As results for the big phase 3 trials for the BNT-Pfizer and Moderna were looming, a debate ramped up: when would the…
It seemed to come out of the blue. Yesterday, the Australian government decided to terminate a billion-dollar vaccine contract. “The University of Queensland vaccine”, Australia’s prime minister announced today, “will not be able to proceed”. With that, the major locally developed Covid vaccine crashed and burned. Just a few weeks ago, the health minister was hailing its success in a phase 1 trial. I was criticizing the developers’ hype, but there was nothing to give a clue about the crisis unfolding behind the scenes over those results.
The scientists have known for weeks that several trial participants had tested positive for HIV. They weren’t infected with HIV. But because the vaccine, called v451, had been built partly on a protein component of HIV, some people were developing HIV antibodies. Those antibodies are already fading away, but they had been picked up by HIV tests. The developers had hoped maybe screening processes for HIV could be changed, to cope with this phenomenon.
If we lived in a world where HIV generated no fear or stigma, science communication with the global public was easy and highly effective, and there was no worldwide social movement ever-poised to attack any or all vaccines, that could sound reasonable – if such programs could even be changed easily. But we don’t live in that world, and many probably responded to this as I did: They thought what?!
To their credit, no one is hiding or fudging what happened. Scientists and politicians alike are speaking openly and answering the barrage of journalists’ questions. And the fact that a vaccine candidate is being abandoned wasn’t a shock. In pre-Covid times, around a quarter of vaccines didn’t make it past a first-in-human trial. Even more stumbled at the next stage, a phase 2 trial, and 15% that made it to phase 3 trial didn’t achieve Food and Drug Administration (FDA) approval. According to the New York Times Coronavirus Vaccine Tracker, there are dozens of coronavirus vaccines in clinical trials at the moment. If past is prologue, quite a few more aren’t going to last the distance.
Yet I’m shocked. And that’s because, as closely as I follow Covid vaccine development, I had no idea that there was a vaccine with even a ghost of HIV in its lineage. And regardless of whether it constituted any risk to health, it was an extraordinarily high risk strategy from a community and activism point of view. The scientist who developed that part of the vaccine has said that in hindsight, if they could do it again, they would make different choices, but they were in a hurry.
You would have to have way more expertise about this aspect of science than I do to have picked up on it with a very careful reading of a preprint of preclinical results for this vaccine. But I discovered today I had missed another publication that made its origins clear: sooner or later, anti-vaccine activists were going to land on it. This was going to become an issue, whether people tested positive for HIV or not. People are scare-mongering about Covid vaccines based on the most tenuous whiff of an issue, and even on fantasies. In an interview today, a scientist said he’d been warning the government about this for months, but “No one wanted to listen”. You could already see the problem, he said, in the results of the preclinical research.
That scientist is from the development team of a different Australian Covid vaccine that hasn’t enjoyed that level of government support. Perhaps his clear conflict of interest got in the way of his message. Whatever the reason, it’s not an issue that ever made it into the general public discourse about Covid vaccines.
All of us who don’t have expertise in that part of the science are relying on the people who do to make this kind of issue clear for the rest of us. And because scientists’ perspectives can be so different from those of their communities – isn’t this a perfect example of just that? – we need radical trial transparency, and fast. For this vaccine, trial participants were warned about the possibility of such antibodies. If all the trials’ informed consent forms were public, many of us would have understood sooner that this vaccine was so very high risk for controversy.
At least the right thing happened before the vaccine progressed into a phase 2/3 trial. The system did work. Eventually. With more transparency for these trials, though, at least we’d be informed and prepared for the battles likely to come. What’s more, the Australian government had not committed to pay for the vaccine unless it could be used, and other vaccines could now be purchased instead. That underscores the importance of questions about many aspects of these arrangements. If this happens again, as seems more likely than not, people might not be so lucky.
Update, April 6, 2021: The team behind this vaccine resumed work on this vaccine, without the problematic component, which is very welcome news. They reported being at the preclinical stage.
My latest Covid vaccine piece at WIRED: tips for reading about Covid vaccine results
Disclosures: My only interest in Covid-19 trials is as a person worried about the virus, as one of my sons is immunocompromised. I have worked for an institute of the NIH in the past, but not the one working on the vaccine (NIAID). More about me. I am an Australian, living in Australia.