Phase III, Randomized, Single-blind, Placebo-controlled, Multi-center Study to Evaluate Non-interference of Concomitant Administration of Routine Pediatric Vaccines on the Antibody Response of an Investigational Live-attenuated Respiratory Syncytial Virus (RSV) Vaccine in Healthy Infants and Toddlers (CORAL)

This study is a Phase III, randomized, single-blind, placebo-controlled, multi-center study to be conducted in healthy infants and toddlers which will be enrolled at approximately 6 months of age (Cohort 1) and approximately 12 months of age (Cohort 2). The primary objective of the study will be to assess non-inferiority of the RSV infant and toddler (RSVt) vaccine antibody response when administered concomitantly with routine pediatric vaccines at 6 months of age (Diphtheria and Tetanus Toxoids and Acellular Pertussis, Inactivated Poliovirus, Haemophilus b Conjugate and Hepatitis B Vaccine [Vaxelis® or Pentacel® and Recombivax HB®] Prevnar 20®, and RotaTeq®), and 12 months of age (M-M-R II, VARIVAX, and Prevnar 20 or per local country recommendations) compared to when administered non-concomitantly.

Start Date13 May 2024

Sponsor / Collaborator

Sanofi Pasteur SA

NCT04490499

/ CompletedPhase 3

A Hepatitis B Vaccine Challenge Study to Demonstrate the Durability of Protection Against Hepatitis B Virus Infection in Healthy Children Vaccinated Approximately 9 Years Previously With a 2- or 3-Dose Infant Series and Toddler Dose of Vaxelis®

The purpose of this study is to demonstrate the durability of protection against hepatitis B virus (HBV) infection approximately 8-9 years after vaccination with Vaxelis®. This is an estimation study, and no formal hypothesis testing was performed.

Start Date02 Sep 2020

Sponsor / Collaborator

Merck Sharp & Dohme Corp.

NCT03893448

/ CompletedPhase 3

A Phase 3, Multicenter, Randomized, Double-blind, Active-Comparator-controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of a 4-dose Regimen of V114 in Healthy Infants (PNEU-PED)

The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of V114 in healthy infants. The primary hypotheses are that: 1) V114 is non-inferior to Prevnar 13™ for the 13 shared serotypes between V114 and Prevnar 13™ based on response rates at 30 days following Dose 3; 2) V114 is non-inferior to Prevnar 13™ for the 2 unique V114 serotypes based on the response rate of the 2 unique V114 serotypes compared with the lowest response rate of any of the shared serotypes in Prevnar 13™, excluding serotype 3, at 30 days following Dose 3; 3) V114 is non-inferior to Prevnar 13™ for the 13 shared serotypes based on anti-pneumococcal polysaccharide (PnPs) serotype-specific immunoglobulin g (IgG) geometric mean concentrations (GMCs) at 30 days following Dose 3; 4) V114 is non-inferior to Prevnar 13™ for the 2 unique V114 serotypes based on the anti-PnPs serotype-specific IgG GMCs of the 2 unique V114 serotypes compared with the lowest IgG GMC of any of the shared serotypes in Prevnar 13™, excluding serotype 3, at 30 days following Dose 3; 5) V114 is non-inferior to Prevnar 13™ for the 13 shared serotypes between V114 and Prevnar 13™ based on anti-PnPs serotype-specific IgG GMCs at 30 days following Dose 4; and 6) V114 is non-inferior to Prevnar 13™ for the 2 unique V114 serotypes based on anti-PnPs serotype-specific IgG GMCs of the 2 unique V114 serotypes compared with the lowest IgG GMC of any of the shared serotypes in Prevnar 13, excluding serotype 3, at 30 days following Dose 4.

Start Date19 Jun 2019

Sponsor / Collaborator

Merck Sharp & Dohme Corp.

100 Clinical Results associated with Hepatitis B vaccine(Merck Sharp & Dohme)

100 Translational Medicine associated with Hepatitis B vaccine(Merck Sharp & Dohme)

100 Patents (Medical) associated with Hepatitis B vaccine(Merck Sharp & Dohme)

Literatures (Medical) associated with Hepatitis B vaccine(Merck Sharp & Dohme)

01 May 2025·Transplant Infectious Disease

Posttransplant HBV Vaccine Compliance, Seroprotection, and Kinetics of Hepatitis B Surface Antibody in Thoracic Organ Transplant Recipients

Article

Author: Brumble, Lisa M. ; Beam, Elena ; Chiu, Chia‐Yu ; Vikram, Holenarasipur R. ; Watt, Kymberly D. ; Sampathkumar, Priya

ABSTRACT:

Introduction:

Vaccination is crucial to the thoracic solid organ transplant (SOT) population to reduce vaccine‐preventable infection. However, data on posttransplant hepatitis B virus (HBV) vaccination compliance and vaccine‐induced seroprotection are lacking.

Methods:

We conducted a retrospective study of adult thoracic organ (heart and lung) transplant recipients at Mayo Clinic sites in Minnesota, Arizona, and Florida between January 2018 and August 2023. Recombivax HB was used before 2020, and Heplisav‐B was preferred after 2020. Recipients with posttransplant hepatitis B surface antibody (HBsAb) < 10 IU/L were eligible for the HBV vaccine. HBV seroprotection was defined as an HBsAb ≥ 10 IU/L.

Results:

A total of 1116 recipients were evaluated, all of whom underwent posttransplant HBsAb testing. Of these, 751 (67%) had an HBsAb level < 10 IU/L and were eligible for posttransplant HBV vaccination. Of the eligible recipients, 117 (16%) completed the HBV vaccine series during the study period. Among these 117 recipients, 40 (34%) had their HBsAb levels rechecked after completing the vaccine series, with a seroprotection rate of 37.5% (15/40). There was no statistically significant difference in the seroprotection rates between Heplisav‐B and Recombivax HB vaccines (39% [13/33] vs. 29% [2/7]; p = 0.691). In addition, HBsAb levels were lowest at week 2 but rebounded at week 4 posttransplant and pretransplant HBsAb levels of ≥100 IU/L ensured 5‐year seroprotection.

Conclusion:

Suboptimal compliance with HBV vaccination and poor vaccine‐induced seroprotection occur in thoracic organ transplant recipients, regardless of the vaccine used. These findings underscore the necessity of enhancing vaccination strategies for SOT recipients. image

01 Sep 2024·CLINICAL TRANSPLANTATION

Hepatitis B Vaccine Compliance, Serologic Response, and Durability in Adult Thoracic Organ Transplant Recipients

Article

Author: Brumble, Lisa M. ; Beam, Elena ; Chiu, Chia‐Yu ; Vikram, Holenarasipur R. ; Watt, Kymberly D. ; Sampathkumar, Priya

ABSTRACT:

Introduction:

Hepatitis B virus (HBV) vaccination is recommended for solid organ transplant (SOT) candidates. However, there is a lack of data on the HBV vaccine compliance, serologic response, and durability of HBV seroprotection in thoracic organ transplantation recipients.

Methods:

We conducted a retrospective study of adult thoracic organ (heart and lung) transplant candidates who received HBV vaccination at Mayo Clinic sites in Minnesota, Arizona, and Florida between January 2018 and August 2023. Conventional recombinant hepatitis B vaccine (Recombivax HB) was used before 2020, and Heplisav‐B was preferred after 2020. HBV seroprotection was defined as hepatitis B surface antibody (HBsAb) ≥ 10 IU/L. Furthermore, we compared characteristics between recipients who maintained HBV seroprotection and those who lost HBV seroprotection (HBsAb < 10 IU/L) at 30 days posttransplantation (D30).

