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Flulaval Quadrivalent Influenza Vaccine 2023

GSK's Flulaval Quadrivalent is an inactivated influenza vaccine from viruses propagated in hens' eggs. Each of the four influenza viruses is produced and purified separately. The viruses are inactivated with ultraviolet light treatment followed by formaldehyde treatment, purified by centrifugation, and disrupted with sodium deoxycholate. Flulaval Quadrivalent (STN: BL 125163) is formulated without preservatives and does not contain thimerosal, according to the U.S. Food and Drug Administration (FDA). 

The World Health Organization (WHO) announced the flu vaccine composition for the 2023 southern hemisphere flu season. On March 7, 2023, the U.S. FDA presented the Influenza Virus Vaccine Strain Selection for the composition of the influenza vaccines for 2023-2024.

GSK confirmed on July 13, 2023, that it expects to distribute over 40 million doses of its influenza vaccine to the U.S. market. Both FLULAVAL QUADRIVALENT and FLUARIX QUADRIVALENT will be available in a 0.5mL, single-dose, pre-filled syringe and are indicated for patients six months and older for the current flu season in the U.S.

GlaxoSmithKline plc (GSK) is located in Brentford, United Kingdom, and Philadelphia, PA.

Flulaval Quadrivalent Indication

Flulaval Quadrivalent is indicated for active immunization to prevent disease caused by influenza A subtype and type B viruses in the vaccine. FLULAVAL QUADRIVALENT is approved for use in persons aged six months and older.

Flulaval Quadrivalent and COVID-19 Vaccines

The US Centers for Disease Control and Prevention (CDC) previously issued interim clinical considerations stating that 'COVID-19 vaccines and other vaccines, including influenza vaccines, can be administered without regard to timing.

Flulaval Quadrivalent Dosage

Flulaval Quadrivalent is approved for use in persons aged six months and older. Flulaval Quadrivalent is administered as an intramuscular injection. Do not administer Flulaval Quadrivalent to anyone with a history of severe allergic reactions (e.g., anaphylaxis) to any vaccine component, including egg protein, or following a previous dose of any influenza vaccine. For detailed dosage information, visit GSK.

Flulaval Quadrivalent Side Effects

Flulaval Quadrivalent is generally well-tolerated. Do not administer FLULAVAL QUADRIVALENT to anyone with a history of severe allergic reactions (e.g., anaphylaxis) to any vaccine component, including egg protein, or following a previous dose of any influenza vaccine. Suppose Guillain-Barré syndrome has occurred within six weeks of receipt of a prior influenza vaccine. In that case, the decision to give FLULAVAL QUADRIVALENT should be based on carefully considering the potential benefits and risks. Suppose you or your loved one has an adverse reaction to the vaccine. In that case, that information should be reported to VAERS, a U.S. passive reporting system that relies on individuals to send reports of their vaccine experiences. Anyone can submit a report to VAERS, including parents and patients. Furthermore, healthcare providers are required by law to report to VAERS.

Flulaval Quadrivalent News

September 12, 2023 - The U.S. CDC ACIP Releases 2023-2024 Influenza Vaccine Recommendations.

July 13, 2023 - GSK plc announced the availability of flu vaccines for the 2023-2024 season.

March 17, 2023 - The CDC weekly influenza surveillance reported seasonal influenza activity remains low nationally.

May 4, 2022 - Flu News Europe announced for week 16, of 39 countries and areas reporting on the intensity of influenza activity, 18 reported baseline intensity (across the Region), 14 reported low-intensity (across the Region), six reported medium-intensity (Denmark, Georgia, Kazakhstan, Latvia, Lithuania, and Romania), and one reported high-intensity (Estonia).

April 8, 2022 - The CDC FluView report indicated that Influenza activity increased nationally this week. Influenza activity is highest in the central and south-central regions of the country and is increasing in the northeastern regions.

November 11, 2021 - Despite increased influenza testing, levels continue to remain low, reported the WHO.

October 16, 2021 - The US CDC reported in week 41 that 0.1% of long-term care facilities reported > 1 influenza-positive test among residents. And no jurisdictions reported high or very high ILI activity.

October 7, 2021 - During week 40, the U.K. reported eight influenza-positive cases.

