The FDA approved Moderna’s new mRNA RSV vaccine, bypassing its independent vaccine advisory committee, which typically offers recommendations for such drugs.

The mRNA respiratory syncytial virus (RSV) vaccine from Moderna was licensed by the U.S. Food and Drug Administration (FDA) last week for people 60 years of age and above.

As stated in its approval letter, the FDA approved the drug without consulting its independent vaccine advisory committee, which normally offers recommendations regarding such drugs. This was because the FDA did not view any “concerns or controversial issues” that would require consultation during the approval process.

For its new mRNA RSV medication, Moderna is conducting at least 11 clinical trials on a variety of various patient demographics, such as young children, adolescents, and healthy adults.

The vaccine is Moderna’s second-ever FDA-approved medication, and it is sold under the brand name mResvia. Its COVID-19 Spikevax vaccination makes use of the same mRNA platform.

CEO of Moderna Stéphane Bancel stated, “The FDA’s approval of our second product, mRESVIA, builds on the strength and versatility of our mRNA platform.”

Before the medication can be used, the Centers for Disease Control and Prevention (CDC) must endorse it. At its meeting the following month, the CDC advisory group would debate and vote on the vaccination.

If the vaccine is approved, Moderna, whose first-quarter sales dropped 91% when compared to the same period in 2023, will have an additional source of income.

According to the corporation, the vaccine should be available in time for the autumn 2024 immunization season.

The FDA approved GSK’s Arexvy and Pfizer’s Abrysvo RSV vaccines for the same age range a year before approving Moderna’s mRNA RSV vaccine.

It is also permitted for pregnant women to use Abrysvo. Pfizer is testing their medication on kids and teenagers and is looking for permission for people 18 years of age and up. This month, GSK anticipates receiving approval for Arexvy for individuals 50 years of age and above.

According to Bancel, Moderna’s shot has an advantage over the RSV vaccinations now available on the market because it is delivered in a pre-filled syringe, which reduces the possibility of administration errors and makes administration speedier.

Given the post-pandemic decline in revenues, Moderna stated that it intends to take a piece of the $10 billion market for RSV vaccinations.

The business also disclosed last week that it is in discussions with the US government to provide funding for the mRNA bird flu vaccine’s later stages of trials.

Experts say efficacy is exaggerated and safety concerns ignored 

The Phase 3 trial, which included over 35,000 adults from 22 different countries and was published in December 2023, provided evidence that the vaccine was 83.7% successful in preventing at least two RSV symptoms, such as fever and cough, almost four months after immunization. This evidence was used to support Moderna’s approval.

According to the business, the FDA’s follow-up research revealed further cases and decreased the efficacy to 79%. According to Reuters, that efficacy rate is comparable to Arexvy, which is presently leading the RSV vaccine market.

Dr. Peter McCullough, a cardiologist, stated on his Substack that the efficacy claims were false.

“The absolute risk reduction for significant outcomes was far below 1%, meaning this product will not have a significant clinical impact,” he wrote.

The real risk differential between the treatment group and the control group is referred to as absolute risk reduction.

The study data was given by the corporation using a metric called relative risk reduction, which quantifies the extent to which a therapy decreased the likelihood of an unfavorable result in comparison to the control group. It frequently causes people to overestimate the efficacy of a treatment.

According to data released in February, Moderna’s injection exhibits quicker efficacy reductions than those of GSK and Pfizer, as reported by Reuters.

Moderna reported that the trial revealed no significant safety issues. Injection site discomfort (55.9%), fatigue (30.8%), headache (26.7%), muscle pain (25.6%), joint pain (21.7%), underarm swelling or tenderness (15.2%), and chills (11.6%) were among the adverse effects recorded in the clinical trial.

After 42 days, there were also two occurrences of acute pericarditis. Those situations, according to the investigator, had nothing to do with the shot.

The CDC reports that there were no incidences of Guillain-Barré syndrome, which Pfizer and GSK both discovered in their clinical studies and which has now been shown to be “more common than expected” with the other RSV vaccinations.

McCullough did note that there are worries with myocarditis, auto-immunity, genomic integration, and oncogenicity with all mRNA doses. Several of these problems cannot be identified in the time required by the quick approval process.

