VidPrevtyn® Beta COVID-19 Vaccine
The Vidprevtyn® (VAT00002, VAT00008) protein-based vaccine combines innovative technologies from Sanofi-GSK to produce an adjuvanted recombinant protein-based COVID-19 vaccine. Combining a protein-based antigen and an adjuvant is a well-established vaccine technology. When a person is given VidPrevtyn® Beta, their immune system identifies the protein as foreign and produces antibodies and T cells against it. If, later on, the vaccinated person comes into contact with the SARS-CoV-2 betacoronavirus, the immune system recognizes the spike protein on the virus and is prepared to attack it. The antibodies and immune cells can protect against COVID-19 by working together to kill the virus, prevent its entry into the body's cells, and destroy infected cells.
Sanofi Pasteur is contributing its S-protein COVID-19 antigen based on recombinant DNA technology. This Sanofi technology has produced an exact genetic match to proteins found on the surface of the SARS-CoV-2 coronavirus. In addition, the DNA sequence encoding this antigen has been combined into the baculovirus expression platform's DNA, based on Sanofi's licensed recombinant influenza Flublok product in the USA. GSK contributed to its proven adjuvant technology. An adjuvant is added to some vaccines to enhance the immune response and has been shown to create a more robust and longer-lasting immunity against infections than the vaccine alone.
On July 31, 2020, the U.S. government stated it would provide up to $2.1 billion for development, including clinical trials, manufacturing scale-up, and delivery of an initial 100 million doses. The vaccines intended for the USA will be produced in Sanofi's Swiftwater, PA facility. In addition, the U.S. government can further discuss purchasing up to 500 million doses long-term.
Sanofi and GSK announced that on December 11, 2020, a Phase 1/2 study showed an immune response comparable to patients who had recovered from COVID-19 in adults aged 18 to 49 but a lower immune response in older adults, likely due to an insufficient antigen concentration. On May 17, 2021, the companies confirmed that 'The Phase 2 interim results showed 95% to 100% seroconversion following a second injection in all age groups (18 to 95 years old) and across all doses, with acceptable tolerability and no safety concerns.
The EMA confirmed on July 20, 2021, that the CHMP committee started a rolling Vidprevtyn review. In the VAT0008 Phase 3 primary series trial, two doses of the Sanofi-GSK vaccine in seronegative populations demonstrated 100% efficacy against severe COVID-19 disease and hospitalizations, 75% efficacy against moderate or severe COVID-19 disease, 57.9% efficacy against any symptomatic COVID-19 disease, in line with expected vaccine effectiveness in today's environment dominated by variants of concern, as of Feb. 23, 2022. The companies announced on November 10, 2022, VidPrevtyn® Beta was approved by the European Commission. This is the first protein-based adjuvanted COVID-19 booster approved in Europe.
Additionally, on February 23, 2022, the companies announced that we intend to submit data from both booster and Phase 3 efficacy trials as the basis for regulatory applications for a COVID-19 vaccine. To evaluate the immunogenicity of the Sanofi-GSK vaccine as a booster, human immune sera samples were tested by Monogram Biosciences, located in San Francisco, CA, using an FDA-approved standardized pseudovirus neutralization test against the D614G prototype virus. On June 13, 2022, the results of the COVIBOOST study found that the booster vaccine candidate delivers an immune boost in adults primed with mRNA vaccines, with a stronger immune response than the Comirnaty booster vaccine.
On September 13, 2023, The Lancet Respiratory Diseases published the results from the efficacy of a bivalent (D614 + B.1.351) SARS-CoV-2 recombinant protein vaccine with AS03 adjuvant in adults: a phase 3, parallel, randomized, modified double-blind, placebo-controlled trial. The bivalent variant vaccine conferred protection (estimated 75.1% effective against symptomatic COVID-19 among previously infected people and 30.9% among those never-infected amid Omicron variant predominance. No adverse event of special interest, serious adverse event, or death was deemed treatment-related. There were no reported cases of thrombosis with thrombocytopenia syndrome, myocarditis, pericarditis, Bell's Palsy, Guillain–Barré syndrome, or other immune-mediated diseases. The funding for this study came from Sanofi, the US Biomedical Advanced Research and Development Authority (BARDA), and the US National Institute of Allergy and Infectious Diseases. In an associated Commentary, Keith Chappell, Ph.D., of the University of Queensland in Australia, wrote, 'The findings from this trial provide important new insights while bolstering existing knowledge of vaccine-mediated protection against COVID-19.'
