Where is Dr. Peter Hotez's Corbevax vaccine?
And why does there appear to be limited information on its safety?
Dr. Peter Hotez has been in the spotlight the past several weeks for his remarks against Joe Rogan having on RFK Jr, in which the discussion included RFK Jr.’s criticisms of vaccine clinical trials.
I won’t rehash the ideas around the debate (or lack thereof) as others have already discussed them before.
However, in reading some of the comments and articles I noticed something interesting.
For instance, Stephanie Brail of Wholistic mentioned in a Note that Dr. Hotez has a more traditional vaccine that doesn’t appear to be used in the US.
She made similar remarks in her post on Dr. Hotez as well:
I recall watching one of Dr. Hotez’s appearances on Joe Rogan’s podcast, but I can’t recall if he mentioned that he was developing his own COVID vaccine.
Now, this sparked some interest into looking a bit and seeing what I can find with respect to Dr. Hotez’s vaccine, which is a more traditional subunit vaccine called Corbevax.
The vaccine contains the receptor-binding domain of the Wuhan strain of SARS-COV2, with some slight modifications. It also includes two adjuvants: aluminum hydroxide as well as a CpG oligodeoxynucleotide labeled 1018.
I’ll leave others to discuss the role of the adjuvants in this vaccine, as the intent here is to discuss what exactly has come of this vaccine.
Where in the world is Corbevax?
Strangely, Corbevax has seen use predominately in India. As Stephanie Brail and others have outlined, India seems to have administered over 70 million doses of Corbevax to its citizens, mostly in children and with adults now having it as a possible booster vaccine.
It’s strange that this vaccine is seeing use predominately in India. As Corbevax was developed at Texas Children’s Hospital and Baylor College of Medicine.
It’s also been touted as “the World’s COVID vaccine”, which adds more confusion over its limited use.
In a House Hearing from April/May of 2020, Dr. Hotez described how his team was developing a vaccine to target the original SARS-COV strain in 2003, which took years to develop. By the time it was developed and ready to manufacture interest had waned, and Dr. Hotez’s team could not garner investor interest and funding.
I bring up this point because this appears to be one of the issues that Dr. Hotez’s team ran into again with their SARS-COV2 vaccine, where investor interest appeared to be more aligned with the mRNA vaccines rather than he and Dr. Bottazzie’s vaccine.
As noted in a January 2022 article from Vice, Dr. Hotez and Dr. Bottazzi sought out funding from various sources, only to receive scant funding relative to what Pfizer and Moderna received by both private investors as well as through the government:
“If we had even a fraction of the funding that Moderna had gotten, there's a possibility the world could have been vaccinated by now,” said Hotez. “And nobody would have ever heard of the Omicron variant.”
As of late October 2020, the U.S. government had invested $12 billion dollars in vaccine development as part of Operation Warp Speed. The Texan team invested just $6-7 million total to develop Corbevax, all raised through private donations and one $400,000 grant from the National Institutes of Health (NIH).
Bottazzi told Motherboard that her team “constantly” sought government funding “at all levels” in 2020. They made pleas during congressional hearings, webinars, conferences, to journalists, and through op-eds. The philanthropic arm of the Texas-based Tito’s Vodka, which donated $1 million dollars to the effort, has contributed more funds than the U.S. government.
There are a few questions as to why Dr. Hotez/Dr. Bottazzi’s team did not receive nearly as much funding as other pharmaceutical companies.
One possibility, as noted in the Vice article, points towards the fact that there is likely to be far more money to be made in the world of mRNA vaccines compared to the old-school versions. It’s likely that financial incentives were a large driver in the development of these newer, more “flashy” vaccines, because newer is always better in the eyes of the public, I suppose...
Now, before anyone gets into a tizzy about this piece being pro-vaccine, remember that the point of outlining this information is to answer the question of why this vaccine doesn’t appear to be available in the US, and only seems to see use predominately in India and other South/Southeast Asian countries.
It’s possible that the lack of funding here in the US, and the inability to fund clinical trials, may have led Corbevax to seek international support.
In late December 2021, a press release came out which noted that Carbevax would see emergency use in India based on clinical trials conducted in the country:
HOUSTON, TX (December 28, 2021) – Texas Children’s Hospital and Baylor College of Medicine announced today that CORBEVAX™, a protein sub-unit COVID-19 Vaccine, whose technology was created and engineered at its Center for Vaccine Development (CVD), has received Emergency Use Authorization (EUA) approval from the Drugs Controller General of India (DCGI) to launch in India with other underserved countries to follow.
