Vaccine News

Moderna, Inc., a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, and Merck today announced the initiation of the pivotal Phase 3 randomized V940-001 clinical trial evaluating V940 (mRNA-4157), an investigational individualized neoantigen therapy (INT), in combination with KEYTRUDA, Merck's anti-PD-1 therapy, as an adjuvant treatment in patients with resected high-risk (Stage IIB-IV) melanoma.

INTs are designed to train and activate the immune system so that a patient can generate an antitumor response specific to their tumor mutation signature.

V940-001 is the first Phase 3 study of a planned comprehensive clinical development program initiated following the positive primary analysis of the Phase 2b KEYNOTE-942/mRNA-4157-P201 trial. 

Global recruitment in V940-001 has begun, and the first patients are now enrolling in Australia.

"The initiation of the V940-001 Phase 3 trial is an exciting and important milestone for us as we work with our colleagues at Merck and the melanoma patient community to investigate how individualized neoantigen therapy may potentially transform the treatment of the most serious form of skin cancer," said Kyle Holen, M.D., Moderna's Senior Vice President and Head of Development, Therapeutics and Oncology, in a press release on July 26, 2023.

Melanoma, the most serious form of skin cancer, is characterized by the uncontrolled growth of pigment-producing cells.

Nearly 325,000 new cases were diagnosed worldwide in 2020.

In the U.S., skin cancer is one of the most common types of cancer diagnosed, and melanoma accounts for a large majority of skin cancer deaths. It is estimated there will be nearly 100,000 new cases of melanoma diagnosed and almost 8,000 deaths resulting from the disease in the U.S. in 2023.

Over the past eighteen months, numerous reports of avian influenza infections in birds, mammals, and even people in 47 states have been reported.

Since January 2022, based on its genetic features, about 836 flocks, and over 58 million birds have been infected with the highly pathogenic avian influenza (HAPI) virus.

To date, more than 6,500 people in 52 jurisdictions have been monitored since 2022, and only one human case has been identified in the U.S.

However, the U.S. Animal and Plant Health Inspection Service posted some excellent 'bird flu' news on July 25, 2023.

There has not been a confirmed bird flu outbreak in the U.S. since May 18, 2023.

On July 7, 2023, the U.S. CDC published an updated Technical Report that confirmed the overall risk to human health associated with the ongoing outbreaks of highly pathogenic A(H5N1) viruses in wild birds and poultry has not changed and remains low at this time.

Should a bird flu outbreak occur in humans, the U.S. government has already invested in developing related vaccines.

Press Trust of India (PTI) today reported the Bacillus Calmette Guerin (BCG) vaccine manufactured by the Serum Institute of India will soon be exported to Canada for immunotherapy to treat bladder cancer.

BCG is a live freeze-dried preparation derived from an attenuated strain of Mycobacterium bovis.

As part of the therapy, the vaccine is administered into the bladder through a catheter, where it stays in the lining of the bladder for a specific duration affecting the cells and fighting cancer without impacting other body parts.

The product is for intravesical instillation and is available in 40 mg and 80 mg presentations, reported PTI PLB on July 25, 2023.

When cancer starts in the bladder, it is called bladder cancer, says the U.S. Centers for Disease Control and Prevention (CDC). Smoking is the most important risk factor for bladder cancer.

Since the 1970s, the BCG vaccines have been administered as an immunotherapeutic treatment for bladder cancer patients. And BCG has been the standard therapy for treating high-risk nonmuscle-invasive bladder cancer patients to avoid the recurrence and progression of the disease.

Using a catheter, BCG is given in a solution placed directly into the bladder. Intravesical treatments flush the bladder with drugs that kill cancer cells that remain after surgery.

According to the National Cancer Institute, this lowers the chance of cancer returning.

The 100 years old BCG vaccine is primarily used to prevent tuberculosis disease worldwide.

The World Health Organization (WHO) today announced a case of Middle East Respiratory Syndrome Coronavirus (MERS-CoV) cases was confirmed in Abu Dhabi, the United Arab Emirates (UAE).

According to the WHO's Disease Outbreak News on July 24, 2023, this MERS-CoV case had no history of direct or indirect contact with camels, goats, or sheep. 

Prior to this WHO notification, the last MERS-CoV infection reported from the UAE was in November 2021.

