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Human Papillomavirus (HPV) Vaccines 2025

The World Health Organization (WHO) recommends vaccinating against human papillomavirus (HPV) to prevent infections and associated cancers. As of April 15, 2025, six licensed HPV vaccines protect men and women against cancers caused by HPV. These bivalent, quadrivalent, and nonavalent HPV vaccines are available in 140 countries. The WHO has prequalified five HPV vaccines.

In the U.S., the Centers for Disease Control and Prevention (CDC) has recommended HPV vaccination for women since 2006 and for men since 2011. The current CDC HPV vaccination schedules were updated in 2025. HPV vaccine availability status in the U.S. is posted at View-Hub. On April 15, 2025, Carla L. DeSisto, PhD, MPH, presented: Reduced number of doses for HPV vaccination series: ACIP Work Group progress and literature update.

HPV Vaccines Approved

Gardasil - Merck's Gardasil® vaccine contains four HPV types: 6, 11, 16, and 18. It was approved in China for both men and women in 2025.

Gardasil 9® consists of HPV proteins Types 6, 11, 16, 18, 31, 33, 45, 52, and 58.

Cervarix—GlaxoSmithKline's Cervarix is a non-infectious recombinant, AS04-adjuvanted vaccine that contains recombinant L1 protein, the major antigenic protein of the capsid of oncogenic HPV types 16 and 18.

Cecolin—Innovax Biotech Ltd.'s Cecolin HPV bivalent vaccine protects women against HPV 16 and 18. Cecolin 9 is a second-generation nonavalent HPV 6/11/16/18/31/33/45/52/58 vaccine approved for one dose.

Wa Biotechnology's recombinant bivalent HPV vaccine is effective against HPV strains 16 and 18. China's National Medical Products Administration approved it in March 2022.

Yuxi Zerun Biotechnology Co., Ltd. Walrinvax® two-dose HPV vaccine was approved in China in February 2024 and prequalified by the WHO in August 2024.

Cervavac is the Serum Institute of India's quadrivalent human papillomavirus vaccine (qHPV), authorized in India for 9-to 26-year-olds. Local availability began in 2023. 

HPV Vaccine Candidates

PDS Biotech's Versamune® HPV (formerly PDS0101) is conducting multiple phase 2 studies in 2024.

RGVax - The U.S. FDA completed its review of the investigational new drug application for its licensed monovalent component, HPV16 RG1-VLP, and concluded that a Phase 1 clinical trial might proceed as of March 29, 2023. RGVax is a chimeric HPV VLP platform that displays 360 copies of the highly conserved, neutralizing HPV epitope. PathoVax LLC licensed the underlying RGVax foundational technology from Johns Hopkins Univers. Transgene's TG4001 HPV16 vaccine candidate uses an attenuated and modified poxvirus as a vector that expresses the HPV16 E6 and E7 proteins and interleukin-2. Data presented on June 5, 2023, demonstrates that Transgene's TG4001 could induce a specific immune response against the antigens vectorized within this vaccine.

Nykode Therapeutics announced positive results from the Phase IIa trial of its cervical cancer vaccine, VB10.16, delivered in combination with atezolizumab to 52 participants. Patients who received the vaccine were tracked for 1 year, with a median overall survival of 16.9 months. A second, more extensive trial of VB10.16 in cervical cancer is set to begin in 2023.

VGX-31 - Inovio's investigational immunotherapy vaccine includes DNA plasmids targeting the E6 and E7 proteins of HPV types 16 and 18.

INO-3107 - INOVIO announced positive interim results from an ongoing Phase 1/2 clinical trial evaluating INO-3107. The results showed a statistically significant improvement in the clinical endpoint, the number of surgical interventions required to control papilloma growth. INO-3107 was also well-tolerated and immunogenic in the trial.