These vaccines seem to come with the notion that they can help more underdeveloped countries in their fight against COVID, allowing for more equitable accessibility to vaccines due to their lower cost of development and less stringent storage needs.
The press release goes on to state the following:
“This announcement is an important first step in vaccinating the world and halting the pandemic. Our vaccine technology offers a path to address an unfolding humanitarian crisis, namely the vulnerability the low- and middle-income countries face against the delta variant,” said Dr. Peter Hotez, Professor and Dean of the National School of Tropical Medicine at Baylor and Co-Director of the Texas Children’s Hospital Center for Vaccine Development. “Widespread and global vaccination with our Texas Children’s-Baylor-BE vaccine would also forestall the emergence of new variants. We have previously missed that opportunity for the alpha and delta variant. Now is our chance to prevent a new global wave from what might follow.”
But why exactly was India, of all places, chosen?
India has been the site of many clinical trials in recent years. Some arguments over the use of India as a site for clinical trials rests on the argument that India is one of the most populated nations in the world, and thus clinical trials there are necessary to help aid India’s fight in eliminating diseases. This appears, in some parts, to be one of the explanations for the clinical trials for COVID vaccines conducted in India as it has been touted as a necessity in order to manage infections in suck a populated country..
India also has a rather heterogenous population, and trials conducted in India may be far cheaper relative to other parts of the world.
India is also one of the main countries in which pharmaceuticals are manufactured, which has caused some conflicts between India and China over being the main exporter of drugs worldwide (anyone remember the fire in a COVID vaccine factory in India?).
But India has also been considered a controversial region for clinical trials due to the fact that less stringent regulatory and ethical policies were in place up until a few years ago.
While many countries altered their ethics criteria for research following World War II, India was late to adopt many of these same guidelines, with one of the first policies on ethical research appearing in 1980 (Sanmukhani, J., & Tripathi, C. B.1):
The Indian Council of Medical Research (ICMR), in February 1980, released a ‘Policy Statement on Ethical Considerations involved in Research on Human Subjects’. This was the first policy statement giving official guidelines for establishment of ethics committees (ECs) in all medical colleges and research centres. But as with other nations of the world, these guidelines were not respected by many researchers and India was not free of controversial research works.
But even as modifications to research ethics were developing in India, there was also a boon in pharmaceutical manufacturers using India as a hotspot for clinical trials, leading to news reports at the turn of the millennia to cast a negative light on how clinical trials in India were conducted, as noted in a 2011 review article from Bhan, A.2:
Research being conducted by pharmaceutical and biotechnology companies in India has been on the increase. Added to this, has been the mounting quantum of outsourced research facilitated by Contract Research Organizations (CROs) with the promise of cheaper and faster conduct of trials as compared to the west.[7] From 40 to 50 trials in 2003, the country saw around 1850 trials registered with the government registry in June 2011.[8] Mushrooming clinical research courses, often unregulated,[9] have sprung up with an aim of servicing the need of personnel for conducting clinical research.
While the escalating research quantum has, to some extent, served to benefit the Indian population which now is undergoing a demographic transition with both infectious and non-communicable diseases being commonplace, it has also raised concerns that ethical conduct is often forgone when the primary interest increasingly is profit generation. The specter of unethical trials being frequently reported is a reflection of an ailing and substantially ineffective research regulation system in India. While biomedical research in the country has increased exponentially in the last decade, reforms in regulations have only occurred at snail's pace. Intent has been demonstrated towards such reform,[10] but needs to be substantiated with priority policy changes. Regulatory progress is only one element of the solution—other steps are also needed to move forward in this area.
This sudden increase seemed to have come after a 2005 amendment led to easier global drug trials to be conducted in India, with the unfortunate consequence that many deaths and adverse events seemed to have occurred in the following years, as reported in a 2015 article from the Pharmaceutical Journal:
Since regulations in India were amended in 2005 in a bid to liberalise the conduct of global drug trials, companies have flocked there because of the genetic diversity of the population. However, trials in the country have been plagued by scandal. Government data show that more than 2,600 patients participating in clinical trials in India died between 2005 and 2012, and nearly 12,000 suffered serious adverse effects. Of these, 80 deaths and more than 500 serious adverse effects were directly attributed to the drug being trialled.