September 11, 2021 - Nationwide, during week 36, 2.3% of patient visits reported through ILINet were due to ILI. The percentage of patient visits for ILI remains below the baseline of 2.6% nationally.

September 4, 2021 - According to the US CDC, the percentages of visits for ILI reported in ILINet have been stable or decreasing among adult age groups (25-49 years, 50-64 years, and 65+ years) and may starting to stabilize among the younger age groups (0-4 years and 5-24 years).

August 26, 2021 - The U.S. FDA confirmed (30) lots of FluLaval Quadrivalent from I.D. Biomedical Corporation of Quebec has been released and is available for distribution in the USA.

July 26, 2021 - The global influenza vaccines market is projected to exceed the US$ 9.5 Billion mark by 2027 and present ample opportunities to the industry's players. In 2020, GlaxoSmithKline plc influenza vaccines (Fluarix/FluLaval) sales were up 35% from the previous year.

July 23, 2021 - GSK announced it started shipping its quadrivalent influenza vaccines to U.S. healthcare providers and pharmacies for the 2021-22 flu season. "GSK's focus continues to be increasing vaccination rates during the COVID-19 pandemic, and the flu vaccination is an integral part of that public health effort," said Judy Stewart, Senior Vice President and Head of U.S. Vaccines at GSK.

July 2, 2021 - The U.S. FDA issued a Supplement Approval letter to GSK for active immunization to prevent disease caused by influenza A subtype and type B viruses in the vaccine.

July 28, 2020 - GSK begins shipping a record number of its influenza vaccine doses for the 2020-21 season for the U.S. market. FLULAVAL QUADRIVALENT will be available in a 0.5mL, single-dose, pre-filled syringe and indicated for patients six months and older in line with CDC recommendations.

November 18, 2016 - GSK announced it had received approval from the U.S. Food and Drug Administration's (FDA) Center to expand the indication for FluLaval® Quadrivalent (Influenza Vaccine) to include use in children six months and older. Before this, the vaccine was only approved for active immunization against influenza A subtype and type B viruses in persons three years of age and older.

Flulaval Quadrivalent Clinical Trials

Flulaval Quadrivalent Influenza Vaccine has been tested in over 20 clinical trials.

Zika Vaccine VLA1601 Clinical Trials, Dosage, Indication, Side Effects

Valneva SE's VLA1601 is a second-generation, purified, inactivated whole Zika virus (ZIKV) vaccine candidate, adsorbed on aluminum hydroxide. As of December 2025, VLA1601 is the most advanced Zika vaccine developed and optimized on the original manufacturing platform of Valneva's licensed Japanese Encephalitis vaccine, IXIARO®. As of 2025, no preventive vaccines or effective treatments against ZIKV are approved by the U.S. Food and Drug Administration (FDA) or the European Medicines Agency (EMA). Zika is included in the FDA's Tropical Disease Priority Review Voucher Program. On August 12, 2025, the Company stated that no preventive vaccines or effective treatments are available and, as such, Zika remains a public health threat.

Valneva reported the results of its Phase 1 clinical trial (NCT03425149), showing immunogenicity and safety results for the tested doses and schedules. On March 26, 2024, Valneva announced the initiation of an additional Phase 1 clinical trial (VLA1601-102) to investigate the safety and immunogenicity of VLA1601 with a two-dose priming regimen on Days 1 and 29, with follow-up at 1 month (Day 57), 6 months, and 12 months. Primary Objectives: assessment of safety and tolerability up to 7 days after each vaccination and assessment of immunogenicity at Day 57 (1 month after completion of priming). Top-line data from this phase 1 clinical trial are expected in 2025. The Company has plans to expedite approvals with government agencies.

On November 4, 2025, Valneva announced positive results from its Phase 1 clinical trial (VLA1601-102, NCT06334393). The immune response induced by the double-adjuvanted VLA1601 vaccine candidate was significantly improved compared to the first-generation vaccine candidate, with higher peak seroconversion rates (>93% vs 86%) and a higher peak Geometric Mean Fold Increase in titers (>56-fold vs >7-fold). The Company stated: Despite the medical need, regulatory pathways and market opportunities for potential Zika vaccines remain uncertain. Valneva will therefore only consider further potential development steps for VLA1601 if concrete major private and public funding opportunities materialize.