Results:

Among 922 candidates who were eligible for HBV vaccination, 430 (47%) completed the HBV vaccine series. Patients receiving Heplisav‐B were more likely to complete the series than Recombivax HB (81% vs. 60%, p < 0.001) and Heplisav‐B had a higher seroprotection rate than Recombivax HB (75% vs. 64%, p = 0.023). Multivariate logistic regression analysis identified receiving Heplisav‐B as an independent predictor for HBV seroprotection (adjusted odds ratio [aOR] 1.723; 95% confidence interval [CI] 1.056–2.810; p = 0.029). A total of 145 thoracic organ transplant recipients achieved HBV seroprotection at the date of transplantation. Loss of HBV seroprotection occurred in 38 (26%) patients at D30. Multivariate logistic regression analysis identified two predictors for HBV seroprotection loss at D30: age ≥ 60 years (aOR, 2.503; 95% CI 1.026–6.107; p = 0.044), and pretransplant HBsAb level between 10 and 100 IU/L (aOR, 18.575; 95% CI 5.211–66.209; p < 0.001).

Conclusions:

Although less than half of thoracic organ transplant candidates completed HBV vaccine series pretransplant, Heplisav‐B provided a higher vaccine completion rate and seroprotection than the 3‐dose Recombivax HB. Clinicians should also be aware of the increased loss of HBV seroprotection in thoracic organ transplant recipients with age ≥ 60 years and pretransplant HBsAb between 10 and 100 IU/L. Assessment of seroprotection after HBV vaccination should be prioritized during the pretransplant period.

01 Oct 2021·VaccineQ3 · MEDICINE

Serological response with Heplisav-B® in prior Hepatitis B vaccine non-responders living with HIV

Q3 · MEDICINE

Article

Author: Fischetti, Briann ; Bakshi, Anjali ; Berkowitz, Leonard ; Cope, Rebecca ; Khaimova, Rebecca

BACKGROUND:

As people living with HIV (PLWH) are at risk for contracting Hepatitis B Virus (HBV), they should be screened for HBV and vaccinated if not immune. Seroconversion rates in PLWH receiving traditional recombinant HBV vaccines (Engerix-B® and Recombivax-HB®) have historically been low with at most 70% achieving immunity. In 2017, a recombinant, adjuvanted HBV vaccine (Heplisav-B®) was approved for use in HIV-negative patients. Heplisav-B® has shown superior seroprotection in this population compared to Engerix-B® and Recombivax-HB®, as well as interim analysis showing higher seropositivity rates in patients undergoing dialysis. However, its efficacy in PLWH is currently unknown. This study evaluates the rate of seroconversion following Heplisav-B® administration in PLWH with previous HBV vaccination failure.

METHODS:

Retrospective, cross-sectional study at The Brooklyn Hospital Center's HIV primary care clinic in Brooklyn, NY. HIV-positive adults who received at least two doses of Heplisav-B® and had previously failed to seroconvert after vaccination with Engerix-B® or Recombivax-HB® were included. The primary outcome is the percentage of PLWH who became seropositive following Heplisav-B®.

RESULTS:

A total of 67 patients met the inclusion criteria. Twenty-five (37.3%) PLWH had failed at least 2 courses of recombinant vaccines. Fifty-eight (86.6%) PLWH became seropositive (Anti-HBs > 10 mIU/mL) at least two months after completing Heplisav-B®. For the 9 (13.4%) patients that did not develop immunity, 3 (33%) had a detectable HIV RNA and 3 (33%) had a CD4 count < 200 cells/uL³.

CONCLUSIONS:

Heplisav-B® was highly effective in achieving immunity to HBV in PLWH who failed non-adjuvanted recombinant vaccines.

News (Medical) associated with Hepatitis B vaccine(Merck Sharp & Dohme)

