Vaccine News

According to the recent Nationally Notifiable Infectious Diseases and Conditions weekly report, the number of mpox cases in the United States has more than doubled compared to Week #15 in 2023.

As of April 13, 2024, 750 mpox cases had been reported, compared to 336 cases at the same time last year.

The U.S. CDC highlights New York City (151), California (72), and Texas (55) as mpox case leaders.

The U.S. Health and Human Services (HHS) was initially charged with coordinating the federal response to the mpox outbreak. According to the General Accountability report issued on April 18, 2024, HHS is recommended to adopt a coordinated, department-wide program that incorporates input from external stakeholders to identify and resolve challenges.

In the United States, Bavarian Nordic's JYNNEOS® vaccine was initially offered to healthcare staff in Boston on May 24, 2022.

Since then, over 1.2 million (1-dose: 38.8% and 2-dose: 24.3%) JYNNEOS doses have been administered in U.S. Jurisdictions. 

As of April 2024, JYNNEOS remains the only FDA-approved non-replicating smallpox and mpox vaccine for military and non-military use and has recently become commercially available at U.S. pharmacies.

Various media sources reported Merck would only supply 18.8 million HPV vaccine doses to Gavi-supported countries in 2024. Merck had previously promised to supply 29.6 million doses.

According to the Peoples Gazette, on April 19, 2024, Merck spokesman Patrick Ryan said the company "experienced a manufacturing disruption," requiring it to hold and check numerous doses manually.

Ryan disclosed that Burundi, Tajikistan, Mozambique, Sierra Leone, Ivory Coast, and Burkina Faso will not receive HPV vaccines in 2024.

By the end of 2022, 32 countries had successfully launched their HPV vaccine national program with Gavi support, fully immunizing more than 16.3 million girls since 2014.

GAVI says HPV vaccination is critical to reducing cervical cancer, especially in lower-income countries with a high disease burden and less developed cervical cancer screening and treatment programs.

On March 13, 2024, Merck announced plans to initiate clinical development of a new investigational multi-valent HPV vaccine designed to provide broader protection against multiple HPV types.

Separately, the company also plans to conduct clinical trials in both females and males to evaluate the efficacy and safety of a single-dose regimen of the GARDASIL®9 vaccine compared to the approved three-dose regimen.

"Evidence continues to emerge showing the importance of GARDASIL and GARDASIL 9 to public health," said Dr. Eliav Barr, senior vice president, head of global clinical development, and chief medical officer, Merck Research Laboratories, in a press release.

"These significant investments build upon our leadership and, importantly, provide the opportunity to further impact the global burden of certain HPV-related cancers and diseases."

The latest addition to Merck's pipeline employs the company's proprietary virus-like particle (VLP) technology to incorporate additional VLPs for expanded HPV-type coverage.

This includes several types known to have a greater impact on African and Asian populations and individuals of African and Asian descent. First-in-human phase 1 clinical studies are scheduled to start in the fourth quarter of 2024.

In the U.S., HPV vaccines remain available at clinics and pharmacies in 2024.

While measles outbreaks have been reported in dozens of countries in 2024, recent attention has focused on the cities of Chicago and London.

The U.K. Health Security Agency (UKHSA) published an updated epidemiological overview on April 18, 2024, stating that an additional 86 cases of measles were confirmed in England last week.

This data brings the total number of confirmed cases since October 2023 to 1,109.

About 39% of the U.K.'s measles cases (76 of 191) were in London during the last four weeks.

In a press release, Dr. Vanessa Saliba, UKHSA Consultant Epidemiologist, commented, "We know some communities in London have very low measles-mumps-rubella (MMR) vaccination rates. The MMR jab offers the best protection against measles."

The effective Priorx MMR vaccine is generally available at clinics and pharmacies in England. However, no measles-only vaccines are offered in England.

In the U.S., the Centers for Disease Control and Prevention (CDC) reported 121 measles cases in eighteen jurisdictions in 2024.

Most of these cases (61) have been reported by the Chicago Department of Public Health over the past two months.

The U.S. CDC republished a global Watch-Level 1, Practice Usual Precautions, Travel Health Notice in March 2024, alerting international travelers of potential health risks and identifying measles outbreaks in 49 countries.

The CDC recommends speaking with a travel vaccine consultant one month before traveling abroad to any outbreak countries.

According to Quebec's National Institute of Excellence in Health and Social Services (INESSS), there will be an increasing demand for emergency services in 2024, which shows the need for all infants to be protected from Respiratory Syncytial Virus (RSV).

As of April 18, 2024, INESSS recommends BEYFORTUS® to prevent RSV lower respiratory tract disease (LRTD) in all neonates and infants aged eight months. 

BEYFORTUS (Nirsevimab-alip) is not a vaccine but is the first approved single-dose, extended half-life monoclonal antibody offering passive immunization in children.

Furthermore, the INESSS Standing Committee on Deliberation—Reimbursement and Access unanimously agrees that BEYFORTUS provides significant clinical benefits compared to placebo in reducing lower respiratory tract infections that require medical assistance and hospitalization due to RSV infection in the healthy, full-term, or premature pediatric population during the first RSV season.

The Committee also recognizes the therapeutic value of BEYFORTUS in the population for whom the risk of developing a serious infection persists for a second RSV season.

Sanofi Canada confirmed it is working with Quebec provincial authorities to make BEYFORTUS available to a broad cohort of infants for the 2024-25 RSV season.

Delphine Lansac, General Manager, Vaccines Canada, Sanofi, stated in a press release, "Parents and physicians who experience the impacts of RSV annually have been waiting for a preventative option that can cover the entire infant population and protect our most vulnerable."

