Cancer Vaccine Breaking News

Takeda and Biological E. Limited today announced a strategic partnership to accelerate access to QDENGA® (Dengue Tetravalent Vaccine [Live, Attenuated]) multi-dose vials (MDVs).

MDVs offer economic and logistical advantages for National Immunization Programs by minimizing packaging and storage expenses and reducing medical and environmental waste.

These doses will ultimately be made available for government procurement in dengue-endemic countries by 2030 to support National Immunization Programs.

"Takeda's long-term goal for our dengue program has been to make QDENGA broadly available to those at risk who may benefit from immunization. Within the last year, we've successfully launched in private markets, are now launching in some public programs, and working with partners to support a broader public health impact," said Gary Dubin, M.D., president of the Global Vaccine Business Unit at Takeda.

According to the press release on February 27, 2024, BE will ramp up to a manufacturing capacity of up to 50 million doses a year, accelerating Takeda's efforts to manufacture 100 million doses annually within the decade.

The partnership will build upon existing manufacturing capacity for the vaccine at Takeda's facility in Singen, Germany, and Takeda's long-term collaboration with IDT Biologika GmbH.

Dengue fever is among the most common mosquito-borne viral diseases worldwide. Dengue is endemic in more than 100 countries and causes an estimated 390 million infections yearly.

The Americas, Southeast Asia, and Western Pacific regions are the most seriously affected, with Asia alone representing ~70% of the global disease burden.

In 2024, the state of Florida reported two cases of locally acquired dengue from two counties. In 2023, positive samples from 186 humans were reported from five counties.

QDENGA is currently available in the private market in countries in Europe, Indonesia, and Thailand and in private and some public programs in Argentina and Brazil.

As of late February 2024, QDENGA is not approved by the U.S. FDA.

The U.S. Centers for Disease Control and Prevention (CDC) has confirmed Gonorrhea can be cured with the proper treatment for several years.

However, in 2024, the bacteria causing Gonorrhea is recognized by the World Health Organisation as a priority pathogen, for which resistance to existing treatments is rising.

According to industry news, an innovative product may offer better options than the CDC's recommended therapy (ceftriaxone).

GSK plc announced on February 26, 2024, that they had obtained positive headline results from the pivotal EAGLE-1 phase III trial for gepotidacin.

The clinical trial met its primary efficacy endpoint, with gepotidacin (oral, two doses of 3,000mg) demonstrating non-inferiority to intramuscular (IM) ceftriaxone (500mg) plus oral azithromycin (1,000mg), which is a leading combination treatment regimen for Gonorrhea.

Gepotidacin is a potential first-in-class oral antibiotic that has a novel mechanism of action for treating uncomplicated urogenital Gonorrhea in adolescents and adults.

In a press release, Chris Corsico, Senior Vice President, Development at GSK, said, "With rising incidence rates and concern around growing resistance to existing treatments, Gonorrhea threatens public health globally."

"These positive headline results demonstrate the potential for gepotidacin to provide a novel oral treatment option in the face of rising resistance and for patients who cannot take other treatments due to allergies or intolerance."

Detailed results from the EAGLE-1 trial will be presented at an upcoming scientific meeting and shared with global health authorities.

Gonorrhoea is a sexually transmitted infection caused by bacteria called Neisseria gonorrhoeae. It has been estimated that there are 82 million new cases globally each year.

Recently, repurposed vaccines have shown effectiveness against Gonorrhoea, while vaccine candidates conduct late-stage studies.

It has been reported by local media that the new Pfizer COVID-19 vaccine is now available at some pharmacy chains in Mexico.

According to Mexico News Daily, certain branches of Farmacias del Ahorro, Farmacias Benavides, Farmacias San Pablo, and Farmacias Guadalajara, among others, offer nurse-administered vaccinations.

As of February 20, 2024, Pfizer's updated Comirnaty Omicron XBB 1.5 vaccine costs between $49.78 to $58.65.

The Mexican health regulatory agency authorized the sale of Pfizer's vaccine in December 2023.

While the global dengue outbreak continues in 2024, many parts of the Americas are at risk. A trendy vacation destination in Central America reports a significant surge in dengue cases this year.

According to the Costa Rica Ministry of Health, there have been 4,787 confirmed cases of dengue during the first six reporting periods of this year.

As of February 23, 2024, Costa Rica's Central North region concentrates the highest accumulated notification of dengue cases this year with 1,228 cases, followed by the Central Pacific with 832 and the Central South with 762 cases.

During 2023, there were over 24,914 dengue cases, an increase from the 7,485 dengue patients in 2022.

To alert international travelers of this mosquito-transmitted health risk, Costa Rica was included in the U.S. CDC's Level 1 - Practice Usual Precautions, dengue notice on February 09, 2024.

The Ministry of Health has called on the population to constantly clean and empty the containers in which water is stored for domestic use. Likewise, residents are urged to collaborate with our officials when they visit your homes for fumigation, presenting proper identification.

The Vector Control Program team recently carried out 16,645 fumigations in the towns of La Carpio, Pavas, and Alajuela.

