Despite the rush to return pre-pandemic society, a vaccine is the only way to truly get there. Anxiously, the world waits on a vaccine for COVID-19 to get us back to work, back to school, back to play, and back to basic human connection.
In addition to names like Moderna, Pfizer, and Johnson and Johnson, there are 20 other companies working on coronavirus vaccines or treatments. Barring the development of an effective treatment, a vaccine appears to be the only solution to the current pandemic, a public health crisis that has resulted in over one million deaths globally. Under normal circumstances, vaccine development takes 10-15 years. A complex process, vaccine development is far more difficult than developing a treatment (note, 40 years later, the world still lacks an HIV vaccine despite having treatments for it). However, due to necessity, all companies are compressing this complicated process.
While a vaccine will help resolve the crisis, a rushed vaccine—that ignores safety standards for the sake of speed–will compound it. In addition to risking public health, vaccine companies also are gambling with their own reputations. Thus, pharmaceutical and biotech companies must balance a sense of urgency while adhering to rigorous safety standards.
Rushing a Vaccine to Market: Those Who Forget the Past Are Condemned to Repeat It
Rushing vaccines through the development and approval process can be dangerous for public health as it risks cutting corners and missing important safety cues. To illustrate, return to the early- to mid-1900s, in which the world was facing the dreaded polio. This disease caused horrific symptoms mainly paralysis which affected the limbs and often chest muscles and diaphragm. This left victims unable to walk and even breathe independently. As late as the early 1950s, as a result of polio, many parents were facing their worst nightmares, their children incapacitated in iron lungs. Remarkably, Jonas Salk engineered a vaccine to guard against the polio virus. Of note: it took over 50 years since the first polio epidemic to see widespread availability of the Salk vaccine. Even then, the public still had issues.
Immediately upon approval in 1955, pharmaceutical companies such as Eli Lilly obtained the Salk formula and manufactured it rapidly. A little lesser known firm—Cutter Laboratories—also manufactured some batches. Unfortunately for the public, these vaccines were manufactured with haste. Cutter Laboratories, the most egregious of the bunch, distributed a vaccine so contaminated that 70,000 children developed muscle weakness, 164 became permanently paralyzed, and 10 died. Aside from a public health catastrophe, the Cutter incident destroyed public confidence in vaccines. Historian David Oshinsky writes that “The summer of 1955 came and went with few children getting their shots,” resulting in major outbreaks in Boston and Chicago. It is not clear as to how the blame was targeted and the level that was placed on the industry.
Despite previous public backlash, expedited vaccines still found their way into the public health system. Fearing a new swine flu strain genetically close to the lethal 1918 version–which killed 50 million worldwide, in 1973, U.S. President Gerald Ford authorized a mass vaccination program. Similar to Operation Warp Speed, Ford’s program would move at a rapid pace to vaccinate the entire U.S. population for swine flu.
Unfortunately, this effort failed. Children often failed to mount an immune response and developed adverse reactions such as high fevers and very sore arms. In a small number of cases, those inoculated developed Guillain-Barré syndrome, a neurological disorder that can result in paralysis. Ford’s failed vaccination program led to a large public backlash against vaccines which had lasting ramifications. To this day, anti-vaccine proponents often cite Ford’s failed vaccination program to prove their claims.
More recently, in the Philippines in 2017, officials had to halt a school-based vaccination program for dengue virus after hospitalizations for the inoculated children increased. Dengue is feared by officials as it is a leading cause of death in some Asian and Latin American countries and has a case fatality rate of 1.03%. Correspondingly, the vaccine increased the risk of a more severe infection, a phenomenon known as antibody dependent enhancement (ADE). Like Ford’s flu vaccine, the Philippines vaccine, Dengvaxia, was rushed through approval, an action which probably caused researchers to miss cases of ADE. Relative to COVID-19, scientists have observed ADE in previous attempts to make coronavirus vaccines.
Various case studies fast-tracked vaccines have exemplified the link between a compressed vaccine development or manufacturing timeline with disastrous public health crises. Participants have been permanently injured and even killed because of these efforts. The past has proven that safety can be sacrificed for the benefit of an expedited vaccine, a deadly tradeoff.
Tradeoffs of a Rushed Vaccine
In contrast to treatments, healthcare providers administer vaccines to health people who require an extra level of scrutiny. Thus, the vaccine conception, development, and approval processes are quite rigorous. In addition to guarding against adverse side effects, innovators must prove that the vaccine produces an immune response. Vaccine development usually takes 10-15 years. Compare this those for the COVID-19 vaccines in development, which by necessity has been compressed down to a matter of months.
Further rushing of the development process may undermine a vaccine’s efficacy and safety in two ways. First, limited time to setup trials may affect innovators’ ability to effectively evaluate a sufficient number of people. Second is on the micro level. When it comes to COVID-19, the more serious symptoms of the disease emerge four to five weeks after being exposed. As the timeline is already shortened, researchers are already working against the challenge of limited time to determine if the vaccine is efficacious for a singular person. Further accelerating the process accentuates this risk.
Sputnik V-The Exact Wrong Thing to Do
Russia’s Sputnik V demonstrates exactly what not to do. Although they completed Phase I and II trials, Russia has not completed Phase III trials and instead opted to start inoculating its officials. While Sputnik V reports promising results from their early trials, Dr. Natalie Dean, an infectious disease expert at the University of Florida, contends that many vaccines that have showed positive data have flopped in later stages. Moreover, without large randomized control trials, there is no way to know if a vaccine is truly effective. It is in Phase III, where scientists can really identify the more uncommon side effects.
Undermining Public Trust in Vaccines and The Drug Approval Process
Beyond public health crises, if vaccine development and rushed vaccine development and approval can undermine public confidence. As we have written previously, the anti-vaccine movement has grown in recent years. In 2019, before the pandemic, the World Health Organization, listed vaccine refusal as one of its top ten health threats. As the previous vaccine incidents above outline, public trust is a fragile thing. With conspiracy theorists marketing their beliefs all over social media, scientists have one shot to get the COVID-19 vaccine right. Adding to the pressure, scientists are now operating in a precarious situation as nearly half (49%) the American public say they definitely or would probably not get COVID-19 vaccinated at this time according to Pew. A month ago, only 27% of respondents said they probably or definitely would not get a COVID-19 vaccine, a trend associated with declining CDC credibility. Essentially, people who would not normally consider themselves anti-vaxxers are showing their own COVID-19 vaccine hesitancy.
While therapeutics are in development, their widespread availability are likely to be limited in the short-term. Returning to the issue of vaccines, manufacturers are caught between a rock and a hard place. With continual pressure from governments (and even the U.S president personally) vaccine makers face an immense amount of pressure to expedite the process. While it is necessary to compress the timeline, it should not be at the mercy of public safety. A rushed vaccine has the potential to undermine the credibility of not just companies, but also regulators and the industry as a whole.
Alex Fishman is a Snowfish intern. When not working and blogging for us, he is a student at University of Virginia where he is studying Economics and Sociology.
Snowfish has been helping leading pharma, biotech and med device companies optimize their stakeholder networks for almost two decades. Please check out snowfish.net to learn more.
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