In collaboration with the U.S. Department of Defense Joint Program Executive Office for Chemical, Biological, Radiological, and Nuclear Defense under Contract # W15QKN-16-9-1002, Federal U.S. funds from the BARDA supported VidPrevtyn® Beta research. DrugBank Accession Number: DB16427; ATC code J07BX03.
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VidPrevtyn® Beta Availability
France's Haute Autorite de Sante issued authorization for VidPrevtyn® Beta on December 8, 2022. The U.K.'s Medicines and Healthcare products Regulatory Agency (Wales) approved VidPrevtyn® on December 21, 2022.
VidPrevtyn® Beta Indication
Sanofi - GSK Vidprevtyn vaccine is indicated to prevent SARS-CoV-2 betacoronavirus infection, leading to COVID-19 in humans.
VidPrevtyn® Beta Variants of Concern
To broaden protection against circulating and emerging SARS-CoV-2 variants, several variant-containing vaccines have been authorized for use as booster vaccines, including the monovalent Sanofi-GSK Vidprevtyn Beta (a Beta variant containing protein-based vaccine), wrote The Lancet Regional Health Europe on March 31, 2023. The monovalent Beta protein-based vaccine with AS03 adjuvant (Vidprevtyn Beta), as a heterologous booster, also induced consistently higher neutralizing antibody response against Omicron BA.1 than BNT162b2, with a GMT ratio of 2.53 (95% CI [1.80, 3.57]) at day 28. Beta variant containing booster vaccines could induce high cross-reactive immune responses against Omicron BA.1, which probably resulted from K417N, E484K, and N501Y substitutions in the Beta variant spike.
On June 24, 2022. Sanofi and GSK announced positive data that evaluated an adjuvanted bivalent D614 and Beta (B.1.351), the first vaccine candidate to demonstrate efficacy in a placebo-controlled trial in an environment of high Omicron variant circulation. In Stage 2 of the Phase 3 COVID-19 vaccine trial VAT00008 of more than 13,000 adults, the Sanofi-GSK Beta-containing vaccine candidate demonstrated an efficacy of 64.7% against symptomatic COVID-19 and 72% efficacy in Omicron-confirmed symptomatic cases (sequencing was performed. The vaccine candidate also showed a favorable safety and tolerability profile. On June 13, 2022, the next-generation booster vaccine candidate demonstrated the potential to protect against COVID-19 VoCs, including Omicron BA.1 and BA.2.
VidPrevtyn® Beta Dosage
The Lancet reported on September 13, 2023, that The efficacy-evaluable population after dose 2 comprised 11 416 participants (5736 in the vaccine group and 5680 in the placebo group). The median duration of follow-up was 85 days (IQR 50–95) after dose 1 and 58 days (29–70) after dose 2. 121 symptomatic COVID-19 cases were reported at least 14 days after dose 2 (32 in the vaccine group and 89 in the placebo group), with an overall vaccine efficacy of 64·7% (95% CI 46·6 to 77·2). Vaccine efficacy against symptomatic COVID-19 was 75·1% (95% CI 56·3 to 86·6) in SARS-CoV-2 non-naive participants and 30·9% (–39·3 to 66·7) in SARS-CoV-2-naive participants. Viral genome sequencing identified the infecting strain in 68 (56·2%) of 121 cases (omicron [BA.1 and BA.2] in 63; delta in four; and both omicron and delta in one).
The randomized, double-blind, multi-center-dose-ranging phase 2 study was conducted in healthy adults aged 18 years of age and older, including those with high-risk medical conditions, to evaluate the safety, reactogenicity, and immunogenicity of two injections given 21 days apart, with three antigen dose levels of 5, 10 and 15 µg.