France-based Valneva is a specialty vaccine company focused on developing vaccines for diseases with significant unmet needs. Valneva's vaccine portfolio includes two commercial vaccines for travelers. Valneva's 2023 Sustainability Report provides an in-depth account of the Group's activities and its future priorities. The Report's format is in accordance with French Decree No. 2017-1265 of August 9, 2017.

Zika Vaccine VLA1601 Indication

VLA1601 is a vaccine candidate indicated for the prevention of Zika infection. Vaccination should also protect against severe complications.

Zika Vaccine VLA1601 Dosage

In a phase 1 clinical trial, two doses of VLA1601 were administered intramuscularly in the deltoid muscle. Each dose is administered intramuscularly in the deltoid muscle on Days 0 and 28. Additionally, an accelerated vaccination schedule, administered on Days 0 and 7, was evaluated.

Zika Virus Impact

Zika was first identified in monkeys in Uganda in 1947 and later detected in humans in 1952. This mosquito-borne disease remains a public health threat throughout the Americas in 2025. According to the World Health Organization, there is a scientific consensus that ZIKV causes cases of microcephaly and Guillain-Barré syndrome. As of 2025, several countries and territories in the Americas, including Costa Rica and Puerto Rico, have reported evidence of mosquito-transmitted Zika virus infection.

On July 3, 2025, The Lancet published: A decade later, what have we learned from the Zika epidemic in children with intrauterine exposure? The Zika virus in pregnancy carries severe teratogenic potential to the fetus. Among children with congenital Zika syndrome, dysphagia and seizures are common, as are hospitalisations for pneumonia and urinary tract infections; overall, morbidity and mortality are extremely high. Children without congenital Zika syndrome but exposed to the Zika virus antenatally are also at risk of developmental disorders. Additionally, in utero exposure to the Zika virus does not lead to the production of neutralizing antibodies.

Zika Vaccine VLA1601 News

November 4, 2025 - Juan Carlos Jaramillo, M.D., Chief Medical Officer of Valneva, commented in a press release, "We are pleased by the notable safety and immunogenicity results demonstrated for our Zika vaccine candidate and especially our double-adjuvantation results."

February 18, 2025 - Valneca SE confirmed that Phase 1 results are forecasted for 2025.

October 10, 2024 - Valneva SE provided an update on its vaccine candidate.

March 26, 2024 - Juan Carlos Jaramillo, M.D., Chief Medical Officer of Valneva, said in a press release, "Valneva's commitment to our vision – to live in a world in which no one dies or suffers from a vaccine-preventable disease – fuels our pursuit for preparedness solutions against the Zika virus. As global temperatures rise and rainfall increases, the habitat for disease-carrying mosquitoes expands, presenting an ongoing public health challenge."

March 20, 2024 - Valneva SE stated that a vaccine against the Zika virus would complement the Company's portfolio of travel vaccines against mosquito-borne diseases, which already includes IXCHIQ® and IXIARO®.

November 9, 2023 - The Company announced the re-initiation of clinical development for ZIKA VACCINE CANDIDATE—VLA1601, with further program evaluation planned.

March 30, 2023 - Valneva's Chief Medical Officer, Juan Carlos Jaramillo, MD, will host a discussion on the opportunities and challenges of developing Zika vaccines on April 4, 2023.

VLA1601 Clinical Trial

In March 2024, Valneva initiated a Phase 1 clinical trial (NCT06334393) to investigate the safety and immunogenicity of VLA1601. As of November 4, 2025, the randomized controlled Phase 1 trial, VLA1601-102, enrolled approximately 150 participants aged 18 to 49 years in the U.S. Participants received two administrations of the highly purified, inactivated, aluminum-adjuvanted vaccine candidate VLA1601 at low, medium, or high doses, four weeks apart. In addition, the low dose of VLA1601 was evaluated with additional adjuvants, either the CpG 1018® adjuvant from Dynavax Technologies Corporation or the 3M-052-AF adjuvant from the Access to Advanced Health Institute. Data up to Day 57 (four weeks after the second dose) (Part A Analysis) showed that VLA1601 was generally safe and well-tolerated across all five treatment arms, with no safety concerns identified. Additionally, an independent Data Safety Monitoring Board found no safety issues. Two doses of VLA1601 were immunogenic across all five treatment arms investigated (i.e., alumadjuvanted Low, Medium, and High antigen dose; Low with additional adjuvants). The strongest immune response was observed in the double-adjuvant treatment arms (Low+alum+3M-052-AF and Low+alum+CpG1018) with statistically significantly higher neutralizing antibody titers (Geometric Mean Titers - GMTs) at Day 43 and Day 57 than in the single-adjuvant (alum) treatment arm. The immune response induced by the double-adjuvanted VLA1601 second-generation vaccine candidate was successfully improved compared to the first-generation vaccine candidate, with higher peak seroconversion rates (>93% vs 86%) and peak Geometric Mean Fold Increase of titers (>56 fold vs >7 fold)

