Vaccine News

The World Health Organization (WHO) has reported a critical shortage of Oral Cholera Vaccines (OCV), which is affecting cholera outbreak responses.

As of May 16, 2024, the WHO's External Situation Report #14 classified the global resurgence of Cholera as a grade 3 emergency, its highest internal level for emergencies, due to the increasing number of outbreaks and their geographic spread, as well as the shortage of vaccines and other resources, 

Since January 2023, OCV requests have surged, with 15 countries requesting 82 million doses, nearly double the 46 million doses produced during this period.

As of early May 2024, the OCV vaccine stockpile had 3.2 million doses, below the global target of five million.   

From January 2024 to April 2024, a cumulative total of 145,900 cholera cases and 1,766 deaths were reported from 24 countries across five WHO regions.

No cholera outbreaks were reported in the United States.

The U.S. CDC says Cholera is an infection of the intestines caused by the bacterium Vibrio cholerae. You can get Cholera from drinking water or eating food containing cholera bacteria.

Most people who get Cholera don't get sick. However, Cholera can cause life-threatening watery diarrhea and vomiting.

As of May 2024, there are various OCVs available.

Two doses of OCV protect against Cholera for at least three years. Since October 2022, only one dose of vaccine has been used in outbreak response, offering protection for about a year.

In the U.S., cholera vaccines are generally available at travel clinics and certified pharmacies.

Eisai Co., Ltd. and Biogen Inc. recently announced the initiation of a rolling submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for LEQEMBI® subcutaneous autoinjector for weekly maintenance dosing. 

According to the company's press release on May 14, 2024, the injection process requires less time than the intravenous (IV) formulation.

If approved by the FDA, the LEQEMBI autoinjector could be used to administer LEQEMBI at home or medical facilities.

LEQEMBI (lecanemab-irmb) is a humanized immunoglobulin gamma 1 monoclonal antibody. It is indicated for the treatment of Alzheimer's disease (AD) in patients with Mild Cognitive Impairment or mild dementia stage of disease.

LEQEMBI is now approved in the U.S., Japan, and China, and applications have been submitted for review in the European Union, Australia, Brazil, Canada, Hong Kong, Great Britain, India, Israel, Russia, Saudi Arabia, South Korea, Taiwan, Singapore and Switzerland.

Previously, Eisai submitted a Supplemental BLA for monthly LEQEMBI IV maintenance dosing to the FDA in March 2024.

According to the Alzheimer's Association's Alzheimer's Disease Facts and Figures, an estimated 6.5 million Americans aged 65 and older live with dementia due to AD.

As of May 16, 2024, the FDA has not approved a vaccine that prevents AD.

An analysis published in the journal Travel Medicine and Infectious Disease revealed that 86% of travelers diagnosed with chikungunya virus (CHIKV) infection over two years experienced joint pain, significantly impacting their quality of life.

Furthermore, 42.6% of patients with chronic arthralgia reported a recurrence of symptoms once they felt they had disappeared. 

Published on May 15, 2024, this study underscores the need for comprehensive pre-travel advice and the effective management of patients enhancing outcomes.

Additionally, an in-depth knowledge of this disease is essential for early identification, particularly in non-endemic areas with competent mosquito vectors for virus transmission. 

The World Health Organization says CHIKV was identified in nearly 115 countries in 2024, primarily in the Region of the Americas. In 2024, over 160,000 CHIKV cases and 50 deaths have been reported worldwide.

In the United States, the U.S. FDA-approved IXCHIQ® single-dose chikungunya vaccine is awaiting a commercial release in 2024.

Blackstone today announced the launch of the Blackstone Life Sciences portfolio company Uniquity Bio, a clinical-stage drug development company focused on immunology and inflammation.

Uniquity Bio launches with the U.S. FDA's acceptance of its Phase 2 investigational new drug application for solrikitug, a monoclonal antibody targeting TSLP.

Solrikitug is a highly potent anti-TSLP monoclonal antibody that prevents the binding of TSLP to its receptors. Given TSLP's position as the "master switch" cytokine at the top of the inflammatory cascade, solrikitug could have potential utility in various immunology and inflammation programs.

Solrikitug was in-licensed from Merck & Co., Inc.

Up to $300 million in capital from Blackstone will advance Solrikitug in multiple indications.

"Our investment in Uniquity Bio illustrates Blackstone Life Sciences' commitment to finding, developing, and delivering potentially transformative medicines to patients around the world," said Nicholas Galakatos, Ph.D., Global Head of Blackstone Life Sciences, in a press release on May 15, 2024.

"We are proud to partner with Uniquity's team of veteran industry leaders as they advance solrikitug and expand their immunology and inflammation pipeline with additional programs in the near future."

The company aims to deliver best-in-class efficacy with solrikitug across several critical respiratory and GI indications with significant unmet needs. In the next month, Uniquity Bio will launch Phase 2 clinical trials in chronic obstructive pulmonary disease — the third leading cause of death worldwide, according to the World Health Organization — and asthma, which the WHO estimates affects more than 260 million people across the globe.

