Travel Vaccine Breaking News

Clover Biopharmaceuticals, Ltd. today announced positive preliminary immunogenicity and safety data in the older adult cohort from its Phase 1 clinical trial evaluating SCB-1019, the company's bivalent RSV prefusion-stabilized F (PreF)-Trimer subunit vaccine candidate, which is based on Clover's Trimer-Tag vaccine technology platform.

Results indicate that SCB-1019 could potentially have a differentiated and favorable safety and reactogenicity profile compared to currently approved oil-in-water adjuvanted4 and/or mRNA5-based RSV vaccines.

"As the first RSV PreF vaccine candidate developed in China to enter the clinical trial stage and generate clinical data, SCB-1019 .... demonstrate broad and significant neutralizing antibody responses against both RSV-A and RSV-B as well as a favorable tolerability profile," said Joshua Liang, Chief Executive Officer & Board Director of Clover, in a press release on June 18, 2024.

"We look forward to the full clinical readout by the end of 2024 to support further development and strengthen our potentially differentiated profile for markets globally."

Preliminary results for RSV-neutralizing antibodies (nAbs) and safety for SCB-1019 at the selected dose level are summarized below:

Immunogenicity Results:

RSV-A nAbs: SCB-1019 induced geometric mean titers (GMTs) in RSV-A nAbs of up to 7,906 IU/mL compared to 1,078 IU/mL for placebo at Day 28.

RSV-B nAbs: SCB-1019 induced GMTs in RSV-B nAbs of up to 46,674 IU/mL compared to 12,185 IU/mL for placebo at Day 28.

Geometric Mean Fold Rise (GMFR): High baseline nAb titers at Day 0 (pre-vaccination), especially to RSV-B, were observed, potentially reflecting recent outbreaks near the clinical trial sites.

Thus, sub-analysis in subjects with the lowest quartile baseline nAb titers was performed: GMFRs for SCB-1019 were up to 8-fold for RSV-A nAbs and 11-fold for RSV-B nAbs at Day 28 compared to Day 0 (pre-vaccination). No increases in RSV-A or RSV-B nAbs were observed for the placebo on Day 28.

nAb results across both RSV-A and RSV-B appear to be in line or potentially favorable compared to other protein subunit RSV PreF vaccines.

Given that other monovalent RSV-A vaccines have previously observed lower immune responses and/or efficacy against RSV-B, we continue to support Clover's bivalent RSV-A/B approach, wrote the company.

Results further confirm that Clover's PreF antigens in SCB-1019 are in the stabilized prefusion and trimeric fo. This is additionally supported by exploratory immunogenicity results demonstrating significant increases in Site Ø and Site V nAb-competitive titers.

Safety & Reactogenicity Results: SCB-1019 was generally well-tolerated. Local and systemic adverse events (AEs) were generally mild and comparable to saline placebo. No serious adverse events, adverse events of special interest, or AEs leading to discontinuation were observed.

These preliminary results in older adults & elderly cohort (aged 60-85) are consistent with the positive results in younger adults (aged 18-59) announced earlier this year. 

As of June 18, 2024, the U.S. FDA has approved three RSV vaccines and one monoclonal antibody (Beyfortus) for infants for the 2024-2025 RSV season.

Today's dynamic digital vaccine news typically involves fact-checking by trusted third parties, but it rarely includes a manufacturer openly responding to a potentially biased article.

Recently, the news industry has been challenged in its ability to comprehend vaccine-related clinical trials and technical journal articles.

For example, on June 16, 2024, The Economic Times published a headline stating, 'Bharat Bio's Rotavirus vaccine Rotavac may be unsafe for children: Study.'

Later that day, the company posted on X its response....Unfair Journalistic Practices and Breach of Ethics by The Economic Times.

While this vaccine efficacy debate may be illuminated on social media for days and probably never settled, vaccine hesitancy and reduced trust in the healthcare delivery system will continue.

In most countries, government agencies, such as the U.S. FDA, play vital roles in communicating virology (vaccines, immunotherapies, gene therapy, monoclonal antibodies) risks and benefits, not media-centric fiction.

The U.S. Biomedical Advanced Research and Development Authority (BARDA) today announced up to $500 million in Project NextGen funding for multiple Phase 2b clinical trials to evaluate novel vaccines administered as a nasal spray or as a pill to protect against symptomatic COVID-19.

While currently approved COVID-19 vaccines are administered intramuscularly, they are limited in their capacity to induce a robust immune response in mucosal areas such as the mouth, nose, and gut, where the SARS-CoV-2 coronavirus first enters people.

Successful development of intranasal and oral vaccines would provide safe, effective, needle-free, easier-to-administer options with the potential to improve vaccine access.

“We learned a lot during the COVID-19 pandemic that we can use to better prepare for future public health crises. That includes finding new ways to administer vaccines to make it even easier for everyone to protect themselves from illness,” U.S. HHS Secretary Xavier Becerra said in a press release on June 13, 2024. 

The project awards were made to:

Up to $453 million to Vaxart of San Francisco, California, developing an oral pill vaccine candidate, adenovirus serotype 5. BARDA will provide an initial $65.7 million for early trial milestones, with remaining funds provided as the effort successfully advances toward trial execution. Vaxart will execute its own Phase 2b clinical trials.

