Cancer Vaccine Breaking News

Bavarian Nordic A/S today announced that the U.S. Biomedical Advanced Research and Development Authority (BARDA) placed a new order valued at USD 120 million, primarily covering the manufacturing of new bulk product for the Company's JYNNEOS®  smallpox/mpox vaccine. 

The bulk product, representing USD 96 million of the contract value, will be manufactured and invoiced in 2023 and will only partly restore the inventory used to manufacture vaccines in response to the global mpox outbreak that began in May 2022.

Nearly 5.5 million JYNNEOS doses have been manufactured for the U.S. government throughout 2022 and 2023, and replenishment of the bulk inventory is necessary to fulfill the Company's long-term commitment to deliver a freeze-dried version of the vaccine for U.S. smallpox preparedness.

In addition, Bavarian Nordic will manufacture and supply additional liquid-frozen vaccine doses in 2023, valued at USD 3 million.

The agreement includes additional services totaling USD 21 million, of which the majority will be received in 2024 and 2025.

Paul Chaplin, President & CEO of Bavarian Nordic, said in a press release on August 3, 2023, "The U.S. government's foresight enabled us last year to rapidly respond to the global mpox outbreak by converting the readily available bulk product into final vaccine dose."

"Together with our U.S. manufacturing partner, we have completed manufacturing all doses ordered by the U.S. government during the mpox outbreak."

"However, maintaining the readiness to respond to future health crises is essential, and this new contract will enable us to deliver on the contract for a freeze-dried version of the vaccine, awarded to us by the U.S. government back in 2017, which aims to strengthen the nation's preparedness against smallpox."

Since 2003, Bavarian Nordic has worked with the U.S. government on the development, manufacturing, and supply of a non-replicating smallpox vaccine. The JYNNEOS (MVA-BN, IMVANEX®) vaccine has been deployed globally since 2022.

In 2023, mpox outbreaks have been reported Africa, the Americas, Chicago, China, Denver, France, Japan, London, New York, Portugal, South Korea, and Spain. Furthermore, mpox breakthrough cases in vaccinated people have been confirmed in 2023.

The Janssen Pharmaceutical Companies of Johnson & Johnson recently announced the submission of a supplemental New Drug Application to the U.S. Food and Drug Administration (FDA) seeking to expand the indication of EDURANT® to include the treatment of human immunodeficiency virus type 1 (HIV-1) infection in children weighing 10 kg or more.

As of July 28, 2023, a parallel Marketing Authorization application was submitted to the European Medicines Agency to support a type II variation and line extension for expanded pediatric use in Europe.

If the new applications are approved, EDURANT could be administered to younger pediatric patients via standard 25 mg tablets or new 2.5 mg tablets for oral dispersion that were developed to aid administration and weight-adjusted dosing for children.

“We’ve been working to fight HIV for decades and are proud to have helped bring forward nine medicines for people living with HIV,” said Penny Heaton, M.D., Global Therapeutic Area Head, Infectious Diseases and Vaccines, Janssen Research & Development, LLC, in a related press release. 

“These filings are the latest example of our longstanding work to make different treatment options available to meet the diverse needs of people living with HIV.”

EDURANT is not a preventive vaccine but is an HIV-1 specific, nonnucleoside reverse transcriptase inhibitor indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in treatment-naïve patients 12 years of age and older and weighing at least 35 kg with HIV-1 RNA less than or equal to 100,000 copies/mL. 

As of August 2, 2023, the FDA has not approved an HIV vaccine.

The U.S. Department of State officially launched the Bureau of Global Heath Security and Diplomacy.

The Bureau’s overarching mission is to fortify the global health security architecture to effectively prevent, detect, control, and respond to infectious diseases, including HIV/AIDS, wrote the Secretary of State on August 1, 2023. 

By leveraging and coordinating U.S. foreign assistance, the Bureau aims to foster robust international cooperation, enhancing protection for the United States and the global community against health threats through strengthened systems and policies.

To ensure U.S. leadership is sustained moving forward, the Bureau will provide a unified voice of leadership on global health security and diplomacy, combining strengths, functions, personnel, and resources from various offices.

Ambassador-at-Large Dr. John N. Nkengasong will lead the Bureau.

This new Bureau will seamlessly integrate global health security as a core component of U.S. national security and foreign policy, underscoring the Department of State’s commitment to advancing human health worldwide, wrote the State Department.

The State Department also issued security notices for most countries, found at this link.

