Enlarge / A pharmacist holds a bottle containing Moderna's bivalent COVID-19 vaccine. (credit: Getty | Mel Melcon )

The Food and Drug Administration on Tuesday altered its authorizations for mRNA-based COVID-19 vaccines , retiring the original monovalent versions entirely, streamlining immunizations for the unvaccinated, and offering spring bivalent boosters to those aged 65 and older and people with certain immune compromising conditions.

The changes will need a sign-off from Rochelle Walensky, director of the Centers for Disease Control and Prevention, before they go into effect. The agency will convene its advisory panel of vaccine experts Wednesday to discuss the changes. Walensky is likely to sign off soon after.

With the changes, the only mRNA-based COVID-19 vaccines authorized and in use in the country will be the bivalent formulations from Moderna and Pfizer-BioNTech, which initially rolled out last fall. These vaccines target the ancestral COVID-19 strain and the omicron BA.4/5 subvariants.

Enlarge / Moderna CEO Stephane Bancel testifies before the Senate Health, Education, Labor, and Pensions Committee in the Hart Senate Office Building on Capitol Hill on March 22 in Washington, DC. (credit: Getty | Chip Somodevilla)

In Congressional testimony Wednesday, Moderna CEO Stéphane Bancel unabashedly defended the company's plans to raise the US list price of its COVID-19 vaccines by more than 400 percent—despite creating the vaccine in partnership with the National Institutes of Health, receiving $1.7 billion in federal grant money for clinical development, and making roughly $36 billion from worldwide sales.

Bancel appeared this morning before the Senate's Health, Education, Labor, and Pensions committee, chaired by Sen. Bernie Sanders (I-Vt.), who has long railed at the pharmaceutical price gouging in the US and pushed from policy reforms. After thanking Bancel for agreeing to testify, Sanders didn't pull any punches. He accused Moderna of "profiteering" and sharing in the "unprecedented level of corporate greed" seen in the pharmaceutical industry generally.

Sanders contrasted a recent survey finding that 37 percent of Americans can't afford their prescription drugs to the billions of dollars in profits reaped by drug companies. He noted several times that Bancel became a billionaire overnight amid the pandemic. Bancel is now estimated to be worth over $4 billion, Sanders added.

Enlarge / Moderna pharmaceutical and biotechnology company's CEO Stephane Bancel speaks during a session of the World Economic Forum annual meeting in Davos on January 18, 2023. (credit: Getty | Fabrice COFFRINI )

Moderna CEO Stéphane Bancel on Monday pushed back on criticism of the company's plans to raise the price of its mRNA-based COVID-19 vaccines by 400 percent, arguing that the billions of dollars in federal funding the company received played little role in the vaccine's development.

Speaking at the Wall Street Journal Health Forum , Bancel suggested that the vaccine's development is thanks to private investors and that the federal funding merely hastened development that would have occurred regardless. The comments came in response to a question of whether the company has a "moral obligation" to give back to the taxpayers who helped develop the life-saving immunization—presumably by not dramatically hiking the vaccine's price as it moves from federal distribution to the commercial market this year.

While the government most recently paid $26 per dose for Moderna's updated booster dose, the company is planning to raise the price of its shots to $110 to $130 per dose .

Enlarge (credit: DeFodi Images )

Vaccine maker Moderna has forked over $400 million to the National Institutes of Health for using a molecular stabilizing technique borrowed from government and academic researchers in its mRNA-based COVID-19 vaccine—which the company made roughly $36 billion selling amid the deadly pandemic, according to The New York Times .

Moderna mentioned the payment in the company's latest earnings report , which described the sum as a "catch-up payment" negotiated with the NIH in December as part of a new royalty-bearing license agreement. The agreement will also grant the NIH "low single-digit royalties on future COVID-19 vaccine sales." The company expects to make around $5 billion in COVID-19 vaccine sales in 2023.

The molecular technique at the center of the agreement is designed to stabilize the SARS-CoV-2 spike protein so that it can spur a strong immune response following vaccination. The mRNA-based vaccine delivers genetic code for the spike protein, which is then translated by human cells into protein. Researchers at the NIH's National Institute of Allergy and Infectious Diseases (NIAID)—as well as collaborators at Dartmouth and The Scripps Research Institute in La Jolla, California—came up with a method of tweaking the mRNA code so that, when translated, the spike protein would stay locked in a specific conformation best for generating an immune response. They had developed the technique years before the pandemic, publishing it in a 2017 study involving the spike protein from a SARS-CoV-2 relative, MERS-CoV, aka the Middle East respiratory syndrome coronavirus. Moderna began collaborating with the NIAID on a general design for mRNA-based vaccines in 2016, but none of its scientists were authors of the 2017 paper.

