Vaccine News

Mark Suzman, the CEO of the Bill & Melinda Gates Foundation, published a change of leadership message today.

On May 13, 2024, Suzman wrote, 'I am writing to share some important news. Melinda French Gates has decided to resign from her role as co-chair of the foundation. Her last day of work at the foundation will be June 7, 2024.

Melinda cares deeply about the foundation and is extremely proud of all of you and the work you do every day to help millions of people live better lives. She made this decision, after considerable reflection, based on how she wants to spend the next chapter of her philanthropy.

Melinda has new ideas about the role she wants to play in improving the lives of women and families in the U.S. and worldwide.'

The entire unedited message is posted at this Gates Foundation link.

And listen to the Gates Foundation's $8.6 billion budget 2024 Annual Letter, read by Suzman.

The Gates Foundation has been a global leader in expanding access to vaccines.

For example, In 1988, when the Global Polio Eradication Initiative (GPEI) was launched, polio was present in more than 125 countries and paralyzed about 1,000 children per day.

Thanks to the Gates immunization efforts, nearly 3 billion children have been immunized, and the incidence of polio has decreased by 99%.

Gate and GPEI have recently successfully deployed the nOPV2 vaccine to over 1 billion people.

Developed by Chengdu Weisjin Biomedical Technology Co., Ltd. (Wesjin Biotech), WGc-043 is an mRNA therapeutic cancer vaccine that recently received IND approval from the U.S. Food and Drug Administration (FDA).

According to public information from the FDA, WGc-043 Injection has been approved for two categories of indications: one is for adult patients with Epstein-Barr virus-positive advanced solid tumors who have undergone second-line systemic treatment.

The second indication is for adult patients with relapsed or refractory virus-positive hematoma.

This achievement, announced on May 9, 2024, marks the world's first approval of an Epstein-Barr virus (EBV)- related mRNA therapeutic cancer vaccine.

Once successfully launched, WGc-043 will provide a new treatment option for patients with advanced EB virus-positive solid tumors and hematologic malignancies.

EB virus is highly correlated with more than ten malignancies, including nasopharyngeal carcinoma, natural killer T-cell lymphoma, gastric cancer, lung cancer, liver cancer, esophageal cancer, breast cancer, cervical cancer, and autoimmune diseases such as multiple sclerosis and systemic lupus erythematosus.

According to a press release on May 10, 2024, WGc-043 shows promising efficacy, low toxicity, broad applicability, efficient scalability, and cost-effectiveness.

The company says that WGc-043 has already completed investigator-initiated trials, demonstrating superior safety and efficacy compared to other publicly available mRNA therapeutic cancer vaccines.

Specifically, the technical features of WGc-043 also include the antigen being the most broad-spectrum and safe protein sequence.

The originally designed immune enhancer (IE) is introduced into the mRNA molecule, and the mRNA delivery carrier is independently developed and obtained

A new type of LNP authorized by US and European patents (the safety of this LNP: has been verified in clinical trials of 3 varieties).

These designs enable WGc-043 to activate the patient's own anti-tumor immunity and generate tumor-killing cytotoxic T cells, antigen-specific antibodies, and memory T cells in the body, which is equivalent to CAR-T. The combined anti-tumor effect of monoclonal antibodies can also prevent tumor recurrence, have more efficient anti-cancer effects, and be superiorly safe.

Weisjin Biotechnology has filed over 60 invention patents, including the patent for ionizable lipids, which has been authorized by China, the United States, Europe, and other countries and regions. 

As of May 12, 2024, no date has been announced regarding WGc-043's availability in the United States.

The U.S. CDC reported today that seasonal influenza activity continues to decline nationally, with outpatient respiratory illness stable and below baseline for the fifth consecutive week.

As of Week #18, the CDC says that flu viruses are among the several contributing factors to respiratory disease activity. To help people understand their health risks, the CDC provides updated, integrated information about influenza, RSV, and other disease activity every week.

From a local perspective, the Walgreens Flu Index recently identified three Texas cities that led the USA with influenza activity in late April 2024.

These cities are:

1. El Paso, Texas (Las Cruces, N.M.
2. Harlingen-Weslaco-Brownsville-McAllen, Texas
3. Corpus Christi, Texas

The CDC also disclosed that about 63 million flu shots have been administered at pharmacies and physician offices this flu season, which indicates about 6% fewer flu shots administered than last season.

These vaccines remain available at most pharmacies in the U.S.

The World Health Organization (WHO) today announced three human cases, including one death, of Middle East respiratory syndrome coronavirus (MERS-CoV) by the Ministry of Health of the Kingdom of Saudi Arabia (KSA).

According to the WHO's Disease Outbreak News on May 8, 2024, all three cases were middle-aged males with underlying health conditions.

The three cases are epidemiologically linked to exposures in a Riyadh healthcare facility, although investigations are ongoing to verify this and understand the transmission route.

In 2024, a total of four cases and two deaths have been reported from the KSA.

MERS is a viral respiratory infection caused by the MERS-CoV. Humans are infected with MERS-CoV from direct or indirect contact with dromedary camels, the virus's natural host and zoonotic source.

