Vaccine News

Vaccine news brought to you by Precision Vaccinations.

Nov 15, 2024 • 3:25 pm CST
GPEI November 2024

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.

 

Nov 15, 2024 • 11:57 am CST
US CDC Nov. 2024

According to new estimates from the World Health Organization (WHO) and the U.S. Centers for Disease Control and Prevention (CDC), there were an estimated 10.3 million cases of measles worldwide in 2023, a 20% increase from 2022.

The new data show that an estimated 107,500 people, primarily children younger than 5 years of age, died due to measles in 2023.

These agencies confirmed on November 14, 2024, that measles is vaccine-preventable. However, an estimated 83% of children received their first dose of measles vaccine last year, while only 74% received the recommended second dose.

“Measles vaccine has saved more lives than any other vaccine in the past 50 years,” said Dr Tedros Adhanom Ghebreyesus, WHO Director-General, in a press release.

Geographically, 57 countries experienced large or disruptive measles outbreaks in 2023.

The CDC maintains a global Watch-Level 1, Practice Usual Precautions, Travel Health Notice, identifying measles outbreaks in 56 countries. The CDC encourages all international travelers to fully immunize against measles before visiting outbreak countries.

In the United States, the CDC reported 59 measles cases in 20 jurisdictions in 2023. Unfortunately, 277 measles cases in 32 U.S. jurisdictions were confirmed in 2024.

The vast majority of measles cases in the U.S. are detected in unvaccinated international travelers.

Nov 14, 2024 • 2:43 pm CST
US CDC November 14, 2024

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.

Nov 14, 2024 • 6:52 am CST
WHO Mpox Cases October 2024

Tonix Pharmaceuticals Holding Corp. today announced the publication of a paper entitled, “Recombinant Chimeric Horsepox Virus (TNX-801) is Attenuated Relative to Vaccinia Virus Strains in Both In Vitro and In Vivo Models.”

Data published in the peer-reviewed journal mSphere demonstrate that TNX‐801 is less virulent than 20th-century vaccinia vaccines in immune-compromised mice.

The publication describes data in which TNX-801 was compared with older vaccinia vaccine strains used to eradicate smallpox for tolerability in both in vitro and in vivo models.

Together, TNX-801 was shown to be more than 10—to 1,000-fold more attenuated (or less virulent) than the older vaccinia smallpox vaccines.

Combined with the ability of TNX-801 to protect animals against lethal challenge with Clade Ia mpox virus, the Company believes that the new tolerability data support the idea that TNX-801 is a candidate vaccine to control the ongoing mpox Clade Ib and mpox Clade IIb outbreaks.

Previously, single-dose vaccination with TNX-801 was shown to protect animals from a lethal challenge with Clade Ia mpox.

The new Clade Ib mpox is spreading among children in Africa and, so far, has been carried by adult travelers from Africa into non-African countries.

The global mpox outbreak from Clade IIb, which commenced in May 2022, continues in various countries, including the United States.

“Addressing the new Clade Ib mpox outbreak and the ongoing spread of Clade IIb mpox may require a single dose mpox vaccine that provides durable protection,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals, in a press release on November 13, 2024.

The current standard of prevention focuses on Bavarian Nordic's JYNNEOS® (MVA-BN®, IMVAMUNE®, IMVANEX®) two-dose vaccine, which is commercially available in the United States.

Nov 14, 2024 • 6:27 am CST
US CDC

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. 

Nov 14, 2024 • 5:34 am CST
WHO TB 2024 Report

The recently released World Health Organization (WHO) 2024 Global Tuberculosis Report revealed tuberculosis remains a leading infectious disease globally.

Unfortunately, the WHO African Region continues to be significantly impacted by tuberculosis (TB) outbreaks.

For example, Nigeria and the Democratic Republic of Congo (DRC) are among the eight countries that account for over 60% of the people estimated to have developed TB in 2023.

Nigeria has 4.6% of the global new cases, while the DRC has 3.1%.

When visiting Nigeria or the DRC, the U.S. CDC's Travel Health Notices do not recommend TB vaccination. 

