Vaccine News

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).

The Global Polio Eradication Initiative (GPEI) reported that three countries confirmed additional polio outbreaks this week.

As of November 15, 2024, Pakistan reported three more wild poliovirus type 1 (WPV1) cases from Sindh, Balochistan, and Khyber Pakhtunkhwa, bringing the total number of cases to 48 this year.

Additionally, Nigeria revealed seven more circulating vaccine-derived poliovirus type 2 (cVDPV2) cases, and Chad confirmed two cVDPV2 cases.

In August 2024, the World Health Organization confirmed that the spread of the poliovirus remained a Public Health Emergency of International Concern.

To notify international travelers of this health risk, the U.S. CDC maintains a Global Polio Alert - Level 2, Practice Enhanced Precautions Travel Health Notice, regarding polio outbreaks and poliovirus detections in 37 countries.

The CDC recommends that future travelers to these countries speak with a travel vaccine expert at least one month before departing abroad about immunization options.

The U.S. Centers for Disease Control and Prevention (CDC) today reported that in Alaska, nirsevimab (Beyfortus™) was 89% effective in preventing RSV-associated hospitalization for infants in their first RSV season and 76% and 88% effective against medically attended illness for children in their first and second seasons, respectively.

On November 14, 2024, the CDC's MMWR 73(45);1015–1021 stated these findings support current CDC recommendations for all infants in their first RSV season to either receive nirsevimab or be protected through maternal vaccination and for children entering their second season with increased risk for severe RSV illness, including all AI/AN children, to receive nirsevimab.

According to the manufacturer, 50mg and 100mg of Beyfortus injection doses will be available for the 2024-2025 RSV season. And supply is secured for 20 countries.

AC Immune SA today announced positive interim safety and immunogenicity data from the Phase 2 VacSYn clinical trial evaluating ACI-7104.056, its anti-alpha-synuclein (a-syn) active immunotherapy candidate, for the treatment of patients with early Parkinson's disease (PD).

ACI-7104.056 is an optimized formulation of its clinically validated anti-a-syn predecessor active immunotherapy. It generated a target-specific antibody response against pathological oligomeric a-syn to inhibit spreading and downstream neurodegeneration in early PD.

The accumulation of alpha-synuclein protein aggregates has been shown to cause inflammatory stress in cells and contribute to the degeneration of neurons in the brain.

Dr. Andrea Pfeifer, CEO of AC Immune SA, commented in a press release on November 14, 2024, "We are encouraged by these initial Phase 2 safety and immunogenicity data on our ACI-7104.056 active immunotherapy being studied in early PD.'

"The level of immunogenicity after only 3 months of treatment, as well as the continued positive safety profile, reinforces the best-in-class characteristics of our clinically validated anti-a-syn active immunotherapy for treating PD."

"We look forward to sharing further updates in H1 2025, including the decision to expand into Part 2 of the VacSYn study."

The U.S. NIH says Parkinson's is a progressive movement disorder of the nervous system. It causes nerve cells (neurons) in parts of the brain to weaken, become damaged, and die, leading to symptoms that include problems with movement, tremors, stiffness, and impaired balance. People with PD may have difficulty walking, talking, or completing other simple tasks as symptoms progress. 

The Texas Department of State Health Services (DSHS) reports an increase in pertussis cases in 2024, with about triple the number of cases reported this year compared with the same period in 2023.

Texas has confirmed 772 pertussis cases in 2024, compared to 264 last year.

This DSHS announcement on November 12, 2024, follows a national trend, which has seen a more than fivefold increase in 2024 cases based on preliminary data posted by the U.S. CDC.

As of week #44, reported on November 2, 2024, CDC data show that more than five times (22,240) as many pertussis cases were reported compared to (4,209) at the same time in 2023.

According to a state-based analysis, Pennsylvania reported about 10% (2,462) of all pertussis cases in 2024.

Pertussis is a highly contagious illness caused by the bacteria Bordetella pertussis and is vaccine-preventable, says the CDC.

Early symptoms are very similar to the common cold. People may develop paroxysms (coughing fits) one to two weeks after the first symptoms start. The cough generally gets worse and becomes more common as the illness continues. It can cause people to vomit or make a “whoop” sound when breathing in.

DSHS advises clinicians to follow the recommendations below and report any cases to their local health department within one workday.