Enlarge / The Comirnaty (Pfizer/BioNTech) and Moderna COVID-19 vaccines. (credit: Getty | Marcos del Mazo )

Two Republican lawmakers in Idaho have introduced a bill that would make it a misdemeanor for anyone in the state to administer mRNA-based vaccines—namely the lifesaving and remarkably safe COVID-19 vaccines made by Pfizer-BioNTech and Moderna. If passed as written, it would also preemptively ban the use of countless other mRNA vaccines that are now in development, such as shots for RSV , a variety of cancers, HIV, flu, Nipah virus, and cystic fibrosis, among others.

The bill is sponsored by Sen. Tammy Nichols of Middleton and Rep. Judy Boyle of Midvale, both staunch conservatives who say that stand for freedom and the right to life. But their bill, HB 154 , proposes that "a person may not provide or administer a vaccine developed using messenger ribonucleic acid [mRNA] technology for use in an individual or any other mammal in this state." If passed into law, anyone administering lifesaving mRNA-based vaccines would be guilty of a misdemeanor, which could result in jail time and/or a fine.

While presenting the bill to the House Health & Welfare Committee last week, Nichols said their anti-mRNA stance stems from the fact that the COVID-19 vaccines were initially allowed under emergency use authorizations (EUAs) from the Food and Drug Administrations, not the agency's full regulatory approval. "We have issues that this was fast-tracked," she told fellow lawmakers, according to reporting from local news outlet KXLY.com .

Enlarge (credit: DeFodi Images )

Moderna's mRNA-based vaccine against RSV (respiratory syncytial (sin-SISH-uhl) virus) was effective at preventing disease in older adults, according to preliminary, top-line results of an ongoing phase III clinical trial the company announced Tuesday . Moderna said it will now seek regulatory approval for the vaccine in the first half of this year.

According to the company, the vaccine was 83.7 percent effective at preventing RSV-associated lower respiratory tract disease (RSV-LRTD) involving two or more symptoms in adults age 60 and over. It was 82.4 percent effective at preventing RSV-LRTD with three or more symptoms in the same group. No safety concerns were identified.

The findings are another positive sign for mRNA vaccine platforms generally, which Moderna and other pharmaceutical companies have quickly shifted to for fighting various other infections and diseases given the global success of mRNA-based COVID-19 vaccines. mRNA-based vaccines are now in development for everything from seasonal flu to HIV and certain cancers.

Enlarge / Moderna CEO Stephane Bancel during a Bloomberg Television interview on the closing day of the World Economic Forum in Davos, Switzerland, on May 26, 2022. (credit: Getty | Jason Alden )

Moderna is considering raising the price of its COVID-19 vaccine by over 400 percent—from $26 per dose to between $110 and $130 per dose— according to a report by The Wall Street Journal.

Ars has reached out to Moderna for comment but has not yet received a response. The plan, if realized, would match the previously announced price hike for Pfizer-BioNTech's rival COVID-19 vaccine .

The Journal spoke with Moderna CEO Stephane Bancel at the JP Morgan Healthcare Conference in San Francisco Monday, who said of the 400 percent price hike: "I would think this type of pricing is consistent with the value.”

Enlarge / Reisa Lancaster RN, left, administers the Covid-19 vaccine to 14 month old Ada Hedge, center, being comforted by mom Sarah Close and dad Chinmay Hedge, right at Children's National Research and Innovation Campus, in Washington, DC. (credit: Getty | The Washington Post, Bill O'Leary )

The Food and Drug Administration has greenlit updated COVID-19 vaccine doses for children under the age of 5, but the change to the authorized vaccination regimens is far from straightforward. This may further hamstring efforts to vaccinate the youngest Americans, which are already off to an abysmal start.

After months of availability, only about 3 percent of infants and toddlers 6 months to 2 years old have completed a primary series. Just 6.5 percent have gotten at least one shot, according to data from the Centers for Disease Control and Prevention . For those aged 2 to 4 years, just under 5 percent have completed a primary series, with 9 percent having gotten at least one dose.

It was back in June when the FDA authorized—and the CDC endorsed—small doses of both Moderna's and Pfizer's COVID-19 vaccines for children as young as 6 months old.

Enlarge / A pharmacist prepares to administer COVID-19 vaccine booster shots during an event hosted by the Chicago Department of Public Health at the Southwest Senior Center on September 9 in Chicago. The recently authorized booster vaccine protects against the original SARS-CoV-2 virus and the more recent omicron variants, BA.4 and BA.5. (credit: Getty | Scott Olson )

In mice, the BA.5-targeting bivalent booster now rolling out nationwide did an equally good job at thwarting the BA.5 omicron subvariant as the bivalent booster targeting its predecessor, BA.1, which US regulators passed on.

That's according to a pre-print study —which hasn't been peer-reviewed or formally published—authored by researchers at Moderna and Washington University School of Medicine.

Although the study is still a preprint and only involved mice, it provides some of the first head-to-head data comparing the two omicron-targeting booster options considered for this fall—one of which is currently going into arms across the US. And the findings may raise questions about the US booster strategy.