Valneva concluded the Phase 1 trial for the first-generation vaccine (NCT03425149). It was first posted on February 7, 2018.

HilleVax HIL-214 Norovirus Vaccine Clinical Trials, Dosage, Indication, Side Effects

The HilleVax, Inc. HIL-214 investigational virus-like particle (VLP) based bivalent vaccine candidate is targeted to prevent moderate-to-severe acute gastroenteritis (AGE) caused by norovirus. The HIL-214 vaccine includes antigens from genotypes GI.1 and GII.4 to represent the genogroups that cause most human illnesses. Noroviruses, previously called Norovirus-like viruses, are members of the Norovirus genus in the family Caliciviridae, a group of non-enveloped viruses.

The Company announced on August 8, 2024, that it is exploring the potential for continued development of its HIL-214 and HIL-216 norovirus vaccine candidates in adults. On July 8, 2024, the Company announced plans to discontinue further development of HIL-214 in infants. "We are disappointed that the NEST-IN1 study did not meet its primary efficacy endpoint," said Rob Hershberg, MD, PhD, Chairman and Chief Executive Officer of HilleVax, in a press release on July 8, 2024. "While HIL-214 previously showed clinical benefit in adults, NEST-IN1 was the first efficacy study conducted in infants for a norovirus vaccine candidate. We believe the efficacy in the infant setting may have been impacted by the appearance of multiple emerging GII.4 strains in this trial."

As of December 31, 2024, and December 31, 2023, HilleVax, Inc. had cash, cash equivalents, and marketable securities totaling $171.4 million and $303.5 million, respectively. For 2024, research and development expenses were $78.2 million for the entire year ending December 31, 2024, compared to $33.3 million for the fourth quarter of 2023 and $106.7 million for the whole of the year ending December 31, 2023.

HilleVax (NASDAQ GS: HLVX) is a clinical-stage biopharmaceutical company located at 75 State St, Suite 100, Boston, MA 02109, focused on developing and commercializing novel vaccines. For information about HilleVax, visit the Company's website at http://www.HilleVax.com - CORPORATE PRESENTATION JANUARY 2023. Takeda Pharmaceutical Company Limited (TSE:4502/NYSE: TAK) and Frazier Healthcare Partners announced a collaboration to launch HilleVax, Inc. on July 29, 2021.

HIL-214 Vaccine Indication

Globally, norovirus is estimated to result in over 700 million cases of AGE and 200,000 deaths per year, resulting in over $4 billion in direct health system costs and $60 billion in societal costs per year. HIL-214 is indicated to prevent moderate or severe AGE due to norovirus, a common intestinal infection marked by watery diarrhea, vomiting, abdominal cramps, nausea, and sometimes fever that may lead to clinically significant dehydration. Globally, norovirus is estimated to result in approximately 700 million cases of AGE and 200,000 deaths per year, resulting in over $4 billion in direct health system costs and $60 billion in societal costs per year. In a study published in 2020, the cost of norovirus to the U.S. economy was estimated at $10.5 billion per annum, mainly driven by children under five and adults over 65.

HIL-214 Vaccine Dosage

The HIL-214 vaccine candidate is administered as an intramuscular injection.

HIL-214 Vaccine News

March 31, 2025 - Net loss for the fourth quarter 2024 was $33.9 million and $147.3 million for the year ended December 31, 2024, compared to $37.0 million for the fourth quarter 2023 and $123.6 million for the full year ended December 31, 2023.

