Vaccine News

Emergent BioSolutions today announced it had completed the sale of its travel health business to Bavarian Nordic and may receive up to $380 million in potential future payments.

Bavarian Nordic acquired the rights to Vivotif®, the licensed typhoid vaccine, and Vaxchora®, the licensed cholera vaccine, and the development-stage chikungunya vaccine candidate CHIKV VLP.

These travel-related vaccines are part of an estimated international market growth rate (9.9%) thru 2028. This data indicates millions of travelers are under-vaccinated before visiting disease-endemic countries. 

Bavarian Nordic also acquired manufacturing facilities in Bern, Switzerland, and development facilities in San Diego, California.

"This deal achieves two significant outcomes key to our mission and future success," said Robert G. Kramer, Emergent president, and chief executive officer, in a press release on May 15, 2023.

Other market research reports indicate an uplift in international travel is coming. 

Such as the Expedia Group's Traveler Insights reveals traveler searches increasing globally by 25% in Q1 2023, which means travelers are looking toward mid-year getaways.

The U.S. Centers for Disease Control and Prevention (CDC) announced a Health Alert Network Health Update today to inform clinicians and public health agencies that the mpox outbreak is not over.

As of May 15, 2023, the CDC continues to receive reports of mpox cases that reflect ongoing community transmission in the U.S. and Europe (France).

For example, from April 17 to May 5, 2023, a total of 12 confirmed and one probable mpox case was reported to the Chicago Department of Public Health.

Unfortunately, nine (69%) of 13 cases were among men who had received both doses of the U.S. FDA-approved JYNNEOS® (MVA-BN) vaccine.

The travel history was available for nine men; 4 recently traveled (New York City, New Orleans, and Mexico).

Although vaccine-induced immunity is not complete, vaccination continues to be one of the most important prevention measures, says the CDC.

However, data posted by the CDC on December 8, 2022, indicates the effectiveness of one JYNNEOS dose was 37%, two doses were 69%, and the duration of immunity is unknown. 

The CDC announced on February 22, 2023, the Interim Clinical Considerations mpox vaccination should continue to be offered to people with the highest potential for exposure to mpox.

Furthermore, the CDC expects additional mpox cases among previously vaccinated people to occur during the spring and summer seasons in 2023 as people gather for festivals and other events.

Additional mpox outbreak news is posted by Precision Vaccinations.

Theratechnologies Inc. recently presented data from a study in which the use of Trogarzo® (ibalizumab), a monoclonal antibody antiretroviral therapy (ART), was associated with favorable virologic outcomes compared to non-ibalizumab regimens used in routine care in heavily treatment-experienced people with HIV.

In the new study, using ibalizumab resulted in a statistically significant doubling of the likelihood of viral undetectability and a much longer duration of undetectability and viral suppression compared to a real-world, non-ibalizumab control group from the Observational Pharmaco-Epidemiology Research & Analysis (OPERA®) database.

The ibalizumab study is thought to be the first matching-adjusted indirect treatment comparison study in HIV, an approach designed to facilitate a closely matched comparison from a synthesized, real-world population when randomization to a control arm would be impractical or unethical.

Christian Marsolais, Ph.D., Senior Vice President and Chief Medical Officer of Theratechnologies, stated in a press release on May 4, 2023, “This is the largest dataset and longest follow-up for Trogarzo® since our Phase 3 study, and reinforces its importance in a patient population that historically has had limited novel treatment options.”

The study evaluated data from 76 participants in two clinical trials (Phase 2b and Phase 3) who received 800 mg of ibalizumab every two weeks (treatment arm) and compared those data to outcomes from 65 individuals treated with non-ibalizumab-containing regimens as routine care in the OPERA® cohort (control arm).

Standardized mortality rate weighting ensured a balance between the treatment and control groups regarding baseline age, CD4 cell count, viral load, and susceptibility to specific ART agents.

At 24 weeks, investigators observed a statistically significant doubling of the likelihood of viral undetectability (defined as VL <50 c/mL) in the treatment arm versus the control arm (SMR-weighted hazard ratio [HR]: 1.98; 95% confidence interval [CI]: 1.02, 3.69).

Achievement of viral suppression (defined as VL <200 c/mL) was also more likely with ibalizumab, though this finding did not reach statistical significance (SMR-weighted HR: 1.28; 95% CI: 0.82, 2.06).

Among those who achieved undetectability on ibalizumab, 95% maintained undetectability through the end of follow-up.

