Travel Vaccine Breaking News

In late 2023, the World Health Organization issued its first-ever prequalification approval for a vaccine under its Emergency Use Listing (EUL) regulatory pathway, the novel oral polio vaccine type 2 (nOPV2).

Since this next-generation vaccine rollout began in March 2021, the Global Polio Eradication Initiative (GPEI) reported about 1 billion nOPV2 doses have been administered across 35 countries, protecting children against disease.

WHO prequalification will enable additional countries to access the vaccine in response to outbreaks of type 2 variant poliovirus (cVDPV2). 

As of January 3, 2024, the GPEI reported that 325 cases of cVDPV2 had been confirmed in 2023, compared to 689 cases in 2022.

While nOPV2 has played a vital part in this reduction, its success, like any polio vaccine, depends on the ability to implement high-quality immunization campaigns that reach every child rapidly, says the GPEI.

"This is a historic milestone for polio eradication and public health," commented WHO Director-General Dr Tedros Adhanom Ghebreyesus in a press release.

"Novel oral polio vaccine type 2 has blazed a trail for other new vaccines that address critical health emergencies, and its use demonstrates the utility of the EUL mechanism in helping to rapidly get new products to where they're needed most."

The nOPV2 vaccine is genetically more stable than existing oral polio vaccines, with a lower risk of reversion to neurovirulence. In addition, this nOPV2 vaccine produces a gut reaction that stops virus transmission using a more stable version of the OPV, which is much less likely to cause paralysis. 

The WHO's EUL is reserved for using yet-to-be-licensed vaccines, medicines, and diagnostic tools during public health emergencies like polio outbreaks.

As of January 10, 2024, the nOPV2 vaccine is unavailable in the United States.

According to a recent U.S. CDC Travel Health Notice, over 30 countries reported polio outbreaks in 2023.

HilleVax, Inc. and Chengdu Kanghua Biological Products Co., Ltd. today announced the entry into an exclusive license agreement for rights to Kangh's hexavalent virus-like particle (VLP) vaccine candidate for norovirus.

Referred by HilleVax as HIL-216, outside of Greater China, this VLP targets six of the most common norovirus genotypes, including GI.1, GII.2, GII.3, GII.4, GII.6, and GII.17.

HilleVax stated it intends to launch a Phase 1 trial in 2024.

According to the press release on January 8, 2024, the Investigational New Drug application for HIL-216 was cleared by the U.S. FDA in September 2023.

As of January 9, 2024, the FDA has not approved any norovirus vaccine candidate for use in the U.S.

Rob Hershberg, MD, Ph.D., Chairman and Chief Executive Officer at Hillevax, commented, "Our bivalent norovirus VLP vaccine candidate, HIL-214, remains the most advanced norovirus vaccine candidate in clinical development, and we are on track to report topline safety and efficacy data in mid-2024."

"We believe that HIL-214 will be the first norovirus vaccine submitted for registration and, if approved, would address the significant unmet medical need in infants and other at-risk populations."

"We further believe that HIL-216 is an exciting addition to the HilleVax portfolio as a next-generation, higher valency VLP-based vaccine and is an ideal fit with the expertise, capabilities, and long-term aspirations of HilleVax."

HilleVax confirmed it will pay Kangh an upfront payment of $15 million with the potential for additional payments of up to $255.5 million upon achieving specific development and sales milestones. Kangh can also receive a single-digit tiered royalty on net sales outside of Greater China.

Globally, norovirus is estimated to result in approximately 700 million cases of acute gastroenteritis and 200,000 deaths per year, resulting in over $4 billion in direct health system costs and $60 billion in societal costs per year. 

According to the U.S. CDC, norovirus is a contagious virus that causes vomiting and diarrhea. Anyone can get infected and sick with norovirus. Most norovirus outbreaks in the U.S. happen from November to April.

From August through November 13, 2023, there were 202 norovirus outbreaks reported by NoroSTAT-participating states. During the same period last season, 134 norovirus outbreaks were reported by these states, according to the CDC.

HilleVax is a clinical-stage biopharmaceutical company based in Boston, MA, focused on developing and commercializing novel vaccines.

Transgene and NEC Corporation today announced the signing of a further development collaboration agreement to continue the clinical evaluation of the individualized neoantigen cancer vaccine TG4050.

TG4050 is currently being evaluated in a randomized multicenter Phase I trial as a single agent in the adjuvant treatment of HPV-negative head and neck cancers. Based on promising data obtained in this Phase I trial, Transgene and NEC are preparing a randomized Phase I/II extension of this trial slated to start in 2024.

This new trial builds on compelling first signs of efficacy and induction of specific T-cell responses to generate a comprehensive set of immunological and clinical data to demonstrate the potential of TG4050 further.

Additional immunological and clinical data from the Phase I trial is expected at a scientific conference in the first half of 2024.

Alessandro Riva, Chairman and CEO of Transgene, commented in a press release, "We are pleased to announce the extension of our agreement with NEC, which marks a significant milestone in our collaboration."

