RFK stops oral COVID vax trial; Some thoughts on the future direction of vax research

Although this decision likely comes from a place of anti-vax sentiment, there is discussion to be had about our research priorities and the balance between public vs private trial funding

A few days ago, I read a recent report about RFK Jr. halting a $9.2 million dollar contract to Vaxart for running a Phase IIb trial testing a new oral COVID-19 vaccine in 10,000 participants. This grant was part of a Biden-era initiative called Project NextGen to allocate over $5 billion towards the development of new vaccines and therapeutics to counter COVID-19. By April 2020, Vaxart had shown positive results in animal models per their original press release and this contract would have helped them through this next stage of the trial process.

I wish I could say that I were surprised, but given RFK’s past views on vaccines, a move like this is well within the realm of possibility. I have written previously on why I thought RFK made a poor HHS candidate, but alas he was confirmed by the slimmest of margins and here we are.

This has also fallen in line with the Trump administration and DOGE’s larger philosophy of slashing and burning anything they feel is wasteful government spending - in a method I think is unconstitutional. They have recently brought their torches to the NIH, the largest funder of biomedical research in the word. I aim to cover this in a future post. This has been referred to as a “War on Science,” a description I find apt.

I am sure everyone can agree that there is certainly some government fat that is worth trimming and that saving taxpayer money and addressing our deficit is certainly a big priority. But medical research should be at the absolute bottom of that list. If anything, this work is an investment that we get a large ROI from. There is a frequently mentioned statistic that for every $1 the NIH spends, over $2 is generated in economic activity. Not only this, but medical research also serves as a backbone of our society by developing treatments that keeps our population healthy, happy, and productive.

All of this aside, I couldn’t help but think of a few difficult yet intriguing questions about the landscape of our public research priorities, how we should decide what and what not to fund, and the balance between public and private funding of trials like these. I would be very interested in hearing others’ thoughts on this. I’ll divide my thoughts into a few loosely organized sections.

Do we need an oral COVID-19 vaccine trial?

While COVID-19 remains prevalent in most nations and continues to infect many people, we simply aren’t in the state of worldwide emergency that we were a few years ago. Per the CDC’s most recent estimates, only 4.3% of people with symptoms who tested are positive and only 0.8% of people coming into the ED have COVID. In terms of severity, COVID currently carries a hospitalization rate of 2.7 per 100,000 and it only accounts for 1.1% of all deaths in the US. Around the country and the world, there are no restrictions on activity, mask mandates have been lifted, and schools and businesses are open. Most people I know either have received the mRNA vaccines, had COVID one or more times, or both. Most of society has acknowledged that we will always have a level of risk of contracting the virus, but we will continue life as normal, much like the flu.

Combine this with the fact that we have do have two mRNA vaccines (also subsidized through government contracts) that are widely available and have demonstrated very high rates of efficacy (Pfizer-BioNTech and Moderna Spikevax) in preventing hospitalization and severe death.

So for a disease that is no longer the major public health risk that it once was for which we have good vaccines, I am struggling to see the benefit of subsidizing another trial in this space. The main draws I see of a trial like this are for the few people who may be hesitant to get vaccinated because of the pain, fear of needles, and side effect profile of the mRNA vaccines. For those who are just plain anti-vaccine, I am unconvinced that an oral form is going to make them any more amenable towards getting vaccinated, though I have not seen much data on this.

Perhaps more important trials in this space would be to examine the long term safety profiles of our current COVID vaccines. While these vaccines have been readily added to the CDC’s routine recommendations, there is still much to learn about any long term safety signals, especially given the haste and situation in which they were initially approved.

I am by no means saying that this Vaxart oral vaccine trial should not be run at all, rather if it should be as big a priority that our government puts funding towards. This brings me to my next question.

What should we subsidize and what should Pharma fund on its own?

This is the million-dollar question. I would love to live in a world where we could completely fund any and all medical research. However, this is not the case, and the limited research budget we do have should be aimed at maximizing benefit for the largest amount of people possible.

Most of vaccine research does fall into this bucket. Vaccines are perhaps modern medicine’s greatest innovation and have reduced both the morbidity and mortality of some truly horrible pathogens that have plagued humans for millennia. I would go as far as to say that they have improved the global quality of life greater than any other intervention in the past century.

Historically, most of our vaccines have been developed as public-private partnerships that depended on large investments and protection by our government, but perhaps it may be time to revisit this relationship.

When vaccine technology was first being developed, companies were miniscule in size and were risky to invest in from the private sector due to fear of litigation from possible adverse affects of the novel technology. This led to the passage of blanket-immunity laws and the PREPA act that shielded manufacturers from any suits related to vaccine-related harms. Fun fact - vaccine manufacturers actually lobbied for this legislation by threatening to not make new vaccines unless this was passed. This blanket-immunity legislation is unique to vaccine-makers and does not apply to durg-makers or medical device manufacturers.

Fast-forward to today - vaccine companies are multibillion dollar corporations still operating under these immunity shields. Pfizer and Moderna made almost $100 billion in two years for their vaccines during the pandemic. Given their efficacy, I’d say these profits are well-deserved. But I would also say that vaccine makers are in a better position than ever before to put more of their own meat into the pie and fund future trials on their own, especially like an oral COVID vaccine which may only provide a marginal public benefit at best.

Our attention should once again turn towards funding innovative and promising projects that may have a bigger impact on routine care. This brings me to my last question.

Could some of this money be better spent in other aspects of our broken healthcare system?

Improving health outcomes is the ultimate goal of medical research, but funding medical research into new therapies itself is not the only way to get there. Some of the largest health burdens we have in the US are from disease that is either preventable or disease that we have treatments for - take cardiovascular disease and diabetes for example. However, many continue to suffer largely due to a broken healthcare system that leaves many with little to no access to routine, high-quality care. These are systemic issues that cannot be solved by selling a pill and do not have entities like Big Pharma willing to sponsor studies on potential interventions.

This can be best exemplified in a recent post I made discussing the novel CRISPR-based therapy Casgevy for sickle cell. Although millions were invested into a therapy that can practically cure the disease, it costs $2 million for patients. Add on top of this the fact that the majority of sickle cell patients don’t even get routine care. So even with the cure in our hands, the burden of sickle cell remains high the US, especially among racial minorities and those with lower socioeconomic status.

Unless we are developing novel vaccines for pathogens with a high burden or no other high-quality treatment, perhaps our limited government funds would be better suited to expand medical education and residency spots to address our doctor shortage or beefing up our Medicare/Medicaid reimbursement rates to improve access to care for our least fortunate.

As someone going into medicine, I am intrigued by the complex interplay between public and private forces in our drug and vaccine development process and how groundbreaking therapies go from being an idea to being on the shelves in our hospitals. Given this, I am disheartened to read about RFK Jr. and Trump’s “War on Science.” Nevertheless, I think it raises several important questions we should consider as we decide on the future directions of biomedical research.