VTP-2 - Vaccitech's ChAdOx1-HPV immunotherapy for high-risk HPV infection and low-grade cervical intraepithelial neoplasia. The platform has a differentiated ability to induce CD8+ T cells and cells of the immune system that naturally clear HPV-infected cells in cervical tissue. In addition, VTP-200 targets six early proteins from five high-risk HPV groups and therefore covers more HPV types than any other immunotherapy previously tested. Data from the first 58 women enrolled who reached their 6-month timepoint in the HPV001 phase 1/2study were reviewed internally, and the trial will continue as planned to the 12-month primary endpoint.

HB-201 - HOOKIPA Inc.'s monotherapy uses an arenavirus backbone (LCMV for HB-201) to express the antigen, an E7/E6 fusion protein derived from HPV16+.

VB10.16 - Nykode Therapeutics is developing a potential first-in-class, off-the-shelf therapeutic cancer vaccine for HPV16-positive cancers.

REC603 - Jiangsu Technology's REC603 is a recombinant HPV 9-valent vaccine used in a phase 3 clinical trial. The REC604a is equipped with the novel adjuvanted BFA04 independently developed by the Company, which aims to reduce the vaccination dose by enhancing the immunogenicity and cross-protection effects.

Defence Therapeutics Inc. developed the AccuVAC-PT007, a protein-based vaccine targeting the E7 oncoprotein of the HPV virus. 

LinKinVax is conducting a first-in-human Phase I/IIa clinical trial with CD40HVac, a new therapeutic vaccine candidate in immuno-oncology targeting dendritic cells against head and neck cancer associated with HPV. The first patient was dosed with CD40HVac for HPV-positive oropharyngeal cancer on September 18, 2023.

Genexine GX-188E (tirvalimogene teraplasmid) is a DNA therapeutic vaccine fused with encoding both E6 and E7 antigens and the extracellular domain of Flt3L to target and activate dendritic cells. A Multi-Center, Open-label Phase Ib-II Trial of the Combination of GX-188E Vaccination and Pembrolizumab in Patients with Advanced, Non-Resectable HPV-Positive Cervical Cancer.

PDS Biotechnology PDS0101 is a novel investigational HPV-targeted immunotherapy that stimulates a potent targeted T-cell attack against HPV-positive cancers. The VERSATILE-002 Phase 2 trial is for the treatment of recurrent or metastatic HPV16-positive head and neck cancer.

Precigen, Inc. presented PRGN-2009 AdenoVerse™ immunotherapy alone and in combination with an investigational anti-PDL1/TGF-Beta Trap checkpoint inhibitor in patients with recurrent/metastatic HPV-associated cancers (NCT04432597) in Abstract #2628.

Aston Sci. received Phase 2 Clinical Investigational New Drug approval from the U.S. FDA on September 12, 2023, for the AST-201 vaccine, which was explicitly designed for ovarian cancer.

HPV Vaccine Doses

The WHO's global recommendation for one-dose HPV vaccine schedules in 2022 significantly reduced barriers to scaling up vaccination programs. The Americas Region and the Regional Office for Africa also issued recommendations for the single-dose vaccination schedule. On April 11, 2022, the WHO's Strategic Advisory Group of Experts on Immunization concluded that a single-dose HPV vaccine provides virus protection comparable to that of 2-dose schedules. The UK's Joint Committee on Vaccination and Immunisation announced on August 5, 2022, that one HPV dose is as effective as two doses in preventing HPV-related cancers in adolescents. The CDC's recommendations for 2 or 3 HPV vaccinations were updated in 2023. 

According to estimates from the WHO, the switch to a single-dose vaccine schedule resulted in an additional six million girls vaccinated against HPV in 2023. That year, 27% of girls aged 9 to 14 years received a single dose of the HPV vaccine, compared with 20% in 2022. As of 2024, 57 countries, up from 37 last year, had adopted the new vaccination schedule.

HPV Vaccine Effectiveness

The Journal of the National Cancer Institute published results from a study in January 2024 that found no cases of invasive cancer among women in Scotland who were immunized at 12 or 13 years of age, irrespective of the number of bivalent vaccine doses. Women vaccinated at 14 to 22 years of age and given three doses of the bivalent vaccine showed a significant reduction in incidence compared with all unvaccinated women (100,0002/100,000 [95% confidence interval (CI) = 2.1 to 4.6] vs. 8.4 [95% CI = 7.2 to 9.6]).

