Vaccine News

The Global Polio Eradication Initiative (GPEI) released its weekly update, which indicated that three countries reported new polio cases as the poliovirus continues to spread in 2024.

On June 19, 2024, the GPEI reported that Afghanistan confirmed one wild poliovirus type 1 (WPV1), bringing the total number of cases in 2024 to six.

Nigeria reported three cases of circulating vaccine-derived poliovirus type 2 (cVDPV2), bringing the total for the year to 30.

And South Sudan reported its sixth cVDPV2 case of the year.

The U.S. CDC stated on May 23, 2024, that before traveling to any of these 34 destinations, adults who had previously completed the full, routine polio vaccine series may receive a single, lifetime booster dose of the polio vaccine.

In the U.S., the IPV vaccine is generally available at pharmacies and travel clinics. In Africa, the nOPV2 vaccine has become standard in most countries during 2024.

The nOPV2 has been 'triple-locked' using genetic engineering to prevent it from producing a gut reaction.

As a result, the GPEI reports that nOPV2 is more genetically stable than approved oral polio vaccines, with a lower risk of reversion to neurovirulence and less likely to mutate and cause paralysis.

ImmunityBio, Inc. today announced the initial treatment of multiple patients in the U.S. to receive therapy with ANKTIVA®, the company's recently approved immunotherapy for Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) carcinoma in situ.

The first bladder cancer patients to receive commercial doses are located throughout the U.S., and several are being treated by community urologists, as the therapy does not require any special handling or equipment that would limit its use to specialty medical centers.

ANKTIVA  (nogapendekin alfa inbakicept-pmln) was approved by the U.S. Food and Drug Administration (FDA) on April 22, 2024, for the treatment of patients with BCG-unresponsive NMIBC CIS with or without papillary tumors.

The intravesical therapy employs a combination of ANKTIVA, an IL-15 agonist, in combination with the BCG vaccine.

The combination is the first FDA-approved immunotherapy in NMIBC that functions by activating the body’s NK and killer T-cell immune system to attack tumor cells while simultaneously activating memory T cells, leading to a prolonged duration of complete response exceeding 47 months for some patients.

“In addition to its unique mechanism of action, ANKTIVA can be readily administered by urologists in their own offices and clinics, enabling more patients to receive it in familiar settings from their own providers,” said Richard Adcock, President and CEO of ImmunityBio, in a press release on June 20, 2024.

“We look forward to ANKTIVA reaching more and more eligible NMIBC patients and for our science to deliver even more therapies from our pipeline.”

In May 2024, ImmunityBio announced it had drug substance sufficient for 170,000 doses of ANKTIVA for commercial and clinical trial use.

In the U.S., the American Cancer Society estimates there will be 83,190 new cases and 16,840 deaths from bladder cancer in 2024. 

Vaxxinity, Inc. announced today that the journal Nature Medicine has published groundbreaking exploratory data from the Company's Phase 1 clinical trial of UB-312 in patients with Parkinson's disease (PD).

The Phase 1 successfully met its primary outcome measures, demonstrating that UB-312 was generally well-tolerated and induced anti-aggregated α-synuclein (αSyn) antibody responses in healthy volunteers and PD patients. Specifically, 12 of 13 PD patients who completed dosing developed anti-αSyn antibodies.

And UB-312-induced antibodies significantly decreased levels of αSyn, a key pathology in PD and other synucleinopathies. This suggests that UB-312 can help to eliminate the buildup of harmful, toxic forms of the protein αSyn in the brain.

Furthermore, patients with detectable UB-312-induced antibodies in cerebrospinal fluid exhibited significant improvement in motor experiences of daily living as measured by the MDS-UPDRS Part II, a commonly accepted clinical scale.

This announcement marks a potentially significant milestone in pursuing innovative PD care.

"UB-312 has the potential to become an important and potent disease-modifying therapy for Parkinson's disease. It would be truly amazing if we could vaccinate people against Parkinson's disease in the future!" said Professor Geert Jan Groeneveld, neurologist and principal investigator of the Phase 1 clinical trial performed at the Centre for Human Drug Research in Leiden, the Netherlands, in a press release on June 20, 2024.

Parkinson's disease, a progressive neurodegenerative condition, currently lacks an approved disease-modifying treatment. Alpha-synuclein, a key protein in PD pathology, forms aggregates known as Lewy bodies that contribute to neuronal degeneration.

This active immunotherapy medicines research was funded by the Michael J. Fox Foundation, assessing target engagement in collaboration with the Mayo Clinic and UTHealth Houston in Texas.

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.