Additionally, the exact significance emerged for maintaining viral suppression, which was 18 times lower for real-world non-ibalizumab regimens.

For both durability analyses, confidence intervals were wide but statistically significant (SMR-weighted HR: 18.36; 95% CI: 2.48, 135.68).

Note: Monoclonal antibody antiretroviral therapy is not an HIV vaccine candidate.

The U.S. Centers for Disease Control and Prevention (CDC) reissued its Alert - Level 2, Practice Enhanced Precautions notice regarding the ongoing Marburg virus disease (MVD) outbreak in the Republic of Equatorial Guinea.

As of May 12, 2023, the CDC says, 'Reconsider non-essential travel to mainland Equatorial Guinea.'

If you travel to Equatorial Guinea, you should:

• Avoid contact with sick people with fever, muscle pain, and rash symptoms.
• Avoid contact with blood and other body fluids.
• Avoid contact with dead bodies or items that have been in contact with dead bodies, participate in funeral or burial rituals, or attend a funeral or burial.
• Avoid visiting healthcare facilities in the outbreak area for nonurgent medical care or non-medical reasons.
• Avoid visiting traditional healers.
• Avoid contact with fruit bats and the caves and mines where they live.
• Avoid nonhuman primates (e.g., chimpanzees, gorillas).

Furthermore, visitors should watch their health for symptoms of Marburg, a viral hemorrhagic fever, while in the outbreak area and 21 days after leaving the outbreak area.

As of May 14, 2023, other Marburg outbreak alerts have been issued this year for Africa. 

Unfortunately, there are no Marburg vaccines available.

Local media recently reported a case of Ebola virus disease in The Democratic Republic of Congo (DRC) on May 8, 2023. The last Ebola outbreak in the DRC occurred in 2022.

“Regarding Ebola virus disease surveillance, we received a sample that turned out to be positive from the Kyondo health zone and in the Butembo site. We have received four samples, and among the four, one is positive,” commented Damulo Luhavo, the communicator of the provincial health division of Butembo.

Luhavo called on the local population to continue to be vaccinated. 

As of May 13, 2023, various Ebola vaccines and Monoclonal Antibody therapies are available.

This news article did not disclose which type of Ebola, Sudan or Zaire, was detected.

CNA reported yesterday another young woman living in Taiwan was diagnosed with the A H1N2 variant (H1N2v) of the novel swine influenza virus.

As of May 11, 2023, this is only the third swine flu case ever seen in Taiwan, according to the Centers for Disease Control.

This zoonotic influenza case came into contact with swine from working at a pig farm. But the virus was not detected in any of the pigs on the farm where the girl worked.

Close contacts were identified, but none tested positive for the H1N2v virus.

Taiwan's first human H1N2v infection was reported in April 2021.

Unlike swine flu, avian influenza Highly Pathogenic Avian Influenza (HAPI) viruses have been detected in birds, mammals (cats, bears, dogs), and humans during 2022-2023.

The U.S. Centers for Disease Control and Prevention (CDC) Technical Report issued on March 17, 2023, confirmed the current risk to the public from HPAI A(H5N1) viruses remains low.

However, continued sporadic human infections are anticipated because of the potential for influenza viruses to evolve.

As of April 6, 2023, about 240 cases of human infection with avian influenza A(H5N1) virus have been reported from four countries within the Western Pacific Region since January 2003.

Of these bird flu cases, 135 were fatal, resulting in a case fatality rate of 56%.

Should a human pandemic occur in 2023, the U.S. government has already stockpiled U.S. FDA-approved bird flu vaccines, and other development efforts have been funded as of May 12, 2023.

Furthermore, the CDC says annual flu shots are not designed to protect people against either bird or swine flu infections.

The World Health Organization (WHO) External Situation Report #2 confirmed yesterday that the Kingdom of Eswatini reported its first cholera case in April 2023, related to cross-border transmission from Mozambique and a second case without travel history. 

In total, 24 countries have reported cholera cases since the beginning of 2023.

The overall capacity to respond to multiple and simultaneous outbreaks continues to be strained due to the global lack of resources, including shortages of the oral cholera vaccine.

Based on the current situation, the WHO assessed on May 11, 2023, the risk at the global level is very high.

Cholera outbreak news is posted by Vax-Before-Travel.

Before visiting Eswatini in southeast Africa, the U.S. CDC suggests various travel vaccinations, including yellow fever.