Just after New Year’s Day, regulators in India granted authorization for restricted use to Bharat Biotech’s Covaxin, adding another Covid-19 vaccine to the list of those that have been approved for use in various countries around the world.
New vaccines against Covid-19 are sorely needed worldwide, especially in low-income countries, which are being left behind as high-income countries adopt “vaccine nationalism” and snatch up doses at the expense of those with less means.
The Covaxin rollout, however, illustrates another worrisome trend. Regulators in India gave the vaccine the go-ahead before data from large-scale clinical trials are available, just as Russian and Chinese regulators did for their own homegrown vaccine candidates.
Data from large clinical trials, which generally include tens of thousands of volunteers, aim to demonstrate a vaccine’s effectiveness and probe its potential side effects. This is important information to have in hand before giving injections to millions or billions of healthy people.
Premature approvals in India, Russia, and China reveal a different side of vaccine nationalism, one that prioritizes political advantage over scientific evidence and risks undermining widely accepted standards for vaccine testing and development.
In India, Prime Minister Narendra Modi hailed news of the authorization as evidence of the success of his government’s policy of Indian self-reliance. The decision, however, has been questioned by scientists for its lack of transparency and criticized by health watchdogs and opposition politicians as having been pushed through by Modi’s government without sufficient basis in scientific data. These concerns have been fueled further by the surfacing of allegations that Bharat Biotech failed to follow ethical procedures in its clinical trial.
Similar criticism has been leveled by external vaccine experts at Russia, which vaccinated thousands of at-risk individuals with a product that had only been tested in 76 people before approval, and China, which has administered its vaccines to millions of citizens without the benefit of full-scale clinical data.
Russian President Vladimir Putin claimed Russia’s approval as a “world first” while drawing accusations of applying political pressure in an effort to bolster the country’s scientific leadership status. In China, government officials directed vaccine developers to treat their work as an “important political task” as several outside observers have highlighted the diplomatic value of being one of the first to make a vaccine available.
Following the approvals and rollouts, Russia and China eventually made available data from large clinical trials indicating that certain of their vaccines are safe and effective.
But their decisions to authorize the vaccines before they had sufficient data may still have lasting implications for global health and future pandemic response efforts. Moreover, some of these implications may be amplified if there is a public perception that countries got away with issuing approvals without waiting for full clinical data, setting a concerning precedent for future decision makers.
Vaccine hesitancy is high or increasing in many parts of the world, and has been identified as a top threat to global health. The concerns of vaccine skeptics, however unfounded, can only be stoked by rushed approvals, claims of effectiveness that fail to prove out or, in the worst case, unforeseen side effects that arise during administration under emergency use authorizations, all possible effects of vaccine nationalism.
Even if issues of safety and effectiveness do not arise, the mere perception that undue political pressure may have played a role in vaccine development threatens to undermine public confidence.
In the United States, enough questions were raised by the convergence of vaccine timelines with the presidential election that nine companies pledged to develop and test their candidates following scientific principles only, without political considerations. This was evidently a valid concern as, at the time of the pledge, polling indicated a low of 50% of Americans saying they would take a Covid-19 vaccine if available. In subsequent polling, respondents cited concerns with the rushed development timeline and politicization as reasons they would not get a vaccine.
Meanwhile, the Chinese vaccines have met significant skepticism among populations outside China, despite the millions of doses that have been administered in China under emergency use, owing at least in part to the slow and at times confusing release of efficacy data. China approved one vaccine based on interim clinical data suggesting 79% effectiveness, while trials have reported widely varying efficacy data for a second vaccine — including a total efficacy rate that fell 30% from a previously reported figure in a Brazilian study — leading to concerns among scientists and regulatory delays.
This new side of vaccine nationalism threatens to undermine scientific and ethical principles that provide the foundation of vaccine development. Scientists employ large-scale controlled trials as the gold standard to provide vital information about a vaccine’s safety and effectiveness. That information allows public health officials to balance the risks and benefits of administering vaccines to healthy people.
This process is nowhere more important than during the Covid-19 pandemic, as countries around the world prepare to inoculate billions of people in the largest global vaccination campaign in history.
Eroding these norms and standards developed over decades of experience risks harming our ability to respond to future epidemics.
