Vaccine News

According to a recent Morbidity and Mortality Weekly Report, more than half of school-aged children in American Samoa have evidence of a dengue fever virus infection. 

The estimated seroprevalence among all students aged 7–16 years was 59% (95% CI = 47%–71%) and was 60% (95% CI = 48%–72%) among those age-eligible for vaccination (i.e., those aged 9–16 years).

Dengue seroprevalence was lowest among children aged 8 (46%; 95% CI = 32%–60%).

The U.S. CDC's Notes from the Field (73(31);686–688) published on August 8, 2024, suggests American Samoa exceeds the minimum 20% threshold established for the introduction of recommended dengue vaccines to reduce the risk of hospitalization and severe dengue in seronegative children and adolescents.

The authors concluded, "In American Samoa, dengue vaccines could be part of a broader strategy for dengue control."

As of August 13, 2024, access to dengue vaccines in the United States is very limited.

American Samoa is located in the Pacific Ocean, halfway between Hawaii in the north and New Zealand in the south. The CDC recommends checking the vaccines and medicines list and visiting your healthcare provider at least a month before your trip to American Samoa to get necessary supplies. 

These authors disclosed no potential conflicts of interest.

Pfizer Inc. today announced positive top-line safety and immunogenicity results from substudy B of the ongoing pivotal Phase 3 clinical trial.

The trial is evaluating two doses of the ABRYSVO™ vaccine in immunocompromised adults aged 18 and older at risk of developing severe respiratory syncytial virus (RSV)- associated lower respiratory tract disease.

ABRYSVO was well-tolerated during the trial, showing a safety profile consistent with findings from other vaccine studies.

While the company evaluated two doses, a single 120 µg dose of ABRYSVO generated a strong neutralizing response against both subtypes of RSV, RSV-A, and RSV-B across all cohorts and age groups in the study.

Pfizer plans to share these findings at an upcoming scientific conference, publish them in a peer-reviewed scientific journal, and submit the data to the regulatory agencies for review.

“Immunocompromised adults, such as patients with cancer or autoimmune disorders, have a substantially increased risk of experiencing severe complications from RSV, yet there are currently no vaccines approved for those aged 18 to 59 in the U.S.,” said Annaliesa Anderson, Ph.D., Senior Vice President and Chief Scientific Officer, Vaccine Research and Development, Pfizer, in a press release on August 12, 2024.

“We are encouraged by the positive top-line data from this study, which provide important evidence that ABRYSVO has the potential to address a significant unmet need in this vulnerable population.”

These most recent data in immunocompromised adults build on the body of evidence supporting the profile of ABRYSVO in high-risk adults. 

As of early August 2024, three RSV vaccines have been approved for use in the U.S., and several vaccine candidates are conducting late-stage studies.

Additionally, the U.S. CDC reported on August 9, 2024, that RSV sections were generally low, except for the state of Florida.

Throughout 2024, the Florida Department of Health has reported various mosquito-transmitted diseases infecting people. Florida has confirmed that 14 species of Anopheles mosquitoes transmit diseases to humans. 

While Dengue fever gets most of the media headlines, diseases such as Chikungunya, Malaria, and West Nile virus have also been detected this year.

For example, on August 5, 2024, a locally acquired case of West Nile Virus was confirmed in Broward County.

As a direct response, the Broward County Mosquito Control Section recently announced it would spray organic larvicide as part of an integrated pest management approach. Truck-mounted larviciding will be performed between August 5 - 22, 2020.

This month, portions of Hollywood, Pembroke Pines, Davie, and Southwest Ranches are being targeted in southeast Florida.

The larvicide used is VectoBac WDG, which is not harmful to humans, pets, bees, aquatic habitats, or environmentally sensitive areas. The active ingredient is Bacillus thuringiensis israelensis (Bti, strain AM6552), a naturally occurring, biodegradable bacterial mosquito larvicide.