08 Jan 2026

·www.merck.com

Merck Statement on the U.S. Child and Adolescent Immunization Schedule

January 8, 2026 4:57 pm EST Rahway, N.J., Jan. 8, 2026 – At Merck, we share the same fundamental belief with health care providers and parents alike: every child deserves to grow up safe, healthy and able to thrive. Nothing is more important to us than the safety of our medicines and vaccines and the wellbeing of the people who rely on them. For many families today, diseases such as measles, polio and hepatitis B may feel like distant history. That progress exists because childhood vaccination has been remarkably successful. Decades of science-based immunization policy, supported by continuous safety monitoring and real-life evidence across millions of children, have helped protect communities. The U.S. child and adolescent immunization schedule has long reflected this rigorous approach. Vaccines are studied extensively in clinical trials using specific dosing regimens, and vaccinations are timed based on multiple scientific considerations, including when maternal antibodies wane, when children are most likely to be exposed to or susceptible to certain diseases, how immune systems respond at different ages and how healthcare providers can most effectively deliver protection. As the Department of Health and Human Services (HHS) makes changes to the immunization schedule, it is critical that changes are informed by comprehensive data and guided by experts in vaccinology, pediatrics, infectious diseases and epidemiology. International comparisons should also be evaluated in the proper context, recognizing differences in disease burden, healthcare infrastructure and population needs. Shared clinical decision-making plays an important role in healthcare, helping clinicians and families consider individual circumstances and risks. However, clear, evidence-based recommendations remain essential to support informed decisions and ensure that children and adolescents receive reliable protection against preventable diseases. As recent outbreaks in the U.S. have shown, sustained confidence in vaccination programs is critical to protecting individuals and communities. When vaccination rates decline, the consequences can be serious. Merck stands firmly behind an immunization framework grounded in rigorous science, strong regulatory processes and ongoing safety monitoring. We remain committed to working with public health partners to support policies that help protect children and adolescents, strengthen communities and preserve the progress achieved through immunization. Indication for M-M-R®II M-M-R®II is a vaccine indicated for active immunization for the prevention of measles, mumps, and rubella in individuals 12 months of age or older. The first dose of M-M-R®II is administered at 12 to 15 months of age and the second dose of M-M-R®II is administered at 4 to 6 years of age. Select Safety Information for M-M-R®II M-M-R®II is contraindicated in certain individuals, including those with: a history of hypersensitivity to any component of the vaccine, including gelatin; a history of anaphylactic reaction to neomycin; individuals who are immunodeficient or immunosuppressed due to disease or medical therapy; an active febrile illness; active untreated tuberculosis; or those who are pregnant or are planning to become pregnant within the next month. Due caution should be employed in administration of M-M-R®II to persons with: a history of febrile seizure or family history of febrile seizures; immediate-type hypersensitivity reactions to eggs; thrombocytopenia. Vaccination should be deferred in individuals with a family history of congenital or hereditary immunodeficiency until the individual’s immune status has been evaluated and the individual has been found to be immunocompetent. Immune globulins (IG) and other blood products should not be given concurrently with M-M-R®II. The ACIP has specific recommendations for intervals between administration of antibody-containing products and live virus vaccines. The following adverse reactions have been identified during both the subcutaneous and intramuscular use of M-M-R®II or its components in clinical trials or reported during post-approval use: fever, rash, and injection-site reactions. The following adverse reactions have been identified during the subcutaneous use of M-M-R®II or its components in clinical trials or reported during post-approval use: headache, dizziness, febrile convulsions, anaphylaxis and anaphylactoid reactions, arthritis, thrombocytopenia, encephalitis and encephalopathy. Dosage and Administration for M-M-R®II FOR INTRAMUSCULAR OR SUBCUTANEOUS USE ONLY. M-M-R®II vaccine can be administered concurrently with other live viral vaccines. If not given concurrently, M-M-R®II vaccine should be given one month before or one month after administration of other live viral vaccines to avoid potential for immune interference. Before administering M-M-R®II, please read the accompanying Prescribing Information. The Patient Information also is available. Indication for ProQuad® ProQuad is a vaccine indicated for active immunization for the prevention of measles, mumps, rubella, and varicella in children 12 months through 12 years of age. VARIVAX is a vaccine indicated for active immunization for the prevention of varicella in individuals 12 months of age or older. M-M-R®II is indicated for active immunization for the prevention of measles, mumps, and rubella in individuals 12 months of age or older. Select Safety Information for ProQuad Hypersensitivity: ProQuad, M-M-R®II (Measles, Mumps, and Rubella Virus Vaccine Live), and VARIVAX® (Varicella Virus Vaccine Live)are contraindicated in patients with a history of anaphylactic reaction or hypersensitivity to any component of the vaccine (including gelatin or neomycin) or to a prior dose of measles, mumps, rubella, or varicella-containing vaccine. Use caution when administering ProQuad and M‑M‑R®II to individuals with anaphylaxis or immediate hypersensitivity to eggs. ProQuad, M-M-R®II, and VARIVAXare contraindicated in certain individuals, including those with: immunodeficiency or who are immunosuppressed; an active febrile illness; untreated tuberculosis. Pregnancy: ProQuad, M-M-R®II, and VARIVAX are contraindicated for use in pregnant women. Do not administer ProQuad or VARIVAX to individuals who are planning to become pregnant in the next 3 months. Do not administer M-M-R®II to individuals who are planning to become pregnant in the next month. Febrile Seizures: Administration of ProQuad (dose 1) to children 12 to 23 months old who have not been previously vaccinated against measles, mumps, rubella, or varicella, nor had a history of the wild-type infections, is associated with higher rates of fever and febrile seizures at 5 to 12 days after vaccination when compared to children vaccinated with a first dose of both M-M-R®II and VARIVAX administered concomitantly. Febrile Seizures: Use caution when administering ProQuad and M-M-R®II to individuals with a history of febrile seizures. Family History of Immunodeficiency: Vaccination with ProQuad, M-M-R®II, and VARIVAX should be deferred in individuals with a family history of congenital or hereditary immunodeficiency until the individual’s immune status has been evaluated and the individual has been found to be immunocompetent. Thrombocytopenia: Transient thrombocytopenia has been reported within 4-6 weeks following vaccination with measles, mumps, and rubella vaccine. Carefully evaluate the potential risk and benefit of vaccination in children with thrombocytopenia or in those who experienced thrombocytopenia after vaccination with a previous dose of a measles, mumps, and rubella-containing vaccine. Varicella Transmission and Precautions: Advise vaccinees administered ProQuad or VARIVAX to avoid: close contact with high-risk individuals susceptible to varicella for up to 6 weeks following vaccination since transmission of varicella vaccine virus to susceptible contacts has been reported. Varicella vaccine virus transmission may occur between vaccine recipients and contacts susceptible to varicella including healthy individuals. Immune Globulins and Other Blood Products: Immune Globulins and other blood products should not be given concomitantly with ProQuad, M-M-R®II, or VARIVAX. Use of Salicylates: Avoid use of salicylates in children and adolescents administered ProQuad or VARIVAX for 6 weeks following vaccination due to the association of Reye Syndrome with salicylate therapy and wild-type varicella infection. Adverse Events: The following adverse events have been reported for both subcutaneous and intramuscular injections of ProQuad, M-M-R®II, and VARIVAX: fever, injection-site reactions (pain/tenderness/soreness, erythema, and swelling); and rash on the body or at the injection site. Additionally, irritability has been reported for the subcutaneous injections of ProQuad, M-M-R®II, and VARIVAX. ProQuad Systemic Vaccine-Related Adverse Events: Systemic vaccine-related adverse events that were reported at a significantly greater rate in recipients of subcutaneous ProQuad than in recipients of the component vaccines administered concomitantly were fever and measles-like rash. VARIVAX Dose-related Adverse Events: In a clinical trial involving children who received 2 doses of VARIVAX 3 months apart, the incidence of injection-site clinical complaints observed in the first 4 days following vaccination was slightly higher post-dose 2 (overall incidence 25.4%) than post-dose 1 (overall incidence 21.7%), whereas the incidence of systemic clinical complaints in the 42-day follow-up period was lower post-dose 2 (66.3%) than post-dose 1 (85.8%). Concomitant Vaccines With ProQuad: ProQuad may be administered concomitantly with diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DTaP), Haemophilus influenzae type b conjugate (meningococcal protein conjugate) and hepatitis B (recombinant) vaccine. It may also be administered concomitantly with pneumococcal 7-valent conjugate vaccine and/or hepatitis A vaccine (inactivated) at separate injection sites. Concomitant Vaccines With VARIVAX: VARIVAX can be administered with other live viral vaccines. If not given concurrently, at least 1 month should elapse between a dose of a live attenuated measles virus-containing vaccine and a dose of VARIVAX. In children, at least 3 months should elapse between administration of 2 doses of a live attenuated varicella virus-containing vaccine. Tuberculin Testing: If a tuberculin test is to be done with M-M-R®II and ProQuad, it should be administered either any time before, simultaneously with, or at least 4 to 6 weeks after vaccination. With VARIVAX, tuberculin testing may be performed before the vaccine is administered or at least 4 weeks following vaccination. Additional M-M-R®II Precautions: Additional adverse reactions, which have been reported without regard to causality, include febrile convulsions, arthritis, thrombocytopenia, anaphylaxis, anaphylactoid reactions, arthritis, encephalitis and encephalopathy in their diverse clinical presentations. Additional VARIVAX Precautions: It is not known if varicella vaccine virus is excreted in human milk. A boost in antibody levels has been observed in vaccinees following exposure to wild-type varicella, which could account for the apparent long-term persistence of antibody levels in studies. The duration of protection from varicella infection after vaccination is unknown. ProQuad/VARIVAX and Herpes Zoster: The long-term effect of VARIVAX on the incidence of herpes zoster, particularly in those vaccinees exposed to wild-type varicella, is unknown at present. Efficacy: Vaccination with ProQuad, VARIVAX, or M-M-R®II may not result in protection in 100% of vaccinees. Dosage and Administration for ProQuad ProQuad: Each dose of ProQuad is approximately 0.5 mL and is administered intramuscularly or subcutaneously. At least 1 month should elapse between a dose of a measles-containing vaccine such as M-M-R®II and a dose of ProQuad. At least 3 months should elapse between a dose of varicella-containing vaccine and ProQuad. VARIVAX: Each dose is approximately 0.5 mL and is administered intramuscularly or subcutaneously. The first dose is administered at 12 to 15 months of age. The second dose is administered at 4 to 6 years of age. There should be a minimum interval of 3 months between doses. 