So far, non-sustained human-to-human transmission has occurred among close contacts and in healthcare settings. However, the WHO reports limited human-to-human transmission outside of healthcare settings.

Since 2012, when the first MERS-CoV case was reported in KSA, 2,613 MERS-CoV cases and 941 deaths (36%) have been reported from 27 countries in all six WHO regions.

Fortunately, no MERS-CoV cases have been reported from countries outside the Middle East since 2019.

The notification of the new cases does not change WHO's overall risk assessment, which remains moderate at both the global and regional levels.

As of May 9, 2024, no approved MERS vaccines are available.

However, in late 2023, Barinthus Biotherapeutics plc, the Coalition for Epidemic Preparedness Innovations, and the University of Oxford collaborated on fast-tracking the development of the VTP-500 vaccine candidate.

This $34.8 million project intends to take this MERS vaccine through Phase II clinical trials.

Dynavax Technologies Corporation today announced that HEPLISAV-B® vaccine net product revenue grew 10% year-over-year to approximately $48 million in the first quarter of 2024.

HEPLISAV-B is the first and only adult hepatitis B vaccine approved in the U.S., the European Union, and Great Britain to enable series completion with only two doses in one month.

In 2024, HEPLISAV-B's total estimated market share in the U.S. increased to approximately 41%, and its estimated market share in the retail pharmacy segment increased to approximately 55%.

"The U.S. adult hepatitis B vaccine opportunity remains significant with over 130 million patients eligible, one of the largest addressable patient populations in the U.S., and the vast majority remaining unvaccinated," said Ryan Spencer, Chief Executive Officer of Dynavax in a press release on May 8, 2024.

Hepatitis B is a viral infection that affects the liver and can cause acute or chronic disease.

Driven by the U.S. CDC's Advisory Committee of Immunization Practices' universal recommendation for adult hepatitis B vaccination, the hepatitis B vaccine market continues to expand in the U.S. Dynavax believes the U.S. market has the potential to grow to over $800 million by 2027, with HEPLISAV-B well-positioned to achieve a majority market share.

A supplemental Biologic License Application for HEPLISAV-B vaccination of adults on hemodialysis is currently under review by the U.S. FDA, with a Prescription Drug User Fee Act action date planned for May 13, 2024.

A recent study aimed to compare the positive benefits between two U.S. FDA-approved influenza antiviral medications.

Published in the journal Influenza and Other Respiratory Viruses on May 6, 2024, this study concluded that Xofluza (baloxavir marboxil, BMX) appears to be more effective than Tamiflu (oseltamivir, OTV) in lowering the secondary attack rate.

The Poisson regression modeling showed that in those cases treated with BXM and OTV, the benefits were 10.8% and 18.5%, respectively; the adjusted relative reduction was 41.8% (95% confidence interval: 1.0%–65.7%, p = 0.0456) greater with BXM than OTV. 

These researchers wrote that one reason for this result may have been the difference in administration: a single dose of BXM versus twice daily for five days for OTV. Thus, BXM is expected to have higher compliance than OTV in children.

In summary, this post hoc analysis found that the secondary influenza illness attack rate was lower in household contacts exposed to BXM-treated than OTV-treated index cases.

ImmunityBio, Inc. announced today that the drug substance had been completed and successfully qualified for “fill finish” (filling vials and finishing packaging), sufficient for 170,000 doses of 400mcg ANKTIVA®.

ANKTIVA (nogapendekin alfa inbakicept-pmln) is the first U.S. FDA-approved immunotherapy for non-muscle invasive bladder cancer that activates natural killer cells, T cells and memory T cells for a long-duration response.

Coupled with the recent announcement of a partnership with the Serum Institute of India for enhanced BCG vaccine availability, this provides the Company with a significant initial supply of ANKTIVA for commercial and clinical trial use in advance of the full operation of the Company’s drug substance and fill-finish manufacturing plants in California and New York.

In 2024, Anktiva will be priced at $35,800 per dose. The cost of the BCG vaccine is additional.

Since the Company’s merger with NantKwest in 2021, ImmunityBio has made significant capital investments in personnel, plants, and equipment to ensure the global capacity of the ANKTIVA drug product for both the commercial launch and clinical trials in bladder cancer and other tumor types in its pipeline.

Both drug substance and drug product facilities are nearing completion to ensure sufficient capacity and multiple GMP manufacturing sites for ANKTIVA in its approved indication and for clinical trials and future indications.

“Our belief in the importance of this molecule and its potential to evolve immunotherapy to the next level guided our strategic plan to invest for the future with anticipation of ANKTIVA’s approval,” said Rich Adcock, CEO & President ImmunityBio, in a press release on May 7, 2024.

“I’m grateful for our employees and our investors who have supported and believed in our commitment to invest for our long-term vision and future.”

The Company is applying its science and platforms to treating cancers, including developing potential cancer vaccines, immunotherapies, and cell therapies that we believe will sharply reduce or eliminate the need for standard high-dose chemotherapy.

TCompany says these platforms and their associated product candidates are designed to be more effective, accessible, and easily administered than current standards of care in oncology and infectious diseases.