Moderna to Begin Late-Stage Trial of COVID-Flu Combo Vaccine

Pfizer and Moderna bivalent COVID-19 vaccines are readied for use at a clinic in Richmond, Va., on Nov. 17, 2022. Steve Helber/AP Photo

Moderna is moving to the late stage trial of its COVID-influenza combination vaccine following positive results in preliminary trials, the company said, even as the brand’s COVID-19 vaccine raised multiple concerns about safety.

A combination vaccine is a mixture of individual vaccines. The mixing is done prior to administering it so that multiple vaccines can be delivered to the individual in a single injection. Moderna’s preliminary phase 1 and 2 trials of its mRNA-1083 combination vaccine against influenza and COVID-19 produced “positive interim results,” the company said in an Oct. 4 press release.

Moderna now plans to move on to the phase 3 late-stage trial of the vaccine.

The preliminary trials compared the mRNA-1083 combination vaccine against two influenza vaccines—Fluarix and Fluzone HD. Fluarix was administered to adults aged 50 to 64, while Fluzone HD is an enhanced influenza vaccine given to people aged 65 to 79.

For both groups, the combination vaccine was compared to the company’s Spikevax bivalent COVID-19 vaccine.

According to the drug manufacturer, the preliminary trials showed mRNA-1083 yielding antibody levels in blood similar to or greater than the two licensed influenza vaccines. It also yielded antibody levels similar to the firm’s COVID-19 vaccine.

The rate of adverse reactions for the mRNA-1083 was found to be “similar” to the Spikevax vaccine. A majority of adverse reactions were “grade 1 or 2 in severity.” Fewer than 4 percent of participants reported adverse reactions categorized to be grade 3 in severity.

“No new safety concerns were identified for mRNA-1083 compared to the standalone vaccines,” the company said.

The interim results of Moderna’s combination vaccine come after a July 20 study found that the company’s booster shot may be linked to a risk of damage to the myocardium, the muscular middle layer of the heart responsible for the organ’s pumping action.

The study published in the European Journal of Heart Failure analyzed the effect of Moderna’s mRNA-1273 COVID shot among health care workers in Switzerland.

It found that the vaccine was associated with “elevation of markers of myocardial injury” at the rate of about 1 in 35 individuals or 2.8 percent. In a generally healthy population, the rate would typically be about 1 percent, the researchers said.

“According to current knowledge, the cardiac muscle can’t regenerate, or only to a very limited degree at best. So it’s possible that repeated booster vaccinations every year could cause moderate damage to the heart muscle cells,” University Hospital Basel professor Christian Mueller, a cardiologist and the lead researcher of the study, said in a statement.

Moderna’s Combo Vaccine Push

Moderna is planning to start the phase 3 trial of mRNA-1083 in adults aged 50 and above this year, aiming to get regulatory approval for the vaccine in 2025.

A health care worker prepares the Moderna coronavirus vaccine at Lestonnac Health Clinic in Orange, Calif., on March 9, 2021. John Fredricks/The Epoch Times

“Combination vaccines offer an important opportunity to improve consumer and provider experience, increase compliance with public health recommendations, and deliver value for healthcare systems,” said Stephane Bancel, CEO of Moderna.

“We are excited to move combination respiratory vaccines into Phase 3 development and look forward to partnering with public health officials to address the significant seasonal threat posed to people by these viruses.”

Moderna estimates the U.S. influenza market to be 150 million doses annually, with the fall 2023 market estimated to be 50 million to 100 million doses.

The company anticipates that the market for COVID-19 vaccines will also “approach the influenza market” over time in the United States “given the burden of disease.”

According to data from the U.S. Centers for Disease Control and Prevention (CDC), new COVID-19 hospital admissions in the country are at a low level compared to the past two years.

For the week ending Sept. 23, there were 19,079 admissions, less than the over 26,000 admissions around the same time last year and the 62,000 admissions during this period in 2021.

COVID-19 Vaccine Dangers

While COVID-19 vaccines are being heavily promoted by governments and organizations across the world as critical to health care, numerous studies are pointing to a different picture, with one study blaming the vaccines for excess deaths.

A Sept. 17 report published by Correlation calculated that there were 17 million COVID-19 vaccine-related deaths worldwide from 13.25 billion injections as of Sept. 2.

Researchers found that the overall risk of death due to COVID-19 vaccines is 1,000 times greater than previously reported in data from clinical trials, cause-of-death statistics from death certificates, and adverse event monitoring.

According to CDC files recently obtained by The Epoch Times through the Freedom of Information Act, over 277,000 COVID-19 cases among individuals who received at least one dose of COVID-19 vaccine were not reported to the public.

Reports have cited heart injuries as a key concern among COVID-19-vaccinated individuals. A Japanese study which compared 700 vaccinated individuals against 303 unvaccinated people found that those who got a COVID-19 shot had higher levels of a glucose analogue, suggesting heart inflammation. The vaccinated people had taken vaccines from Moderna or Pfizer.

Cardiologists Dr. Aseem Malhotra (L) and Dr. Peter McCullough in Dallas on Nov. 29, 2022. Bao Qiu/The Epoch Times

In his testimony to the European Parliament in September, cardiologist Dr. Peter McCullough called on lawmakers to “apply all pressure and due urgency to remove the COVID-19 vaccines from market.”

“COVID-19 vaccines and all of their progeny and future boosters are not safe for human use,” he said. Dr. McCullough stated that the spike protein from the COVID-19 vaccines is “proven” in 3,400 peer-reviewed manuscripts to cause four major domains of disease—cardiovascular, neurological disease, blood clots, and immunological abnormalities.

“Across Europe and across the United States, sports leagues were injecting young people who had no medical necessity, no clinical indication with these vaccines, and we have seen a montage of cardiac arrests in young individuals,” he said.

“I’m telling you as an expert cardiologist, these cardiac arrests are due to the COVID-19 vaccine until proven otherwise.”

Zachary Stieber contributed to this report.