Cancer Vaccine Breaking News

CSL Seqirus today announced it was selected by the Biomedical Advanced Research and Development Authority (BARDA) to deliver one bulk lot of H5N8 A/Astrakhan antigen to the U.S. government.

This acquisition of a bulk lot will increase BARDA's stockpile of vaccines to support rapid response in an associated influenza pandemic.

CSL Seqirus has been working with BARDA in a longstanding partnership for over a decade, including numerous R&D and manufacturing activities and awards supporting BARDA's pandemic preparedness objectives.

Confirmed on August 28, 2023, this is the third award CSL Seqirus has received from BARDA in the last two years related to the ongoing outbreak of HPAI in the United States.

As of August 2023, the Pan American Health Organization reported H5N1 viruses (clade 2.3.4.4b) had been detected in 15 countries in Latin America, the Caribbean, the United States, and Canada over the past 18 months.

This award follows the February 2022 award to produce an H5N8 A/Astrakhan virus vaccine seed and the subsequent October 2022 announcement of the selection of CSL Seqirus to deliver an H5N8 A/Astrakhan virus vaccine candidate for assessment in a Phase 2 clinical study.

While the likelihood of sustained human-to-human transmission of bird flu is "low," according to the U.S. Centers for Disease Control and Prevention (CDC) and World Health Organization, there have been reported a small number of human cases of avian influenza A(H5), including one in the U.S. in April 2022, a case in Ecuador in January 20235 and Chile in March 2023.

"While human cases are rare, sporadic, and isolated, consistent detection of bird and mammalian cases demands vigilance," commented Marc Lacey, Executive Director, Pandemic Response Solutions, CSL Seqirus, in a press release.

"Ongoing surveillance and preparedness efforts are critical to minimize the public health risk."

CSL Seqirus used its cell-based influenza vaccine technology, as utilized for FDA-approved AUDENZ™ (Influenza A(H5N1) Monovalent Vaccine, Adjuvanted), to manufacture the H5N8 A/Astrakhan bulk vaccine at the company's Holly Springs, North Carolina, facility, which was built in partnership with BARDA.

CSL Seqirus has established and will maintain the required pandemic readiness to deliver 150 million doses of cell-based pandemic influenza vaccine within six months of an influenza pandemic declaration in the U.S.

This $46.3 million project has been supported in whole or in part with federal funds from the Department of Health and Human Services, Administration for Strategic Preparedness and Response; BARDA, under contract number 75A50122D00004.

Valneva SE today reported positive initial Phase 3 safety data in adolescents for its single-dose chikungunya virus (CHIKV) vaccine candidate VLA1553.

On August 28, 2023, Valneva announced the initial safety data generated in the ongoing trial VLA1553-321, Valneva's first clinical trial in an endemic area (Brazil) and with individuals previously infected with CHIKV, showed that VLA1553 was generally safe and well tolerated in adolescents aged 12 to 17 years, regardless of previous CHIKV infection.

In this study, 754 individuals were vaccinated in trial VLA1553-321, and the present analysis includes safety data up to Day 29. An independent DSMB has continuously evaluated safety data during the trial and identified no safety concerns.

Overall, the adverse event profile is consistent with the profile observed in Valneva's pivotal Phase 3 trial in adults, reported in March 2022.

Immunogenicity data for this new trial are expected in November 2023.

Juan Carlos Jaramillo, M.D., Chief Medical Officer of Valneva, commented in a press release, "These new safety data in a younger population and individuals previously infected with the chikungunya virus confirm the safety profile we previously observed in adults and the elderly."

"Chikungunya represents a major threat for people traveling to or living in areas where chikungunya virus is endemic, it is, therefore, our objective to make this vaccine available to all age groups, especially as no vaccine or specific treatments are currently available for this debilitating disease."

Funded by the Coalition for Epidemic Preparedness Innovations and conducted in collaboration with Brazil's Instituto Butantan, the VLA1553-321 adolescent trial is intended to support label extension in this age group following a potential initial regulatory approval in adults from the U.S. Food and Drug Administration. The trial is also expected to support the vaccine's licensure in Brazil, which would be the first potential approval for use in endemic populations.

The present safety analysis will also enable regulatory submission to the European Medicines Agency in 2023.

If licensed, this would be the first CHIKV vaccine candidate approved.

Since dengue outbreaks cause about 400 million infections yearly, the Pan American Health Organization (PAHO) and other agencies continue issuing health alerts for this deadly disease.

In the Americas, the total number of dengue cases reported was 2,997,097 through July 2023. Additionally, 1,302 deaths were reported in the Region.

To limit these deaths, two dengue vaccines have been approved and deployed in 2023.

According to a new study published in the journal Vaccines on August 22, 2023, the effectiveness of these vaccines varies.

Dengvaxia® has shown an efficacy of 60.8 % (95 % CI, 52.0–68.0) against symptomatic, virologically confirmed dengue (VCD) caused by any of dengue's four serotypes more than 28 days after the third dose in Asia (2 to 14-year children), and Latin America (9 to 16-year children) [15], respectively.