Approximately $34 million was donated to Castlevax, part of the Mount Sinai Health System in New York City, to develop an intranasal vaccine candidate, CVAX-01.    

Approximately $40 million will go to Cyanvac of Athens, Georgia, to develop an intranasal vaccine candidate, CVXGA. 

Castlevax and Cyanvac Phase 2b trials are in partnership with BARDA’s Clinical Studies Network.

These awards are just one component of BARDA’s Project NextGen medical countermeasures portfolio. To date, BARDA has leveraged more than $2 billion in Project NextGen funding to support the development of next-generation vaccines, treatments, and enabling technologies. 

As of June 14, 2024, the U.S. government has approved three COVID-19 vaccines, while the World Health Organization has qualified 13 vaccines.

Gavi, the Vaccine Alliance, today announced support for human rabies vaccines for post-exposure prophylaxis (PEP) as part of routine immunization.

On June 13, 2024, Gavi stated eligible countries are receiving guidance on how to access these vaccines under Gavi’s cofinancing policy. The first round of applications will be accepted by mid-July 2024. Ninety-five percent of human rabies deaths occur in Africa and Asia.

“This commitment from Gavi is crucial and will expedite efforts to halt human fatalities caused by dog-mediated rabies,” said Dr Jérôme Salomon, Assistant Director-General for Universal Health Coverage, Communicable and Noncommunicable Diseases at WHO, in a press release. 

“WHO will provide technical assistance to countries, not only to support their funding applications to Gavi but to draw up comprehensive plans of action that can deliver real progress towards the Zero by 30 goal.”

This development complements the ongoing global efforts of the Zero by 30 campaign, led by United Against Rabies partners, including the Food and Agriculture Organization, the World Health Organization, and the World Organisation for Animal Health, to eliminate dog-mediated human rabies by 2030.

In the United States, the Centers for Disease Control and Prevention reports bats, not dogs, are the leading source of rabies cases.

The Democratic Republic of the Congo (DRC) is having its largest surge of mpox cases ever recorded, says the U.S. CDC. Since January 2023, the DRC has reported more than 20,000 suspected mpox cases, and about 1,000 deaths have been reported. 

To notify international travelers of their potential mpox risk, the CDC reissued a Travel Health Advisory on June 10, 2024.

Mpox is a disease caused by infection with the monkeypox virus. It is divided into two Clades. Clade IIb is responsible for the global outbreak that began in May 2022, while Clade 1 is causing the Mpox outbreak in the DRC.

There have been no cases of the type of mpox spreading in DRC reported in the United States, says the CDC. The risk to the general public in the U.S. from this type of mpox is very low.

In 2023, the CDC published a Health Advisory stating that mpox Vaccines are expected to be effective for both Clade I and Clade II infections. However, as the European CDC recently reported, real-world data regarding the effectiveness of the JYNNEOS vaccine against Clade 1 is lacking.

CSL Seqirus today announced it was selected by the Health Emergency Preparedness and Response Authority (HERA) to provide 665,000 pre-pandemic vaccine doses for fifteen EU and EEA Member States and the "Union Civil Protection Mechanism.".

The 4-year contract includes an option for participating authorities to purchase up to an additional 40 million doses of the egg-based, non-mRNA pre-pandemic vaccine over the contract duration. 

Announced on June 11, 2024, this European Commission (EC) acquisition of pre-pandemic (zoonotic) vaccine will create a stockpile of vaccines available to support the EC’s outbreak and pre-pandemic response.

According to media reporting on June 5, 2024, Finland became the first EU country to offer avian influenza vaccinations to people this year.

Four influenza pandemics have occurred over the past century, with the 1918 pandemic being the most severe in recent history, with an estimated mortality of up to 50 million people worldwide.

Raja Rajaram, CSL Seqirus, Head of Global Medical Strategy, commented in a press release, “This agreement will help in Europe’s resolve to maintain robust preparedness and rapid response capabilities for this potential threat.”

Under the terms of the agreement, CSL Seqirus will deliver pre-pandemic vaccines that are well-matched to the H5 of the currently circulating H5N1 strain.

The risk of influenza-associated morbidity and mortality is greater with pandemic influenza than with seasonal influenza because there is likely to be little or no pre-existing immunity to the novel virus in the human population. The timing and severity of pandemic influenza (bird flu) is unpredictable.

In Europe, various pandemic vaccines have already been approved.

In the U.S., the Food and Drug Administration has already approved CSL Sequirus's AUDENZ™, an inactivated vaccine for active immunization to prevent disease caused by the influenza A virus H5N1 subtype.

As of June 11, 2024, the U.S. CDC says annual flu shots are not designed to protect people from pandemic influenza.

A U.S. Food and Drug Administration committee unanimously voted to recommend the approval of an Eli Lilly medication for early Alzheimer’s disease.

According to the New York Times on June 10, 2024, this news indicates the FDA may approve donanemab for people diagnosed with mild cognitive impairment due to Alzheimer’s in late 2024.

To support their request, Lilly submitted data from a JAMA Original Investigation in the early stages of the disease, with either mild cognitive impairment or mild dementia.

Donanemab, similar to the approved LEQEMBI™, is not a vaccine but is given as intravenous infusions.