Broward County Mosquito Control Section continues to work closely with the Florida Department of Health and Code Enforcement partners in Broward's 31 municipalities to reduce the population of mosquitoes and their habitats. Any Broward County resident experiencing mosquito problems can request service by calling 311.

Regarding disease prevention, the U.S. Centers for Disease Control and Prevention (CDC) recently recommended Valneva SE's IXCHIQ®, a monovalent, single-dose, live-attenuated chikungunya vaccine. Vaccination is advised for international travelers since five chikungunya cases with onset in 2024 have been reported in individuals with a travel history to Brazil.

As of August 10, 2024, the CDC has not issued vaccination requirements for Florida residents or visitors.

The European Centre for Disease Prevention and Control (ECDC) today alerted travelers and clinicians today about the risk of Oropouche virus disease, a zoonotic disease caused by the Oropouche virus (OROV).

The ECDC's Threat Assessment, published on August 9, 2024, reported that during June and July 2024, 19 imported cases of Oropouche virus disease were reported for the first time in EU countries: Spain (12), Italy (5) and Germany (2).

Eighteen of these cases had a travel history to Cuba and one to Brazil.

The principal vector (Culicoides paraensis midge) is widely distributed across the Americas but is absent in Europe. There has been a lack of evidence as to whether European midges or mosquitoes could transmit the virus.

In 2024, outbreaks of OROV disease were reported in several countries across South America, Central America, and the Caribbean.

The ECDC says this health risk is moderate for people traveling to or living in epidemic areas in South America, Central America, and the Caribbean.

However, it noted that the risk is higher for those visiting heavily affected areas, including Brazil's northern states and the Amazon region, and for those who don't take adequate protective measures.

Oropouche virus disease can manifest as an acute febrile illness with headache, nausea, vomiting, muscle and joint pains, and occasionally more severe symptoms. The prognosis for recovery is good, and fatal outcomes are infrequent.

Recently, the Brazilian Ministry of Health reported six possible cases of OROV disease being passed from mother to child during pregnancy. The potential risk during pregnancy and fetopathic effects of OROV infection are still under investigation and have not been confirmed.

Furthermore, horizontal, human-to-human virus transmission has not been documented.

The ECDC says areas affected by OROV, such as Brazil, are also classified with current or previous Zika virus (ZIKV) transmission. Therefore, travel advice for pregnant women combines ZIKV and OROV warnings.

Unfortunately, there are no vaccines to prevent OROV or Zika diseases.

HilleVax, Inc., a company focused on developing and commercializing novel vaccines, announced financial results for the June 30, 2024 quarter and highlighted recent progress.

As of June 30, 2024, and December 31, 2023, the company had cash, cash equivalents, and marketable securities totaling $245 million and $303.5 million, respectively.

On August 8, 2024, the company confirmed it is exploring the potential for continued development of its HIL-214 and HIL-216 norovirus vaccine candidates in adults.

However, the company has discontinued further development of HIL-214 in infants.

This is unfortunate news since no U.S. FDA-approved norovirus vaccines are available to meet disease prevention needs.

The U.S. CDC recently reported norovirus is the leading cause of vomiting and diarrhea from acute gastroenteritis among people of all ages and causes 58% of foodborne illnesses acquired in the United States.

Each year, there are about 2,500 reported norovirus outbreaks in the U.S., including on cruise ships.

New whooping cough data published today by the U.K. Health Security Agency (UKHSA) shows that laboratory-confirmed cases have exceeded 10,400.

The latest data for England shows cases of whooping cough peaked in May 2024 but continue at high levels, with 2,427 cases reported in June.

On August 8, 2024, the UKHSA  confirmed one additional infant death in June, bringing the total to 10 since the current outbreak, which began in November 2023.

Evidence from England shows that vaccination at the right time in pregnancy is highly effective, offering 92% protection against infant death.

The latest uptake data for the vaccination offered to pregnant women to protect newborn infants against whooping cough continues to decline - with coverage in March 2024 at 58.9% compared to the peak coverage (72.6%) in March 2017.