July 8, 2024 - The NEST-IN1 clinical study did not meet its primary or secondary efficacy endpoints, and the Company will discontinue further development of HIL-214 in infants. The Company is exploring the potential for continued development of HIL-214 and HIL-216 in adults. "We sincerely thank the trial investigators, clinical sites, and the HilleVax team for conducting a highly rigorous study, and we deeply appreciate the infants and families that participated in this trial," said Dr. Hershberg.

January 18, 2024 - HilleVax, Inc. announced the appointment of Sean McLoughlin as Chief Operating Officer.

September 25, 2023 - The Company announced it raised $115 million in funding. HilleVax intends to use the net proceeds from the offering to fund the clinical development of HIL-214.

April 25, 2023 - "I am excited to announce the completion of enrollment of our NEST-IN1 study, which brings us one step closer to topline results in the first quarter of 2024," said Rob Hershberg, MD, Ph.D., Chairman and Chief Executive Officer of HilleVax. "There are no approved vaccines for norovirus, which results in approximately 700 million cases of acute gastroenteritis and 200,000 deaths per year."

December 5, 2022 - "We are very pleased with the immunogenicity results from the NEST-IN1 run-in cohort, which were consistent with our expectations based on previous studies of HIL-214 given to infants," said Rob Hershberg, MD, Ph.D., Chairman and Chief Executive Officer of HilleVax. "We now look forward to the full NEST-IN1 topline safety and efficacy data, which remain on track for the second half of 2023."

August 31, 2022 - HilleVax, Inc. reported that an independent safety data monitoring committee completed a prespecified review of safety data from the 203 subjects enrolled in the run-in portion of NEST-IN1, the Company's Phase 2b trial for HIL-214. Based on this review, the DMC recommended continuing NEST-IN1 without modification, and enrollment has subsequently resumed.

September 8, 2021 - HilleVax, Inc. announced the close of a $135 million crossover financing.

July 29, 2021 - "Takeda and Frazier have a history of successfully partnering together, and we are confident in HilleVax's capabilities to progress HIL-214, the most advanced norovirus vaccine candidate in development with the potential to address the huge global burden of norovirus-associated acute gastroenteritis," said Rajeev Venkayya, M.D., President of the Global Vaccine Business Unit, Takeda, in a press release.

HIL-214 Vaccine Clinical Trials

As of 2025, HIL-214 has been studied in nine clinical trials. HIL-214 has been the subject of various Phase 1, 2, and 3 clinical trials. In Q3 2023, HilleVax initiated three clinical trials supporting the advancement of HIL-214, including NOR-109, a Phase 1 clinical trial of HIL-214 in Japanese infants, NOR-206, a Phase 2 clinical trial co-administering HIL-214 with other standard infant vaccinations, and NOR-215, a Phase 2 serology study of HIL-214 in adults.

On December 5, 2022, HilleVax reported results from a prespecified immunogenicity analysis of the 203 subjects enrolled in the run-in cohort of NEST-IN1 (Norovirus Efficacy and Safety Trial for Infants), the Company's ongoing Phase 2b trial for HIL-214. Immunogenicity Results: Geometric Mean Titers (GMTs) of pan-IG antibodies 28 days following the second dose were 11,102.0 IU/mL and 2,185.5 IU/mL for GI.1 and GII.4, respectively, for HIL-214 compared to 59.6 IU/mL and 73.5 IU/mL for GI.1 and GII.4, respectively, for placebo. These titers corresponded to a Geometric Mean Fold Rise (GMFR) versus a baseline of more than 18-fold for HIL-214. And Seroresponse rates (SRRs) for HIL-214, defined in NOR-212 as the percentage of subjects with at least a 4-fold increase in pan-Ig (immunoglobulin) antibody titers 28 days following the second dose compared to pre-vaccination baseline, were 99.0% for GI.1 and 86.9% for GII.4. SRRs for placebo were 4.1% and 3.1% for GI.1 and GII.4, respectively.

On April 25, 2023, the Company announced the completion of enrollment of NEST-IN1, with over 3,000 subjects enrolled in six countries. The phase 2/3 study was last updated on May 25, 2023. Topline safety and clinical efficacy data from NEST-IN1 are expected in the first quarter of 2024. In addition to infants, the Company plans to seek approval for HIL-214 in additional age groups, such as older children and adults.

