In a race to create a vaccine, some countries, such as China and Russia, have accelerated the development process by forgoing lengthy late-stage vaccine clinical trials. In a global public health emergency, this may seem like a necessary move, but it comes with serious risks.
Largest global AIDS organization calls on the global public health community and governments to exercise caution and due diligence in fast-tracking vaccine candidates for prevention of COVID-19.
WASHINGTON (August 26, 2020) AIDS Healthcare Foundation (AHF), the largest global AIDS organization, calls on the global public health community and governments to exercise caution and due diligence in fast-tracking vaccine candidates for prevention of COVID-19.
Since the beginning of the pandemic, COVID-19 has infected 24 million people and claimed 821,654 lives. The devastating effects of the pandemic on all aspects of human activity cannot be understated. The impact of the virus on public health, the global economy, politics and civic institutions will likely be felt for generations. Amid this crisis, the possibility of an effective vaccine for COVID-19 holds a hopeful promise for a gradual end to the pandemic.
But in a race to create a vaccine, some countries, such as China and Russia, have accelerated the development process by forgoing lengthy late-stage vaccine clinical trials. In a public health emergency, this may seem like a necessary move, but it comes with serious risks.
“The urge to fight for the living compelled advocates to demand accelerated clinical trials and fast-tracking of treatment in the early days of the AIDS epidemic,” said AHF President Michael Weinstein. “Many useful and applicable parallels have been drawn between the global AIDS response and strategies for getting COVID-19 under control. However, in the case of the rush to fast-track a vaccine, the situation is different. When we were fighting for early antiretroviral therapy (ART), people were dropping dead like flies—it was vital to get urgent treatment to try to stop countless deaths. With COVID-19, the situation is dire, but the death rate is substantially lower than in the pre-ART days of AIDS – and a fast-tracked vaccine would be for prevention, not lifesaving treatment. The need to bypass standard safety procedures is just not here to warrant people’s health being put at risk with a rushed vaccine.”
In a typical vaccine development cycle, initial small-scale efficacy and safety trials in animals and humans are usually followed by large-scale, randomized, placebo-controlled clinical trials involving thousands of people over a period of years. This final and most rigorous step is designed to confirm with a high degree of certainty if a vaccine is safe and effective on a population level.
Vaccines have saved millions of lives across the world from death, disability and illness. Smallpox, which typically killed 30% of infected patients, was eradicated in the 1970s thanks to an effective vaccine. Polio, a crippling disease primarily affecting children, has been eradicated in many parts of the world as a result of a concerted vaccination campaign spanning decades.
Annual influenza inoculations save thousands of lives and human papilloma virus vaccine prevents thousands of cases of cervical cancer each year. There is no doubt that vaccines save lives and are safe when adequate time is spent on testing and studying them before they become publicly available.
The safety record of vaccines speaks to how well the development and approval process works. There have only been a handful of serious vaccine adverse events in recent history, but those events underscore the fact that there are risks associated with vaccines.
The most recent example involves a Sanofi Pasteur vaccine for dengue fever which was rolled out in the Philippines in 2016. About a year after launch, when 800,000 Philippine children had already been vaccinated, Sanofi Pasteur acknowledged that the vaccine increased the risk of hospitalization for children who have never been exposed to dengue prior to vaccination. Several children who had been vaccinated died after developing a more severe form of dengue. The incident in turn led to a public panic and an outbreak of measles, due to the growing reluctance among parents to vaccinate their children.
Another example involving a large-scale vaccination campaign occurred in 1976 in the United States. After 40 million Americans had been vaccinated with a swine flu vaccine, federal health officials decided to withdraw the vaccine because it was associated with a small increase in the risk of developing a neurological disorder called Guillain-Barre syndrome.
Notwithstanding a handful of adverse vaccine events that have occurred in the past, there are many more vaccines that have saved countless lives; however, rushed vaccine development increases the risk of unforeseen negative health outcomes. Setting aside any economic or political reasons governments and private companies might have in being first to develop an effective COVID-19 vaccine, this striving is understandable on humanitarian grounds – millions of people are suffering, and thousands are dying – but following well-established vaccine approval processes is imperative.
“Public trust in global and national health institutions is vital to the world – without it, there can be no public health. In a rush to develop a COVID-19 vaccine by taking shortcuts to bypass rigorous clinical trials, governments recklessly risk the lives of millions of people, along with their trust in institutions that undergird the entire structure of healthcare and global health security,” said Dr. Jorge Saavedra, Executive Director of the AHF Global Public Health Institute at the University of Miami. “We urge the global public health community, the pharmaceutical industry and governments to be transparent about the risks and unknowns in the development of a COVID-19 vaccine. They should pursue rapid vaccine development in the interest of humanity, while following time-proven clinical trial protocols, to ensure the highest possible level of vaccine safety and efficacy.”