Mixed Reactions to HHS Investment in Vaccine Development

This week, the Department of Health and Human Services revealed plans to invest $500 million in a National Institutes of Health project aimed at creating a vaccine platform for potential pandemic-causing pathogens. While some scientists in the vaccinology field were supportive of continued investment in vaccine innovation, there were also significant concerns about the approach being employed.

Many thought it was encouraging that HHS and NIH are prioritizing vaccine development. However, questions arose regarding the decision to utilize whole killed viruses—a method rooted in last century—as the foundational technology for these vaccines.

“It’s puzzling,” remarked a vaccine development scientist, referencing the fact that this approach was used by Jonas Salk for the first polio vaccine back in the 1950s.

Another expert, familiar with research efforts for a universal flu vaccine targeting several severe strains, bluntly stated, “There’s impressive work happening, but this isn’t it.”

Several of the scientists interviewed expressed fears about backlash for criticizing the project, given that the NIH represents the largest scientific research funding body globally. They voiced concerns about investing heavily in outdated vaccine development methods. One compared it to trying to reverse progress. Veteran researcher Arnold Monto observed, “This isn’t a breakthrough.”

While the official announcement didn’t specify funding details, reports indicated that the allocated budget is indeed $500 million. The process for awarding this funding drew scrutiny as well. Since the project is overseen by NIH insiders, it bypassed the thorough peer-review process, typical for academic researchers seeking NIH support. “It seems rather insular,” commented one scientist.

Stanley Plotkin, known for developing vaccines for rubella and rotavirus, raised similar questions about the project’s vetting and whether the funding was justified.

“We absolutely need improved influenza vaccines, but it’s unclear whether this project will deliver without a deeper examination,” Plotkin shared, emphasizing the necessity of expert review.

Some scientists who assessed early findings from a Phase 1 trial of the NIH’s universal flu vaccine—targeting merely four subtypes of flu—were less than impressed with the results, which suggested only moderate antibody increases from injections.

While Monto acknowledged that a Phase 1 trial examines safety rather than immunogenicity, he pointed out that with just 45 participants, drawing strong conclusions is challenging.

The project, termed Generation Gold Standard, aspires to establish a vaccine platform utilizing inactivated or killed viruses, theoretically offering protection against viruses that pose a pandemic risk.

The historical context of using killed viruses for vaccine development reminds us that this was once standard practice, as seen in early flu vaccines. Despite claims of enduring protection from this method, flu vaccines have always needed annual updates to keep up with the virus’s rapidly evolving nature.

Over the decades, vaccine technology has evolved significantly, yielding faster production methods and minimizing side effects, causing the whole killed virus approach to largely fall out of favor—though some vaccines still use it, like rabies. “We can certainly do better with newer technologies,” noted one skeptic of the plan.

In a statement, Director Jay Bhattacharya touted the initiative as “a paradigm shift,” claiming it would enhance vaccine efficacy beyond strain-specific targets and prepare for not just current, but also future viral threats.

He boldly suggested that a universal flu vaccine, a complicated endeavor pursued worldwide, might achieve approval by as early as 2029.

Plotkin, however, expressed skepticism regarding the understanding of scientific complexities reflected in the announcement.

Funding for this initiative has been redirected from resources previously designated for developing next-generation countermeasures against Covid-19. Some biotech firms have recently been informed that their funding under this program, named Project NextGen, would be cut.

While STAT requested an interview with key project leader Matthew Memoli, there was no response. However, a statement from the NIH defended the funding decision, albeit with a lack of clarity regarding the project’s objectives.

Some scientists raised alarms that this focus might signal a shift away from mRNA vaccines, which had been crucial during the pandemic. A leading candidate for a universal flu vaccine currently employs mRNA to target 20 different influenza A and B subtypes, while the NIH’s current vaccine only aims at four subtypes.

Scott Hensley, a microbiology professor working on an mRNA-based flu vaccine, acknowledged the NIH funding as positive but emphasized the importance of pursuing diverse approaches.

Monto echoed the sentiment, pointing out the necessity of considering a range of technologies.

Interestingly, mRNA vaccines, despite their significant role during the Covid response, have faced opposition from the political base of Health Secretary Robert F. Kennedy Jr. His administration recently indicated it was reviewing a substantial award given to Moderna to develop vaccines against avian influenza viruses, although the current status of that review remains unclear.

Producing mRNA vaccines is notably faster compared to traditional methods, which often require extensive virus cultivation—a slow process that has proven inadequate during previous pandemics when quick responses were crucial.

Existing flu vaccines don’t target the entire virus but rather train the immune system to recognize specific proteins. Using whole viruses could expedite production slightly, though it doesn’t match mRNA speed, according to Monto.

Kennedy’s recent remarks about the ineffectiveness of vaccines targeting a single antigen has left experts puzzled. Monto indicated that additional clarity is needed regarding how these vaccines would be deployed, emphasizing the importance of intent whether for pre-pandemic immunity or immediate use during an outbreak.

While whole killed vaccines can offer enhanced protection, they may also lead to more severe adverse effects. Vaccination approaches must balance efficacy against potential risks, a discussion raised by microbiologist Adolfo Garcia-Sastre, who is also exploring universal flu vaccine strategies.

The Generation Gold Standard team is investigating intranasal vaccine options but must approach these cautiously due to possible adverse reactions associated with other vaccines previously on the market.