Clinical Trial NCT03039790:  Long-Term Immunogenicity of the Norovirus GI.1/GII.4 Bivalent Virus-like Particle (VLP) Vaccine (NoV Vaccine) in Adults (Active)

Clinical Trial NCT02153112: Safety and Immunogenicity of Norovirus GI.1/GII.4 Bivalent Virus-Like Particle (VLP) Vaccine in Children (Completed) Results: In 6–12 month-old infants and children up to 4 years of age, robust immune responses to the bivalent norovirus VLP vaccine candidates were observed; the highest HBGA responses in both age cohorts were observed after two doses of the 50/150 μg formulation. Further clinical evaluation of these formulations is underway in infants < 6 months of age.

Clinical Trial NCT01609257:  Norovirus Bivalent-Vaccine Efficacy Study (Completed) This Phase 1/2 study aims to determine whether the norovirus vaccine effectively prevents acute gastroenteritis due to the experimental human Norovirus GII.4 challenge dose. The purpose is also to evaluate the safety and immunogenicity of the vaccine. Takeda has published the results of this challenge study, which showed that the candidate vaccine is generally well-tolerated and had a clinically relevant impact on the symptoms and severity of norovirus illness after the challenge.

PreHevbrio™ Vaccine Clinical Trials, Dosage, Efficacy, Side Effects, Usage

PreHevbrio™ (PreHevbri®, Sci-B-Vac) is a third-generation hepatitis B trivalent vaccine that mimics all three surface antigens, pre-S1, pre-S2, and S of the hepatitis B virus ("HBV"). PreHevbrio has demonstrated safety and efficacy in over 500,000 patients. As of April 2024, PreHevbri is the only 3-antigen hepatitis B vaccine, comprised of the three hepatitis B surface antigens of the hepatitis B virus, administered in three doses over six months, approved for use in the United States, European Union/European Economic Area, United Kingdom, Canada, and Israel.

In December 2017, VBI Vaccines Inc.(VBI) initiated patient dosing in a global Phase 3 clinical program with two concurrent pivotal studies: PROTECT, a safety and immunogenicity study, and CONSTANT, a lot-to-lot consistency study. Data from both the PROTECT study and the CONSTANT study. During an August 2020 presentation, Adam Finn, M.D., Ph.D., Professor of Paediatrics at the University of Bristol, UK, and principal investigator of the CONSTANT Phase 3 clinical study discussed the successfully met primary endpoint of CONSTANT – demonstration of the consistency of immune response as measured by the geometric mean concentration (GMC) of hepatitis B antibodies (anti-HBs titers) across three consecutively-manufactured lots of vaccine. Additional data highlighted included: High anti-HBs titers: GMC of anti-HBs for Sci-B-Vac was more than 7.5x compared to Engerix-B after two vaccinations (day 168) and more than 3x after three vaccinations (day 196); Rapid Onset of Seroprotection: After two vaccinations, Sci-B-Vac elicited a 90.4% seroprotection rate (SPR) compared to 51.6% with Engerix-B, increasing to 99.3% vs. 94.8% after the 3rd dose. On Oct. 12, 2021, the JAMA Network published an Original Investigation: Immunogenicity and Safety of a 3-Antigen Hepatitis B Vaccine vs. a Single-Antigen Hepatitis B Vaccine, phase 3 study. It found the 3-antigen HBV vaccine had higher seroprotection rates after the second and third vaccinations than the single-antigen HBV vaccine.

On Feb. 2, 2021, the U.S. Food and Drug Administration (FDA) accepted the Biologics License Application (BLA) filing. On Dec. 1, 2021, the FDA approved PreHevbrio to prevent infection caused by all known subtypes of HBV in adults. On Jan. 12, 2022, Francisco Diaz-Mitoma, M.D., Ph.D. – Chief Medical Officer, VBI, presented 'The Safety & Immunogenicity of a 3-Antigen Hepatitis B Vaccine, PreHevbri, during the U.S. CDC's Advisory Committee on Immunization Practices meeting. Then, on Feb. 23, 2022, LCDR Mark K. Weng, MD MSc, CDC Hepatitis Vaccines Work Group, Advisory Committee on Immunization Practices, presented PreHevbrio for adult hepatitis B vaccination Evidence to Recommendation and GRADE. Following a positive vote, PreHevbrio is now recommended for prophylactic adult vaccination against HBV infection.