"We look forward to continuing to treat patients with our individualized cancer vaccine TG4050. The compelling initial Phase I data presented with NEC at ASCO 2023 showed that all evaluable patients treated with TG4050 monotherapy developed a specific immune response and remained disease-free."

"Our joint clinical development plan builds on these promising data in a setting where there is no approved treatment to prevent patient relapse after adjuvant chemoradiotherapy."

"We believe that TG4050, by combining a powerful and immunogenic viral vector with an extremely sophisticated neoantigen selection tool, has the potential to address major medical needs in the adjuvant treatment of solid tumors."

TG4050 is based on Transgene's viral vector-based myvac® platform and powered by NEC's cutting-edge AI capabilities for identifying and predicting the most immunogenic neoantigens.

According to a Medical News Brief by Emily Harris with The JAMA Network, observational data from more than 1.6 million people in the United States suggests that a high-dose vaccine may also be more effective than standard-dose vaccines for certain adults.

Reported in the New England Journal of Medicine in December 2023, the Original Article evaluated a recombinant vaccine that contains more than triple the amount of influenza hemagglutinin protein compared with standard-dose vaccines.

Flu cases were about 15% lower for people aged 50 to 64 who received the recombinant vaccine.

Because standard-dose vaccines only prevent up to 40% to 60% of influenza cases, decreasing the number of cases by an additional 15% would still “provide a substantial public health benefit, especially during more severe influenza seasons,” the researchers wrote.

As of December 31, 2023, the U.S. CDC reported that over 155 million egg, cell, and nasal-based influenza vaccines, which are generally available at local pharmacies, had been distributed this flu season.

The Philadelphia Department of Public Health reported today that there is a cluster of measles among unvaccinated residents.

As of January 4, 2024, in addition to an index case, three locally acquired cases have been confirmed, with two of those cases being hospitalized and released.

Furthermore, there are at least two more possible cases that have been hospitalized.

If you visited any of these sites on the days listed at this link, you may have been exposed to measles.

These measles cases are connected with the notice issued on December 23, 2023.

Health Commissioner Dr. Cheryl Bettigole commented in a press release, “Unfortunately, we are seeing cases of measles that have spread to vulnerable individuals, including young children, due to people declining vaccination and also failing to adhere to quarantine recommendations."

The Health Department is strongly recommending that anyone who may have been exposed to measles should quarantine themselves by staying home and away from others.

Additionally, people who have not received both doses of a Measles, Mumps, and Rubella (MMR) vaccine should talk with their healthcare provider about getting caught up.

Pfizer Canada announced the Health Canada approved its bivalent Respiratory Syncytial Virus (RSV) vaccine ABRYSVO™ Vaccine.

ABRYSVO is indicated for the prevention of lower respiratory tract disease caused by RSV in individuals 60 years of age and older by active immunization, and the prevention of lower respiratory tract disease and severe lower respiratory tract disease caused by RSV in infants from birth through 6 months of age by active immunization of pregnant women.

"Vaccines are considered to be the most effective tool in public health for preventing illness and can help reduce the stress on our healthcare system and professionals, including nurses, doctors, and others on the frontline," said Dr. Darine El-Chaâr, Maternal Fetal Medicine physician at The Ottawa Hospital, in a press release on January 4, 2024. 

"Vaccines administered through maternal immunization can also help play a critical role in decreasing the gap of vulnerability in the first few months of an infant's life, as well as helping to protect their mothers, who may be at increased risk of severe disease compared with non-pregnant women."

RSV is a common respiratory virus that causes mild disease with cold-like symptoms in the fall and winter months.

In more vulnerable populations, like adults 60 and over, an RSV infection can be severe, especially among those with underlying respiratory or cardiac conditions.

For infants, RSV infection can result in respiratory distress, especially in those less than six months of age and those with higher risk factors such as congenital heart or lung disease or prematurity.

Pfizer Canada is currently assessing the availability timeline for ABRYSVO and is committed to bringing a supply of this vaccine to Canadians as quickly as possible.

As of January 5, 2024, RSV vaccines and monoclonal antibody therapy that deliver passive immunization to infants are approved for use in the United States.

Sanofi Canada recently announced the National Advisory Committee on Immunization's annual Statement on Seasonal Influenza Vaccine for 2024-2025 continues to recommend Fluzone® High-Dose Quadrivalent among the preferential influenza vaccines to protect adults 65 years of age and older against influenza.

Delphine Lansac, General Manager, Vaccines Canada, Sanofi, commented in a press release on January 3, 2023, "This long-standing recommendation as a preferential influenza vaccine for adults 65 years of age and older speaks to the science that Fluzone® High-Dose Quadrivalent is built on and demonstrates our continued leadership in vaccines."

"It's been a groundbreaking year, where over 50% – more than one in two – seniors who received influenza vaccines in Canada were immunized with Fluzone® High-Dose Quadrivalent Influenza Vaccine."

Fluzone® High-Dose Quadrivalent Influenza Vaccine is designed to protect seniors with four times the active component dosage of a standard flu shot.

To date, Fluzone® High-Dose is available in more than 20 countries, including the United States, Canada, and Germany.

As of December 23, 2023, over 155 million flu shots had been distributed in the U.S. this season.