A study published by the Journal of Infectious Diseases on October 12, 2023, found genital HPV infections within 24 months in abCI: 33.4 48.433.4-48.4) of unvaccinated young women in new heterosexual relationships. Other sexually transmitted disease vaccine news is posted at this link. 

Lauri E. Markowitz, M.D. Division of Viral Diseases, U.S. CDC Advisory Committee on Immunization Practices presented on June 23, 2022, which summarized: 'There are now data on 1-dose HPV vaccination, including efficacy data from a randomized controlled trial with 18-month follow-up. In addition, long-term follow-up from other studies suggests a long duration of protection (>10 years) with a single dose. And Julia Gargano, Ph.D., presented: 'Impact of the US HPV vaccination program on HPV-associated outcomes. Declines in HPV16/18 prevalence have translated into declines in cervical precancer incidence in young women.' 

A systematic review of 138 peer-reviewed studies, published between March 2016 and March 2020, within MEDLINE, EMBASE, and Google Scholar, involving 14 years of follow-up data, details the Impact and effectiveness of GARDASIL through immunization programs in 23 countries across Africa, Asia, Europe, Australia, South America, and North America. The most significant reductions were observed in younger age groups (14-17 years), with up to 73% reduction in CIN3+ among vaccinated females. Consistent with previous reviews, declines in the incidence of anogenital warts continue to be observed in vaccine-targeted female age groups, with more pronounced decreases (up to 88%) in younger age groups.

HPV Vaccination and HIV

A peer-reviewed study published on October 1, 2022, found that MSM with HIV would benefit from Gardasil 9 immunization, particularly the youngest and those with prior gonococcal infection.

HPV Vaccination and Pregnant Women

HPV vaccination is not recommended for use by women during pregnancy. 

HPV Cancer and Men

The Lancet Global Health pre-released a September 2023 report showing that almost 33% of men over 15 are infected with at least one genital HPV type, and 20% are infected with one or more high-risk or oncogenic HPV types.

HPV Cancers

In 2024, patients aged 65 and older had the most significant increase (32.2%) in HPV diagnoses. The Global HPV Consortium, which focuses on accelerating the prevention of HPV and eliminating cervical, throat, anal, and other HPV cancers, was launched on September 4, 2023, and is led by the Sabin Vaccine Institute as its Secretariat. The Lancet Oncology reported in September 2023 that African countries are home to 19 of the 20 countries with the highest burden of cervical cancer. 

HPV Vaccine Cost

The HPV vaccine is the most expensive of all routinely recommended pediatric vaccines, according to a July 2023 study. This study found that net returns from HPV vaccine cost reimbursements are lowest for family physicians ($0.34/dose) and highest for pediatricians ($5.08/dose). Furthermore, reimbursement for HPV vaccine costs by private payers is adequate; however, return margins are small for non-pediatric specialties. The CDC reported in August 2023 that HPV vaccination initiation fell among adolescents insured by Medicaid and remained lowest among the uninsured, two of the four groups that constitute the Vaccines for Children population. The Vaccines for Children Program Vaccine Price List was updated in 2025.

Insight Partners stated that the HPV vaccine market is projected to reach $5.73 billion by 2028, growing at a CAGR of 5% from 2022 to 2028. HPV vaccine prices and discount information are posted at InstantRx™.

CONTENT SOURCES:  World Health Organization, US Centers for Disease Control and Prevention, FDA, research studies, manufacturer announcements, and the Vax-Before-Travel news network, reviewed by healthcare providers, such as Dr. Bob Carlson.

