Vaccine News

The U.S. Centers for Disease Control and Prevention (CDC) today reported the 166th influenza-associated pediatric death for the 2022-2023 flu season.

As of August 4, 2023, the CDC reported two additional influenza-associated pediatric deaths during week #30. Both deaths were associated with influenza A(H1N1) viruses.

Last flu season, there were only 47 flu-related pediatric deaths confirmed.

The CDC says the current flu shots offer protection against this type of influenza. For most persons, including children, who only one dose of an approved influenza vaccine is needed for the season.

Furthermore, vaccination should ideally be offered during September or October in the U.S.

And flu season in the Southern Hemisphere usually occurs between April and September.

Moreover, vaccination should continue throughout each flu season as long as influenza viruses are circulating.

Recent news indicates there will be plenty of flu shots available this season.

As of early August, about 100 million vaccines have already been distributed for the 2023-2024 flu season. Last season, the CDC reported that about 173.37 million flu shots were distributed in the U.S.

Various flu shots are available at health clinics and community pharmacies in the U.S.

The U.S. Centers for Disease Control and Prevention (CDC) today reported the global dengue outbreak is impacting the United States.

On August 2, 2023, the CDC provisionally confirmed the U.S. States reported 225 dengue cases, and Territories reported 315.

For all of 2022, the CDC reported, the CDC reported 2,016 dengue cases.

From a state perspective, the Florida Health Department reported as of week #30 in 2023, there had been 147 travel-associated dengue cases. The majority (98) of travel cases were related to Cuba.

Florida has also reported six locally acquired dengue cases in 2023.

To alert travelers to their dengue health risk, the CDC recently issued Travel Health Notices for the Americas (2023), Africa/Middle East (July 21, 2023), Costa Rica, and Asia/Pacific Islands (July 25, 2023). 

The CDC says dengue is a vaccine-preventable disease. As of August 3, 2023, two dengue vaccines are in use worldwide.

The U.S. CDC's Advisory Committee on Immunization Practices (ACIP) is meeting today to review Respiratory Syncytial Virus (RSV) Maternal/Pediatric vaccine and a long-acting monoclonal antibody.

On August 3, 2023, Dr. Grace  Lee is leading the ACIP meeting agenda, which includes, but is not limited to, the following presentations:

• Introduction - Dr. S Long

• EtR summary for nirsevimab  - Dr. J Jones

• Nirsevimab implementation considerations - Dr. G Peacock

• Clinical considerations for nirsevimab & Workgroup considerations / proposed recommendations - Dr. J Jones

At around 2 pm ET today, the ACIP is scheduled to vote on two recommendations.

Previously, the U.S. Food and Drug Administration approved Beyfortus (nirsevimab-alip) for the prevention of RSV lower respiratory tract disease in neonates and infants born during or entering their first RSV season and in children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season.

In the U.S., the RSV season generally starts in Florida in the fall. As of August 3, 2023, there have not been any RSV outbreaks reported this year.

UPDATED at 2:55 CT

The ACIP unanimously recommends routine use of Beyfortus™ to protect all infants below 8 months of age. The committee also voted unanimously to include Beyfortus in the Vaccines for Children program, supporting equitable access for all eligible infants.

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.