12 months to 12 years of age: If a second dose is administered, there should be a minimum interval of 3 months between doses. Adolescents (≥13 years of age) and Adults: 2 doses, to be administered with aminimum interval of 4 weeks between doses. The first dose is administered at 12 to 15 months of age. The second dose is administered at 4 to 6 years of age. There should be a minimum interval of 3 months between doses. 12 months to 12 years of age: If a second dose is administered, there should be a minimum interval of 3 months between doses. Adolescents (≥13 years of age) and Adults: 2 doses, to be administered with aminimum interval of 4 weeks between doses. M-M-R®II: The dose for any age is approximately 0.5 mL administered intramuscularly or subcutaneously. The recommended age for primary vaccination is 12 to 15 months and the second dose should be given at 4 to 6 years of age. The recommended age for primary vaccination is 12 to 15 months and the second dose should be given at 4 to 6 years of age. Before administering VARIVAX (Varicella Virus Vaccine Live), M-M-R®II (Measles, Mumps, and Rubella Virus Vaccine Live), or ProQuad (Measles, Mumps, Rubella and Varicella Virus Vaccine Live), please read the accompanying Prescribing Information. The Patient Information also is available for VARIVAX , M-M-R®II , and ProQuad. Indication for RECOMBIVAX HB® RECOMBIVAX HB is indicated for prevention of infection caused by all known subtypes of hepatitis B virus. RECOMBIVAX HB is approved for use in individuals of all ages. RECOMBIVAX HB Dialysis Formulation is approved for use in adult predialysis and dialysis patients 18 years of age and older. Select Safety Imformation for RECOMBIVAX HB Do not administer RECOMBIVAX HB to individuals with a history of severe allergic or hypersensitivity reactions (eg, anaphylaxis) after a previous dose of any hepatitis B-containing vaccine or to any component of RECOMBIVAX HB, including yeast. The vial stopper and the syringe plunger stopper and tip cap contain dry natural latex rubber, which may cause allergic reactions in latex-sensitive individuals. Apnea following intramuscular vaccination has been observed in some infants born prematurely. Decisions about when to administer an intramuscular vaccine, including RECOMBIVAX HB, to infants born prematurely should be based on consideration of the individual infant’s medical status and the potential benefits and possible risks of vaccination. For RECOMBIVAX HB, this assessment should include consideration of the mother’s hepatitis B antigen status and high probability of maternal transmission of hepatitis B virus to infants born to mothers who are HBsAg positive if vaccination is delayed. Hepatitis B vaccination should be delayed until 1 month of age or hospital discharge in infants weighing <2000 g if the mother is documented to be HBsAg negative at the time of the infant’s birth. Infants weighing <2000 g born to HBsAg positive or HBsAg unknown mothers should receive vaccine and hepatitis B immune globulin (HBIG) in accordance with ACIP recommendations if HBsAg status cannot be determined. Hepatitis B virus has a long incubation period. RECOMBIVAX HB may not prevent hepatitis B infection in individuals who have an unrecognized hepatitis B infection at the time of vaccination. Vaccination with RECOMBIVAX HB may not protect all individuals. In healthy infants and children (up to 10 years of age), injection site reactions and systemic adverse reactions were reported following 0.2% and 10.4% of the injections, respectively. The most frequently reported systemic adverse reactions (>1% injections), in decreasing order of frequency, were irritability, fever, diarrhea, fatigue/weakness, diminished appetite, and rhinitis. In a study that compared the 3-dose regimen (5 mcg) with the 2-dose regimen (10 mcg) of RECOMBIVAX HB in adolescents, the overall frequency of adverse reactions was generally similar. In a group of studies involving healthy adults, injection site reactions and systemic adverse reactions were reported following 17% and 15% of the injections, respectively. The following adverse reactions were reported (≥1% of injections) injection site reactions, fatigue/weakness, headache, fever, malaise, nausea, diarrhea, pharyngitis, and upper respiratory infection. Additional adverse reactions have been reported with the use of the marketed vaccine. Because these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or establish a causal relationship to a vaccine exposure. Use in Special Populations Pregnancy There are no adequate and well-controlled studies designed to evaluate RECOMBIVAX HB in pregnant women. Available post-approval data do not suggest an increased risk of miscarriage or major birth defects in women who received RECOMBIVAX HB during pregnancy. Nursing Mothers Data are not available to assess the effects of RECOMBIVAX HB on the breastfed infant or on milk productions/excretion. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for RECOMBIVAX HB and any potential adverse effects on the breastfed child from RECOMBIVAX HB or from the underlying maternal condition. Pediatric Use The safety and effectiveness of RECOMBIVAX HB Dialysis Formulation in children have not been established. Geriatric Use Clinical studies of RECOMBIVAX HB did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. However, in later studies it has been shown that a diminished antibody response can be expected in persons older than 60 years of age. In addition, the responses to these vaccines may be lower if the vaccine is administered as a buttock injection. Predialysis and Dialysis Patients Predialysis and dialysis adult patients respond less well to hepatitis B vaccines than do healthy individuals; however, vaccination of adult patients early in the course of their renal disease produces higher seroconversion rates than vaccination after dialysis has been initiated. Known or Presumed Exposure to HBsAg Refer to recommendations of the Advisory Committee on Immunization Practices (ACIP) and to the package insert for hepatitis B immune globulin (HBIG) for management of persons with known or presumed exposure to the hepatitis B virus (eg, neonates born of infected mothers or persons who experienced percutaneous or permucosal exposure to the virus). When recommended, administer RECOMBIVAX HB and HBIG intramuscularly at separate sites (eg, opposite anterolateral thighs for exposed neonates) as soon as possible after exposure. Dosage and Administration for RECOMBIVAX HB The vaccination regimen for RECOMBIVAX HB for persons from birth through 19 years of age consists of a series of 3 doses (0.5 mL each) given on a 0-, 1-, and 6-month schedule. The vaccination regimen for RECOMBIVAX HB for adolescents 11 through 15 years of age consists of a series of 3 doses (0.5 mL each) given on a 0-, 1-, and 6-month schedule, or a series of 2 doses (1.0 mL each) on a 0- and 4- to 6-month schedule. The vaccination regimen for RECOMBIVAX HB for persons 20 years of age and older consists of a series of 3 doses (1.0 mL each) given on a 0-, 1-, and 6-month schedule. The deltoid muscle is the preferred site for intramuscular injection for adults, adolescents, and children 1 year of age and older whose deltoid is large enough for intramuscular injection. The anterolateral aspect of the thigh is the preferred site for intramuscular injection for infants younger than 1 year of age. RECOMBIVAX HB should not be administered in the gluteal region, as injections given in the buttocks have resulted in lower seroconversion rates than expected. Consider subcutaneous administration only in persons who are at risk of hemorrhage following intramuscular injections. Predialysis and Dialysis Adult Patients: The vaccination regimen for RECOMBIVAX HB Dialysis Formulation for adults on predialysis and dialysis consists of a series of 3 doses (1.0 mL each) given on a 0-, 1-, and 6-month schedule. Consider a booster dose or revaccination with RECOMBIVAX HB Dialysis Formulation (blue color code) in predialysis/dialysis patients if the anti-HBs level is less than 10 mIU/mL at 1 to 2 months after the third dose. The duration of the protective effect on RECOMBIVAX HB in healthy vaccinees is unknown at present and the need for booster doses is not yet defined. RECOMBIVAX HB should be administered as soon as possible after being removed from refrigeration. Before administering RECOMBIVAX HB, please read the accompanying Prescribing Information. Indication for VAXELIS® VAXELIS is a vaccine indicated for active immunization to prevent diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, and invasive disease due to Haemophilus influenzaetype b. VAXELIS is approved for use as a 3-dose series in children 6 weeks through 4 years of age (prior to the 5th birthday). Select Safety Information for VAXELIS VAXELIS is contraindicated in children with a history of severe allergic reaction (eg, anaphylaxis) to a previous dose of VAXELIS, any ingredient of VAXELIS, or any other diphtheria toxoid, tetanus toxoid, pertussis-containing vaccine, inactivated poliovirus vaccine, hepatitis B vaccine, or H. influenzaetype b vaccine. Do not administer VAXELIS to anyone with a history of encephalopathy (e.g., coma, decreased level of consciousness, prolonged seizures), within 7 days of a pertussis-containing vaccine that is not attributable to another identifiable cause. Do not administer VAXELIS to anyone with a history of progressive neurologic disorder until a treatment regimen has been established and the condition has stabilized. Vaccination with VAXELIS may not protect all individuals. Carefully consider benefits and risks before administering VAXELIS to persons with a history of: fever of ≥40.5°C (≥105°F), hypotonic-hyporesponsive episode (HHE) or persistent, inconsolable crying lasting ≥3 hours within 48 hours after a previous pertussis-containing vaccine. seizures within 3 days after a previous pertussis-containing vaccine. If Guillain-Barré syndrome occurred within 6 weeks of receipt of a prior vaccine containing tetanus toxoid, the risk for Guillain-Barré syndrome may be increased following VAXELIS. Apnea following intramuscular vaccination has been observed in some infants born prematurely. The decision about when to administer an intramuscular vaccine, including VAXELIS, to an infant born prematurely should be based on considerations of the individual infant’s medical status and the potential benefits and possible risks of vaccination. Urine antigen detection may not have definitive diagnostic value in suspected H. influenzatype b disease following vaccination with VAXELIS. The solicited adverse reactions following any dose were irritability (≥55%), crying (≥45%), injection site pain (≥44%), somnolence (≥40%), injection site erythema (≥25%), decreased appetite (≥23%), fever ≥38.0°C (≥19%), injection site swelling (≥18%), and vomiting (≥9%). Dosage and Administration for VAXELIS The 3-dose immunization series consists of a 0.5 mL intramuscular injection, administered at 2, 4, and 6 months of age. A 3-dose series of VAXELIS does not constitute a primary immunization series against pertussis; an additional dose of pertussis-containing vaccine is needed to complete the primary series. Before administering VAXELIS, please read the accompanying Prescribing Information. The Patient Information also is available. About Merck At Merck, known as MSD outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities. For more information, visit www.merck.com and connect with us on X (formerly Twitter), Facebook, Instagram, YouTube and LinkedIn. Forward-Looking Statement of Merck & Co., Inc., Rahway, N.J., USA This news release of Merck & Co., Inc., Rahway, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions. The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s Annual Report on Form 10-K for the year ended December 31, 2024 and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov). 1 VAXELIS™ is the result of the U.S.-based business joint-partnership (MCM) created in 1991 between Merck & Co., Inc., Connaught Laboratories and Pasteur Mérieux Serums & Vaccins, the latter two now known as Sanofi Pasteur, the vaccines unit of Sanofi. Media Contacts: Melissa Moody (732) 594-1530 melissa.moody@merck.com Alayna Shamy (732) 403-0397 alayna.shamy@merck.com Investor Contacts: Peter Dannenbaum (732) 594-1579 peter.dannenbaum@merck.com Damini Chokshi (732) 594-1577 damini.chokshi@merck.com