VidPrevtyn® Beta Side Effects
The phase 3 clinical trial (VAT00008) results identified immediate unsolicited adverse events reported by four (<0·1%) participants in the vaccine group and seven (0·1%) participants in the placebo group. Immediate unsolicited adverse reactions within 30 min after any injection were reported by four (<0·1%) participants in the vaccine group and six (<0·1%) participants in the placebo group. In the reactogenicity subset with available data, solicited reactions (solicited injection-site reactions and solicited systemic reactions) within seven days after any injection occurred in 1398 (57·8%) of 2420 vaccine recipients and 983 (40·9%) of 2403 placebo recipients. Grade 3 solicited reactions were reported by 196 (8·1%; 95% CI 7·0 to 9·3) of 2420 vaccine recipients and 118 (4·9%; 4·1 to 5·9) of 2403 placebo recipients within seven days after any injection, with comparable frequencies after dose one and dose 2 in the vaccine group. At least one serious adverse event occurred in 30 (0·5%) participants in the vaccine group and 26 (0·4%) in the placebo group. The proportion of adverse events of special interest and deaths was less than 0·1% in both study groups. No adverse event of special interest, serious adverse event, or death was deemed treatment-related.
CoV2 preS dTM-AS03 Booster Vaccine
A Sanofi and Biomedical Advanced Research and Development Authority-funded phase 3 clinical trial determined in July 2023 that CoV2 preS dTM-AS03 boosters demonstrated acceptable safety and elicited robust neutralizing antibodies against multiple variants, regardless of the priming vaccine.
VidPrevtyn® Beta News
September 13, 2023 - In this phase 3 trial evaluating a bivalent vaccine containing both the ancestral (D614) and beta (B.1.351) variant S protein as a primary series during a period of predominant omicron (BA.1 and BA.2) circulation, the primary objective was met in all participants, demonstrating efficacy against symptomatic COVID-19 higher than 50%, with a lower bound of the 95% CI higher than 30%.
November 29, 2022 - The Austrian National Vaccination Panel updated its recommendations on COVID-19 vaccination to include VidPrevtyn® Beta.
November 10, 2022 - After the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for VidPrevtyn® Beta, the European Commission approved the vaccine as a booster for the prevention of COVID-19 in adults 18 years of age and older. Shipments of VidPrevtyn Beta are ready to be distributed to European countries as per Advance Purchase Agreements.
June 24, 2022 - GSK plc and Sanofi announced positive data from their vaccine trial, which evaluated an adjuvanted bivalent D614 and Beta (B.1.351) vaccine candidate. Sanofi-GSK's vaccine is the first candidate to demonstrate efficacy in a placebo-controlled trial in an environment of high Omicron variant circulation.
June 13, 2022 - Sanofi reported data from two trials, VAT02 Cohort 2 and COVIBOOST VAT013, conducted with its new next-generation COVID-19 booster vaccine candidate modeled on the Beta variant antigen and including GSK's pandemic adjuvant. Next-generation booster vaccine candidate demonstrates the potential to protect against COVID-19 variants of concern, including Omicron BA.1 and BA.2, with a favorable safety and tolerability profile.
March 30, 2022 - The Paul-Ehrlich-Institut, an Agency of the German Federal Ministry of Health, confirmed the Committee for Medicinal Products for Human Use (CHMP) at the EMA started the evaluation procedure on 30 March 2022 for the conditional marketing authorization application submitted by Sanofi Pasteur for the protein-based SARS-CoV-2 vaccine Vidprevtyn. The EMA began its rolling review on 20 July 2021.
February 23, 2022 - Sanofi and GSK announced that they intend to submit data from their booster and Phase 3 efficacy trials as the basis for regulatory applications for a COVID-19 vaccine.
December 15, 2021 - Sanofi and GSK announced their jointly developed booster vaccine showed neutralizing antibodies increased 9- to 43-fold regardless of the primary vaccine received (AstraZeneca, Johnson & Johnson, Moderna, Pfizer/BioNTech) and was found well tolerated, with a safety profile similar to currently approved COVID-19 vaccines.
