Butterfly Effect: The Unscientific Vaccine
WHY YOU SHOULD CARE
The standard checks and balances have collapsed. Only the personal integrity of researchers stands between us and a substandard vaccine.
Charu Sudan Kasturi
OZY Senior Editor Charu Sudan Kasturi's column, "Butterfly Effect," connects the dots on seemingly unrelated global headlines, highlighting what could happen next and who is likely to be impacted.
It should be a period of rising hope, of anticipation. Instead, there’s a stench that’s increasingly hard to ignore.
On Tuesday, Russian President Vladimir Putin announced that a COVID-19 vaccine, “Sputnik V” — a reference to the world’s first man-made satellite, launched by the Soviet Union in 1957 — was ready for mass use. A half-dozen vaccine candidates in the United States, China and Europe are in phase 3 trials, where they’re being tried on large numbers of patients. A vaccine in India is also in advanced stages of testing. In the coming months, we might well have vaccines that are effective against a disease that has already killed more than 700,000 people and infected in excess of 20 million people. But if we do get to a place of celebration, it will be an astonishing feat of individual integrity even more than of science.
The reason? These coronavirus vaccines — whether in the U.S., China, Russia or India — are being developed under circumstances that are inverting the process of science.
Usually, medical researchers searching for a treatment or vaccine present their findings first to peer-reviewed scientific journals. Once the scientific community accepts those results as valid, researchers — or the companies they work for — approach regulators such as the Food and Drug Administration. After regulators are satisfied with the drug, vaccine or device and approve it, companies mass-manufacture it for the market.
But this is 2020, and the normal procedures no longer apply. Russia, for instance, hasn’t published the results of any vaccine trials for scientific scrutiny, though Putin insisted Tuesday that the vaccine had cleared all tests. Meanwhile, pharmaceutical giants have kick-started the manufacturing of millions of doses of unproven vaccines that are still undergoing clinical trials, based on preorders from the U.S., European nations and Japan.
This scramble to manufacture vaccines has risks that the world witnessed 65 years ago, at a similarly pivotal moment for medical science.
It was a breakthrough all of America had been waiting for. In April 1955, scientists confirmed that a vaccine developed by researcher Jonas Salk had proved effective against polio, a debilitating and often fatal disease that afflicted tens of thousands of Americans a year. Confident that it would work, companies began the mass-manufacture of the vaccine while clinical trials were still being conducted. But while Salk’s vaccine relied on an inactivated poliovirus, the rushed manufacture meant tens of thousands of people were injected with doses that accidentally included the live virus. As polio symptoms started manifesting in people who had taken the vaccine, horrified regulators pulled thousands of doses from shelves. The incident took a severe toll on public confidence in vaccination.
This time, the risks — and the stakes — are even higher. The Indian government has asked its top research lab to ensure that a vaccine is ready by Aug. 15 — India’s Independence Day. That goal is almost impossible, but don’t be surprised if Prime Minister Narendra Modi claims a vaccine is just around the corner when he addresses the nation on Saturday. And in the U.S., President Donald Trump is betting on a vaccine by October to propel his floundering reelection campaign.
The U.S. federal government has invested more than $8 billion in vaccine research firms. And it has preordered several hundred millions of doses from drug firms Pfizer and Sanofi, even though their vaccines are still under trial. Pfizer has struck similar deals with the U.K. — as has AstraZenica, another pharma giant — and Japan.
These companies know they have billions of dollars in promised revenue, provided they swiftly deliver a vaccine. And the political pressure on regulators to approve vaccines is no secret. Remember how the FDA approved the use of hydroxychloroquine for COVID-19 after Trump advocated for it, even though tests on its efficacy were still being conducted? The FDA withdrew its approval after multiple trials in different parts of the world showed that hydroxychloroquine can actually be dangerous.
The pressure to bring out a vaccine soon is telling even on public health veterans: Last week, America’s top infectious diseases expert, Dr. Anthony Fauci, conceded that even a vaccine effective in 50 to 60 percent of cases would be acceptable.
Now imagine researchers at Pfizer, Sanofi or AstraZenica who know that even a less-than-ideal vaccine might well clear regulators and bring their firms billions of dollars. Imagine the pressure — if they do conclude that their trials aren’t showing the results they had hoped for — to shut up and play along.
With most standard processes and checks and balances thrown out the window, it’s only the personal integrity — and possibly the fear of being sued — of researchers, FDA inspectors and corporate executives that stands in the way of potential shortcuts. The consequences could range from a boost for the anti-vax movement and the deepening of existing suspicions among Black Americans — who have been used as vaccine guinea pigs in the past — to sickness and even death for those who take the shot.
It’s a scary thought. As journalists, we always like to believe we’re right. For once, I hope I’m wrong.
- Charu Sudan Kasturi Contact Charu Sudan Kasturi