While QDENGA® has shown around 80.2 % (95 % CI, 73.3–85.3) efficacy.

And during a phase 1 clinical trial, the efficacy against VCD at 28 days after a single dose of a U.S. NIH-developed vaccine candidate was 79.6 %.

This study assessed the safety and immune response regarding nAbs induced by the SII Dengue vaccine in healthy adults in Australia.

The study showed the vaccine was safe and highly immunogenic in adults, primarily seronegative at baseline.

In the vaccine group, 59.0 % of participants showed DENV vaccine viremia post-vaccination.

This vaccine (Dengusiil) was formulated at Serum Institute of India Pvt. Ltd. (SII) to contain DENV 1, DENV 3, and DENV 4 serotypes at not less than 2.5 log10 PFUs and DENV 2 at not less than 3 log10 PFUs per single dose of 0.5 mL.

SII executive director Rajeev Dhere recently informed the TOI, "The Phase-I trial was conducted in Australia as we needed participants who had not been exposed to dengue previously."

"India has a significant proportion of people with dengue antibodies, so it was essential to test the vaccine's safety and effectiveness on individuals who were not already immune to the disease."

As of August 27, 2023, Dengvaxia is approved in the U.S., but availability requires pre-admission testing.

During 2023, the state of Florida and Puerto Rico have reported locally acquired and travel-related dengue cases.

Pfizer Inc. recently announced in a press release that the European Commission (EC) has granted marketing authorization for ABRYSVO™, the company's bivalent respiratory syncytial virus (RSV) prefusion F (RSVpreF) vaccine, to help protect both infants through maternal immunization and older adults.

ABRYSVO is the first licensed vaccine designed and studied explicitly for maternal immunization. Now, a single dose of the vaccine could be administered in the EU between weeks 24 and 36 of gestation.

In addition, ABRYSVO has been studied in adults 60 and older.

"The approval of ABRYSVO in Europe marks significant progress in the scientific community's efforts to provide meaningful protection against RSV, a common respiratory virus that could potentially be severe and even life-threatening, especially for infants and older adults," commented Annaliesa Anderson, Ph.D., Senior Vice President and Head Vaccine Research and Development, Pfizer on August 24, 2023.

"Last year's significant number of newborns, children, and adults being hospitalized across Europe demonstrated the immense need for protection against severe RSV cases. The approval of the vaccine for both older adults and infants through maternal immunization is a triumph for public health, and we hope to see a tremendous impact for future (RSV) seasons."

This authorization is valid in all 27 EU member states, plus Iceland, Liechtenstein, and Norway.

RSV is a contagious virus and a common cause of respiratory illness worldwide. 

In the EU, approximately 245,000 yearly hospital admissions were associated with RSV in children younger than five. 

The disease burden for older adults is also significant. Each year, the virus causes more than 270,000 hospitalizations and about 20,000 deaths in individuals and older.

The virus can affect an infected individual's lungs and breathing passages, potentially causing severe illness or death.

As of August 26, 2023, two RSV vaccines are approved for seniors and available at clinics and pharmacies in the United States.

The World Health Organization (WHO) today announced that although encouraged by the reported progress, the Committee unanimously agreed that the risk of international spread of poliovirus remains a Public Health Emergency of International Concern (PHEIC) and recommended the extension of Temporary Recommendations for a further three months.  

As of August 25, 2023, only two genetic clusters of WPV1 were identified, compared to three in 2022 and five in 2021.

However, there have been multiple chains of transmission within these two genetic clusters, detected primarily in the endemic zones of Eastern Afghanistan and South KP of Pakistan, including an extreme orphan virus, indicating some gaps in surveillance.

And there is a large pool of unvaccinated "zero dose" children in Afghanistan, which could reintroduce wild-type poliovirus into the southern region.

The also noted suboptimal immunization coverage during campaigns in southeastern Africa, Malawi, Mozambique, Zambia, and Zimbabwe. The nOPV2 vaccine has been deployed over 700 million times in Africa.

Based on the current situation and the reports provided by affected countries, the WHO Director-General accepted the Committee's assessment. It determined that the poliovirus situation continues to constitute a PHEIC.

While poliovirus has been detected in southern New York in 2022 and 2023, no outbreak has been confirmed.

Various polio vaccines are approved and available in August 2023 in the U.S. and globally.

The Republic of Finland recently reported another H5N1 avian influenza outbreak at a fur farm involving blue foxes. This outbreak, reported by EuroNews on August 24, 2023, increases the number of 'bird flu' outbreaks at such farms to 23.

In June 2023, several outbreaks of H5N1 were identified among larids in Finland. The first cases in fur farms were detected in July.

Given these findings, the Finnish authorities decided to cull 120,000 foxes and mink on farms affected by the epidemic.

Finland is Europe's leading producer of fox fur, with around 400 fur farms. For example, FashionFinFur is owned by a fur-farming family in Vörå, Finland, that has been In the business since the 1980s.

In the northern hemisphere, bird flu outbreaks among birds, mammals, and people continue in 2023.

As of August 2023, access to bird flu vaccines is controlled by government agencies.