Vaccine News

According to the World Health Organization (WHO), the International Health Regulations Emergency Committee met today regarding the upsurge of clade I mpox cases.

On November 22, 2024, the WHO Director-General agreed with the advice of the Committee and determined that the upsurge of mpox continues to constitute a public health emergency of international concern.

The upsurge of mpox in the Democratic Republic of the Congo and its spread to neighboring countries (Burundi, Central African Republic, the Republic of the Congo, Rwanda, and Uganda) was declared a public health emergency of international concern on August 14, 2024.

The decision was based on the rising number and continuing geographic spread of cases, operational challenges in the field, and the need to mount and sustain a cohesive response across countries and partners.

A report of this meeting will be issued next week, wrote the WHO.

To alert international travelers of this health risk, the U.S. CDC issued a Level 2 - Practice Enhanced Precautions, Travel Health Advisory in September 2024. The CDC says mpox vaccination is now recommended for people, regardless of gender identity or sexual orientation, who anticipate the following sexual activities during travel to countries with ongoing person-to-person transmission of clade I mpox.

In the United States, Bavarian Nordic's JYNNEOS® (MVA-BN®) vaccine is commercially available at many pharmacies and is also recommended by the CDC to prevent clade II mpox cases. 

According to new data, seasonal influenza activity in the United States is increasing slightly among children but remains low nationally.

The U.S. Outpatient Influenza-like Illness Surveillance Network monitors outpatient visits for respiratory illnesses. Nationally, during Week #45, 2.5% of patient visits reported to the U.S. CDC were due to respiratory illness, including fever, cough, or sore throat.

As of November 22, 2024, the CDC says the best way to avoid respiratory illnesses is to discuss vaccination options with your healthcare provider.

The CDC's Advisory Committee on Immunization Practices recommends annual influenza vaccination for all persons aged ≥6 months and a single lifetime dose of respiratory syncytial virus (RSV) vaccine for older adults.

By November 9, 2024, an estimated 34.7% of adults had received a flu shot for the 2024–25 season.

And 39.7% of adults aged ≥75 years and 31.6% of adults aged 60–74 years at increased risk for severe RSV disease had ever received RSV vaccine.

This CDC data indicates many unvaccinated people are unprotected heading into the Thanksgiving holidays.

The good news is that over 92 million flu shots have been distributed to healthcare providers and pharmacies. Hence, everyone still has time to get protected ahead of the peak respiratory virus season.

Most people live within five miles of a pharmacy, which offers a variety of flu shots and RSV vaccines.

The U.K. Health Security Agency says the timing of the typical norovirus seasonal increase and peak of activity varies from season to season.

This season, the increase in reporting has begun earlier than in the last five seasons.

As of November 21, 2024, data derived from the Second-Generation Surveillance System up to week 45 of the 2024/2025 season showed that the cumulative number of positive norovirus laboratory reports in England (3,099 laboratory reports) was more than double the 5-season average for the same period (1,342 laboratory reports).

The most commonly detected norovirus genotype worldwide is genogroup II—genotype 4 (GII.4). Historically, there have been five global GII.4 strain replacement events.

While norovirus vaccines are in demand, developing a broadly effective vaccine remains difficult, owing to noroviruses' genetic and antigenic diversity. However, one vaccine candidate continues pursuing U.S. FDA approval.

In the U.S., HilleVax, Inc.'s HIL-214 virus-like particle bivalent vaccine candidate is designed to prevent moderate-to-severe acute gastroenteritis caused by norovirus. HIL-214 vaccine includes antigens targeting genotypes GI.1 and GII.4.

As of November 2024, HIL-214 has been studied in nine clinical trials but has not been approved for commercial use.

ImmunityBio, Inc. recently announced compelling new data from its ongoing QUILT 3.032 study. As of November 2024, 100 patients with Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer with carcinoma in situ (NMIBC CIS) have been treated with ANKTIVA® (nogapendekin alfa inbakicept-pmln) in combination with BCG, achieving a 71% complete response rate.

This significant milestone underscores the potential of ANKTIVA to provide durable responses in patients with limited treatment options. 

In these responders, the range of durable response extended to 54 months.