In the U.S. and the United Kingdom, the development of the Pfizer/BioNTech, Moderna, and AstraZeneca vaccines has been informed by scientific data generated from testing in tens of thousands of volunteers that was made publicly available before regulatory authorization. As a result, there is widespread consensus regarding their safety and effectiveness and public confidence in the products. According to Gallup polling, 63% of Americans were willing to take a Covid-19 vaccine in early December, and a more recent poll puts the figure as high as 84%.
Looking ahead to the next pandemic, the political calculation could change in Western countries if the precedent set by Russia, China, and India lends credence to voices clamoring to make investigational vaccines available without waiting for potentially lengthy and costly large-scale trials. Under the pressure of another epidemic, which seems all but inevitable, those calling for greater scientific rigor may have more difficulty finding support for the time and capital investments required to gather the necessary evidence before vaccinating millions with experimental products.
With several Covid-19 vaccine candidates in use and millions of doses administered without data from large clinical trials, countries must now reaffirm their commitments to rigorous public health standards to avoid sliding down the slippery slope.
Data transparency must be emphasized as developers finish Phase 3 clinical trials and seek approval for general use of their vaccines. The global community must insist that the results and protocols of those studies are promptly published and analyzed with the same level of scrutiny as would apply outside of emergency use circumstances. Governments around the world must commit to a spirit of open cooperation, in which lifesaving products are treated as public goods rather than state secrets. And they must demonstrate to the public that the breakneck speed with which these Covid-19 vaccines are introduced has nothing to do with vaccine nationalism but is instead owing to the hard work and innovation of the developers and volunteers involved in their research, development, and testing.
Patrick Ho is senior counsel at IAVI, a global health nonprofit based in New York, and was co-founder and vice president of Vaxess Technologies, a Cambridge, Mass.-based life science company developing delivery technologies for vaccines and therapeutics. The opinions in this article are the author’s and do not necessarily reflect those of his employer.
It must be understood that Pfizer/BioNTech and Moderna can’t supply the whole world population with vaccines within a year and that locally produced vaccines in the largest countries in the world would still be needed even without local development.
The “preemptive” approvals for vaccines in many countries are based on several factors:
1. Political stability – public uncertainty for the future, chaos within the economy and day to day business, and disease pandemics tend to cause political instability in the country which governments want to prevent before it gets out of control.
2. Patriotic pride – governments want their citizens to be “proud” of their nation. That pride must be motivated by something that the citizens can physically observe as empty promises don’t reinforce this feeling. Many politicians are using these vaccines as a “cause” to bolster patriotism and public approval.
3. Public feelings of safety and security – if a virus is killing millions directly and indirectly worldwide the citizens of a nation are not going to feel safe and secure. And they will blame politicians and national leadership for this feeling of distress. It may even lead to civil disobedience and possibly violence, which governments don’t want. So the governments will try to make the public feel safe with promises that whatever is causing their distress will soon be over, because of a vaccine or some other medication.
This is quite common behavior no matter the country or local ideology. Some maintain strict regulations and standards for these situations, others don’t, frequently going by whims(impulsive behavior) of local leadership(who have varying degrees of responsibility to their citizens).
The attitude of the U.S. authorities regarding the AstraZeneca vaccine is somewhat puzzling, especially because it has been approved by the UK/European regulators. Yes, they screwed-up a portion of the trial….but the “half-dose”, full-dose” trial with people 55 and under at 90% effectiveness seems to have tainted the rest of the study.
I can see why the authorities would reject that trial – the people who most want the vaccine are people over 55 – so the 90% effectiveness is not particularly relevant. And not being able to adequately explain why the first half-dose produced a better result is troubling.
However, the other part of the study (the full-dose, full-dose) trial seems to fall within the parameters of an acceptable vaccine – apparently safe and more than 60% effective. Certainly the UK/European regulators thought it was good enough, if not as effective as the Moderna/Pfizer-BioNTech vaccines.
I understand that the U.S. is requiring AstraZeneca to complete a new trial with results in April…..while that may provide the necessary assurance, the differing approvals between the U.S. and UK/European regulators has to trouble a lot of people….especially with the current shortage of vaccine in the U.S. Is the U.S. making good the enemy of perfect?
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