Roadblocks In The Global Race For An Effective And Safe COVID-19 Vaccine

With worldwide restrictions, more confirmed cases of infections and increasing deaths due to COVID-19, everyone wonders when or if there will be a return to normalcy. As of October 19th, John Hopkins University shows 40,346,078 confirmed global coronavirus cases, and 8,213,035 of these are in the United States alone. Experts forewarn a troubling surge in COVID-19 or suspected cases as the holidays and influenza season approaches. Any hope to return to normalcy rests upon a successful vaccination that would provide long-term protection against COVID-19 infection and severity.

Health authorities and vaccine developers from across the world hope to be the one to produce a vaccine in record time. However, vaccine development is a process that can take many years. The U.S. Food and Drug Administration (FDA) states that not only does a vaccine need to be effective and elicit an immune response, it also needs to be safe and ensure there are no adverse complications or side effects. In the U.S. such safety concerns are the reason that several coronavirus clinical trials have been paused.

On October 12th, Johnson and Johnson, one of the largest COVID-19 vaccine clinical trials with 60,000 participants, temporarily paused the third phase after an unexplained illness in a study participant. In a statement made by the company, they assure there is a pause for further independent review by the Data Safety Monitoring Board any time there is a reported unexpected serious adverse event (SAE) such as illnesses and accidents that may be related to a vaccine or study drug. Johnson and Johnson stated, “SAEs are not uncommon in clinical trials, and the number of SAEs can reasonably be expected to increase in trials involving large numbers of participants.”  The company further indicated that due to the double-blind, placebo-controlled nature of the trials, it was not apparent whether the participant received the study treatment or a placebo.

Just one day following Johnson and Johnson’s announcement to pause vaccine trials, the clinical trials testing antibody treatment for COVID-19 developed by the company Eli Lilly have also been paused due to safety concerns. Like the Johnson and Johnson trials, it is unclear what specific health or safety concerns caused the pause.

These COVID-19 clinical trials are not the first to be paused, the company AstraZeneca halted its late-stage trial in early September due to the reporting of sick volunteers. CNN notes the initial differing explanations by AstraZeneca and its partner, the University of Oxford, which described volunteers as having “unexplained neurological symptoms.” Although trials of AstraZeneca’s vaccine have resumed in other countries, U.S. trials continue to be on hold pending further approval by the FDA.

While the pauses in the experimental trials may be disheartening, they do not necessarily need to be alarming. Experts agree that these pauses are routine and even necessary to ensure safety and effectiveness. CNN quoted the dean of  Brown University’s School of Public Health, Dr. Ashish Jha, that due to the size of the trial, “This is completely expected, and it’s just a reminder how ridiculous it is to try and meet a political timeline…” Lawrence Gostin, public health expert and legal expert at Georgetown and John Hopkin Universities, as quoted in USA Today, also echoes Dr. Jha’s sentiment on the pauses, stating, “This is an indication that the system is working as it was designed to work to protect human subjects in clinical trials. It demonstrates that the ethical guardrails on vaccine trials are working.”  These mechanisms set in place by both individual companies and regulatory agencies can help ease some of the suspicions regarding the safety and effectiveness of the vaccine spurred by the speed at which the vaccines are being developed.

Further information is necessary to find out if the illnesses or reactions that halted the trials are related to the vaccine or whether they are possible coincidences. If the unexplained illnesses are related to the vaccine, the plans to produce a vaccine by the desired timelines could be further prolonged. Although the exact illness and its cause of the participant in the Johnson and Johnson and previous trials are unknown, internal and external investigations will determine if the experimental vaccine caused any dangerous side effects.

While certain companies pause their COVID-19 vaccine trials, the race to find an effective and safe vaccine continues. According to the World Health Organization, there are over one 100 vaccine candidates, with several of these in the human phase. Once a vaccine is proven to be effective and safe with minimal effects, vaccine distribution can begin, as can the prevention of new cases of illness and deaths, and eventually, COVID-19 restrictions will be eased and a sense of normalcy will return.