UV1 Cancer Vaccine Clinical Trials, Efficacy, Indication, Side Effects

Ultimovacs ASA's UV1 is a peptide-based vaccine inducing a specific T-cell response against the universal cancer antigen telomerase. As a universal cancer vaccine, UV1's unique action mechanism can apply to most cancer types. Unlike algorithm-selected vaccine peptides, the UV1 peptides contain epitopes documented by cancer patients' immune systems. In addition, the UV1 universal cancer vaccine candidate leverages the high prevalence of the human telomerase (hTERT) to effectively cross the dynamic stages of the tumor's growth and microenvironment.

Immune responses against several hTERT epitopes, including novel hTERT epitopes not present in the vaccines, were detected in blood samples from long-term surviving patients following vaccine treatment but not in patients without clinical benefit. Based on these data, three peptides to elicit robust T cell responses across different cancer types were selected as the UV1 vaccine components.

UV1 is being developed as a therapeutic cancer vaccine, which may serve as a platform for use combined with other immunotherapy that requires an ongoing T cell response for their mode of action. In addition, UV1's unique mechanism of action can apply to most cancer types. UV1 consists of long, synthetic peptides that induce CD4+ T cells displaying a Th1 cytokine profile. By directing the immune system to hTERT antigens in over 80% of all cancers, UV1 drives CD4 helper T cells to the tumor to activate an immune system cascade to increase anti-tumor responses.

On March 2, 2024, Ultimovacs ASA announced that the results from the randomized controlled Phase II clinical trial, NIPU, were published in the European Journal of Cancer. On August 5, 2024, Ultimovacs announced the topline results from the Phase II FOCUS trial (NCT05075122). The topline data readout demonstrated that adding UV1 to the standard of care pembrolizumab did not lead to clinical benefits in progression free survival or overall survival in those late-stage HNSCC patients, therefore, the study did not meet its primary and secondary endpoints. Ultimovacs is also investigating UV1 in ovarian cancer in the ongoing Phase II DOVACC trial, which evaluates a combination of olaparib and durvalumab +/- UV1 vs. olaparib alone as second-line maintenance treatment for patients with high-grade BRCA-negative ovarian cancer. Topline results are expected in the first half of 2025, well within the current financial runway, which reaches the fourth quarter of 2025.

Oslo, Norway-based Ultimovacs ASA is a pharmaceutical company (OSE ULTI) developing novel immunotherapies against cancer. The lead product candidate is UV1, a peptide-based vaccine inducing a specific T cell response against the universal cancer antigen telomerase and immune activation for a prostate cancer-specific therapeutic. The Company's clinical studies are listed here.

UV1 Cancer Vaccine Indication

The UV1 telomerase peptide vaccine has demonstrated robust immune response induction and promising clinical activity in several malignancies. Ultimovacs has a long-standing commitment to the development of UV1-based treatments for melanoma. Malignant melanoma is a skin cancer with a significant and unmet medical need for improved therapies. More than 130,000 new cases of melanoma are diagnosed worldwide every year, and an estimated 50,000 people die from metastatic melanoma every year.

UV1 Cancer Vaccine News

October 17, 2023 - "For patients with malignant mesothelioma, few treatment options are available after first-line chemotherapy. The NIPU study showed that patients receiving UV1 vaccination as an add-on to nivolumab and ipilimumab experienced an increased objective response rate and a clinically meaningful prolonged survival. These encouraging results provide a foundation for advancing further clinical development with UV1 vaccination in mesothelioma patients," said Principal Investigator of the NIPU clinical trial, Professor Åslaug Helland, MD, Ph.D.

October 12, 2023 - Jens Bjørheim, Chief Medical Officer at Ultimovacs, stated in a press release, "The UV1-103 study treats the same patient population as our Phase II study INITIUM. As we await data from the first three randomized UV1 Phase II trials in the near-term, we are increasingly optimistic about UV1's potential to benefit cancer patients."

June 19, 2023 - "We are very encouraged to observe a 67% overall survival rate at 3-year follow-up in this Phase I study, which treats the same patient population as our UV1 Phase II study, INITIUM. These data further strengthen the previously reported results from the study, including good safety for UV1 and a remarkable 33% complete response rate in patients with metastatic malignant melanoma where surgery is not an option. The data continue to show that UV1 in combination with pembrolizumab has promising signs of efficacy," said Jens Bjørheim, Chief Medical Officer at Ultimovacs. 