The only vaccine use to prevent TB is about 100 years.

Today, over ten versions of the Bacillus Calmette-Guérin (BCG) vaccine are used worldwide.

Over the decades, BCG vaccination has been found effective for children but less so for adults. The good news is that various TB vaccine candidates are in late-stage development, with authorizations expected soon.

Nov 13, 2024 • 10:51 am CST
by Julia Sezemova

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.

Nov 13, 2024 • 10:20 am CST
by Gerd Altmann

Novavax, Inc. today announced its financial results and operational highlights for the third quarter ended September 30, 2024. A few highlights are inserted below:

For the third quarter of 2024, total revenue was $85 million, compared to $187 million in the same period in 2023. And ended the quarter with $1 billion in cash and receivables.

Advanced preparation for Sanofi to assume lead commercial responsibility of Nuvaxovid™ COVID-19 vaccine for the 2025-2026 vaccination season in the U.S., Europe, and select major markets not currently subject to Novavax Advanced Purchase Agreements or existing partnership agreements.

Entered the U.S. market with an improved Nuvaxovid presentation and broader access, available in pre-filled syringes in over 30,000 locations across major pharmacy retailers and regional grocers.

John C. Jacobs, President and Chief Executive Officer of Novavax, commented in a press release on November 12, 2024, “In addition to progress on our other value drivers, this past quarter, we made significant progress defining our R&D strategy as we look to expand beyond COVID-19 and influenza."

"We intend to develop our early-stage pipeline with a disciplined approach, as we focus on areas where our technology can have a positive impact on public health and generate value.”

An example is the R21/Matrix-M™ vaccine that includes Novavax's proprietary saponin-based Matrix-M adjuvant. This malaria vaccine is manufactured by the Serum Institute of India Private Ltd and is available in various African countries in 2024.

Nov 12, 2024 • 11:20 am CST
from Pixabay

ImmunityBio, Inc. today announced its financial results for the third quarter ended September 30, 2024. The company achieved a net product revenue of approximately $6 million during the three months ended September 30, 2024, surpassing net product revenue of $1 million in the prior quarter and analyst estimates.

ANKTIVA® (N-803), U.S. FDA-approved and commercially available since May 2024, is now widely accessible to patients through commercial and government insurance programs (VA, DoD, Medicare). ImmunityBio has secured coverage for over 200 million medical lives through medical reimbursement policies.

ANKTIVA is a cytokine interleukin-15 (IL-15) that plays a crucial role in the immune system by affecting the development, maintenance, and function of key immune cells—NK and CD8+ killer T cells—that are involved in killing cancer cells.

By activating NK cells, ANKTIVA overcomes the tumor escape phase of clones resistant to T cells and restores memory T cell activity, resulting in a prolonged duration of complete response.

“The U.S. launch of ANKTIVA for non-muscle-invasive bladder cancer (NMIBC) CIS continues to gain momentum, and we are pleased to see the clinical impact for patients,” said Richard Adcock, President and CEO of ImmunityBio, in a press release on November 12, 2024.

“The Centers for Medicare and Medicaid Services have issued our permanent J-code, effective January 1, 2025."

"Our submission of ANKTIVA for NMIBC CIS to the U.K.'s MHRA for potential approval demonstrates our plans for global expansion. Further, we anticipate an EU submission this quarter.”

Nov 12, 2024 • 5:10 am CST
by Gerd Altmann

Arcturus Therapeutics Holdings Inc. today announced that the U.S. Food and Drug Administration (FDA) has issued a “Study Can Proceed” notification for the Company’s Investigational New Drug application, ARCT-2304, a self-amplifying mRNA (sa-mRNA) vaccine candidate for active immunization to prevent pandemic influenza disease caused by H5N1 virus.

The sa-mRNA vaccine candidate is designed to make many copies of mRNA within the host cell after intramuscular injection to enhance the expression of haemagglutinin and neuraminidase antigens, thereby enabling lower doses than conventional mRNA vaccines.

