Vidprevtyn COVID-19 Vaccine Description
The Sanofi - GSK Vidprevtyn protein-based vaccine candidate combines innovative technologies to produce an adjuvanted recombinant protein-based COVID-19 vaccine. Combining a protein-based antigen and an adjuvant is well-established and used in several vaccines.
Sanofi Pasteur is contributing its S-protein COVID-19 antigen based on recombinant DNA technology. This 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 product in the USA.
GSK has 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 and manufacturing scale-up and delivery of an initial 100 million doses. The vaccines intended for the USA will be produced in Sanofi's Swiftwater, Pennsylvania facility. In addition, the U.S. government has a further option to discuss purchasing up to 500 million doses long-term.
On October 28, 2020, Sanofi and GSK announced they initiated a Phase 1/2 study on September 3rd with 440 subjects enrolled and anticipated first results in early December 2020 to support forming a pivotal Phase 3 study before the end of 2020. If these data are sufficient for licensure application, it is planned to request regulatory approval from the first half of 2021.
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 years but a lower immune response in older adults, likely due to an insufficient concentration of the antigen.
On February 22, 2021, Sanofi and GSK announced the initiation of a new Phase 2 study with 720 volunteers aged 18 and over to select the most appropriate antigen dosage for Phase 3 evaluation of their adjuvanted recombinant protein COVID-19 vaccine candidate.
On May 17, 2021, the companies confirmed '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 with no safety concerns. Overall, the vaccine candidate elicited strong neutralizing antibody levels comparable to those generated by natural infection, with higher levels observed in younger adults (18 to 59 years old). In addition, after a single injection, high neutralizing antibody levels were generated in participants with evidence of prior SARS-CoV-2 infection, suggesting strong potential for development as a booster vaccine.'
"Our Phase 2 data confirm the potential of this vaccine to play a role in addressing this ongoing global public health crisis, as we know multiple vaccines will be needed, especially as variants continue to emerge and the need for effective and booster vaccines, which can be stored at normal temperatures, increases", said Thomas Triomphe, EVP and Global Head of Sanofi Pasteur, on May 17, 2021. "With these favorable results, we are set to progress to a global Phase 3 efficacy study. We look forward to generating additional data and working with our partners around the world to make our vaccine available as quickly as possible."
The Phase 3 study initiation follows the global interim Phase 2 results. The adjuvanted recombinant COVID-19 vaccine candidate achieved high neutralizing antibody responses in all adult age groups, with 95 to 100% seroconversion rates. In addition, after a single injection, high neutralizing antibody levels were also generated in participants with evidence of prior SARS-CoV-2 infection, suggesting strong potential for development as a booster vaccine.
The EMA confirmed on July 20, 2021, the CHMP committee had started a rolling review of Vidprevtyn. 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 SARS-CoV-2, the virus that causes COVID-19, and may help protect against the disease. The EMA will evaluate data as they become available to decide if the benefits outweigh the risks. The rolling review will continue until enough evidence is available for a formal marketing authorization application. When medicines are under rolling review, EMA's CHMP evaluates clinical trial data as soon as these become available until it decides there is enough evidence for the developer to apply for marketing authorization.
Federal funds supported the phase 2 study from the BARDA 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.
GSK is a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer. GSK is the leading manufacturer of vaccines globally.
Sanofi is dedicated to supporting people through their health challenges. "We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain, and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions."
Vidprevtyn COVID-19 Vaccine Indication
Sanofi - GSK Vidprevtyn vaccine candidate is indicated to prevent SARS-CoV-2 coronavirus infection, leading to COVID-19 in humans. Pediatric, oncology, and pregnancy vaccine efficacy verification are pending.
Vidprevtyn COVID-19 Vaccine - Variants of Concern
To address the emergence of variant strains, Sanofi Pasteur is developing monovalent and bivalent vaccines for use as a universal late booster and/or variant prime vaccines, which will be studied in three additional Phase 3 study cohorts that are added to the initial Phase 2 protocol cohorts. Supplemental Cohorts 1 and 2 will evaluate booster vaccine candidates and supplemental Cohort 3 will evaluate priming immunization with variant-containing vaccines.
Vidprevtyn COVID-19 Vaccine Dosage
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 3 antigen dose levels of 5, 10 and 15 µg.
Recently published preclinical data indicated the candidate has the potential to strongly boost immune responses following primary vaccination across multiple vaccine technology platforms and against a broad spectrum of variants of concern. The booster studies4 began this summer in the U.S., Australia, France, and the U.K. The first results are expected by the end of Q4 2021, stated Sanofi.
Vidprevtyn COVID-19 Vaccine News
September 28, 2021 - Sanofi announced it continues its efforts in the 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 include a study of the vaccine as a potentially broadly protective booster to address evolving public health needs. Last Update Posted: July 28, 2021.
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 review will continue until the CHMP decides that sufficient data are available for a formal marketing authorization application. Compliance of Vidprevtyn with the usual E.U. standards for effectiveness, safety, and quality will be assessed by EMA.'
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 more than 35,000 volunteers aged 18 and older from several countries, including sites in the US, Asia, Africa, and Latin America. 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. Collectively 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 years, but a low immune response in older adults likely due to an insufficient concentration of the antigen. 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 made 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 conduct manufacturing at Sanofi's Swiftwater PA, location. The company is currently 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 of which supports further development of the vaccine, including clinical trials. The remainder is used for manufacturing scale-up and delivery of an initial 100 million doses of the vaccine.
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. And, 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.
Vidprevtyn COVID-19 Vaccine 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 10µg dose, combined with GSK's pandemic adjuvant, in the coming weeks. This Phase 3 trial is expected to enroll more than 35,000 adult participants from a broad range of countries. It will assess the efficacy of two vaccine formulations, including the D614 (Wuhan) and B.1.351 (South African) variants.