October 25, 2022 - Ultimovacs ASA announced that the first patient had been randomized in the LUNGVAC study. The study in non-small cell lung cancer is the fifth Phase II clinical trial in which UV1 is being investigated in combination with checkpoint inhibitors.

October 18, 2022 - Ultimovacs ASA presented clinical endpoints and biomarker results from patients in the UV1-103 Phase I trial.

June 30, 2022 - Ultimovacs ASA announces the completed recruitment of 154 patients in the INITIUM trial. INITIUM is Ultimovacs' Phase II clinical trial of its universal cancer vaccine UV1 combined with the checkpoint inhibitors ipilimumab and nivolumab in metastatic malignant melanoma. Consistent with INITIUM's event-driven design, topline progression-free survival results will be disclosed after the progression of cancer or death has been observed in 70 patients.

February 17, 2022 - Ultimovacs ASA announced its fourth-quarter 2021 results. A private placement was completed on October 26, 2021, raising gross proceeds of MNOK 270 (net MNOK 259.0).

December 15, 2021 - Ultimovacs ASA announced that the first patient had been enrolled in a randomized Phase II clinical trial (DOVACC) assessing the impact of the UV1 telomerase vaccine on ovarian cancer's standard of maintenance care. Topline data from DOVACC is expected in 2023.

December 2, 2021 - Ultimovacs ASA announced that the U.S. FDA had granted orphan drug designation for the Company's universal cancer vaccine UV1 to treat stage IIB – IV melanoma. UV1 is used as an add-on therapy to checkpoint inhibitors ipilimumab and nivolumab. UV1 is currently being studied as a first-line treatment for metastatic melanoma in a Phase II trial named INITIUM.

November 11, 2021 - Ultimovacs ASA announced its third-quarter 2021 results. Highlights for the third quarter of 2021: Ultimovacs reported that UV1 would be investigated in a Phase II clinical trial in combination with pembrolizumab in non-small cell lung cancer. A private placement was completed on 26 October 2021, raising gross proceeds of MNOK 270. Total cash and cash equivalents were reduced by MNOK32.9 during Q3-21 and amounted to MNOK 347.8 as of 30 September 2021.

November 9, 2021 - The Company announced UV1 vaccine combined with ipilimumab was found in a clinical trial to induce immune responses in 91% of melanoma patients. And the immune responses persist and are detectable for up to 5 years.

October 26, 2021 - Ultimovacs announced that UV1 would be investigated in a Phase II clinical trial with pembrolizumab in non-small cell lung cancer (NSCLC). The LUNGVAC trial will be a multi-center, randomized, open-label trial sponsored by Drammen Hospital, a leading oncology research center in Norway. The trial will enroll approximately 138 patients and be conducted at 8-10 clinical centers in Norway.

October 21, 2021 - Ultimovacs ASA announced its universal cancer vaccine, UV1, combined with checkpoint inhibitors, has received Fast Track designation from the U.S. FDA to treat unresectable or metastatic melanoma as an add-on therapy to pembrolizumab or as an add-on therapy to ipilimumab. Ultimovacs is evaluating UV1 as an add-on therapy to ipilimumab and nivolumab as first-line treatment for unresectable or metastatic melanoma in a Phase II study named INITIUM.

October 13, 2021 - Ultimovacs ASA announced continuing positive topline clinical trial results. The 24-month follow-up data compares favorably with an earlier large-scale study of pembrolizumab alone, which showed an overall survival rate of 58% after 24 months and median progression-free survival of 5.5-11.6 months.

August 20, 2021 - The Company posted the 'Enabling the Immune System to Fight Cancer' presentation - Encouraging results from the Phase I clinical trial of UV1 combined with pembrolizumab in malignant melanoma. And it announced its second-quarter 2021 results.