"I believe every baby deserves to be protected against RSV and this recommendation for BEYFORTUS marks an important milestone towards achieving that goal in Quebec. Now is the time to protect all infants against this devastating illness."

Health Canada issued a Notice of Compliance for BEYFORTUS in April 2023. Additionally, it was approved by the U.S. FDA, China, Japan, the European Union, and Great Britain.

A vaccine to prevent chlamydia infections is considered an important measure to control sexually transmitted and ocular infections.

Chlamydia trachomatis is the most common sexually transmitted bacterial infection worldwide, says the U.S. CDC.

As of April 2024, there is no vaccine against the major global pathogen Chlamydia trachomatis; its different serovars cause trachoma in the eye or chlamydia in the genital tract. 

However, significant research and investment have been made towards developing a chlamydial vaccine, but it has been quite some time since a successful phase 1 trial, commented Wilhelmina Huston, with the School of Life Sciences, University of Technology, Sydney, Australia, in an editorial published by The Lancet.

According to results from a phase 1 study (CHLM-02), Statens Serum Institut's CTH522, adjuvanted with CAF01 or CAF09b, is safe and immunogenic. 85 μg CTH522-CAF01 induces robust serum IgG binding titers.

Intradermal vaccination conferred systemic IgG neutralization breadth, and topical ocular administration increased ocular IgA formation. By day 42, the active groups had a 100% four-fold seroconversion rate, while the placebo group had no seroconversion.

The participants were healthy men and non-pregnant women aged 18–45 years without pre-existing C trachomatis genital infection.

Participants were randomly assigned (1:1:1:1:1) to each of the groups A–E, which received an investigational medicinal product, and group F received a placebo only.

Two liposomal adjuvants, CAF01 and CAF09b, were compared.

Serum IgG anti-CTH522 titers were higher after 85 μg CTH522-CAF01 than 15 μg, although not significantly, with no difference after three injections of 85 μg CTH522-CAF01 compared with CTH522-CAF09b (group E).

Intradermal CTH522 (group C) induced high titers of serum IgG anti-CTH522 neutralizing antibodies against serovars B (trachoma) and D (urogenital).

Topical ocular CTH522 (group B) at days 28 and 112 induced higher total ocular IgA compared with baseline (p<0·001).

Participants in all active vaccine groups, particularly groups B and E, developed cell-mediated immune responses against CTH522.

These findings published by The Lancet indicate the CTH522 vaccine candidate's regimens against ocular trachoma and urogenital chlamydia for testing in phase 2 clinical trials.

This phase 1, double-blind, randomized, placebo-controlled trial was conducted at the National Institute for Health Research Imperial Clinical Research Facility in the U.K.

As of April 17, 2024, the U.S. FDA, the U.K., and the European Medicines Agency have not approved a vaccine to prevent chlamydia infections.

However, Sanofi's multi-antigen chlamydia vaccine candidate is planning a Phase 1/2 study in 2024.

A global biopharmaceutical company developing a new class of transformative medicines based on messenger ribonucleic acid (“mRNA”) announced today a co-development and licensing agreement with The University of Texas MD Anderson Cancer Center to develop novel mRNA-based cancer vaccines.

CureVac N.V. stated in a press release on April 16, 2024, that the collaboration creates strong synergies between its unique end-to-end capabilities for cancer antigen discovery, mRNA design, and manufacturing and MD Anderson’s expertise in cancer antigen discovery and validation, translational drug development, and clinical research.

The collaboration will focus on developing differentiated cancer vaccine candidates in selected hematological and solid tumor indications with high unmet medical need.

Following the selection of the most promising validated vaccine candidates and the completion of Investigational New Drug approvals, Houston, Texas-based MD Anderson will be responsible for conducting initial Phase 1/2 studies in appropriate clinical indications.

“We look forward to collaborating with the team at MD Anderson to push the boundaries of mRNA technology and develop impactful therapeutic options for patients in need,” commented Dr. Alexander Zehnder, Chief Executive Officer of CureVac.

“By combining our respective expertise, we believe we can go further and faster in developing novel, off-the-shelf, mRNA-based cancer vaccines that have the potential to improve patient outcomes significantly.”

Both parties will contribute to identifying differentiated cancer antigens based on whole genome sequencing, combined with long- and short-read RNA sequencing and cutting-edge bioinformatics. 

Despite the expenditure of over $3 billion to fight malaria outbreaks since 2021, the world still witnessed an estimated 600,000 malaria deaths and 247 million clinical malaria cases.

To address malaria outbreaks in Africa, new vaccines have recently been deployed.

The Mosquirix™ RTS,S/AS01E malaria vaccine (RTS,S) was introduced in 2019 by national immunization programs in Ghana, Kenya, and Malawi. Researchers aimed to address questions about feasibility and impact, as well as assess safety signals observed during the phase 3 clinical trial.

In a prospective evaluation published by The Lancet on April 4, 2024, the three primary doses were effectively deployed during the first two years of implementation of RTS,S.

There was no evidence of the safety signals that had been observed in the phase 3 trial, and the introduction of the vaccine was associated with substantial reductions in hospital admissions with severe malaria.

This evaluation continues to assess the impact of four doses of Mosquirix.

This study was funded by Gavi, the Vaccine Alliance, the Global Fund to Fight AIDS, Tuberculosis, and Malaria, and Unitaid. No industry conflicts were disclosed.

In addition to RTS,S, the R21/Matrix-M™ malaria vaccine, co-produced by scientists at the University of Oxford, Novavax AB, and Novavax Inc., has been offered in Africa in 2024.

As of April 2024, the U.S. Food and Drug Administration had not approved either malaria vaccine.