He wrote:

“Our great concern was that mRNA COVID-19 vaccines ushered in the context of an emergency would set a new precedent for more genetic vaccines that depart from all safety standards set forth previously by the US FDA. …

“[The approval] was done without the full dossier of safety information required for a routine approval including 2-3 years of observation for standard vaccines, and at least 5 to 15 years of observation for genetic transfer technology.”

The FDA’s vaccine advisory group did not review the data, therefore there was no public comment period or publicly available discussion of the vaccine’s risk and efficacy, which usually occurs at such meetings.

The committee convened before Arexvy and Abrysvo’s approval.

Common respiratory viruses like RSV typically cause mild cold-like symptoms, but they can also cause hospitalization and even death in certain situations, especially in elderly and baby patients.

It is unknown how many people contract RSV because the virus is rarely identified unless a patient visits a hospital for testing.

An RSV vaccination is usually only beneficial for elderly individuals who are already sick or have a very severe immune deficit, according to internist Dr. Meryl Nass.

“That benefit,” she said, “must be weighed against all the harms, including those from the lipid nanoparticle as well as the mRNA and any DNA plasmids or other extraneous production materials.”

According to her, mRNA vaccines are often costly, and the sum of money required to save one life might have to be taken out of other vital health expenditures.

McCullough said, “Rare illnesses which are mild should not be the target for mass vaccination.”

“In the case of respiratory syncytial virus, the illness is so mild and easily treatable with albuterol and budesonide nebulizers, it is hard to make the case for mass vaccination with a novel mRNA platform,” he added.

Children’s Health Defense Chief Scientific Officer Brian Hooker, Ph.D., stated that the vaccine’s clearance “is an absolute disaster in the making.”

“The clinical trial was too short (average 112 days) to ascertain any long-term sequelae to the vaccine. Even with that, the rate of serious adverse events was 2.8% or 1 in 36 vaccine recipients,” he said. “We can only expect the actual degree of damage will be much worse.”

Moderna conducting testing on pregnant women and their infants

Additionally, despite concerns expressed by this organization regarding existing RSV vaccines, Moderna is testing its mRNA RSV vaccine on expectant mothers and their unborn children, according to a check of the federal clinical trials database.

360 pregnant subjects between 28 and 36 weeks gestation at the time of vaccination will be included in the ongoing Phase 2 research. The purpose of the trial is to ascertain vaccination dosage and any side effects.

GSK discovered a safety signal for premature births among vaccinated women, which led the company to discontinue the development of its RSV vaccine for expectant mothers. In that study, there was one extra preterm birth for every 54 babies born to mothers who received the vaccination.

Neonatal deaths, or newborn deaths during the first 28 days of life, were also more common in the GSK vaccine group (0.4%) and 0.2% (13 of 3,494) in the placebo group (three of 1,739), respectively. However, the difference between the two groups was not statistically significant.

In August 2023, the FDA authorized Pfizer’s Abrysvo for use in pregnancy.

Preterm birth rates were higher among women who received the Abrysvo vaccination, according to Pfizer’s own clinical trial data. However, Pfizer noted that these higher rates were not statistically significant. Abrysvo is quite similar to the vaccine developed by GSK.

However, to lower risk, the FDA only approved the vaccination for women in weeks 32–36 of pregnancy, and it required post-market follow-up studies for eclampsia and preterm birth.

Preterm birth was also listed by the agency as a possible side effect of the vaccination.

Based on the results of the clinical trials, certain members of the FDA’s vaccine advisory group expressed grave reservations about the drug’s safety, and four of them voted against its approval.

Additionally, a recent preprint study demonstrates a statistically significant safety signal for Abrysvo-associated premature birth.

Pregnant women were excluded from the COVID-19 mRNA vaccination clinical studies.

Subsequent investigation, however, revealed that the mRNA given to nursing moms systemically spread from the injection site into the breast milk. Additional post-marketing investigations on the COVID-19 vaccine discovered mRNA in the placenta and umbilical cord blood.

In addition, Moderna is currently conducting several other ongoing clinical trials for the medication, including ones involving healthy adults, children and adults ages 2 to 18, and individuals who are not at risk of developing an RSV-related illness.

Children between the ages of 5 and 24 months are also being tested for the substance.

Recently, GreatGameIndia reported that Moderna’s stock surged as the US government invested millions in covert bird flu vaccine trials amid concerns over H5N1’s spread and potential human-to-human transmission ahead of the presidential elections.