Merck & Co. today announced its human papillomavirus (HPV) vaccines sales increased 47% to reach $2.5 billion, and if you exclude the Impact of Foreign Exchange, sales actually grew by 53%.

Merck's GARDASIL 9® is a vaccine indicated in men and women, 9 through 45 years of age, to prevent cancers caused by the HPV. It has been available in the United States since late 2016.

The original GARDASIL® vaccine consists of 4 proteins of HPV types 6, 11, 16, and 18. is available in other countries.

According to the World Health Organization, HPV vaccination programs that began pre-pandemic reached the same number of women in 2022 as in 2019, with mean coverages reaching 67% in high-income countries and 55% in low- and middle-income countries.

Millions of men and women aged 27–45 may still benefit from HPV vaccination, says Merck.

"We continue to make great progress as we advance our broad and deep pipeline, raise the bar of innovation, and bring forward leading-edge science to save and improve lives around the world," said Robert M. Davis, chairman, and chief executive officer of Merck, in a press release issued on August 1, 2023.

HPV is a double-stranded DNA virus that belongs to the Papillomaviridae family. There are over 100 subtypes of HPV, characterized as high-risk or low-risk. And it is the most common sexually transmitted infection worldwide.

From a clinical perspective, HPV vaccinations reduce anal HPV infection and anal intraepithelial neoplasia (AIN).

A study published on May 31, 2023, concluded there is strong evidence for high vaccine efficacy against anal HPV infection and AIN in HIV-negative individuals vaccinated at age ≤26 years.

The U.S. Fish and Wildlife Service (FWS) Incident Command Team recently confirmed implementing conservation strategies to help California condors in light of the Highly Pathogenic Avian Influenza (HPAI) bird flu outbreak.

As of July 28, 2023, over twenty-one Condors have died related to HPAI infections this year.

In May 2023, the United States Department of Agriculture's Agricultural Research Service announced the emergency use of a HPAI vaccine candidate to prevent additional deaths of California Condors.

The California Condor Vaccination Trial continued will continue into September 2023. 

Blood samples from 13 birds will be collected at 21 and 42-days following vaccination to evaluate the immune response from two different vaccination approaches. 

The first sample will be collected on August 8.

From a recovery perspective, three condors were transferred to the release site in Arizona to reacclimate to their home. A release date will be determined based on their behavior and weather.

The fourth bird that survived also has immunity to HPAI and will be released later as he is currently re-growing molted flight feathers. 

The California Condor Recovery Program continues to implement standard operations, and we are hopeful this will include the release of juveniles in 2023. However, due to the dynamic nature of HPAI outbreaks and logistics around potential future vaccinations, adjustments will be made accordingly, wrote the FWS.

The ongoing bird flu outbreak reached Europe, Asia, and Russia in 2023.

Furthermore, the U.S. government has already approved one bird flu vaccine (Audenz™) for people and invested in vaccine candidates should a pandemic occur.

60 Degrees Pharmaceuticals Inc. today announced that the Canadian Intellectual Property Office issued a patent on using novel tafenoquine regimens for malaria prevention in malaria-naive individuals, and it will remain valid until December 2, 2035.

The Company was issued a similar U.S. patent in 2019.

Tafenoquine is the active molecule in the Company's U.S. Food and Drug Administration-approved regimen for malaria prevention, ARAKODA®.

ARAKODA, an oral tablet containing 100 mg of tafenoquine base, is an anti-malarial indicated for malaria prevention in individuals 18 years and older.

As of July 31, 2023, travelers or individuals at risk of contracting malaria are prescribed 2 x 100 mg tablets once per day for three days (the loading phase) before travel, 2 x 100 mg tablets weekly for up to six months during travel, then 2 x 100 mg in the week following travel.

Travelers from, and residents of, Canada and the United States, are usually malaria naive because they have not previously contracted malaria and thus lack immunity to the disease.

During July 2023, malaria outbreaks have been reported in Florida and throughout Central America in countries such as Costa Rica. And numerous African countries have confirmed malaria outbreaks.

The bite of an infective female Anopheles mosquito spreads malaria. The disease can cause fever, chills, and flu-like illness. If it is not treated, it can cause severe complications and death, says the U.S. CDC.

Typically, about 2,000 malaria cases are diagnosed in the United States yearly.

In Africa, there are two malaria vaccines currently being administered.

And on April 26, 2023, the United States Patent and Trademark Office issued 60 Degrees a patent covering the use of tafenoquine as a treatment for COVID-19 disease.