On May 2, 2022, the Company announced that the European Commission granted Marketing Authorisation for PreHevbri for active immunization against infection caused by all known subtypes of HBV in adults. On Sept. 8, 2022, Valneva SE and VBI Vaccines Inc. announced a partnership in select European markets for the marketing and distribution of PreHevbri®. The brand names for this vaccine are PreHevbri™ (EU/EEA/UK), PreHevbrio™ (US), and Sci-B-Vac® (Israel). In addition, on Dec. 8, 2022, Health Canada approved PreHevbrio™.

As of Mar. 22, 2024, Brii Bio secured exclusive development and commercialization rights for PreHevbri in Greater China and Asia Pacific (excluding Japan) and has submitted two pre-INDs to the CDE for PreHevbriTM's registration plan in China. A Market Authorization Application has also been filed in Hong Kong. In addition, VBI's enveloped virus-like particle (eVLP) platform technology enables the development of eVLPs that closely mimic the target virus to elicit a potent immune response.

Massachusetts-based VBI Vaccines Inc. (Nasdaq: VBIV) is a commercial-stage biopharmaceutical company developing the next generation of vaccines to address unmet infectious disease and immuno-oncology needs. Through its innovative approach to VLPs, including a proprietary enveloped VLP platform technology, VBI develops vaccine candidates that mimic the natural presentation of viruses, designed to elicit the innate power of the human immune system.

PreHevbrio Vaccine Revenues

As of May 16, 2024, PreHevbrio's global net revenue increased 105% year-over-year in the first quarter of 2024 compared to the first quarter of 2023. In the U.S., PreHevbrio sales continue to demonstrate substantial growth in early 2024, with over 80% of the 2023 full-year volume being sold in the first five months of 2024. VBI partners with Valneva SE to make PreHevbri available in certain European countries.

PreHevbrio Availability 2024

As of May 2024, PreHevbrio was available in the U.S., PreHevbri® is available in Europe (Netherlands, Belgium), the U.K., and Sci-B-Vac® in Israel. PreHevbri was approved by the European Commission and the United Kingdom Medicines and Healthcare Products Regulatory Agency in the second quarter of 2022. Valneva SE will lead marketing activities in the United Kingdom, Sweden, Norway, Denmark, Finland, Belgium, and the Netherlands. Valneva and VBI expect PreHevbri to be available in these countries in 2023. Brii Biosciences announced the development and commercialization of PreHevbri in the Asia Pacific region, excluding Japan. Availability is expected in Canada under the brand name PreHevbrio in 2024. In the U.S., PreHevbrio is available for purchase at retail pharmacy chains, including Costco, RiteAid, Walmart, and three of the top 10 regional retail pharmacy networks, as well as through the U.S. Department of Veterans Affairs, Federal Bureau of Prisons, and at certain military treatment facilities.

PreHevbrio Indication

Please visit www.PreHevbrio.com for U.S. Safety Information for PreHevbrio or U.S. Full Prescribing Information. In addition, a full European Summary of Product Characteristics for PreHevbri is available from the European Medicines Agency website. HBV infection is the leading cause of liver disease, and, with current treatments, it is challenging to cure, with many patients developing liver cancers. An estimated 900,000 people die each year from complications of chronic HBV, such as liver decompensation, cirrhosis, and hepatocellular carcinoma. The U.S. CDC. Sci-B-Vac is indicated to prevent hepatitis B in adults 18 and older. It can also be expected that hepatitis D will be controlled by immunization with PreHevbri, as hepatitis D does not occur without hepatitis B infection.

PreHevbrio Dosage

It is administered 10ug and intramuscular injection as a solution on Days 0, 28, and 168. Sci-B-Vac is currently in two Phase 3 clinical trials to support Sci-B-Vac licensure in the U.S., Europe, and Canada. In addition, it can be administered at lower doses than competing hepatitis B vaccines, says the Company.