June 1, 2021 - Ultimovacs announced a peer-reviewed article published in The Journal of Translational Medicine that outlines the mechanistic rationale for combining UV1 with two checkpoint inhibitors, ipilimumab and nivolumab. The dual use of ipilimumab and nivolumab was recently approved as first-line therapy in malignant pleural mesothelioma (MPM), with few therapeutic options available. However, Haakensen et al. explain in the article that observed response rates with checkpoint inhibitors have been moderate in MPM compared to documented performance for the combination of checkpoint inhibitors in other cancers, suggesting that checkpoint inhibitors alone may be insufficient to trigger an immune response.

May 11, 2021 - Ultimovacs ASA announced the publication in Frontiers in Immunology of its positive long-term Overall Survival data from the Phase I trial evaluating the Company's universal cancer vaccine, UV1, in combination with checkpoint inhibitor ipilimumab in patients with metastatic malignant melanoma. As published in the journal, in addition to the achievement of the primary endpoints of safety and tolerability, 50% of the patients were still alive at the data cut-off, supporting the combination of the Company's proprietary UV1 vaccine with ipilimumab, a CTLA-4 checkpoint inhibitor, and standard-of-care treatment, in this late-stage patient population.

December 22, 2020 - Ultimovacs ASA - Initiates FOCUS Phase II Trial for Universal Cancer Vaccine, UV1, Head and Neck Cancer Patients Receiving Pembrolizumab. The FOCUS trial is Ultimovacs' fourth Phase II clinical trial with UV1 and comes in addition to the collaboration Phase II trial announced in May 2020.

February 4, 2020 - Study: Combining UV1 and ipilimumab is safe and induces clinical melanoma responses. The high proportion of immunological responders and early induction of detectable immune responses suggest synergism.

UV1 Cancer Vaccine Clinical Trials

UV1 has been tested in several clinical trials, maintaining a positive safety and tolerability profile and encouraging efficacy signals.

The phase II clinical trial results, NIPU, were published in the European Journal of Cancer. The open-label, multi-center Phase II trial was sponsored by Oslo University Hospital with support from Bristol-Myers Squibb and Ultimovacs. The study did not meet its primary endpoint of improved progression-free survival (PFS) based on blinded independent central review (BICR). Analyses on the secondary endpoints, objective response rate (ORR) by BICR and overall survival (OS), showed a significant benefit of adding the UV1 vaccine to ipilimumab and nivolumab. Local assessment demonstrated an improved PFS among patients in the vaccine arm for all histological subtypes combined, and new subgroup analysis shows further improvement for the epithelioid subtype. The epithelioid subtype represents approximately 70% of all patients with mesothelioma. The safety profile confirms the good safety profile for the UV1 vaccine.

Building on Phase I results, Ultimovacs is enrolling INITIUM, its Phase II clinical trial evaluating UV1 combined with ipilimumab and nivolumab in patients with metastatic malignant melanoma. The Company expects to announce the trial's primary endpoint data in 2H2022. In addition, Ultimovacs has an ongoing and fully-enrolled Phase I trial evaluating UV1 combined with pembrolizumab, a PD-1 checkpoint inhibitor, as a first-line treatment in metastatic malignant melanoma patients. Ultimovacs anticipates announcing data on the primary endpoints for the NIPU and INITIUM studies in 2H2022 and the DOVACC and FOCUS studies in 2023.

Clinical analyses from the UV1-103 study announced on October 18, 2022, indicate efficacy in patients with low levels of PD-L1, a critical predictive biomarker associated with lower efficacy for pembrolizumab and other anti-PD-1 therapies in some tumor types. In addition, the analyses showed robust responses in patients treated with the combination of UV1 and pembrolizumab, regardless of patients' PD-L1 status. In addition to the sub-analysis of the PD-L1 status, the study also evaluated four other key predictive biomarkers, including baseline tumor mutational burden (TMB), predicted neoantigens, interferon-gamma (IFN-gamma) gene signature, and levels of tumor-infiltrating lymphocytes. The analyses of these five biomarkers signal efficacy in patients treated with UV1 in combination with pembrolizumab, regardless of the tumor phenotype.

