Vaccine News

While two approved dengue vaccines are in use today, an innovative vaccine candidate was awarded $5.88 million to support activities to advance it into the clinic.

Codagenix Inc. announced on October 24, 2023, that the U.S. Department of Defense (DoD) awarded the Company $5,880,000 to advance the development of its CodaVax-DENV, a tetravalent live-attenuated dengue vaccine program.

The funds will support good manufacturing practices of drug substances and tetravalent drug product for a Phase 1 study, as well as a first-in-human Phase 1 safety and immunogenicity clinical trial.

This new award complements a $4.4 million DoD grant issued in 2022.

Codagenix's rational vaccine design platform is well-positioned to create a safe and effective dengue vaccine since its codon deoptimization process has the potential to provide immunity against all four dengue serotypes in a tetravalent formulation without the use of a backbone virus.

In addition to CodaVax-DENV, several dengue vaccine candidates are conducting clinical trials in 2023.

"We are honored to be selected for this award and would like to thank the DoD for their continued support, which is a recognition of the advantages of CodaVax-DENV, including codon deoptimization, homologous DENV 1, 2, 3, 4 strains, and the ability to titrate attenuation to develop balanced immunity," commented Jeffrey Fu, Ph.D., Chief Business Officer of Codagenix, in a related press release.

"These qualities uniquely position CodaVax-DENV to address the unmet needs in dengue prevention."

Dengue is a mosquito-borne viral infection, with over 2.4 billion people living in dengue-endemic areas worldwide; it is a leading cause of serious illness in several Latin American and Asian countries in 2023.

To alert international travelers of this health risk, the U.S. CDC recently issued Travel Health Notices regarding dengue outbreaks in the Americas  (September 25, 2023), Africa/Middle East (October 18, 2023), Costa Rica, and Asia/Pacific Islands (July 25, 2023). 

In the United States, Puerto Rico and Florida have reported the most dengue outbreaks in 2023.

The U.S. Centers for Disease Control and Prevention (CDC) today announced the Health Alert Network Health Advisory (CDCHAN-00499) that offers options for clinicians to protect infants from respiratory syncytial virus (RSV) in the context of a limited supply of Beyfortus™ (nirsevimab), a single-dose, long-acting monoclonal antibody product.

In July 2023, the U.S. Food and Drug Administration (FDA) approved Beyfortus for passive immunization to prevent RSV-associated lower respiratory tract disease among infants and young children.

For the 2023–2024 RSV season, the manufacturer reports a limited supply of Beyfortus, particularly the 100mg dose prefilled syringes used for infants weighing ≥5 kg.

Based on manufacturing capacity and currently available stock, the CDC says there are insufficient 100mg dose prefilled syringes of Beyfortus to protect all eligible infants weighing ≥5 kg during the current RSV season.

In the context of limited supply during the 2023–2024 RSV season, CDC recommends prioritizing available Beyfortus 100mg doses for infants at the highest risk for severe RSV disease: young infants (age <6 months) and infants with underlying conditions that place them at highest risk for severe RSV disease.

As of October 23, 2023, the CDC's recommendations for using 50mg doses remain unchanged.

Avoid using two 50mg doses for infants weighing ≥5 kilograms (≥11 pounds) to preserve supply of 50mg doses for infants weighing <5 kilograms (<11 pounds). 

The CDC further recommends that providers suspend using the single-dose Beyfortus in the multidose Synagis® (palivizumab)-eligible children aged 8–19 months for the 2023–2024 RSV season.

These children should receive the multidose Synagis per the American Academy of Pediatrics recommendations.

Synagis was initially approved by the U.S. FDA in 1998.

However, Beyfortus should continue to be offered to American Indian and Alaska Native children aged 8–19 months who are not palivizumab-eligible and who live in remote regions, where transporting children with severe RSV for escalation of medical care is more challenging or in communities with known high rates of RSV among older infants and toddlers.

RSV is a common cause of respiratory infection in U.S. infants, most of whom are infected with RSV during their first year of life. RSV is the leading cause of hospitalization among U.S. infants.

The highest incidence of RSV-associated hospitalization occurs in infants aged <3 months and then decreases with time.