PreHevbrio Side Effects

The safety and tolerability seen in a phase 3 study support the safety profile of VBI's 3-antigen vaccine candidate – with no safety signals observed in either study arm and no new safety risks identified. However, do not administer PreHevbrio to individuals with a history of a severe allergic reaction after a previous dose of any hepatitis B vaccine or any component of PreHevbrio. To report SUSPECTED ADVERSE REACTIONS, contact VBI Vaccines at 1-888-421-8808 (toll-free), VAERS at 1-800-822-7967, or www.vaers.hhs.gov.

PreHevbrio Cost

On March 29, 2022, VBI Vaccines Inc. announced that PreHevbrio™ is now available in the U.S. at a Wholesale Acquisition Cost of $64.75/dose.

PreHevbrio News

April 16, 2024 - “Over the last 12 months, we’ve seen continued progress across all of our lead programs – with increased use of PreHevbrio and an ever-expanding access and distribution network in place, as well as positive clinical data announcements from all lead pipeline programs, we are helping to make great strides in the fight against GBM, hepatitis B, and coronaviruses,” said Jeff Baxter, VBI’s President and CEO. 

July 19, 2023 - Jeff Baxter, President and CEO of VBI, commented: "We are excited to announce the launch of PreHevbri in the Netherlands and Belgium through our partnership with Valneva.

December 8, 2022 - "We are excited to announce Health Canada's approval, a fourth regulatory approval for this vaccine," said Jeff Baxter, VBI's President and CEO. 

September 8, 2022 - Jeff Baxter, President and CEO of VBI, commented: "This partnership is a significant milestone for PreHevbri, enabling us to hit the ground running in Europe. Valneva has substantial local knowledge, experience, and relationships in each of these European countries."

June 1, 2022 - VBI Vaccines Inc. announced that the UK Medicines and Healthcare Products Regulatory Agency granted marketing authorization for PreHevbri™.

May 2, 2022 - VBI Vaccines Inc. announced that the European Commission had granted Marketing Authorisation for PreHevbri™.

February 23, 2022 - VBI announced that, following a discussion at the U.S. CDC Advisory Committee meeting on Immunization Practices, PreHevbrio joined the recommended products for prophylactic adult vaccination against HBV infection.

December 1, 2021 - VBI announced that the U.S. FDA had approved PreHevbrio™.

October 26, 2020 - VBI Vaccines announced across the PROTECT and CONSTANT registrational Phase 3 studies, Sci-B-Vac safely elicited higher anti-HBs titers in all study subjects than Engerix-B, a single antigen HBV vaccine, regardless of age, gender, or underlying comorbidity.

January 9, 2020 - VBI Vaccines Announces Second Pivotal Phase 3 Study of Sci-B-Vac® Meets Primary and Secondary Endpoints; op-line data from CONSTANT, the second pivotal Phase 3 study, assessing lot-to-lot manufacturing consistency of Sci-B-Vac®.

December 2017 - VBI initiated patient dosing in a global, 15-month Phase 3 clinical program that, if successful, will allow the Company to seek marketing authorization in the U.S., Europe, and Canada.

Sci-B-Vac Vaccine Clinical Trials

Sci-B-Vac Vaccine has been tested in several clinical trials and a Phase 4 post-marketing clinical trial.

June 28, 2022 - Timo Vesikari, M.D., Ph.D., Professor Emeritus and Director of the Nordic Vaccine Research Network in Finland, and principal investigator of the PROTECT and CONSTANT Phase 3 clinical studies of VBI's 3-antigen HBV vaccine, highlighted data from his investigator-initiated analysis that evaluated the duration of immune response approximately 2.5 years after completion of vaccination. Immunogenicity was assessed using frozen sera samples from a subset of participants (n=465) enrolled at five clinical sites in Finland as part of PROTECT. In the follow-up analysis, participants in PROTECT who received VBI's 3-antigen HBV vaccine had 5.5-fold higher mean anti-HBs titers (GMC: 1382.9 mIU/mL vs. 251.4 mIU/mL) and a higher seroprotection rate (SPR: 88.1% vs. 72.4%) compared to those who received Engerix-B. Additionally, 72.9% of participants who received VBI's 3-antigen HBV vaccine retained anti-HBs titers ≥ 100 mIU/mL compared to 32.6% of those who received Engerix-B.