As of 2024, the Dengvaxia® vaccine was sold in private pharmacies in Costa Rica. The price is around $130. 

However, the second-generation QDENGA® dengue vaccine is not offered in Costa Rica.

Bavarian Nordic A/S, a leading pharmaceutical company, announced news today regarding its investigational chikungunya vaccine, CHIKV VLP.

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has granted accelerated assessment for this chikungunya vaccine candidate's Marketing Authorisation Application (MAA).

The CHMP has recognized that the vaccine candidate is of significant interest to public health and therapeutic innovation. 

With this positive development, the company is taking steps toward addressing the unmet medical needs of millions worldwide affected by the Chikungunya virus.

Chikungunya outbreaks continue to be reported in 2024.

Before 2013, chikungunya virus cases and outbreaks had been identified in countries in Africa, Asia, Europe, and the Indian and Pacific Oceans. In late 2013, the first local transmission of chikungunya virus in the Americas was identified in Caribbean countries and territories, according to the U.S. CDC.

Bavarian Nordic also confirmed on February 23, 2024, that it is on track to submit its MAA for CHIKV VLP to the EMA during H1 2024. As a result, the review of the MAA may now take as little as 150 days instead of the usual 210 days.

This means that the vaccine could be available in Europe sooner than expected.

"We are pleased to receive the accelerated assessment in recognition of our chikungunya vaccine candidate and our efforts to bring this novel product to the market. With this, we can accelerate the approval and launch timelines for the vaccine in Europe. As part of our global strategy, we also plan to submit our biologics license application (BLA) for the vaccine candidate to the U.S. Food and Drug Administration later this year," said Paul Chaplin, President and CEO of Bavarian Nordic, in a press release.

In 2023, Bavarian Nordic successfully completed two Phase 3 studies of CHIKV VLP. 

The CHKV-VLA vaccine candidate received the U.S. Food and Drug Administration (FDA) Fast Track designation in May 2018.

Recently, the FDA issued approval for Valneva SE's IXCHIQ® Chikungunya Vaccine. However, the CDC has not given its approval.

According to the AP, Zimbabwe has initiated a polio vaccination campaign to protect over four million children after identifying three polio cases caused by a rare mutation of the weakened virus found in an older version of the oral vaccine.

On February 20, 2024, the authorities confirmed they would use the type 2 novel oral polio vaccine (nOPV2) polio vaccine designed to minimize virus mutations and reduce polio outbreaks.

Zimbabwe aims to provide this vaccine to approximately 4 million children in February and March 2024.

About 1.4 billion nOPV2 doses have been produced since March 2021. 

Since its launch, approximately 1 billion nOPV2 doses have been administered in more than 35 countries worldwide.

As of February 2024, the nOPV2 has not been authorized by the U.S. Food and Drug Administration. However, the U.S. CDC's vaccine committee is reviewing its use case on February 28, 2024.

Zimbabwe is one of 31 countries the CDC lists in its January 2024 global polio outbreak travel alert.

Novavax, Inc. and Gavi, the Vaccine Alliance (Gavi), today announced they have reached a settlement related to the 2021 Advance Purchase Agreement (APA) for Novavax's prototype COVID-19 vaccine.

To further a joint commitment to public health, Novavax and Gavi have agreed to terms that will prioritize Gavi's and Novavax's shared mission to save lives and protect people's health by increasing equitable and sustainable use of vaccines.

Under the terms, Novavax has made an initial payment of $75 million to Gavi and has agreed to make deferred payments of $80 million annually through December 31, 2028, which are due in quarterly installments and total up to $400 million.

Novavax's annual cash obligation would be offset or reduced pursuant to an $80 million yearly vaccine credit, which may be used for qualifying sales of any of the Company's vaccines funded by Gavi for supply to low-income and lower-middle-income countries.

Using the annual vaccine credit for qualifying sales would reduce Novavax's annual cash obligation.

In addition to the annual obligation, Novavax will provide an additional vaccine credit of up to $225 million, should there be additional demand, which can be applied towards qualifying dose purchases of any of the Company's vaccines in such countries throughout the five-year term.

"Novavax is pleased to have reached this agreement with Gavi as it gives us the ability to continue to work together toward our shared mission of ensuring equitable access to safe and effective vaccines," said John C. Jacobs, President and Chief Executive Officer, Novavax, in a press release on February 22, 2024.

"We look forward to a long-term partnership with Gavi to provide continued access to our protein-based non-mRNA COVID-19 vaccine."

This agreement brings the pending arbitration related to the APA to a close.

As of February 2024, Novavax's COVID-19 Vaccine (Nuvaxovid™XBB.1.5 dispersion for injection, NVX-CoV2601) is the leading protein-based vaccine used in various countries, including the United States.

As of February 22, 2024, Nuvaxovid is one of 13 COVID-19 vaccines Listed by the WHO.

Gavi is a public-private partnership that worked with the World Health Organization and various countries to supply vaccines during the recent pandemic.