The VidPrevtyn® Beta vaccine from Sanofi-GSK showed a good immune response against BA4-BA5 variants and 100% efficacy on severe forms of Covid and hospitalizations. The HAS recommends its use as a booster in adults in France.
[Mis à jour le 12 décembre 2022 à 10h00] In a context of epidemic resumption, the High Authority for Health (HAS) has issued a favorable opinion about the use of the new vaccine VidPrevtyn® Beta from Sanofi/GSK in adults as a reminder “to complete the arsenal to fight the virus and offer an alternative to the bivalent mRNA vaccines already available and recommended for the booster, in particular for people reluctant to this type of vaccine and people for whom they are contraindicated“. The results of the CoviBoost study demonstrated a good immune response against BA4/5 variants with this vaccine. Although still limited, these data make it possible to envisage the use of this vaccine as a booster in people over the age of 18, regardless of the vaccine used in primary vaccination. The callback is “the best weapon“, according to the HAS for “protect people at risk of a severe form of the disease and must be carried out without delay by people over 60, those with comorbidities, pregnant women and people who accompany them on a daily basis, including healthcare professionals“. On November 10, 2022, the European Commission granted a marketing authorization (AMM) for the adjuvanted vaccine VidPrevtyn® Beta from Sanofi/GSK, made from Spike (S) protein recombinant SARS-CoV-2and administered intramuscularly according to a vaccination schedule ofa single booster dose. It is expected that orders for this vaccine will be possible in France from mid-December 2022. The results of the phase 3 of their clinical trial had shown that two doses of the Sanofi-GSK vaccine confer 100% effectiveness against severe forms of Covid and hospitalizations, 75% effectiveness against moderate to severe forms and an efficacy of 58% against all symptomatic forms of Covid.
What is the name of the Sanofi-GSK vaccine?
The vaccine developed by Sanofi-Pasteur and GSK is called Vidprevtyn® or VidPrevtyn® Beta.
What is the principle of the Sanofi-GSK vaccine?
The Sanofi/GSK vaccine is a vaccine with recombinant protein adjuvant. Sanofi provides its recombinant antigen and GSK its adjuvant for pandemic use. A recombinant protein vaccine is a vaccine that injects a protein from the virus 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 in particular what allows the coronavirus to enter human cells, including those of the lungs). It’s the principle of some seasonal flu vaccines and hepatitis B vaccine. Adjuvants increase the immunizing potency of the vaccine. “Our recombinant technology is recognized and mastered because we use 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.
How many doses for the Sanofi-GSK vaccine?
The Sanofi vaccine is administered as a booster dose after a primary vaccination with the other Covid vaccines (Pfizer, Moderna, AstraZeneca, Janssen).
Is the Sanofi-GSK vaccine possible as a booster?
Yes, precisely, the VidPrevtyn® Beta vaccine from Sanofi/GSK is to use in second intentiontherefore according to a vaccination schedule ofa single booster dose of adults from the age of 18, reports the HAS in an opinion of December 8, 2022.
When can the Sanofi-GSK vaccine be administered?
► November 10, 2022, the European Commission granted marketing authorization (MA) to the VidPrevtyn® Beta adjuvanted vaccine from Sanofi/GSK, made from the recombinant Spike (S) protein of SARS-CoV-2, and administered intramuscularly according to a vaccination schedule of a single booster dose. It is expected that orders for this vaccine will be possible in France from mid-December 2022.
► December 8, 2022the High Authority for Health issued a favorable opinion on the use of the Sanofi/GSK vaccine only recall in adults. “This vaccine is to be used in second intention, since the HAS maintains its recommendation to preferentially use bivalent mRNA vaccines, regardless of the vaccines used previously.
What are the differences with other vaccines?
► The vaccine developed by Sanofi in partnership with GSK is an adjuvanted vaccine based on recombinant protein, a proven technology that allows the industrial production of very large amounts of antigensthe proteins injected to boost 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 also already proven.
How effective is the Sanofi-GSK vaccine?
As part of the phase III clinical trial, the vaccine against COVID-19 was administered to 722 adults to assess the safety, reactogenicity and immunogenicity of two doses and to determine the optimal booster dose. “The results showed a strong immune response in terms of neutralizing antibodies, with a seroconversion of the order of 95% to 100% after the second injection, in all age groups (18 to 95 years) and for all doses.” The Sanofi-GSK vaccine was well tolerated in both young and older subjectsand no safety signal was observed. The final analysis of the data from the phase 3 study confirmed the universality of the vaccine candidate as a booster dose, regardless of the vaccine administered in the primary series (RNA like Pfizer/Moderna or adenovirus like AstraZeneca, editor’s note)with a multiplication from 18 to 30 times neutralizing antibodies. The phase 3 efficacy study demonstrated that two doses of the Sanofi-GSK vaccine in the seronegative population conferred:
- an efficiency of 100% against severe forms of Covid-19 and hospitalizations
- an efficiency of 75% against moderate to severe forms of Covid-19
- an efficiency of 57.9% against all symptomatic forms of Covid-19comparable to the efficacy of vaccines already available, in an environment dominated by many variants.
What are the side effects of the Sanofi-GSK vaccine?
According the European Medicines Agency (EMA)the most common side effects seen with VidPrevtyn Beta in the studies were:
- pain at the injection site,
- headaches,
- muscle or joint pain,
- a feeling of general malaise
- chills.
These were usually benign and disappeared for a few days after vaccination.
Unlike Pfizer’s messenger RNA vaccine, which must be stored at -70°C, the recombinant protein-based adjuvanted 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.
What is the price of the Sanofi-GSK vaccine?
The lab announces a price of less than 10 euros per dose.
Interview on January 25, 2021.
Sources:
VidPrevtyn® Beta, the new generation booster vaccine against COVID-19 from Sanofi and GSK, approved by the European Commission, November 10, 2022
Sanofi and GSK will seek regulatory approval for their COVID-19 vaccine. February 23, 2022.
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 candidate vaccine against COVID-19. May 27, 2021.
Phase II trial of Sanofi and GSK’s COVID-19 vaccine candidate induces 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.