What’s more, Australia has no clear idea about the future direction of COVID-19 vaccinations. Recent moves by the United States Food and Drug Administration (FDA) have raised alarm about people’s access to improved vaccines. Paul Griffin, associate professor of medicine at the University of Queensland and a leader in running complex clinical trials like those for COVID-19 vaccinations. Dr. von Eschenbach’s sudden decision left him “shocked,” he said, in an interview, calling the FDA’s actions “absurd.”
Griffin’s critical assessment comes in light of the FDA’s move to restrict access to updated vaccines primarily to individuals aged 65 and older, a decision he believes could have serious implications. He noted a particularly worrying trend: a decline in childhood vaccinations that could further exacerbate public health issues. Without this program, Griffin cautioned, millions of healthy adults and children will lose access to life-saving vaccinations. He argues that the new criteria are arbitrary and capricious.
The FDA’s decision seems to be driven by increasing anti-vaccine sentiments in the U.S., a pattern that deeply concerns Griffin. He underscored the importance of ensuring vaccine access across all demographics, stating, “If we restrict vaccines to people over 65, as appears to be the case in the US, there’s a whole host of people who may get a more significant infection who won’t have the option to be protected.” This piece of commentary reveals just how troubled he was. 1) By restricting vaccine access, he argues, we risk more COVID-19 infections in more vulnerable groups—not just the elderly.
Griffin emphasized that severe disease is not confined to specific age groups, noting that “while people with co-morbidities and the elderly are typically more vulnerable, the unfortunate reality is severe disease isn’t restricted to those groups.” His viewpoint calls for us to take an equitable and inclusive view of vaccination. Most significantly, it highlights the need to put public health before burdensome eligibility restrictions.
Griffin pointed to the ethical considerations involved in conducting clinical trials for updated vaccines. He explained that the use of placebos in trials with vaccines that are already approved are usually considered unethical. He stated, “If we’re looking at improving or updating vaccines, we don’t typically go back to including placebos because essentially it’s unethical to do so.” Instead, he advocates for trials that include the current standard of care, emphasizing that “when it comes to any drug or vaccine, when it’s going through the regulatory process, the most expensive and time-consuming component of testing is actually clinical trials,” as noted by Roger Lord.
The concerns don’t stop with ethics. There are significant worries about potential disruptions to vaccine supply chains, too. Lord emphasized that drug manufacturers are stuck with significant costs after they already invest billions into clinical trials. If they can’t make enough profitable vaccines, their incentive to make new or better vaccines will decrease. “If they work out their profit margins are not going to be significant enough to produce more vaccines, it would potentially affect the supply chain in Australia,” Lord explained.
As dire as the situation has become across the Pacific in the U.S., Griffin is optimistic about Australia’s regulatory ecosystem. He said he was very confident in the Therapeutic Goods Administration (TGA). He doesn’t think they’ll take the further step to codify such limits on regulation of medicines in Australia. “I really doubt that the TGA will because they’re a tremendously reputable regulatory body and they do engage a lot of genuine expertise to make the recommendations that they do,” Griffin stated.
He warned that public perception and political pressures could make a big impact on vaccine policy in Australia. “The fear that I have is that people, the public and certain politicians are already aligning with some of those concerning things that are happening abroad, including in the US, and may call for these sorts of things to happen and further undermine their confidence in vaccines,” he warned.
While Australia continues to grapple with these issues, public health officials like Dr. McIntyre remind us that ongoing vigilance against disease requires sustained commitment to vaccination. As the nation moves closer to giving Americans many more doses, Vinay Prasad underscores why everyone needs to better understand vaccine efficacy. “We want to know more about what these products are doing, especially as we enter the seventh, eighth and ninth dose,” he said.
