moderna or to adenovirus like AstraZeneca, editor’s note) “, declared Thomas Triomphe, Executive Vice-President of Sanofi Pasteur. Preliminary results show a multiplication of the order of 9 to 43 of neutralizing antibodies, regardless of the vaccine received as a primary vaccination (AstraZeneca, Johnson & Johnson, Moderna, Pfizer / BioNTech), in all age groups studied. “The booster vaccine has been well tolerated, with a safety profile similar to that of currently approved COVID-19 vaccines. It is the most comprehensive study to date on a booster vaccine technology different from the technologies used. in primary vaccination “ underline Sanofi and GSK. The Independent Data Monitoring and Monitoring Committee (DSMB) recommends the continuation of the test until the beginning of 2022 in order to collect more data. The results are expected at first trimester. The study is continuing at different sites in several countries, including the United States, France and the United Kingdom. “The Omicron variant was not in circulation at the time of the study. Trials analyzing sera from study participants are underway to assess the ability of the adjuvanted recombinant vaccine candidate to neutralize Omicron“ says Sanofi.

The vaccine developed by Sanofi-Pasteur and GSK is called Vidprevtyn.

►Sanofi announced positive interim results from the phase 3 trial on December 15. “These preliminary data show that we have a strong booster vaccine candidate, regardless of the vaccine administered as a primary vaccination (to RNA like Pfizer / Moderna or to adenovirus like AstraZeneca, editor’s note) “, declared Thomas Triomphe, Executive Vice-President of Sanofi Pasteur. Preliminary results show a multiplication of the order of 9 to 43 of neutralizing antibodies, regardless of the vaccine received as a primary vaccination (AstraZeneca, Johnson & Johnson, Moderna, Pfizer / BioNTech), in all age groups studied. “The booster vaccine has been well tolerated, with a safety profile similar to that of currently approved COVID-19 vaccines. It is the most comprehensive study to date on a booster vaccine technology different from the technologies used. in primary vaccination “ underline Sanofi and GSK. The primary endpoint of this ongoing, randomized, double-blind, placebo-controlled phase III trial is prevention of symptomatic forms of COVID-19 in adults who have never been infected with SARS-CoV-2, while its secondary endpoints are prevention of severe forms of COVID-19 and prevention of asymptomatic infection. The first part of this study aims to evaluate the effectiveness of a vaccine formulation containing the spike protein against the original (parent) D614 virus in more than 10,000 participants over the age of 18, randomized to receive either two doses of 10 μg of the vaccine or placebo, 21 days apart, at sites in the United States, Asia, Africa and Latin America. The second part of the study aims to evaluate a second bivalent formulation, adding the spike protein of the variant B.1.351 (Beta).

►Sanofi announced on May 27 the launch of the phase 3, final phase before a possible authorization on the European market. In this international phase III, randomized, double-blind, placebo-controlled study, more than 35,000 volunteers aged 18 and over will be recruited from various countries, including the United States and several countries in Asia, Africa and Latin America. The primary endpoint of the study is prevention of symptomatic forms of Covid-19 in adults never previously infected with SARS-CoV-2, while its secondary endpoints are prevention of severe forms and prevention of asymptomatic infection. The study will take place in two parts to evaluate vaccine formulations targeting, on the one hand, the original virus D.614 and, on the other hand, the variant B.1.351 (South African variant), in different countries where multiple variants of the virus circulate.

► May 17, 2021, Sanofi and GSK have published the results encouraging of their phase 2 trial launched in February 2021 from 722 volunteers recruited in the United States and Honduras, including as many adults aged 18 to 59 as 60 years and over. Their adjuvanted recombinant vaccine candidate induced the production of high concentrations of neutralizing antibodies in adults of all age groups (18 to 95 years), at levels comparable to those seen in people infected and recovered from COVID-19 infection, and with higher concentrations in younger adults (18 to 59 years). In participants previously infected with SARS-CoV-2, a single dose of the vaccine produced the production of high concentrations of neutralizing antibodies, underscoring the strong potential interest in its development for booster vaccination. These intermediate results show seroconversion in 95% to 100% of cases, after administration of a second dose, in all age groups (18 to 95 years) and for all doses studied, with a safety profile. acceptable and without raising any safety concerns. “The results of our phase II study confirm the potential role that this vaccine could play in the fight against this global health crisis, because we know that multiple vaccines will be necessary, especially since virus variants continue to emerge and the need for vaccines efficient and reminder, can be stored at normal temperatures, is more and more felt“, declared Thomas Triomphe, Executive Vice President and Global Head of Sanofi Pasteur.

