Cancer Vaccine Breaking News

Moderna Inc. recently confirmed it has five influenza vaccine candidates in clinical development. As of April 11, 2023, these flu shots include:

• mRNA-1010, a seasonal quadrivalent vaccine using strains recommended by the World Health Organization,
• mRNA-1011/1012, a seasonal penta-/hexa-valent vaccine candidate that includes more hemagglutinin antigens (e.g. H3, H1) to expand strain matching,
• mRNA-1020/1030, a seasonal vaccine candidate that includes neuraminidase antigens to target more conserved regions of the virus.

The Company's first vaccine candidate against influenza is mRNA-1010, developed in adults and is currently being evaluated in two Phase 3 trials.

The first Phase 3 trial (P301) was conducted in the Southern Hemisphere to evaluate the safety and non-inferior immunogenicity compared to a licensed flu vaccine.

The previously announced interim results from the P301 trial indicated that mRNA-1010 demonstrated superiority in geometric mean titers (GMT) for A/H3N2 and non-inferiority in GMT for A/H1N1.

However, mRNA-1010 did not meet non-inferiority for both influenza B/Victoria- and B/Yamagata-lineage strains.

But, mRNA-1010 demonstrated an acceptable safety and tolerability profile in the trial, and the independent Data and Safety Monitoring Board (DSMB) for P301 did not identify any safety concerns.

The second Phase 3 trial (P302) is being conducted in the Northern Hemisphere to evaluate the safety and non-inferior efficacy compared to a licensed flu vaccine.

The independent DSMB has completed the first interim analysis of efficacy and informed the Company that mRNA-1010 did not meet the statistical threshold necessary to declare early success and recommended that the trial continues with efficacy follow-up towards the next analysis.

The DSMB did not identify any safety concerns, and blinded follow-up for safety and efficacy is ongoing in this trial.

A preliminary immunogenicity analysis from a subset of participants in the P302 trial has also been completed.

In this analysis, mRNA-1010 demonstrated geometric mean titer ratios consistent with superiority against both influenza A strains (A/H1N1, A/H3N2) and consistent with non-inferiority against both influenza B strains (B/Victoria, B/Yamagata) relative to the licensed comparator.

The P302 study did not pre-specify success criteria for immunogenicity endpoints.

Additionally, the Company announced it had developed an update to mRNA-1010 that is expected to have improved immunogenicity against influenza B strains. It also announced plans to initiate a confirmatory Phase 3 trial in 2023.

Stéphane Bancel, Chief Executive Officer of Moderna, commented in a related press release, "With mRNA-1010, our first investigational vaccine against seasonal flu, we are encouraged by the consistently strong immunogenicity results against influenza A, and titers consistent with non-inferiority against influenza B strains in the most recent Phase 3 trial."

"With our mRNA platform and technology, as well as our agile manufacturing capabilities, we are confident that we can quickly develop safe and effective vaccines to address critical unmet needs."

The U.S. government today issued a single sentence that announced the termination of the COVID-19 pandemic in the United States.

Posted on Twitter on April 10, 2023, this statement confirmed H.J.Res.7, terminates the national emergency related to the COVID-19 pandemic.

 More than 1.13 million people in the U.S. have died from COVID-19 over the last three years, according to the Centers for Disease Control and Prevention, reported NPR on April 11, 2023.

Moderna, Inc. today announced clinical program updates focusing on Lyme disease, a global health issue impacting about 120,000 people in the U.S. and Europe annually.

To address Lyme's biological complexity, Moderna is advancing a seven-valent approach with two Lyme disease vaccine candidates that will be developed in parallel.

Moderna announced on April 11, 2023, new vaccine candidates, mRNA-1982 and mRNA-1975, represent the Company's first application of its mRNA technology to bacterial pathogens such as Lyme disease.

"Our mRNA platform has changed medicine and will continue to have a major impact on global health. Today we are excited to announce multiple new vaccine candidates, including for enteric viruses, such as norovirus, and targeting Lyme disease, our first bacterial vaccine," said Stéphane Bancel, Chief Executive Officer of Moderna, in a related press release.

mRNA-1982 is designed to elicit antibodies specific for Borrelia burgdorferi, which causes almost all Lyme disease in the U.S.

While mRNA-1975 is designed to elicit antibodies specific for the four major Borrelia species causing disease in the U.S. and Europe.

Lyme disease burden follows a bimodal age distribution, affecting mainly children under 15 and older adults. Patients can develop a rash, fever, headaches, fatigue, joint pain, swelling, stiffness, and headaches.