“Arcturus is actively engaged with the U.S. government to prepare for the next pandemic, and clearance to proceed into the clinic with our STARR® self-amplifying mRNA technology is a key step in this important process,” said Joseph Payne, President & CEO of Arcturus Therapeutics, in a press release on November 11, 2024.

“The Phase 1 clinical trial is designed to evaluate the safety, reactogenicity, and immunogenicity of ARCT-2304 as a potential vaccine to protect against the highly pathogenic H5N1 avian influenza.”

The clinical study is funded by the U.S. Biomedical Advanced Research and Development Authority.

The U.S. and European vaccine agencies have previously approved avian and pandemic influenza vaccines and have recently awarded funding grants for (bird flu) vaccine candidates.

Nov 11, 2024 • 3:41 pm CST
US CDC

The WHO Africa recently announced that the Republic of Rwanda had discharged the last Marburg virus disease (MVD) patient, kicking off the mandatory 42-day countdown to declare the outbreak's end.

As of November 9, 2024, a total of 66 MVD cases and 15 deaths have been recorded during the outbreak, which was declared on September 27, 2024. Health workers, who constitute almost 80% of the cases, primarily became infected while providing emergency care to their colleagues and patients.

"This outbreak demonstrates that with the best available treatment, recovery is possible, and contributions to science can be made," said Dr Sabin Nsanzimana, Rwanda's Minister of Health, in a press release

The World Health Organization published the Marburg vaccine development landscape on February 13, 2023. As of November 2024, no approved MVD vaccines exist.

Marburg is a highly virulent virus with a fatality ratio of up to 88%, and it was initially detected in Germany in 1967 following a lab incident. The virus belongs to the same family as the Ebola virus. Illness begins abruptly with high fever, severe headache, and malaise, and many patients develop severe hemorrhagic symptoms within seven days.

Currently, the U.S. CDC's Level 3—Reconsider Nonessential Travel Advisory remains active. The CDC recommends reconsidering nonessential travel to Rwanda, which is experiencing an outbreak of Marburg.

 

Nov 11, 2024 • 8:45 am CST
Pixabay

Novavax, Inc. today announced that the U.S. Food and Drug Administration (FDA) has cleared the Company to begin enrolling the planned Phase 3 clinical trial following the determination that Novavax satisfactorily addressed all clinical hold issues regarding its COVID-19-Influenza Combination and stand-alone influenza vaccine candidates. 

"We thank the FDA for their partnership and thorough review of the additional information provided as part of our response package," said Robert Walker, MD, Chief Medical Officer, Novavax, in a November 11, 2024 press release.

"We plan to start our Phase 3 trial as soon as possible."

The Company did not estimate the availability of these innovative vaccine candidates.

Novavax is a global company advancing protein-based vaccines with its Matrix-M™ adjuvant, such as the R21/Matrix-M™ malaria vaccine currently available in Africa.

Nov 11, 2024 • 3:24 am CST
WHO

The World Health Organization (WHO) today published its 42nd situation report for the multi-country outbreak of mpox, which provides an update on the epidemiological situation of mpox in the WHO African Region and countries in the WHO Eastern Mediterranean Region.

The number of mpox cases in Africa is generally rising, driven mainly by cases reported from the Democratic Republic of the Congo (DRC).

As of November 11, 2024, the WHO confirmed Clade Ib monkeypox virus (MPXV) had been detected in six provinces in the DRC: South Kivu, North Kivu, Kinshasa, Kasai, Tshopo, and Tanganyika. Additionally, 11 other African countries have also reported clade Ib MPXV cases.

Since the last WHO situation report, three countries outside of Africa have confirmed travel-related cases of clade Ib MPXV,

For the first time, local transmission of clade Ib MPXV in the United Kingdom of Great Britain and Northern Ireland, where three (all) household members of the initial case (who had traveled to affected East African countries with clade Ib) were confirmed to have mpox.

Most impacted countries offer access to Bavarian Nordic's JYNNEOS® (MVA-BN®) vaccine to prevent mpox infections. The first round of mpox vaccination has concluded in the DRC, with around 51 500 people vaccinated across six provinces.