Since July 2012, the UAE has confirmed 94 MERS-CoV cases and 12 related fatalities.

The WHO expects that additional cases of MERS-CoV infection will be reported from the Middle East.

MERS-CoV cases have reached 2,605 globally, including 936 associated deaths as of July 2023. 

These are MERS vaccine candidates in development, but the WHO has not approved any.

With 117 confirmed cases of circulating variant polioviruses and 107 detections in sampled wastewater in the WHO African Region as of July 2023, the Africa Regional Certification Commission (ARCC) recently urged partners to address gaps in polio immunity urgently. 

The ARCC, which held its 31st meeting in early July 2023, called for accelerated implementation of supplementary immunization activities.

"We are looking forward to implementing the additional ARCC recommendations to guide how we can deliver on the promise of the polio-free Democratic Republic of the Congo and Africa," said Dr. Serge Emmanuel Holenn, Deputy Minister of Health of the Democratic Republic of the Congo.

In this response, @WHOAFRO Tweeted on July 24, 2023, that the Republic of Madagascar recently launched a polio vaccination campaign to reach over 18 million people.

Madagascar has reported 13 cVDPV1 cases in 2023. Last year, there were 16 cVDPV1 cases.

And 8 circulating vaccine-derived poliovirus type 1 (cVDPV1) positive environmental samples were reported in Analamanga in July 2023.

Countries with cVDPV1 have the risk of international spread. Therefore, they are subject to WHO temporary recommendations.

The World Health Organization (WHO) says polio is a vaccine-preventable disease.

As of July 2023, 670 million doses of the nOPV2 vaccine had been administered, primarily in Africa. On March 28, 2023, the WHO's SAGE recommended that it be the preferred polio vaccine for response to cVDPV2 outbreaks wherever possible.

The nOPV2 vaccine is not authorized by the Food and Drug Administration. Therefore, it is not available in the U.S.

The ARCC is an independent body established in 1998 to oversee the certification status of the African region as free from indigenous wild poliovirus.

Updated: On July 25, 2023, the WHO confirmed the priority regions (Analamanga, Vakinankaratra, Alaotra Mangoro, and Atsimo Andrefana) and those under 15 in the 19 other regions.

The U.S. Centers for Disease Control and Prevention (CDC) recently reissued a Travel Health Advisory regarding dengue outbreaks in Africa and the Middle East.

While over 120 countries have recently reported dengue cases, the CDC's Level 1 - Practice Usual Precautions notice issued on July 21, 2023, highlights dengue outbreaks in Egypt, Mauritius, São Tomé and Príncipe, Somalia, and Sudan.

These countries are reporting higher-than-usual numbers of dengue cases, and travelers visiting these countries may be at increased health risk.

This CDC notice was initially published on August 27, 2019.

In the U.S., Florida issued a state-based alert in 2023 regarding both locally-acquired and travel-related dengue cases.

Dengue is a vaccine-preventable disease caused by viruses spread through mosquito bites. The disease can take up to 2 weeks to develop, with illness generally lasting less than a week.

In severe cases, health effects can include bleeding, shock, organ failure, and death. 

Recently, dengue outbreaks of significant magnitude have been recorded in the Region of the Americas, with close to three million suspected and confirmed cases of dengue reported in 2023.

As of July 23, 2023, two dengue vaccines are being offered in certain countries.

The U.S. Department of State recently reissued a Level 3 Reconsider Travel advisory for Trinidad and Tobago, a dual-island nation in the West Indies east of Venezuela.

As of July 17, 2023, the State Department said visitors should exercise increased caution in Trinidad and Tobago due to civil unrest and crime.

And U.S. government personnel are prohibited from traveling to the following areas in Port of Spain: Laventille, Beetham, Sea Lots, Cocorite, and the interior of Queen's Park Savannah.

After dark, U.S. government personnel are prohibited from traveling to downtown Port of Spain, Fort George Overlook, and all beaches.

For assistance, the U.S. Embassy Port of Spain is located at 15 Queen's Park West.

If you decide to travel to Trinidad and Tobago, the U.S. government suggests enrolling in the Smart Traveler Enrollment Program to receive Alerts and make it easier to locate you in an emergency.

From a health perspective, the U.S. CDC suggests prospective visitors speak with a healthcare provider about travel vaccinations no less than one month before traveling.