September 28, 2021 - Sanofi announced it continues its efforts to fight against the COVID-19 pandemic with its adjuvanted recombinant protein candidate vaccine, developed in partnership with GSK. In parallel to its ongoing Phase 3 efficacy and safety study, Sanofi has expanded its development program to analyze and research the vaccine as a potentially broadly protective booster to address evolving public health needs.
September 21, 2021 - A non-peer-reviewed study findings show that the vaccine candidates used as a booster have the potential to offer cross-protection against a broad spectrum of variants. This has important implications for vaccine control of SARS-CoV-2 variants of concern and informs on the benefit of a booster with our vaccine candidates currently under evaluation in phase 2 and 3 clinical trials (NCT04762680 and NCT04904549).
August 7, 2021 - The online journal Springer published a 'Rolling review of COVID-19 vaccine Vidprevtyn by EMA. The study will continue until the CHMP decides that sufficient data are available for a formal marketing authorization application. EMA will assess the compliance of Vidprevtyn with the usual E.U. standards for effectiveness, safety, and quality.
July 20, 2021 - The European Medicines Agency confirmed the human medicines committee had started a rolling review of Vidprevtyn, a COVID-19 vaccine developed by Sanofi Pasteur. The CHMP's decision to start the rolling review is based on preliminary results from laboratory studies (non-clinical data) and early clinical studies in adults, which suggest that the vaccine triggers the production of antibodies that target the SARS-CoV-2 coronavirus that causes COVID-19 and may help protect against the disease.
July 8, 2021 - Sanofi and GSK received approval for their Phase 3 clinical study in India to assess the safety, efficacy, and immunogenicity of their adjuvanted recombinant-protein COVID-19 vaccine candidate. The global, randomized, double-blind Phase 3 study will include more than 35,000 volunteers aged 18 and older across the USA, Asia, Africa, and Latin America.
May 27, 2021 - Sanofi and GSK announced they started enrollment in their Phase 3 clinical study to assess the safety, efficacy, and immunogenicity of their adjuvanted recombinant-protein COVID-19 vaccine candidate. The global, randomized, double-blind, placebo-controlled Phase 3 study will include over 35,000 volunteers aged 18 and older from several countries, including the US, Asia, Africa, and Latin America sites. The study's primary endpoint is the prevention of symptomatic COVID-19 in SARS-CoV-2 naïve adults, with secondary endpoints preventing severe COVID-19 disease and the prevention of asymptomatic infection.
May 17, 2021 - Sanofi and GSK announced the adjuvanted recombinant COVID-19 vaccine candidate achieved strong rates of neutralizing antibody responses, in line with those measured in people who have recovered from COVID-19 in all adult age groups in a Phase 2 study with 722 volunteers. Pending positive Phase 3 outcomes and regulatory reviews, the vaccine is expected to be approved in the fourth quarter of 2021.
March 11, 2021 - A non-peer-reviewed study reported: 'sera from 501Y.V2-infected patients also neutralized the 501Y.V3 (P.1) variant first described in Brazil and now circulating globally. These data suggest that the antibody response in patients infected with 501Y.V2 has broad specificity and that vaccines designed with the 501Y.V2 sequence may elicit more cross-reactive responses.'
February 21, 2021 - Sanofi and GSK have initiated a phase 2 study to determine the appropriate dosage of their adjuvanted recombinant protein vaccine. The trial will include healthy adults 18 to 59 and an equal number of those adults over 60 years and older.
December 11, 2020 - Sanofi and GSK announce a delay in their adjuvanted recombinant protein-based COVID-19 vaccine program to improve older adults' immune response. Phase 1/2 study interim results showed an immune response comparable to patients who recovered from COVID-19 in adults aged 18 to 49 but a low immune response in older adults, likely due to insufficient antigen concentration. Sanofi and GSK adjuvanted recombinant protein-based vaccine candidate was selected in July 2020 by the U.S. government's Operation Warp Speed to accelerate its development and manufacturing.
December 3, 2020 - Sanofi vaccines chief Thomas Triomphe said 'the company will announce the price of the potential COVID-19 vaccine developing with Britain's GlaxoSmithKline after it has released Phase I/II results of the trials. The company is expected to release the Phase I/II clinical trials this month (December).'