Furthermore, the clade 2 outbreak that began in May 2022 continues in numerous countries, including the United States.

Nov 10, 2024 • 3:24 pm CST
Google Maps - El Salvador - November 2024

Over the past few days, announcements have indicated more people may visit the Republic of El Salvador next year.

On November 1, 2024, Volaris El Salvador and Miami International Airport officials celebrated the launch of four weekly nonstop flights between San Salvador and Miami, Florida. In 2025, additional U.S. cities will also offer direct flights to this Central American destination.

On November 8, 2024, the U.S. Embassy in El Salvador reported significantly reducing gang-related activity and associated crime in the last two years. Recognizing these positive changes, the U.S. Department of State reduced its travel advisory to Level 2.

To keep visitors informed of local issues, the State Department recommends using major highways and roads and minimizing travel outside metropolitan areas when visiting El Salvador. It also recommends that visitors enroll in the Smart Traveler Enrollment Program to receive alerts and make locating you in an emergency easier.

From a health perspective, the U.S. CDC says dengue outbreaks are a year-round risk in many parts of the world, including El Salvador. As of November 2024, over 7,200 dengue cases were reported, an increase from the 5,788 cases confirmed last year.

Additionally, chikungunya, another mosquito-transmitted disease, has been confirmed in 47 people this year.

"For U.S. travelers with plans to visit El Salvador, it's essential to receive the hepatitis A and typhoid fever vaccines before visiting because you'll want to sample many of the excellent Salvadorian foods while on vacation. Be sure you're up-to-date on all routine vaccines, like hepatitis B, flu, measles (MMR), and tetanus," Jeri Beales, MSN, R.N., informed Vax-Before-Travel.

 

"Mosquitos are also a problem throughout El Salvador, and cases of dengue fever are on the rise this year. Unfortunately, no vaccine is available in the U.S. to protect people against dengue, so be sure to use an insect repellant with at least 20% DEET."

 

"But, the good news for U.S. travelers is you can now vaccinate (IXCHIQ®) against the chikungunya illness and travelers no longer need to take malaria medication while in El Salvador because it has been eradicated from all parts of the country," added Beales, who leads Destination Health Clinic. This Boston-area travel health provider specializes in health education and vaccination for international travelers.

 

The CDC suggests visiting your healthcare provider at least a month before your trip to El Salvador to acquire necessary vaccines such as chikungunya or typhoid. Visit the CDC's page for the latest Travel Health Information. 

Nov 9, 2024 • 5:29 am CST
Google Maps 2024

In recent years, mosquito-transmitted Japanese encephalitis virus (JEV) outbreaks have occurred in many parts of southern and eastern Asia.

According to health agencies, JEV has extended beyond its traditional boundaries to Indonesia, Papua New Guinea, and the Torres Strait and has been detected in Victoria, Australia, since 2022.

To help protect people from this disease, Victoria's Chief Health Officer announced on October 31, 2024, that more Victorians would have protection this mosquito season, with the Allan Labor Government expanding the eligibility of the free JEV vaccine program across the state.

This means people in Alpine, Macedon Ranges, Mansfield, and Mitchell, as well as local government areas, can access the JEV vaccine.

Minister for Health Mary-Anne Thomas said in a media release, "Summer provides mosquitos with an ideal breeding ground. In addition to getting vaccinated against JEV, Victorians in high-risk areas should take simple actions, like wearing loose-fitting clothes and using mosquito repellent."

This announcement means ValnevaSE's IXIARO® (JESPECT®) vaccine is now available to about seven million people in 24 regional local government areas in southeast Australia at a higher risk of exposure to the virus.

Furthermore, over 110 million international visitors are expected to visit Victoria in 2024.

IXIARO is the only JEV vaccine approved by the U.S. Food and Drug Administration. The U.S. Department of Defense has relied on IXIARO since 2010 to protect personnel deployed to JEV-endemic areas.

Valneva recently announced that IXIARO/JESPECT sales increased by 31% in the first nine months of 2024 compared to 2023.