VaccineDrug ApprovalClinical Result

29 Dec 2025

·www.pharmaceutical-technology.com

Sanofi buys hep B vaccine maker for $2.2bn

Sanofi’s executive vice president of vaccines Thomas Triomphe said the deal “brings new option to our portfolio”. Image credit: Below the Sky via Shutterstock.com. Sanofi has agreed to acquire hepatitis B vaccine manufacturer Dynavax for an equity value of around $2.2bn, bolstering the former’s pipeline amid significant vaccine policy changes in the US. The transaction, for a price of $15.50 per share in cash, is expected to close in the first quarter of 2026. Through the deal, Sanofi will acquire Dynavax’s hepatitis B vaccine HEPLISAV-B. The product won approval in the US and Europe in 2017 and 2021, respectively. Sanofi does not currently have a hepatitis B vaccine in its portfolio. The French drugmaker previously won approval for a hepatitis B vaccine in a joint venture with MSD, though the latter company now commercialises the jab, which is known under the HBVaxPro and Recombivax HB brand names in Europe and the US, respectively. Heplisav-B is administered via a two-dose regimen delivered within one month, unlike GSK’s Engerix-B and MSD’s Recombivax HB. These rival products are given in three doses over six months. With the Dynavax acquisition, Sanofi is adding a strong revenue avenue for the virus that causes serious liver infection. HEPLISAV-B generated sales of $268.4m in 2024, with Dynavax forecasting net product revenue of between $305m and $325m for 2025. GlobalData forecasts HEPLISAV-B will reach $677m in annual sales in 2031. GlobalData is the parent company of Pharmaceutical Technology . GlobalData Strategic Intelligence US Tariffs are shifting - will you react or anticipate? Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis. By GlobalData Learn more about Strategic Intelligence William Blair analyst Matt Phipps said: “While the deal value does come slightly below our net present value for Heplisav of $2.6bn, we believe the acquisition makes sense given growing regulatory concerns around vaccines and investor questions on management’s strategy for value creation.” Earlier in December, the US Centers for Disease and Prevention (CDC) changed its guidance to no longer recommend that all US newborns receive the hepatitis B vaccine. The significant policy changes have created volatility in the infectious disease vaccine sector, along with catalysing backlash from several medical bodies . The jewel in Dynavax’s pipeline is its shingles vaccine candidate, currently in a Phase I/II trial. In results announced in August 2025, the jab, dubbed Z-1018, demonstrated comparable efficacy to GSK’s blockbuster Shingrix – a product that dominates the shingles market. However, Z-1018 had fewer local and systemic post-injection reactions, which might give it a market advantage on tolerability. About one in three people in the US develop shingles at least once in their lives, according to the CDC. Shingrix generated £3.4bn globally for GSK in 2024, representing the size of the shingles market. Sanofi’s executive vice president of vaccines Thomas Triomphe said: “Dynavax’s marketed adult hepatitis B vaccine and shingles candidate bring new options to our portfolio and underscore our commitment to providing vaccine protection across the lifespan.” Phipps commented that: “Sanofi is a logical acquisition partner for Dynavax given the company has extensive vaccine capabilities but the portfolio does not have an adult hepatitis B or shingles programme.” Pharmaceutical Technology Excellence Awards - Nominations Closed Nominations are now closed for the Pharmaceutical Technology Excellence Awards . A big thanks to all the organisations that entered – your response has been outstanding, showcasing exceptional innovation, leadership, and impact. Excellence in Action Awarded the 2025 Pharmaceutical Technology Excellence Award for Business Expansion in Integrated Manufacturing , Upperton Pharma Solutions is rapidly expanding its UK GMP and sterile manufacturing footprint. Find out how Upperton’s integrated CDMO model helps pharma companies move from early development to clinical and niche commercial supply with fewer handovers and faster timelines. Discover the Impact