It was a 2009 US$3.6m post-licensure observational study, funded by the Bill & Melinda Gates Foundation, which finally prompted regulatory change. The study, which aimed to evaluate the cost and feasibility of introducing the human papillomavirus (HPV) vaccine into the country’s universal immunisation programme, was run by the Programme for Appropriate Technology in Health (PATH), a non-profit organisation based in Seattle in the United States, the Indian Council of Medical Research (ICMR) in New Delhi, and the Indian state governments of Andhra Pradesh and Gujarat. The trial, which involved 24,777 adolescent girls, was halted by the ICMR in April 2010 following media reports of the deaths of seven participants and a memorandum from 68 human rights and women’s groups to the Indian Minister of Health and Family Welfare opposing the trial’s “unethical” nature[1].
This fallout led to drastic changes in ethics guidelines, much to the chagrin of pharmaceutical manufacturers who began to withdraw from using India as a site for clinical trials. These changes also came with increased compensation for those injured in clinical trials, which also further disincentivized manufacturers.
Now, all this being said, if changes in regulation have been argued to improve the trials being conducted in India, is there really a concern that Dr. Hotez’s team sought out India as a place to conduct clinical trials due to more lackadaisical guidelines.
I can’t argue exactly why Dr. Hotez’s team appeared to use India. It’s likely that he was following along with what was rather typical of industry. As of now, any remarks made by me would be speculative unless I find additional evidence to provide greater insights.
Nonetheless, it’s worth noting that the addition of greater guidelines have still not stopped a scandal from occurring, even during the era of COVID.
In early 2021 an investigation was called due to alleged ethical abuse over clinical trials for India’s COVAXIN vaccine, which is a vaccine similar to the adenoviral vector-based vaccines. The trials occurred in Bhopal, which appear to be a region of lower socioeconomic status.
Among the accusations made, it was argued that participants were not made aware that they were taking part in a clinical trial, and believed that they were actually receiving the vaccine. Some participants were also not able to read the consent forms that they were provided, and many people appeared to not be able to provide information on their adverse reactions.
The Lancet3 provides a bit of context provided by some Bhopal residents:
Many residents recount how a vehicle with a loudspeaker had come around their neighbourhood in December, 2020. The residents allege that the announcement was made that anyone who came to the nearby People's University private hospital could get a COVID-19 vaccine and 750 INR (£7·50). This hospital was one of the sites conducting the COVAXIN trial. Many locals have been unemployed over the past year and children have been out of school because of the pandemic, so the small sum of money was attractive enough for them to take part in the trial.
Several participants said that they are illiterate, and thus could not read the consent forms that they signed. Some, like Ramesh, allege that not much was explained to them verbally either, including the fact that this was a clinical trial and that they would be given either a vaccine candidate or a placebo, that they might have adverse events following the trial, and that they would be entitled to medical care or compensation if the adverse events were serious.
There was one alleged death of a trial participant, which didn’t appear to halt the trial, and in fact the rollout of COVAXIN came on the back of no clinical safety and efficacy data being formally released.
So even as India has attempted to alter their guidelines to allow for more transparency and support for trial participants, it’s hard to look at this information and think that there may be some ethical issues with how some of these COVID vaccine trials were conducted in India.
Again, I can’t argue exactly why Dr. Hotez’s team chose India as a place to run their trials in particular, but this does raise a few questions on Corbevax’s data.
Corbevax’s adverse reactions
In looking into Corbevax I was curious to see if there have been any reported adverse reactions.
Because Corbevax is a subunit vaccine, it’s important to see what overlaps can be gathered based on different vaccine formulations in order to find some form of consilience.
So far, I have only been able to come across 2 reported adverse events in the literature.
In one case4, a 13-year old boy began experiencing retinal venous occlusion 2 weeks after receiving his first dose of the Corbevax vaccine (he presented to the clinic 1 month after his vaccination, but the report notes that he had experienced loss of vision for the past two weeks).
The patient was treated with pulse corticosteroids, and eventually made a full recovery. This appeared to be one of the first reports of retinal venous occlusion occurring in children with respect to COVID vaccination. Remember that this adverse event has been reported for the other COVID vaccines, albeit in adults, so it’s interesting to consider this overlap in adverse events, suggesting again that a spike-related consequence of vaccination may have occurred in the case of this 13-year old boy.
