Vaccine News

The U.S. Food and Drug Administration Current and Resolved Drug Shortages and Discontinuations Report says as of May 14, 2024, Teva Pharmaceuticals USA, Inc. mefloquine hydrochloride tablet medication (Tablet, 250 mg, NDC 0555-0171-78) is in limited supply through August 2024.

The company's contact number is 800-545-8800.

In 2024, the Pan American Health Organization estimated that approximately 41 million people are living in areas where the risk of infection by mosquito-carrying Malaria is considered moderate to high. Most malaria infections in the United States and its territories occur among persons who have traveled to regions with ongoing malaria transmission.

While Teva's product shortage may disrupt summer vacation plans, pharmacists and travel clinics may offer alternative products.

As of May 15, 2024, numerous malaria cases have been reported in the United States in 2024.

While two malaria vaccines are available in Africa, neither are offered in the United States.

An innovative, second-generation vaccine for dengue prevention recently received prequalification from the World Health Organization (WHO).

Developed by Takeda GmbH, QDENGA® (TAK-003) (Dengue Tetravalent Vaccine [Live, Attenuated]) is an approved two-dose vaccine containing weakened versions of the four dengue serotypes that cause disease in people.

As of May 2024, QDENGA was launched in 21 countries and is available in 17 European countries but not the United States.

“The prequalification of TAK-003 is an important step in the expansion of global access to dengue vaccines, as it is now eligible for procurement by UN agencies, including UNICEF and PAHO,” said Dr. Rogerio Gaspar, WHO Director for Regulation and Prequalification, in a press release on May 15, 2024.

The WHO prequalification list also includes the Dengvaxia (CYD-TDV) vaccine developed by Sanofi Pasteur. 

According to the WHO, the most significant number of dengue outbreaks reported was in 2023 with the WHO Region of the Americas reporting about 4.5 million cases and 2,300 deaths. 

A vaccine candidate for control of the cytomegalovirus (“CMV”) in patients undergoing liver transplantation dosed its initial patient in a multi-center, placebo-controlled, randomized Phase 2 clinical study.

Initially developed by the City of Hope, Triplex was exclusively licensed to Helocyte.

Triplex is a universal (non-HLA-restricted) recombinant Modified Vaccinia Ankara viral vector vaccine engineered to induce a robust and durable virus-specific T cell response to three immuno-dominant proteins [UL83 (pp65), UL123 (IE1), UL122 (IE2)] linked to CMV complications in the post-transplant setting.

The trial is funded by a grant from the U.S.S NIH’s National Institute of Allergy and Infectious Diseases to the University of Washington Seattle. This grant has provided $9 million to date, with an estimated additional $12 million over the next four years in support of the Phase 2 clinical trial.

Ajit Limaye, M.D., Professor of Medicine and Director of the Solid Organ Transplant Infectious Disease Program at the University of Washington and Principal Investigator of the “CMV vaccine in Orthotopic Liver Transplant” trial, said in a press release on May 14, 2024, “There remains a significant unmet medical need to develop new therapies that can reduce the frequency and severity of CMV events in the organ transplant setting, where CMV continues to present life-threatening complications that directly impact patient outcomes and survival.”

According to the U.S. CDC, CMV is a common virus for people of all ages.

In the U.S., nearly one in three children is already infected with CMV by age five. About 1 out of 200 babies are born with congenital CMV.

And over half of adults have been infected with CMV by age 40.

Once CMV is in a person’s body, it stays there for life and can reactivate. According to the CDC, most people with CMV infection have no symptoms and aren’t aware that they have been infected.

Helocyte is a clinical-stage company developing novel immunotherapies to prevent and treat cancer and infectious diseases, including CMV and HIV.

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.