On October 12, 2023, Ultimovacs announced encouraging overall survival data from cohort 1 in the UV1-103 Phase I clinical trial in malignant melanoma. No further deaths have been reported among the patients in cohort 1 who were alive at the 3-year follow-up, reaffirming an encouraging trend of durable overall survival benefit from UV1 vaccination. Ultimovacs has previously reported data showing a complete response rate in the UV1-103 study of 33% (complete disappearance of tumors) and an objective response rate of 57% (full or partial disappearance of tumors). On October 17, 2023, the first demonstration of universal cancer vaccine efficacy and therapeutic impact in a randomized Phase II clinical trial supported further clinical development. The UV1 cancer vaccination combined with ipilimumab and nivolumab reduced the risk of death by 27%, meeting the protocol predefined threshold for statistical significance in a hard-to-treat patient group with currently no standard-of-care treatment options. 

Ultimovacs ASA - positive topline results from the first cohort of 20 patients in its ongoing US-based Phase I clinical trial evaluating the Company's lead candidate, UV1, combined with a PD-1 checkpoint inhibitor, pembrolizumab, as a first-line treatment in patients with metastatic malignant melanoma. The results confirm the achievement of the primary safety and tolerability endpoints and indicate initial signs of clinical response.

UV1 is being tested in different randomized Phase II trials: The INITIUM trial is an Ultimovacs-sponsored, global, randomized Phase II trial for patients with metastatic malignant melanoma; The NIPU trial is a randomized, multi-center Phase II trial in which the universal cancer vaccine, UV1, is investigated in combination with the checkpoint inhibitors, ipilimumab, and nivolumab, as second-line treatment in mesothelioma. In addition, a third Phase II clinical trial will evaluate UV1 in a new cancer indication combined with indication-specific standard-of-care cancer therapies different from those tested in INITIUM (malignant melanoma, 154 patients) and NIPU (mesothelioma, 118 patients).

Sinovac PPV23 Pneumococcal Vaccine Description

Sinovac Biotech Ltd.'s PPV23 Vaccine consists of 23 pneumococcal serotypes that are most frequently found in China. It was authorized in China in December 2020. The new PPV23 vaccine is immunologically non-inferior to the control commercial vaccine and well-tolerated in a healthy Chinese population. The China National Medical Products Administration (NMPA) approved and issued a Product license for the Company’s 23-Valent Pneumococcal Polysaccharide (“PPV”) Vaccine to prevent the infection by streptococcus pneumonia in adults and children ages 2 years old and above.

Sinovac started to research and develop the 23-valent pneumococcal polysaccharide vaccine in 2009, completed pre-clinical studies in 2011, and was approved to conduct human clinical trials in May 2014. A phase III non-inferiority study conducted in 2015 demonstrated a good safety and immunogenicity profile, and non-inferiority of immunogenicity of all 23 serotypes was observed, which was published in the Human Vaccines and Immunotherapeutics medical journal.

Mr. Weidong Yin, Chairman, President, and CEO of Sinovac, issued a comment on January 9, 2021, “The approval of our pneumococcal vaccine allows us to provide another high-quality product to address unmet medical needs for the Chinese population. In addition, this is our first bacterial vaccine product approved so far, broadening the potential of the company’s product portfolio.”

Streptococcus pneumoniae (S. pneumoniae) is a major cause of illness and death in children and adults worldwide, causing invasive pneumococcal diseases (IPDs), including bacteremic pneumonia, meningitis, and septicemia; or noninvasive diseases including non-bacteremic pneumonia, otitis media, and sinusitis. In addition, 91 distinct pneumococcal serotypes have been identified, and infection or vaccination with S. pneumoniae can induce specific protective antibodies that exhibit cross-protection against certain serotypes, says the U.S. CDC.

As of 2019, 152 countries have fully or partially introduced routine PCV immunization of infants, while 42 countries have not yet introduced PCV, stated the WHO.

Sinovac Biotech Ltd. is a China-based biopharmaceutical company that focuses on researching, developing, manufacturing, and commercializing vaccines that protect against human infectious diseases.