VaccineDrug ApprovalAcquisitionClinical Result

22 Dec 2025

·www.biospace.com

FDA Policy Tracker: 2025 Was a Year of Change

iStock, CoreDesignKEY Policy initiatives have come fast and furious at the FDA this year. While guidances on rare diseases and vaccines have consumed most of the ink, policy shifts aimed at improving FDA efficiencies and reshoring U.S. manufacturing also got some attention. Here, BioSpace rounds up more than a dozen initiatives relevant to the biopharma industry. From vaccines to rare diseases and the phasing out of animal testing requirements, it was a busy year for biopharma on the policy front as Health Secretary Robert F. Kennedy Jr. and his team at HHS made their mark on the FDA, CDC and National Institutes of Health. Many of the FDA’s 2025 guidances have focused on accelerating the path of cell and gene therapies to the market—particularly those intended for rare and ultrarare diseases. In a year where controversy is almost expected with every news announcement, the need for more and more-effective therapies for rare conditions may be the one area on which Americans of every political stripe can agree. Analysts and other FDA watchers who spoke with BioSpace see the momentum generated in this area in 2025 continuing into the new year. “I do think that, given what we’re seeing from FDA, rare orphan diseases as an area” of great interest for biopharma and investors will persist into 2026, Graig Suvannavejh, managing director of Equity Research at Mizuho Securities, told BioSpace . Married with reports that the FDA will soon begin requiring only one pivotal trial as opposed to the standard two, “this would make it seem ripe for rare orphan [diseases],” he added. Another key area of focus for the HHS under Kennedy—with his long history of antivaccine activism—has been in the vaccines space. On April 30, the Health department announced it would require all new vaccines be tested in placebo-controlled trials before they are approved, a “radical departure” from past practices, an HHS spokesperson told The Washington Post at the time. Earlier this month, Kennedy’s reformulated CDC Advisory Committee on Immunization Practices made another radical departure from the norm, voting to delay the hepatitis B vaccine from birth to two months of age for some infants. “Obviously [Kennedy is] driving a lot of this, from vaccine policy to staffing and everything like that,” Chad Landmon, Hatch-Waxman & Biologics chair at Polsinelli Law Firm, told BioSpace , “so I think it’ll be interesting to see how that continues, whether the same people continue in those roles.” BioSpace has compiled a review of our coverage of this year’s key policy initiatives. We will continue to update this tracker as we move into 2026 and see what comes next. _______________________________________________________________________ Randomized Trials To Be Required for CAR Ts December 8 Randomized, controlled clinical trials will be the FDA’s preferred approach to assessing CAR T cell therapies, Center for Biologics Evaluation and Research (CBER) director Vinay Prasad and three co-authors wrote in a Perspective piece in the Journal of the American Medical Association . Single-arm trials with no controls —the type on which the approvals for the seven currently marketed products were based—will no longer be sufficient. The FDA will also look at the therapy’s benefit in terms of patient survival or on time to the development of a particular event when considering approval, according to the authors. Prasad and colleagues noted in the piece that while the FDA is adjusting its processes to “exercise regulatory flexibilities, when necessary,” it also needs to “maintain the high evidentiary standards for approval.” FDA CAR-T Developers Will Need Randomized Trials as FDA Eyes Tighter Approval Requirements For traditional approval, CAR T therapies will need to establish superiority over current standard treatments, including already-approved CAR T products. December 9, 2025 · 2 min read · Tristan Manalac _______________________________________________________________________ FDA To Reduce Pivotal Trial Requirement From Two to One December 4 In possibly its biggest overarching pivot of 2025, the FDA is planning to require only one pivotal trial, as opposed to two, for companies seeking approval of a new drug. While not yet an official policy—the change was communicated by FDA Commissioner Marty Makary to STAT News in an interview—he told the publication it will be finalized in the next three to six months. “You can achieve the same statistical power with one trial as you would with two,” Makary told STAT . While analysts and other insiders positioned the proposed change as a major coup—biopharma consultant David Alderman in a LinkedIn post called it the “biggest jailbreak in biotech history”—other experts told STAT they were confused because the FDA already allows flexibility in situations where running two trials would be impractical or infeasible. _______________________________________________________________________ FDA Unveils Plausible Mechanism Pathway for Rare Diseases November 13 Makary and Prasad introduced the plausible mechanism approval pathway for rare diseases. Writing in The New England Journal of Medicine , Makary and Prasad said the new pathway would expedite treatments “for products where a randomized trial is not feasible.” In an interview with Fox News in April, Makary introduced the concept of a “conditional approval” pathway for treatments for rare diseases with extremely small patient populations. When the detailed pathway was announced seven months later, Makary and Prasad referenced Baby KJ , a patient with the ultrarare disease CPS1 deficiency whose condition was treated with a custom gene editing therapy. To qualify for the new plausible mechanism pathway, therapies must meet several conditions similar to KJ’s, including targeting known biological causes for a specific disease, and sponsors must produce post-marketing data to show real-world efficacy. FDA Makary’s ‘Conditional Approval’ Pathway for Rare Diseases Poses More Questions Than Answers While sparking excitement among biopharma companies focused on rare and ultrarare indications, experts say FDA Commissioner Marty Makary’s proposal is light on details and raises potential concerns about safety, access and liability. May 19, 2025 · 10 min read · Heather McKenzie _______________________________________________________________________ Guidance To Prevent Refusal-to-File (RTF) Letters October 23 The FDA released draft guidance to help biopharma companies understand what the agency considers to be a complete regulatory submission, and conversely, what will result in a refusal-to-file (RTF) letter. The guidance also explains the difference between filing issues that would result in an RTF and review issues that would result in a rejection. Recommendations include that a drugmaker not submit “materially incomplete or inadequately organized” applications, and that applications using a “single adequate and well-controlled clinical investigation” as the sole basis for approval will be RTF’d if the FDA and the applicant had previously agreed on the need for more than one such study. FDA FDA Provides Guidance To Prevent Returned Applications, Aid Patient-Focused Drug Development In three draft guidance documents, the FDA has laid out pointers to help companies craft better drug development programs and drug applications. October 24, 2025 · 2 min read · Tristan Manalac _______________________________________________________________________ Abbreviated NDAs Aim To Speed U.S. Generics October 3 Just over a week after its guidances for speeding the development of CGT therapies, the FDA on Oct. 3 introduced a new program for accelerating the generic drug industry in the U.S., both on the R&D and manufacturing sides. The agency’s new program includes a quicker review of abbreviated new drug applications —specific regulatory filings for generics—though the FDA did not say by how much it would accelerate review processes. Reviews for generic medicines generally take about 10 months. To qualify for that speedier review, companies must conduct their bioequivalence studies in the U.S. and “exclusively” source their active pharmaceutical ingredients from within the country as well. The finished dosage form must also be made locally. 2025 data showed that most generics are manufactured China and India, representing 22% and 44% of the global market, respectively. Manufacturing FDA Continues US Manufacturing Drive With Domestic Generics Pilot This latest FDA program aims to provide speedier reviews for generic drugmakers who produce their products in the U.S. October 6, 2025 · 2 min read · Tristan Manalac _______________________________________________________________________ FDA Seeks To Streamline Cell, Gene and Regenerative Therapies September 24 In a set of three separate draft recommendations, the FDA published new thinking on how to accelerate development of cell and gene therapies and regenerative medicines. These guidances covered a range of topics, including leveraging “innovative” study designs that use patients’ status prior to a trial as their own control. Other recommendations included using historical or real-world data as controls, allowing mid-trial modifications as studies generate data and deploying new mathematical frameworks to model progressions of a disease to chart the therapy’s efficacy. The agency also addressed diseases with small study populations, stating that early-stage trials could be enough to establish a product’s efficacy given “appropriate quality controls,” as well as post-marketing requirements for CGT products approved under accelerated pathways. FDA FDA Details Thinking for Streamlining Development of Cell, Gene, Regenerative Therapies Three draft recommendation documents published on Wednesday are intended to guide drug sponsors and accelerate the development of cell and gene therapies. September 25, 2025 · 2 min read · Tristan Manalac _______________________________________________________________________ FDA Cracks Down on “Deceptive” Drug Advertising September 9 The FDA on Sept. 9 announced it was sending approximately 100 cease-and-desist letters to pharmaceutical companies with what it called “deceptive advertisements.” The agency would also initiate rulemaking to close the “adequate provision” loophole, created in 1997, that has allowed pharma companies to advertise their drugs without fully disclosing risks, “fueling inappropriate drug use and eroding public trust,” according to the FDA’s statement. However, according to experts involved with writing the 1997 regulation who spoke with BioSpace , it was not a loophole. Instead, it was a deliberate and carefully crafted law that struck a happy medium between the demands for marketing new drugs and informing patients. FDA In New DTC Ad Crackdown, FDA Trying To Close a Loophole That Isn’t While the FDA is trumpeting this new initiative as “sweeping reforms” to the way drug companies can advertise, experts say the regulator is going after a problem that doesn’t exist. September 17, 2025 · 7 min read · Annalee Armstrong _______________________________________________________________________ FDA Unveils Rare Disease Evidence Principles September 4 The FDA’s Center for Biologics Evaluation and Research (CBER) and Center for Drug Evaluation and Research (CDER) on Sept. 4 jointly unveiled a new framework intended to streamline the approval of therapies for ultrarare diseases. The Rare Disease Evidence Principles (RDEP) will allow companies developing certain therapies to approval under an investigational new drug application using only a single-arm trial. This will apply to sponsors developing drugs for diseases that affect a “very small, rare disease population . . . generally less than 1,000 persons in the United States,” according to the FDA’s announcement . Qualifying conditions must also be linked to a known genetic defect and characterized by progressive functional deterioration leading to disability or death “in a relatively short period of time.” The targeted diseases should also lack “adequate” alternative