The Journal of Infectious Diseases published a meta-analysis in October 2023 that found among 8,126 pregnant women, the proportion with respiratory infections that tested positive for RSV ranged from 0.9% to 10.7%, with a meta-estimate of 3.4% (95% CI: 1.9; 54).

As of October 9, 2023, RSV activity was found to be generally low, according to the WHO's Influenza Update N° 455.

Current reports to the National Respiratory and Enteric Virus Surveillance System indicate RSV transmission has increased to seasonal epidemic levels in the Southern regions, such as in Florida, and is expected to continue to increase in the rest of the country within the next few months.

The CDC's RSV detection graphs display the 5-week moving average in U.S. states as of October 19, 2023. 

These interim recommendations by the CDC are subject to change as new evidence becomes available.

Pfizer Inc. recently announced that the U.S. Food and Drug Administration (FDA) approved PENBRAYA™, the first and only pentavalent vaccine that provides coverage against the most common serogroups causing meningococcal disease in adolescents and young adults 10 through 25 years of age.

PENBRAYA combines the components from two meningococcal vaccines, Trumenba® (meningococcal group B vaccine) and Nimenrix® (meningococcal groups A, C, W-135, and Y conjugate vaccine), to help protect against the five most common meningococcal serogroups that cause the majority of invasive meningococcal disease (IMD).

The FDA's decision is based on the positive results from the Phase 2 and Phase 3 trials, including a randomized, active-controlled, and observer-blinded Phase 3 trial assessing the safety, tolerability, and immunogenicity of the pentavalent vaccine candidate compared to currently U.S. licensed meningococcal vaccines, to determine immunologic noninferiority.

"Nearly 9 out of 10 adolescents have incomplete protection against IMD caused by the leading serogroups," said Jana Shaw, MD, Pediatrics Infectious Disease Specialist, Upstate Golisano Children's Hospital in Syracuse, NY, in a Pfizer press release on October 20, 2023.

"For the first time, we have a single vaccine that helps protect against the five most common serogroups and has the potential to improve coverage and increase protection among adolescents and young adults."

Meningococcal disease is an uncommon but serious illness that can lead to death within 24 hours and, for survivors, can result in life-altering, significant long-term disabilities.

The U.S. CDC Advisory Committee on Immunization Practices is scheduled to meet on October 25, 2023, to discuss recommendations for the appropriate use of PENBRAYA in adolescents and young adults and other vaccines.

Various meningococcal vaccines are approved by the CDC in 2023.

Without U.S. FDA-approved vaccines, a common antibiotic may become a "morning-after" pill to reduce the spread of chlamydia, syphilis, and gonorrhea among populations at higher risk for contracting sexually transmitted diseases (STDs).

On October 11, 2023, Dr. Connie Celum, a professor of global health and medicine at the University of Washington School of Medicine, stated in a press release, "Every year for the last six or seven years, there's been an increase in bacterial STDs. So the current approach of testing and treating is just not enough."

"Preventive doxycycline is "the best new intervention identified for STD prevention for quite a long time."

The U.S. Centers for Disease Control and Prevention (CDC) recently issued a preliminary recommendation for doxycycline to be prescribed to trans women and men who have sex with men, who also have experienced at least one sexually transmitted infection in the previous year, and who are at ongoing risk to acquire an STD.

Dr. Celum co-led one research study whose findings motivated the CDC's recommendation for "doxy-PEP."

In 2022, a study ended early because a single dose of 200 milligrams of doxycycline, taken within three days of unprotected sex, was highly effective at preventing the abovementioned STDs.

The most significant reduction was in chlamydia and early syphilis infections, added Celum.

As of October 20, 2023, there are approved vaccines that prevent certain STDs, such as HPV, and various vaccine candidates conducting clinical studies, such as herpes.

 Vaxcyte, Inc. today announced that the U.S. Food and Drug Administration (FDA) has cleared the Company's adult Investigational New Drug application for VAX-31, a 31-valent pneumococcal conjugate vaccine (PCV) candidate designed to prevent invasive pneumococcal disease (IPD).

Vaxcyte expects to initiate the VAX-31 Phase 1/2 clinical study in 2023 and announce topline results in the second half of 2024.