Sinovac PPV23 Pneumococcal Vaccine Indication

Sinovac's 23-Valent Pneumococcal Polysaccharide (“PPV”) Vaccine is indicated to prevent the infection by streptococcus pneumonia in adults and children ages 2 years old and above. There are at least 94 serologically distinct pneumococcal serotypes that have been identified. The distribution of these serotypes varies significantly between countries and populations. In Europe, the most frequent serotypes are 1, 3, 7F, 14 and 19A,4,5 while in China, 19F, 23F, 19A, 6B, 14, 6A and 15B are most frequent.

Sinovac PPV23 Pneumococcal Vaccine News

January 9, 2021 - Sinovac announced that the China National Medical Products Administration has approved and issued a Product license for the Company’s 23-Valent Pneumococcal Polysaccharide Vaccine to prevent the infection by streptococcus pneumonia in adults and children ages 2 years old and above.

December 9, 2020 - Sinovac Announces Product License for 23-Valent Pneumococcal Polysaccharide Vaccine. Mr. Weidong Yin, Chairman, President, and CEO of Sinovac, commented, “The approval of our pneumococcal vaccine allows us to provide another high-quality product to address unmet medical needs for the Chinese population. In addition, this is our first bacterial vaccine product approved so far, broadening the potential of the company’s product portfolio.”

September 21, 2018 - Research paper: A phase III clinical trial to evaluate the safety and immunogenicity of 23-valent pneumococcal polysaccharide vaccine (PPV23) in healthy children, adults, and the elderly. The newly Sinovac PPV23 is immunologically non-inferior to the control commercial vaccine and well-tolerated in a healthy Chinese population aged ≥ 2 years. However, antibody persistence and efficacy studies are needed to guide the vaccine application further.

April 30, 2018 - Sinovac Biotech Ltd. announced it had been forced to destroy the bacterial seeds intended for use in the production of its 23-valent pneumococcal polysaccharide vaccine, or PPV, and to suspend all preparations for and ultimately postpone the China Food and Drug Administration inspection of the manufacturing site necessary for 23-valent PPV production approval.

September 16, 2015 - Immunogenicity and safety of a 23-valent pneumococcal polysaccharide vaccine in Chinese healthy population aged >2 years: A randomized, double-blinded, active control, phase III trial.

March 3, 2011 - Sinovac announced it applied to commence clinical trials for its 13-valent pneumococcal conjugate vaccine to China's State Food and Drug Administration on March 3, 2011. Sinovac initiated its PCV research program in 2008. The vaccine targets infants under two years old in China and is estimated at 34 million.

Sinovac PPV23 Pneumococcal Vaccine Clinical Trials

Clinical Trial NCT02451969: Safety and Immunogenicity Study of 23-valent Pneumococcal Polysaccharide Vaccine in Healthy Children, Adults, and Elderly - Last Update Posted: May 3, 2017. This phase 3 study is a randomized, double-blind, single-center, controlled clinical trial. The purpose of this study is to evaluate the immunogenicity and safety of an investigational 23-valent pneumococcal polysaccharide vaccine (PPV) manufactured by Sinovac Biotech Co., Ltd. This study's primary objective is to demonstrate that the investigational vaccine's immunogenicity is non-inferior to that of a commercialized 23-valent PPV manufactured by Chengdu Institute of Biological Products Co., Ltd; the secondary objective is to assess the safety of the investigational and control vaccines. Participants will be grouped into three cohorts by age: child cohort (2 - 17 years old), adult cohort (18 - 60 years old), and elderly cohort (≥ 61 years old). In each cohort, the participants will be randomly assigned to the experimental group or control group in the ratio of 1:1.

Observed Results

Human Vaccines and Immunotherapeutics published the results on September 21, 2018. The newly Sinovac PPV23 is immunologically non-inferior to the control commercial vaccine and well-tolerated in a healthy Chinese population aged ≥ 2 years. The antibody persistence and efficacy studies are needed to guide the vaccine application further.