therapies. Rare diseases Rare Disease Experts See Futility in FDA’s Proposed Framework The FDA’s proposed Rare Disease Evidence Principles review process is a starting point for getting rare disease therapies across the finish line, but industry leaders say there are more concrete steps the regulator could take to help patients. September 22, 2025 · 5 min read · Dan Samorodnitsky Rare diseases Saol To Pitch Ultrarare Disease Drug as “Poster Child” for RDEP Program Saol Therapeutics received a complete response letter for its pyruvate dehydrogenase complex deficiency treatment a week after the FDA unveiled its Rare Disease Evidence Principles program. On Dec. 18, in a Type A meeting, the biotech will attempt to convince the agency that its drug fits perfectly into the framework. December 9, 2025 · 2 min read · Heather McKenzie _______________________________________________________________________ FDA Pledges to Release CRLs in Real Time September 4 The FDA promised that, going forward, it would release new complete response letters (CRLs) to the public “ promptly after they are issued to sponsors .” In July, in a bid for “ radical transparency , ” the FDA released a bundle of more than 200 CRLs from a variety of drug and biological products applications submitted to the agency between 2020 and 2024. Big Pharmas like Eli Lilly and Regeneron were represented, as well as smaller biotechs like Sarepta. At the time, the FDA said the CRLs released were an “initial batch” without elaborating on its plans. Alongside the FDA’s September announcement, it released a second cache of heavily redacted CRLs, for products including Lykos Therapeutics’ MDMA-based therapy for posttraumatic stress disorder and Stealth BioTherapeutics’ elamipretide for Barth syndrome, approved later that month on a second try. As of December, the archive of CRLs has grown to 392. Complete response letters FDA Publishes Cache of Complete Response Letters in Bid for ‘Radical Transparency’ The trove of more than 200 letters is part of a pledge of transparency from the agency, with the intention to increase public insight into the reasons new drug and biologics applications got rejected. July 10, 2025 · 2 min read · Dan Samorodnitsky FDA Wall Street the Main Beneficiary of FDA’s Real-Time CRL Disclosures By publishing complete response letters as soon as they are issued to drug sponsors, the FDA is expanding transparency in a way that, while positioned as a public health measure, also grants investors greater visibility into regulatory decisions. Experts question whether this is the agency’s proper remit. September 29, 2025 · 6 min read · Ben Hargreaves _______________________________________________________________________ FDA Introduces PreCheck Program To Boost US Drug Manufacturing August 7 The FDA unveiled the PreCheck program with the intention of supporting biopharma companies as they build new facilities in the U.S. The PreCheck program provides manufacturers with more frequent FDA communication at critical development stages, including facility design, construction, and pre-production. A second Application Submission Phase centers around streamlining development of the Chemistry, Manufacturing, and Controls section of the application through pre-application meetings and early feedback. The program follows an executive order issued by President Donald Trump in May instructing the FDA to cut down on the 5–10 years it currently takes to build pharmaceutical manufacturing plants in the U.S. The EO also set the table for the FDA to implement surprise inspections on foreign plants, as opposed to the planned visits that are the current standard operating practice. “A scheduled visit is no inspection,” Makary said from the White House on May 5. The order will also see inspectors spend less time in the countries where the inspections take place, allowing them to “get in and out,” conducting more inspections with the same amount of resources, Makary said. The action is just one of many Trump has undertaken this year aimed at onshoring pharmaceutical manufacturing. Manufacturing Generic Drug and API Manufacturers Call for Onshoring Incentives Having seen Congress spend money to onshore semiconductor production, pharma groups are pushing for similar incentives for domestic drug manufacturing. November 4, 2025 · 4 min read · Nick Paul Taylor Manufacturing Pharmas Hope FDA PreCheck Can Help Avoid Facility-Related Drug Rejections Executives from Eli Lilly, Merck and other companies foresee the FDA’s new onshoring proposal being anything from a bureaucratic waste of time to a transformative program that will eliminate inspection-related complete response letters. October 28, 2025 · 4 min read · Nick Paul Taylor _______________________________________________________________________ Commissioner’s National Priority Voucher Program Introduced June 17 The FDA’s Commissioner’s National Priority Voucher (CNPV) program is intended to shorten review timelines for certain drugs from 10–12 months to 1–2 months. The initiative streamlines reviews by assembling a team-based review in a one-day “tumor board style” meeting, rather than shuttling applications sequentially through offices of the agency. For drugs to be awarded a CNPV, they must be “aligned with U.S. national priorities,” according to the FDA. Those priorities could include addressing a national health crisis, delivering “more innovative cures for the American people,” addressing an unmet public need or increasing domestic drug manufacturing. The FDA announced an initial batch of nine recipients in October, with an additional six awarded in November. A month later, the agency awarded its first CNPV approval of a generic antibiotic produced by USAntibiotic. Regulatory FDA Hands Out First Commissioner’s Priority Vouchers to Regeneron, Sanofi, Disc, Others The Commissioner’s National Priority Voucher awards companies that align with specific national priorities—such as boosting domestic manufacturing and lowering drug prices—with faster reviews and more frequent interactions with the FDA. October 17, 2025 · 2 min read · Tristan Manalac Regulatory Pressure On, Purpose Questioned as Second Round of FDA Priority Review Vouchers Revealed Priority voucher awardees and regulators could feel pressure to “meet the moment” as FDA watchers question the intent and feasibility of the Commissioner’s National Priority Voucher program. November 17, 2025 · 6 min read · Heather McKenzie Regulatory Wegovy, Casgevy Among Latest FDA Priority Review Voucher Recipients The FDA awards a second round of Commissioner’s National Priority vouchers to six larger biopharma companies. And this time, with the exception of Eli Lilly’s orforglipron, the vouchers are for drugs that are already on the market. November 6, 2025 · 3 min read · Dan Samorodnitsky _______________________________________________________________________ FDA Allows Drug Imports From Canada May 21 Drug pricing has been a top agenda item for the first year of President Trump’s second term. In May, Trump signed an executive order instructing U.S. health agencies to attempt to lower drug prices through whatever means are available to them. The FDA responded to that memo with a guidance that allowed states and Indigenous tribes to import prescription drugs from Canada, with the aim of lowering drug prices “without imposing additional risk to public health and safety.” In its announcement, the FDA said it anticipated meeting with states that expressed interest in the import program in the fall, though no such meetings have been announced. The Canadian government, for its part, made it clear that it would not export drugs to the U.S. “if that sale would cause or worsen a drug shortage in Canada,” according to a statement provided to BioSpace at the time. Drug pricing FDA Advances Drug Importation Plan as Canada Moves To Protect Its Supply Canada’s health agency says it has been “taking all necessary action safeguard the drug supply and ensure Canadians have access to the prescription drugs they need.” May 22, 2025 · 2 min read · Annalee Armstrong _______________________________________________________________________ HHS Requires Placebo-Controlled Trials for New Vaccines April 30 The Department of Health and Human Services announced it would require all new vaccines be tested in placebo-controlled trials before they are approved. While vaccines for new pathogens are already tested against placebo, new vaccines for other diseases are evaluated against existing interventions, largely for ethical reasons. The new policy “forces researchers to unethically withhold proven protection from some patients, all under the guise of ‘scientific rigor,’” Larry Bucshon, a cardiothoracic surgeon and former Congressman, wrote in an opinion article for STAT News . An HHS spokesperson told The Washington Post that the flu vaccine would be exempt from the new requirement as it “has been tried and tested for more than 80 years.” In a note to investors on May 1, analysts at Leerink Partners called the new policy “negative news for vaccine manufacturers,” including Merck, BioNTech and Moderna. Policy HHS To Require Placebo-Controlled Trials for All New Vaccines in ‘Radical Departure’ From Past The new policy, revealed by the Department of Health and Human Services on Wednesday, would make vaccines “less available and less affordable,” according to vaccine expert Paul Offit. It could also further complicate the picture for companies like Novavax. May 1, 2025 · 3 min read · Heather McKenzie _______________________________________________________________________ Restricting Pharma Representation on Adcomms April 17 One of FDA Commissioner Marty Makary’s earliest moves was to limit the ability of pharmaceutical company employees to serve on agency advisory committees . Even on committees where they are statutorily allowed to serve, the FDA said it would “prioritize and elevate” others on adcomms, particularly patients and caregivers. The agency noted that the change in policy did not preclude employees of regulated companies from attending or presenting to adcomms, and that exceptions could be made to allow their service on committees if they had unique expertise on a topic. This change was an early example of Makary’s efforts to “boost public trust” in the FDA, as the agency’s announcement put it. FDA FDA Moves To Restrict Industry Influence on Advisory Committees Industry representatives will still be allowed at these meetings, but they will no longer have a spot on the advisory committee. April 18, 2025 · 2 min read · Tristan Manalac _______________________________________________________________________ FDA To Begin Phasing Out Animal Testing April 10 In a move the FDA and U.S. government had been building toward for years, the agency announced plans to phase out its animal testing requirements for monoclonal antibodies and other drugs. The FDA plans to replace these animal models with “more effective, human-relevant methods,” such as AI-based computational models of toxicity, organ-on-a-chip systems and organoids. By leveraging nonanimal models, in addition to real-world human data, “We can get safer treatments to patients faster and more reliably, while also reducing R&D costs and drug prices,” Makary said in a prepared statement. “It is a win-win for public health and ethics.” Clinical Research FDA, NIH Accelerate Shift Away From Animal Research as Experts Warn of Limitations The FDA and NIH recently announced plans to phase out animal testing requirements for some therapies. While organoid and AI providers celebrate, scientists warn that questions over safety, applicability and implementation remain. May 19, 2025 · 6 min read · Natalia Mesa FDA New Approach Methodologies: Redefining Animal Testing Alternatives In this episode of Denatured, Jennifer C. Smith-Parker speaks to Stacey Adam, PhD, Vice President of Science Partnerships at the Foundation for the National Institutes of Health and Patrick Smith, Senior Vice President, Translational Science at Certara, to discuss the latest regulatory news and the future for new approach methologies (NAMs) development. December 4, 2025 · 1 min read · BioSpace Insights