"The FDA clearance of the VAX-31 IND application represents an important step toward our goal of building a best-in-class PCV franchise, including VAX-31 and VAX-24, the 24-valent PCV for which we achieved positive results in two adult Phase 2 clinical studies," said Grant Pickering, Chief Executive Officer and Co-founder of Vaxcyte, in a press release on October 19, 2023.

"Given that VAX-31, which will be the broadest-spectrum PCV to enter the clinic, leverages the foundation already established with VAX-24, we are very excited about the promise of this vaccine candidate."

The VAX-31 Phase 1/2 clinical study is a randomized, observer-blind, active-controlled, dose-finding clinical study designed to evaluate the safety, tolerability, and immunogenicity of VAX-31 compared to Prevnar 20® (PCV20) in approximately 1,000 healthy adults aged 50 and above.

Pneumococcal disease (PD) is an infection caused by Streptococcus pneumoniae (pneumococcus) bacteria. It can result in IPD, including meningitis and bacteremia, and non-invasive PD, including pneumonia, otitis media, and sinusitis.

In the U.S., approximately 320,000 people get pneumococcal pneumonia yearly, estimated to result in about 150,000 hospitalizations and 5,000 deaths. Pneumococci also cause over 50% of all cases of bacterial meningitis in the U.S.

As of October 20, 2023, numerous licensed pneumococcal vaccines and candidates are conducting clinical trials.

Ordering of the new respiratory syncytial virus (RSV) immunization nirsevimab-alip (Beyfortus™) through the Vaccines for Children (VFC) program has been suspended, according to the American Academy of Pediatrics (AAP) News on October 17, 2023.

Beyfortus is the first U.S. FDA-approved extended half-life monoclonal antibody offering passive immunization to prevent lower respiratory tract infections caused by RSV. 

The  American Medical Association has approved two new Current Procedural Terminology codes related to the administration of Beyfortus (96381), one of which accounts for the work associated with providing counseling (96380).

In a letter to state immunization managers in early October 2023, the Centers for Disease Control and Prevention (CDC) cited a "high demand and limited supply" for causing the pause in ordering.

"This approach will help us ensure equitable availability across all awardees," the CDC said to immunization managers.

"Despite an aggressive supply plan built to outperform past pediatric vaccine launches, demand for this product, especially for the 100 mg doses used primarily for babies born before the RSV season, has been higher than anticipated," Sanofi said in a recent statement.

'Our approach for distribution across the private marketplace will be similar. We are working with our Alliance partner in charge of manufacturing, AstraZeneca, to accelerate additional supply and explore several actions to extend the manufacturing network.'

In Texas, the Department of State Health Services (DSHS) recently announced it is pausing provider orders for nirsevimab in the Vaccine Allocation and Ordering System until further notice.

DSHS's understanding from the CDC is that Texas orders placed before October 9, 2023, are already being shipped. DSHS is awaiting confirmation on how the CDC will handle orders placed after October 9, 2023.

The CDC says pediatricians can continue to use the multi-dose Synagis® (Palivizumab) for eligible high-risk children. 

The global outbreak of dengue fever in 2023 includes countries in the Pacific Region, such as Taiwan.

Taiwan's National Infectious Disease Statistics System today reported the local dengue outbreak has begun to recede.

As of October 18, 2023, Taiwan confirmed 17,588 dengue cases and 32 related deaths this year. Tainan City has confirmed 14,017 of these dengue cases.

Separately, the Taipei Times reported the second instance of vertical transmission of dengue fever in 2023.

Taiwan's Centers for Disease Control physician, Lin Yung-ching, stated that a case of mother-to-infant dengue transmission was confirmed, affecting a five-day-old boy, the second such case in 2023, and the third ever in Taiwan.

The mother was diagnosed with dengue one day after giving birth. Dr. Lin said the infant developed a fever five days later and tested positive for dengue.

As the baby had been in hospital since birth and had a short incubation period, the disease was most likely transmitted vertically, he said.

The U.S. CDC says a pregnant woman infected with dengue can pass the virus to her fetus during pregnancy or around birth. And there has been one documented report of dengue spread through breast milk.

Because of the benefits of breastfeeding, mothers are encouraged to breastfeed even in areas with a risk of dengue, says the CDC.

Dengue is a vaccine-preventable disease, with two approved dengue vaccines in 2023.