Dynavax Technologies Corporation today announced a regulatory update for the Company's supplemental Biologics License Application (sBLA) to include a four-dose HEPLISAV-B® vaccine regimen for adults on hemodialysis.

Hemodialysis is a renal replacement therapy in which a machine filters a patient's blood when the kidneys are no longer able to do so.

The U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) in response to the sBLA, stating that the application did not provide sufficient data to support the full evaluation of the effectiveness or safety of a four-dose regimen of HEPLISAV-B.

The CRL stated that the data from HBV-24 were insufficient due to the destruction of data source documents by a third-party clinical trial site operator for approximately half of the subjects enrolled in the trial. In addition, the total number of subjects in the single-arm HBV-24 study was deemed insufficient to evaluate the safety of the four-dose regimen.

The CRL does not affect the approval decision received from the European Commission in October 2023 for the four-dose HEPLISAV-B regimen for the adult hemodialysis population.

The CRL also has no impact on the approved indication for HEPLISAV-B in the U.S., the European Union, and Great Britain, which is for the prevention of infection caused by all known subtypes of hepatitis B virus in adults.

"We remain confident in the data generated to support HEPLISAV-B vaccination for adult hemodialysis patients. All key data collected in HBV-24 were verified against original source documents during the conduct of the trial," said Rob Janssen, M.D., Chief Medical Officer of Dynavax, in a press release on May 14, 2024.

"We are reviewing the agency's feedback and intend to request a meeting with the FDA to evaluate options for providing additional data to support the four-dose regimen for this vulnerable patient population in the U.S."

On May 9, 2024, the Company announced HEPLISAV-B vaccine net product revenue grew 10% year-over-year to approximately $48 million in the first quarter of 2024. It also reaffirmed the full-year 2024 HEPLISAV-B net product revenue guidance of $265 - $280 million.

Although several countries have adopted a single-dose human papillomavirus (HPV) vaccination strategy, many other countries, such as the United States, continue to include multiple doses in their vaccination programs.

As of May 2024, six vaccines are authorized globally to protect males and females against cancers caused by HPV.

According to an article published by the Lancet Infectious Diseases on May 8, 2024, there are ethical reasons to transition to a single-dose strategy.

These scientists discuss how a single-dose HPV vaccination strategy advances equity in three dimensions: vaccine equity, health equity, and gender equity.

Adopting a single-dose strategy eases pressure on vaccine supply, lowers program costs, and is easier to distribute.

This change facilitates vaccine procurement and implementation programs (contributing to vaccine equity) and reaching hard-to-reach people or populations (contributing to health equity).

A lower number of cases of HPV-related diseases that stem from greater vaccine distribution reduces the burden on women, who are at a higher risk of HPV-related disease or who act as caregivers, which prevents them from accessing opportunities that contribute to their empowerment (contributing to gender equity).

Thus, these scientists wrote that pursuing the single-dose HPV vaccination program strategy is ethically desirable.

In April 2022, WHO's Strategic Advisory Group of Experts on Immunization concluded that a single-dose HPV vaccine delivers virus protection comparable to 2-dose schedules.

In the U.S., the Centers for Disease Control and Prevention (CDC) HPV vaccination has been recommended for women since 2006 and for men since 2011. Current CDC HPV vaccination schedules were updated in 2023.

The world's first and only licensed chikungunya vaccine today presented further positive pivotal Phase 3 data in adolescents.

On May 13, 2024, Valneva SE announced following the initial analysis up to Day 29 post-vaccination, the most recent analysis of study VLA1553-321 evaluated the safety and immunogenicity six months after vaccination with a single dose of the chikungunya virus (CHIKV) vaccine IXCHIQ®.

The Day 180 results confirm the initial positive immunogenicity and safety data Valneva reported previously and are intended to support filing for potential label extension for use in adolescents aged 12 to 17 years.

The data are also expected to support the licensure of IXCHIQ® in Brazil, which would be the first potential approval for use in endemic populations.

The U.S. FDA approved IXCHIQ in November 2023, and the Centers for Disease Control and Prevention (CDC) recently adopted the Advisory Committee on Immunization Practices' recommendations on the use of the vaccine in the U.S.

Juan Carlos Jaramillo, M.D., Chief Medical Officer of Valneva, said in a press release, "We are highly encouraged by these data, as they reinforce the strong immunity and safety observed in adults and the elderly, upon which FDA approval was granted."

"Given the substantial risk that chikungunya presents to individuals residing in or traveling to endemic regions, it's imperative to ensure the vaccine is available to all age groups. This broader accessibility can help provide protection and mitigate the burden of this debilitating illness."

Three marketing applications are under review by the European Medicines Agency, Health Canada, and the Brazilian Health Regulatory Agency, with potential approvals in 2024. 

The CDC recently issued an updated Level 2 Travel Health Advisory confirming chikungunya vaccination is recommended for adults traveling to a destination with a current CHIKV outbreak.