Older adults appear to have higher odds of unfavorable treatment response than younger patients, and neurologic manifestations are more common at presentation for this more aging adult population.

Currently, the U.S. Food and Drug Administration has not approved a Lyme disease vaccine.

However, VLA15, a multivalent Lyme disease vaccine candidate produced by Pfizer In. and Valneva SE, is conducting late-stage clinical research.

The U.S. National Parks Service recently reported that Highly Pathogenic Avian Influenza (HPAI) had been confirmed to cause mortality for three California condors in northern Arizona.

As of April 4, 2023, a total of three deceased birds have been retrieved and confirmed as HPAI-positive.

As of April 7, 2023, HAPI had not been detected in the other condor populations in California or Baja California, Mexico. 

The Arizona-Utah condor population moves throughout northern Arizona and southern Utah, using the landscape within Grand Canyon National Park, Zion National Park, Vermillion Cliffs National Monument, the Kaibab Plateau, and surrounding areas. 

On March 9, 2023, the Peregrine Fund, which manages the Arizona-Utah condor flock, first observed a bird in the wild exhibiting signs of illness, initially suspected to be lead poisoning.

Crews continued to monitor this bird and others showing similar behavior. On March 20, they collected the deceased female below her nest, the first bird confirmed positive for HPAI.

Test results are not yet final for five additional deceased birds. Others have been collected and are pending necropsy and testing; information will be provided once test results are available.

Additionally, five birds displaying signs of illness were captured by The Peregrine Fund and sent to Liberty Wildlife in Phoenix, Ariz., for care. Unfortunately, one of the birds died shortly after arrival. The remaining four are in quarantine while samples are tested for HPAI.

This announcement was coordinated with The Peregrine Fund, Liberty Wildlife, Arizona Game and Fish Department, Utah Division of Wildlife Resources, National Park Service, and Bureau of Land Management.

Updated on April 13, 2023 - picture correction.

The World Health Organization (WHO) Western Region recently announced a third human infection with the influenza A(H3N8) virus with one related fatality.

A recent fatal case was a 56-year-old female from Guangdong province, China, with an onset of illness on February 22, 2023. 

And as of April 6, 2023, a total of 240 cases of human infection with avian influenza A(H5N1) virus have been reported from four countries within the Western Pacific Region since January 2003. The last case was reported from China in late 2022.

Of these 'bird flu' cases, 135 were fatal (CFR 56%).

The WHO stated whenever avian influenza viruses circulate in poultry, there is a risk for sporadic infection and small clusters of human cases due to exposure to infected poultry or contaminated environments.

Therefore, sporadic human cases are not unexpected.

The rise in the number of reported human cases of A(H5N6) infection may reflect the continued circulation of the virus in birds and enhanced surveillance system and diagnostic capacity as a direct outcome of the response to the COVID-19 pandemic, added the WHO.

In the U.S., the government has already approved one avian influenza vaccine for people and, as of April 10, 2023, significantly invested in newer bird flu vaccine candidates.

Furthermore, the WHO confirms the 2022-2023 annual flu shots do not protect against these types of avian influenza.

According to the U.S. Centers for Disease Control and Prevention (CDC), measles cases increased by about 80% in 2022 compared to the previous year.

In addition, travel experts continue to warn of expanding measles outbreaks in 2023.

For example, the CDC's top ten list of measles outbreaks is led by India, which has reported over 47,979 cases over the past year.

To emphasize this health risk, the CDC issued a Global Measles Watch - Level 1, Practice Usual Precautions notice on April 6, 2023.

While the U.S. has reported very few measles cases this year, recent cases in Kentucky, Utah, and Ohio have been highlighted in national media.

As of March 30, 2023, the CDC reported six measles cases in 2023 and 121 cases in six U.S. jurisdictions during 2022.

To reduce traveler's health risk, measles is a vaccine-preventable disease, with various vaccines approved in the U.S. and available to local clinics and community pharmacies.

The Swiss Public Health Agency recently announced no COVID-19 vaccination is recommended for spring/summer 2023. However, people at especially high risk can receive a vaccination after consultation with their doctor.

As of April 8, 2023, the Federal Office of Public Health stated nearly everyone in Switzerland had been vaccinated and/or contracted and recovered from COVID-19.

Therefore, almost everyone's immune system has been exposed to the SARS-CoV-2 coronavirus.

And in the spring/summer of 2023, the virus will likely circulate less, and the current variants also cause mild illness.

For autumn 2023, the vaccination recommendation will be re-evaluated and adjusted accordingly.