Dr. Mary Ramsay, Director of Immunisation at the UKHSA, said in a press release, "Vaccination is the best defense against whooping cough, and pregnant women and young infants must receive their vaccines at the right time. Pregnant women are offered a whooping cough vaccine in every pregnancy, ideally between 20 and 32 weeks."

"This (vaccination) passes protection to their baby in the womb so that they are protected from birth in the first months of their life when they are most vulnerable and before they can receive their vaccines."

Whooping cough, also known as pertussis, is a bacterial infection that affects the lungs. The first signs of infection are similar to a cold, such as a runny nose and sore throat, but after about a week, the infection can develop into coughing bouts that last for a few minutes and are typically worse at night, says the UKHSA.

In the United States, whooping cough vaccines are generally available at health clinics and pharmacies.

As of August 2024, the U.S. CDC has not issued a Travel Health Advisory regarding the U.K.'s whooping cough outbreak.

Bavarian Nordic A/S today announced that it had received a new order valued at USD 156.8 million from the U.S. Biomedical Advanced Research and Development Authority (BARDA) to manufacture additional bulk product for JYNNEOS® (MVA-BN®, IMVAMUNE®, IMVANEX®), the company’s smallpox/mpox vaccine.

The new BARDA contract will help replenish the inventory of bulk vaccines required for future manufacturing and supply of freeze-dried vaccines.

The bulk product, representing $139.7 million of the contract value, will be manufactured and invoiced in 2024 and will partly replenish the inventory used to manufacture vaccines in response to the global mpox outbreak that began in May 2022.

Replenishment of the bulk inventory is necessary to fulfill the company’s existing contract to supply a next-generation, freeze-dried version of the vaccine for U.S. smallpox preparedness.

Since 2003, Bavarian Nordic has worked with the U.S. government on the development, manufacturing, and supply of a non-replicating smallpox vaccine.

The vaccine was approved by the U.S. FDA in 2019 under the trade name JYNNEOS®, which is indicated for preventing both smallpox and mpox infection.

In real-world studies, JYNNEOS effectiveness against mpox disease adjusted vaccine effectiveness estimates ranged from 35% (95% CI, -2-59) to 89% (95% CI, 76-95) after one dose and from 66% (95% CI, 47-78) to 90% (95% CI, 86-92) after two doses.

Before FDA approval, Bavarian Nordic had supplied nearly 30 million doses of the liquid-frozen version to the U.S., with the vast majority being delivered for emergency use - and now expired.

“Our smallpox/mpox vaccine represents a key component in the U.S. biological preparedness, as demonstrated during the 2022 mpox outbreak," said Paul Chaplin, President & CEO of Bavarian Nordic, in a press release on August 8, 2024.

"JYNNEOS was also the first smallpox vaccine successfully developed under Project BioShield, a program created by the U.S. Congress in 2004 to accelerate the research, development, procurement, and availability of medical countermeasures against biological, chemical, radiological, and nuclear agents through public-private partnerships."

"We applaud the U.S. government’s steadfast commitment to maintaining a robust preparedness and are proud to continue providing vaccines to protect its citizens against current and future public health threats,” added Chaplin.

The new BARDA contract also includes approximately $17 million for additional services in 2025-2027, including storage of vaccine doses in the U.S.

BARDA has supported the development of a freeze-dried version of the vaccine with a longer shelf life to replace the stockpile and awarded the company a ten-year contract for the supply of freeze-dried vaccines in 2017.

On March 14, 2024, the U.S. CDC's Agam Rao, MD CAPT, U.S. Public Health Service, stated, 'JYNNEOS vaccination is expected to be effective regardless of mpox clade.'

As of August 2024, the JYNNEOS vaccine is commercially available in the United States. Healthcare providers in the U.S. administer JYNNEOS for no charge, regardless of any administration fee. The CDC does not endorse booster doses (3rd).