100 Deals associated with Hepatitis B vaccine(Merck Sharp & Dohme)

External Link

KEGG	Wiki	ATC	Drug Bank
-	-	J07BC01	-

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Hepatitis D	European Union	Merck Sharp & Dohme BV	27 Apr 2001
Hepatitis D	Iceland	Merck Sharp & Dohme BV	27 Apr 2001
Hepatitis D	Liechtenstein	Merck Sharp & Dohme BV	27 Apr 2001
Hepatitis D	Norway	Merck Sharp & Dohme BV	27 Apr 2001
Hepatitis B	United States	Merck & Co., Inc.	23 Jul 1986

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Acute hepatitis B	Phase 3	Finland	Merck & Co., Inc.	25 May 2005
Hepatic Encephalopathy	Phase 3	Finland	Merck & Co., Inc.	25 May 2005

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04490499 (V419-013, CTgov)	Phase 3	Hepatitis B	207	HBVAXPRO™	mutebmcakz = dgcnzhiisg wtawnjvghz (fsgrgxbsnw, cyhrokxzcm - lwmmzldcuq) View more	-	05 Sep 2021
NCT02429583 (CTgov)	Phase 4	Hepatitis C \| Hepatitis C, Chronic	24	Recombivax (Recombivax in HCV Infected Individuals)	mcsgywevdx(bttyiumaxw) = ghkgybykyv xsvwvrwybu (zhaqunsvyu, byxdenbbiu - zaazwygvgx) View more	-	04 Mar 2020
				Recombivax (Recombivax in Healthy Volunteers)	mcsgywevdx(bttyiumaxw) = xreoilxylm xsvwvrwybu (zhaqunsvyu, rndvjgcele - ikknunspnt) View more
NCT01251276 (V232-059-10, CTgov)	Phase 3	Hepatitis B	204	Modified Process Hepatitis B Vaccine (Modified Process Hepatitis B Vaccine in Base Study)	xhbjilillo = ffalxguegf usidtrgatp (trtofwhybf, ktdeltjjgh - qeywzdlqxu) View more	-	28 Aug 2017
				Modified Process Hepatitis B Vaccine (ENGERIX-B™ Vaccine in Base Study)	xhbjilillo = eoopwhjdzl usidtrgatp (trtofwhybf, yxesjclycy - hanyvdqear) View more
NCT02012998 \| EUCTR2013-001602-28-IT (Pubmed \| Vaccine)	Phase 3	Hepatitis B	751	hepatitis B vaccine (Hexavac)	mgvjmypljs(nshdkznknb) = jvbunhrbsm cssxanxvrw (gtosvgljee ) View more	-	13 Jul 2017
				hepatitis B vaccine (Infanrix hexa)	mgvjmypljs(nshdkznknb) = mvfptqkvsn cssxanxvrw (gtosvgljee ) View more
Pubmed \| Hum Vaccin Immunother	Phase 3	-	204	HBvaxPRO®	coecciqsuo(canapscxwj) = tkuimyvhmg ehjaeaxrql (pwmtqgurbu, 34.8 - 56.4)	-	01 Jan 2015
				hepatitis B vaccine (Engerix B™)	coecciqsuo(canapscxwj) = lidlvbpote ehjaeaxrql (pwmtqgurbu, 48.6 - 68.5)
NCT00440297 (Pubmed \| Vaccine)	Phase 3	-	276	recombinant hepatitis B vaccine (mpHBV)	efmmmlgcbh(wthqlgahtl) = pszaxmxhhd binztwgevs (afihwszdnc, 15.7 - 48.0) View more	-	12 Nov 2014
				Licensed hepatitis B vaccine	efmmmlgcbh(wthqlgahtl) = dfulzxsunl binztwgevs (afihwszdnc, 28.7 - 82.7) View more
NCT01463683 (V232-062, CTgov)	Phase 3	Hepatitis B	722	2XP HEPTAVAX™-II SC (V232-2XP SC)	hvxuodpzuc = gktdohehsr qggcvtjrlv (rlpyfjygrq, namqlzengy - pdlmcbiabg) View more	-	17 Feb 2014
				HEPTAVAX™-II (V232-1XP SC)	hvxuodpzuc = arfnloitfk qggcvtjrlv (rlpyfjygrq, qzuhdqamog - opcyrsvacq) View more
NCT00322361 (Pubmed \| Vaccine)	Phase 2	Neonatal infections	566	modified process hepatitis B vaccine (mpHBV)	uqeklkcieo(zhbqbzgywx) = zhubuleqfe dfylrmetks (idcekoykaj ) View more	Negative	14 Feb 2012
				Control vaccine	uqeklkcieo(zhbqbzgywx) = pytadazqdt dfylrmetks (idcekoykaj ) View more
NCT00440531 (Pubmed \| Hum Vaccin)	Phase 3	-	538	hepatitis B vaccine (mpHBV)	xbsglpajta(dqzsvuwwfp) = There were 6 non-vaccine related serious adverse events reported qnfvymovoa (uncysvckih )	-	01 Dec 2011
				hepatitis B vaccine (RECOMBIVAX-HB)
NCT00414050 (Pubmed \| Pediatr Infect Dis J)	Phase 3	-	1,718	5 μg mpHBV	ufryloyawh(cleilwvozk) = bszamqajpe caulqcezqo (udkrnkgazt, 672.0 - 833.1) View more	-	01 Jul 2011
				10 μg mpHBV	ufryloyawh(cleilwvozk) = qqaexoqaxn caulqcezqo (udkrnkgazt, 891.0 - 1081.2) View more

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