What You Should Know About the $1 Billion Taxpayer-Funded Covid Trial
(Thursday, August 31, 2023)
The US government is investing heavily in finding new COVID-19 vaccines both to treat acute infections and to treat long-term side effects of Covid, called Long Covid. In that regard, the US Department of Health and Human Services (HHS) announced an award of $1.4 billion for its latest efforts of which $1 billion will be used for a Phase IIb clinical trial. It is very important for the general public to know how this money will be spent since questions have been raised as to how previous funds allocated for similar anti-Covid efforts were spent.
With the end of the pandemic, there is reduced interest in the industry to conduct research in finding new vaccines for Covid. The available Covid vaccines have been very effective in controlling the infection and reducing the severity of the disease in those individuals who get infected post-vaccination. The worldwide demand for Covid vaccines has dropped precipitously, and most other governments have also curtailed their planned research in this space. At the same time, new strains of SARS-CoV-2 virus are emerging which, so far thankfully, have been less virulent and reasonably controlled by the existing vaccines, further diminishing commercial interest in developing new vaccines or other treatments. All this sets the stage for the US government to allocate resources in public interest so we are not surprised by another uncontrolled pandemic.
However, it is critical that public funds be used appropriately and justifiably. A couple of weeks ago, an NIH initiative to spend almost a billion dollars over 2 and a half years for an observation study for Long Covid was severely criticized. Now we hear about another billion-dollar study for one clinical trial so obviously we should ask questions about its justification. To make it worse, the information about this new study is very hard to find beyond a news release from HHS, a website with bare minimum information, and a hard-to-find link with a clinical protocol synopsis dated May 1 2023 (four months ago).
Here is what we know about the planned study. We must assume there is a newer version of the protocol since the one available publicly is four months old and lacks critical information. The billion-dollar funding is for one Phase IIb clinical trial. This would be a double-blind, active comparator-controlled trial to evaluate the efficacy, immunogenicity, and safety of an investigational next-generation COVID-19 booster vaccine candidate compared to the currently approved/authorized COVID-19 booster vaccines. The study participants will be distributed 1:1 to the standard vaccine and the next-generation vaccine. There will be a total of seven patient visits spread over 12 months.
There are several questions one should ask about this program to better educate. First, there is no mention of which next-generation vaccine will be used. The two established vaccines, that helped control the pandemic, one each from Pfizer and Moderna, are not involved. None of the other vaccines authorized or approved anywhere in the world have been indicated to be better than the top two vaccines. There is a separate allocation of funds to develop next-generation vaccines that would use different routes of administration but none of them are publicly known to be ready for a Phase IIb study of this magnitude.
Second, the clinical protocol has not been made public anywhere on the HHS websites and has not been published on clinicaltrials.gov. Why is there so much secrecy around this protocol? Since the HHS news release, there has been tremendous interest in this study. Trial information should have been readily available so independent critique can be done.
The biggest question should be about the cost of this one trial. At its current budget of one billion, it will cost $100,000 per patient. That’s a pretty expensive study by most standards. The announcement seems to hint that the moneys used will build infrastructure for additional trials but does not indicate how this initial investment will help manage the cost of future trials. On the face of it, this seems like another billion-dollar poorly planned program.
There are going to be more questions once the above are known. It is critical that these large programs be transparent and accountable. Otherwise, it will hurt the cause instead of helping it by making it harder to justify future research funding.
Dr. Mukesh Kumar
Founder & CEO, FDAMap
Linkedin: Mukesh Kumar, PhD, RAC