 Patrick Soon-Shiong, M.D., Executive Chairman and Global Chief Scientific and Medical Officer of ImmunityBio, commented in a press release on November 19, 2024, "These results highlight the potential of ANKTIVA to transform the treatment landscape for patients with BCG-unresponsive NMIBC CIS, offering hope for improved outcomes and cystectomy avoidance, especially with the prolonged duration of response now ranging as much as 54 months in this 100-patient analysis."

"Duration of complete response is the key efficacy element in driving cystectomy avoidance in this BCG-unresponsive population."

"I am pleased that this updated ANKTIVA data confirms that one of the highest durable responses is achieved compared to other approved products in this indication."

According to the company, this data update will be submitted to the European Medicines Agency in a Marketing Authorization Application for ANKTIVA in the European Union, which is anticipated during Q4 2024. 

In 2024, the U.S. Food and Drug Administration (FDA) approved ANKTIVA plus BCG for treating patients with BCG-unresponsive NMIBC with CIS, with or without papillary tumors. The FDA has also approved Merck's TICE® BCG vaccine for this therapy. 

The World Health Organization (WHO) today announced it has granted Emergency Use Listing (EUL) for the LC16m8 smallpox / mpox vaccine, making it the second mpox vaccine to be supported by WHO.

LC16m8 is a vaccine developed and manufactured by KM Biologics in Japan.

It is recommended by the WHO for use in individuals over one year of age as a single-dose vaccine via a multiple puncture technique using a bifurcated needle.

“WHO emergency use listing of the LC16m8 vaccine against mpox marks a significant step in our response to the current emergency, providing a new option to protect all populations, including children,” commented Dr. Yukiko Nakatani, WHO Assistant Director-General for Access to Medicines and Health Products, in a press release on November 19, 2024. 

“Vaccines are one of the important tools to help contain the outbreak as part of a comprehensive response strategy that also includes improved testing and diagnosis, treatment and care, infection prevention control, and engagement and education within affected communities.”

This decision is expected to facilitate increased and timely vaccine access in communities where mpox outbreaks are surging.

Today’s move is particularly relevant as the Government of Japan has announced that it will donate 3.05 million doses of the LC16m8 vaccine and specialized inoculation needles to the Democratic Republic of the Congo. This is the most extensive vaccine donation package announced to date in response to the current mpox emergency.

Previously, the WHO has LIsted Bavarian Nordic A/S JYNNEOS® (MVA-BN®) smallpox / mpox vaccine.

The California Department of Public Health (CDPH) today announced it had identified the first known case of clade I mpox in the United States. This case was confirmed in an individual who recently traveled from Africa and is related to the ongoing outbreak of clade I mpox in Central and Eastern Africa. Historically, clade I has caused more severe illness than clade II.

The clade II outbreak began worldwide in May 2022, reaching Boston in late May.

As of November 9, 2024, 2,410 clade II cases have been confirmed in the U.S. this year. This is a significant increase compared with last year, when 1,267 mpox cases were reported.

The CDPH stated on November 16, 2024, the affected individual received health care in San Mateo County. The individual is isolating at home and recovering. Public health workers are contacting people who had close contact with this individual.

According to the U.S. CDC, there is no concern or evidence that mpox clade I is spreading between individuals in California or other states. 

However, the World Health Organization declared the increasing number of mpox cases reported in the African Region, notably the Democratic Republic of the Congo, a Public Health Emergency of International Concern on August 14, 2024.

Bavarian Nordic's JYNNEOS® (MVA-BN®) mpox/smallpox vaccine has been effective against clade II and is commercially available at clinics and pharmacies in the U.S.

Bavarian Nordic A/S (OMX: BAVA) announced today it's interim financial results and business progress for the third quarter of 2024, highlighting mpox vaccine sales.

Bavarian Nordic stated on November 15, 2024, that it retains sufficient capacity to fulfill the requirement as stated by Africa CDC for at least 10 million doses of MVA-BN® (JYNNEOS®) by the end of 2025 and could even further scale up capacity for future demand if needed.

For 2025, the Company has so far secured revenue from mpox/smallpox vaccine orders of approximately DKK 2,400 million.

Paul Chaplin, President & Chief Executive Officer of Bavarian Nordic, said in a press release, “We have had a busy but highly purposeful and rewarding third quarter, where we have worked intensively to support the efforts to curb the ongoing mpox outbreak in Africa."

In the United States, the government recommends two doses of JYNNEOS to provide more robust protection. However, routine immunization against mpox is not recommended for the general public. The U.S. CDC does not endorse booster doses (3rd).