RFK Jr. poked at vaccine research funds. That could hurt local research, industry

The technology once embraced by President Donald Trump for speeding the development of COVID-19 vaccines is now under scrutiny.

Health Secretary Robert F. Kennedy Jr. recently took sweeping action that canceled 22 mRNA vaccine contracts, vexing researchers, doctors and companies such as Spokane’s Jubilant HollisterStier.

mRNA vaccine technology earned widespread attention during the COVID-19 pandemic, and pharmaceutical businesses tapped it to quickly develop an adaptive, highly effective vaccine. When Pfizer secured authorization from the Food and Drug Administration to proceed with mRNA in 2020, then-President Trump touted the move.

“This is one of the greatest scientific accomplishments in history,” he said at the time.

While mRNA abilities are notably associated with the coronavirus pandemic, their reach extends beyond a contagion like COVID-19.

The science of misinformation

“The majority of vaccines out there right now are either inactivated vaccines or live-attenuated vaccines,” said Professor Deborah Fuller. She works in the Department of Microbiology at the University of Washington School of Medicine. She is also the director of the Washington National Primate Research Center, and she specializes in nucleic acid vaccine research, which includes both ribonucleic – mRNA and self-amplifying – and deoxyribonucleic vaccine types.

“They are very, very safe. I want to emphasize that,” she said. “Examples of inactivated vaccines include those for hepatitis A, rabies and polio. Live-attenuated technology is found in the vaccine for measles, mumps and rubella, and the vaccines for smallpox and yellow fever.”

The mRNA technology is different. While “most other technologies really require months to have the pathogen you either need to enact or attenuate,” Fuller said, RNA vaccines only “need the genetic sequence of what the pathogen is.”

That made this type of vaccine highly applicable to the pressing pandemic. mRNA research had been simmering for more than 30 years. So when the coronavirus struck, “the right technology was ready to go at the right time for this disease,” Fuller said.

One common misconception is that safety protocols were thwarted to allow for mass production and inoculation, Fuller said.

According to the U.S. Centers for Disease Control and Prevention, vaccines are required to proceed through three distinct phases: one focused on side effects and immune response, another that enhances existing safety knowledge and a final efficacy analysis.

What made the coronavirus vaccine process unusual was that scientists overlapped the start of each of those phases as they completed all safety checkpoints.

This accelerated approach is typically avoided due to cost. If a phase is entered before the previous phase is complete, there is a risk of losing a major investment.

“They took that risk, but I think they also had some confidence because of those 30 years of studying mRNA vaccines,” Fuller said.

Another assumption was that mRNA vaccines are more invasive.

“The primary method or mechanism in the body that protects you against those diseases is an antibody response,” Fuller said. mRNA allows cells to “produce that vaccine” so that “they can present the antigen to your immune system in sort of a natural confirmation that your body would typically see if a virus infects.” Essentially, instead of introducing a foreign immune response to the body, mRNA technology lets the body do that work itself.

Unlike inactivated or live attenuated vaccines, the mRNA kind allows for the body to develop strength through its own protein production. Other vaccine forms require the body to respond to an external non-infecting virus, widening the possibility for a “rejection.”

The misinformation spread on this topic is an “attack” that’s primarily “driven by politics,” the researcher said. Rarely are these rumors based in the science that she studies.

The mysterious $500 million

In May, the Trump administration launched Generation Gold Standard, a project aimed at developing a “whole-virus” solution to infections like influenza.

“It’s a so-called universal flu vaccine that consists of a combination of more inactivated vaccines into a pot,” Fuller said.

But the researcher said that technology is outdated.

The efforts are projected to cost around $500 million – the same amount cut from mRNA vaccine contracts.

“It’s almost as if they canceled 22 projects that were really in mid- to late-stage development just to fund this one, less innovative approach,” Fuller said.

A cure for cancer?

The mRNA technology has long been considered for cancer treatments.

Some vaccines that target cancer-causing viral agents “have been very effective,” said Dr. Brett Gourley, a medical oncologist and hematologist at MultiCare. That includes hepatitis B and human papillomavirus, or HPV.

When it comes to incorporating mRNA advancements into cancer treatments, there are different paths.

“The first is similar to the COVID-19 vaccine where we have the mRNA make a particular type of protein,” Gourley said.

“We know that cancer cells can sometimes make unique proteins that are expressed, and by trying to overexpress those proteins, it may help the immune system identify those proteins as foreign.”

A second scenario is “using mRNA to encode not just for a snippet of protein, but actually for a full antibody protein,” he said. This would mean the lab-manufactured antibodies upon which scientists rely could be produced within the body.

“(Current) antibody treatments are wonderful because they allow us to treat cancer and prolong people’s lives, and in certain cases, even cure people,” Gourley said, but “they have to be processed in a very special lab, and it takes a lot of time and effort to produce these.”

Keytruda, Opdivo and Yervoy are among these treatments and can cost from $13,000 to $40,000.

The third mRNA application is through gene editing.

While the three mRNA options have not progressed to FDA approval, Gourley said it’s possible to see these technologies “ready to deploy” in the next five years.

“I started doing oncology only in 2011. So in those 14 years, drug development has accelerated in ways that we could never imagine,” he said.

Recent funding withdrawals may not cause limitations, Gourley said, but companies will be forced to turn to their research and development budgets.

Some companies might ache …

Jubilant-HollisterStier, an international pharmaceutical powerhouse with operations in Spokane, is heavily invested in the business of vaccine development and distribution.

The company’s local plant packages medicines like vaccines.

In 2021, The Spokesman-Review reported the enterprise as being “the only such manufacturer of the COVID-19 vaccines and therapeutics in the state of Washington.” At the time, 900 Spokane-based employees could produce 500,000 vials daily.

A 2022 news release from Jubilant-HollisterStier announced “a cooperative agreement for $149.6 million” with the U.S. government, particularly the department currently headed by Kennedy. The company reported this funding was through the American Rescue Plan – a $1 trillion-plus health and economic stimulus from former President Joe Biden’s administration.

The Trump administration has since pulled billions back from this fund.

This agreement was to create two new production lines. Despite funding changes, the company is “still on track for the expansion to be completed and fully operational by June 2026,” a Jubilant-HollisterStier marketing manager said in an email .

She declined to comment on the source of the funding, including whether the initial amount had been received in full or if government money is crucial to growing the Spokane branch.

… though not all

Some enterprises may benefit from RFK Jr.’s policy.

GeoVax, an American biotechnology company, said the move away from mRNA technology toward other inoculation methods supports its research and testing for multi-antigen vaccines. Generation Gold Standard is one example of federal efforts to back this approach.

For the millions of immunocompromised Americans, “mRNA vaccines, or single-antigen vaccines, are inadequate,” said GeoVax president and CEO David Dodd.

The federal decision “actually bodes very well for (GeoVax),” he said.

While mRNA shots are quick to develop and produce, making them the ideal candidate for a pandemic response, the vaccines researched by GeoVax may have broader protection, Dodd said, though manufacturing is slower.

Despite scientists claiming the technology embraced by the current administration is antiquated, Dodd said “just because something is old, doesn’t mean it doesn’t have value and utility.”

“We feel positive,” he concluded. “For some other players, it‘s going to be a challenge.”