October 28, 2020 - Sanofi and GSK announced they intend to make available 200 million doses of their adjuvanted recombinant protein-based COVID-19 vaccine if approved by regulatory authorities and subject to contract, to the COVAX Facility.
September 22, 2020 - Sanofi and GSK announced agreements with the Government of Canada to supply up to 72 million doses of an adjuvanted COVID-19 vaccine beginning in 2021. The Companies initiated a Phase 1/2 study on September 3, with 440 subjects being enrolled. They anticipate the first results in early December 2020 to support initiating a pivotal Phase 3 study before the end of the year.
September 17, 2020 - Sanofi and GSK finalized an agreement with the European Commission to supply up to 300 million doses of a COVID-19 vaccine once the vaccine is approved. This final agreement confirms both companies' announcement on July 31, 2020, and marks a key milestone in protecting European populations against COVID-19. The contract will allow the purchase of a vaccine against COVID-19 for all Member States of the European Union (E.U.)
September 3, 2020 - Sanofi and GSK announced the Phase 1/2 clinical trial for their adjuvanted COVID-19 vaccine. The vaccine candidate, developed in partnership with Sanofi and GSK, uses the same recombinant protein-based technology as Sanofi's seasonal influenza vaccines with GSK's established pandemic adjuvant technology.
August 4, 2020 - Sanofi confirmed its upcoming venture to develop a COVID-19 vaccine with fellow pharmaceutical giant GlaxoSmithKline and the United States government, including plans to manufacture at Sanofi's Swiftwater, PA location. The company is building up its industrial capabilities to manufacture up to one billion doses a year, some of which will be done locally. "Our Swiftwater facility will conduct finish and fill for the U.S. doses."
July 31, 2020 - Sanofi and GSK announce a collaborative effort with the U.S. government to accelerate developing and manufacturing a COVID-19 recombinant protein-based vaccine. The U.S. government will provide up to $2.1 billion, more than half supporting further vaccine development, including clinical trials. The remainder is used to manufacture scale-up and deliver 100 million vaccine doses.
July 29, 2020 - Sanofi and GSK announced an agreement, subject to a final contract, with the U.K. government to supply up to 60 million doses of a COVID-19 vaccine. Sanofi, the vaccine candidate, in partnership with GSK, is based on the recombinant protein-based technology used by Sanofi to produce an influenza vaccine and GSK's established pandemic adjuvant technology. Ongoing discussions with the European Commission, France, and Italy on the negotiation team and other governments ensure global access to a novel coronavirus vaccine.
June 23, 2020 - Sanofi S.A. said it expects to get approval for the potential COVID-19 vaccine developing with Britain's GlaxoSmithKline Plc. by the first half of 2021, faster than previously anticipated.
May 13, 2020 - Sanofi's Chief Executive Officer Paul Hudson said in an interview with Bloomberg News, 'he warned that Europe risks falling behind unless it steps up efforts to seek protection against a pandemic that's killed more than 290,000 people worldwide.'
April 14, 2020 - Sanofi and GSK announced that they had signed a letter of intent to develop an adjuvanted vaccine for COVID-19, using innovative technology from both companies to address the ongoing pandemic.
February 18, 2020 - David Loew, Sanofi's global head of vaccines, announced the company would partner with the U.S. Biomedical Advanced Research and Development Authority—known as BARDA—to make a vaccine using the company's recombinant DNA platform.
Sanofi-GSK COVID-19 Vaccine (Vidprevtyn) Clinical Trials
The Sanofi and GSK adjuvanted recombinant COVID-19 vaccine candidate Vidprevtyn achieved strong rates of neutralizing antibody responses, in line with those measured in people who have recovered from COVID-19 in all adult age groups in a Phase 2 study with 722 volunteers. A global pivotal Phase 3 study is expected to start in the coming weeks.
The companies plan to initiate a global Phase 3, randomized, double-blind study with the ten µg dose, combined with GSK's pandemic adjuvant, in the coming weeks. This Phase 3 trial will enroll more than 35,000 adult participants from various countries. It will assess the efficacy of two vaccine formulations, including the D614 (Wuhan) and B.1.351 (South African) variants.