On December 15, Sanofi and GSK reported that the results of their Phase 3 trial are expected to occur at first quarter 2022. Initially, Sanofi’s goal was to release its vaccine in fourth quarter 2021.

The vaccine injects the Spike protein of the Covid virus.

The Sanofi / GSK vaccine is a vaccine with adjuvant based on recombinant protein. Sanofi provides its recombinant antigen and GSK its adjuvant for pandemic use. A recombinant protein vaccine is a vaccine which injects a virus protein known as an immunogen (which triggers the immune system), in the case of the Covid vaccine the protein present on the surface of SARS-CoV-2; the spike protein (it is notably this which allows the coronavirus to enter human cells, including those of the lungs). It’s the principle of some seasonal influenza vaccines and hepatitis B vaccine. Adjuvants increase the immunizing power of the vaccine. “Our recombinant technology is recognized and mastered because we are using it as part of an influenza vaccine approved in 2016 in the US (Flublok) and in 2020 in Europe (Supemtek). GSK’s adjuvant is also a validated technology used in pandemic influenza vaccines “ underlines the spokesperson for Sanofi.

• The vaccine developed by Sanofi in partnership with GSK is a vaccine with adjuvant based on recombinant protein, a proven technology that makes it possible to industrially produce very large amounts of antigens, proteins injected to stimulate the immune system’s response against the virus.
• The Pfizer / BioNTech vaccine is a messenger RNA vaccine just like the Moderna vaccine. It is an innovative technique.
• AstraZeneca’s anti-Covid vaccine like that of Johnson & Johnson is a viral vector vaccine, a technique that has already been proven as well.

In his communicated of December 15, the laboratory unveiled the intermediate results of its phase III trial initiated at the end of May 2021. “These preliminary data show that we have a strong booster vaccine candidate, regardless of the vaccine administered as a primary vaccination (to RNA like Pfizer / Moderna or to adenovirus like AstraZeneca, editor’s note) “, declared Thomas Triomphe, Executive Vice-President of Sanofi Pasteur. Preliminary results show a multiplication of the order of 9 to 43 of neutralizing antibodies, regardless of the vaccine received as a primary vaccination (AstraZeneca, Johnson & Johnson, Moderna, Pfizer / BioNTech), in all age groups studied. The results in phase II showed seroconversion in 95% to 100% of cases, after administration of a second dose, in all age groups (18 to 95 years) and for all doses studied, with an acceptable safety profile and without raising security concerns.

“The immune response increases sharply after the second dose”

The Sanofi vaccine candidate would be administered in two doses as a primary vaccination or as a booster dose after a primary vaccination with the other Covid vaccines (Pfizer, Moderna, AstraZeneca, Janssen).

Unlike Pfizer’s messenger RNA vaccine which must be stored at, -70 ° C, the adjuvanted recombinant protein vaccine developed in partnership with GSK can be stored under the temperature conditions applicable to conventional vaccines, that is between + 2 ° C and + 8 ° C, and this thanks to the recombinant technology which allows a stable formulation.

The laboratory aims a price less than 10 euros per dose but we have to wait for a later confirmation. “We will be able to define the price once the optimized antigen formulation is finalized thanks to the results of the Phase 2b study. As previously agreed, the price will remain accessible and affordable for countries around the world.” specifies the spokesperson for Sanofi.

Interview on January 25, 2021.

Sources:

EMA starts rolling review of COVID-19 vaccine Vidprevtyn. 07/20/2021

Sanofi and GSK are starting an international Phase III study to assess the efficacy of their vaccine candidate against COVID-19. May 27, 2021.

The phase II trial of the candidate vaccine against COVID-19 from Sanofi and GSK induces a strong immune response in adults of all age groups. May 17, 2021. Sanofi. Press release

Sanofi and GSK initiate new Phase 2 study of their adjuvanted recombinant protein-based COVID-19 vaccine candidate. February 22, 2021.