Of note, a review from Hotez, et al.5 (yes, the same Hotez), makes a comment that the subunit used in the Corbevax vaccine is capable of binding to ACE-II receptors, which suggests that this vaccine may still be bioactive.
Another case report6 notes a more serious consequence, in which a 13-year old girl presented to a clinic 3 days after her first dose of a Corbevax vaccine due to weakness in her limbs which included a tingling feeling experienced the evening of her vaccination, all of which was later to be diagnosed as Guillain‐Barré Syndrome. Again, this case is another case of an adverse reaction seen predominately in adults occurring in a child, and adds to the fact that GBS has been seen with other COVID vaccine platforms.
So far, these are the only two adverse events I was able to come across, and data on Corbevax appears to be rather limited even though it’s been reported that tens of millions of doses have been administered, predominately in children.
Now, all of this raises a question over the degree of adverse events, and whether lack of transparency and accessibility has limited information relating to this vaccine platform in particular.
It’s important to remember that absence of evidence is not evidence of absence- the limited adverse events cannot be used to argue that this subunit vaccine is safer in nature.
It does, however, raise the question of how much data is being recorded. It raises an even more ethical dilemma over the need to vaccinate the world, as has been touted by the Corbesvax vaccine.
Consider that many people in lower socioeconomic countries may not have available clinics. A hospital or doctor may take hours to access, and if a patient were to reach a clinic would they be able to report an adverse reaction or seek help? Many of these people are likely not able to reach out to anyone if a serious adverse reaction occurs.
And so, in this strange need to vaccinate the world, are there people available to report any issues that may come about, or are we to believe that all is fine? If these vaccines are suggested to be as safe and effective as they are, then I suppose these same individuals may not find a need to see if people have been seriously harmed, meaning any adverse events will not come to light due to neglect to check.
This makes me curious as to how many adverse events have actually been reported with respect to the Corbesvax, and whether anyone bothers to even record such data.
All of this is an aside, but I think it’s worth pondering what consequences the vaccination of lower socioeconomic countries may bring about, and whether those who find the need for massive vaccination will care to do their due diligence to record this data.
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Sanmukhani, J., & Tripathi, C. B. (2011). Ethics in clinical research: the Indian perspective. Indian journal of pharmaceutical sciences, 73(2), 125–130. https://doi.org/10.4103/0250-474x.91564
Bhan A. (2012). Clinical trial ethics in India: One step forward, two steps back. Journal of pharmacology & pharmacotherapeutics, 3(2), 95–97. https://doi.org/10.4103/0976-500X.95501
Bhuyan A. (2021). India begins COVID-19 vaccination amid trial allegations. Lancet (London, England), 397(10271), 264. https://doi.org/10.1016/S0140-6736(21)00145-8
Nangia, P., Prakash, V. J., & Dutta Majumder, P. (2022). Retinal venous occlusion in a child following Corbevax COVID-19 vaccination. Indian journal of ophthalmology, 70(10), 3713–3715. https://doi.org/10.4103/ijo.IJO_1927_22
Hotez, P. J., Adhikari, R., Chen, W. H., Chen, Y. L., Gillespie, P., Islam, N. Y., Keegan, B., Tyagi Kundu, R., Lee, J., Liu, Z., Kimata, J. T., Oezguen, N., Pollet, J., Poveda, C., Razavi, K., Ronca, S. E., Strych, U., Thimmiraju, S. R., Versteeg, L., Villar-Mondragon, M. J., … Bottazzi, M. E. (2023). From concept to delivery: a yeast-expressed recombinant protein-based COVID-19 vaccine technology suitable for global access. Expert review of vaccines, 22(1), 495–500. https://doi.org/10.1080/14760584.2023.2217917
Rohilla, R., Kakkar, A. K., Divyashree, K., Mohindra, R., & Suri, V. (2023). Recombinant protein subunit COVID-19 vaccine-induced Guillain-Barré Syndrome in an adolescent: A case report. British journal of clinical pharmacology, 89(2), 556–560. https://doi.org/10.1111/bcp.15466
A very good point! Thank You for this post.
Do you know the part of the Spike sequence they've put into these Cobravax vaccines? Hotez and his friend did not patent their product so just wonder why when their research on it was already going on for so long..
So interesting! I hate to think of the poor being used as guinea pigs, however it wouldn’t be the first time. Despicable.