Why Some COVID Trials Are Slowing Down Their Pace - COVID-19 Clinical Trial
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Why Some COVID Trials Are Slowing Down Their Pace

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    For more than six months, scientists and researchers across the globe have shared one common goal: to develop a COVID-19 vaccine as rapidly as possible. The excitement and enthusiasm for a vaccine is easy to understand, especially since a readily available vaccine is largely viewed as the only way to return to a “normal” life. 

    But in an attempt to squish an eight to ten year clinical trial process into 18 months, some experts worry the process is moving too fast for its own good. 

    As American scientist and former Harvard Medical School professor, William Haseltine, wrote, “There are risks that come with a fast-tracked vaccine delivered end of this year, not the least of which are the risks related to the safety of the vaccine itself.” 

    Rapid Approval May Cause Unnecessary Dangers 

    The rapid approval of a COVID-19 vaccine is a double-edged sword. On one end, it encourages hope and optimism of safer times right around the corner. On the other end, it potentially puts millions of people at risk of complications from an inefficient or unsafe vaccine formulation.  

    As Haseltine explains, “While preclinical trials to evaluate the potential safety and efficacy of vaccine candidates are likely to include tens of thousands of patients, it is still unclear whether that number will be large enough and a trial will last long enough to evaluate safety for a drug that would be administered to so many.” 

    Assuming the U.S plans to vaccinate hundreds of millions of people with the first successful vaccine candidate, even one serious adverse event per thousand, when given to 100 million people, would put 100,000 otherwise healthy people in danger. Is that a risk worth taking in the face of COVID-19 and its known path of destruction? Not everybody agrees on that answer.  

    The Vaccine’s Efficacy May Not Be Fully Understood 

    Any new vaccine’s efficacy must also be considered. The people at highest risk of COVID-19 are over 60 years of age. Unfortunately, they are the same people with more profound resistance to vaccinations, a process that begins in a person’s early thirties and continues over time. 

    It may be difficult to identify whether a new COVID-19 vaccine can really succeed for the elderly without long-term clinical research. And as Haseltine points out, “The risk goes far beyond the dangers a COVID vaccine alone may hold. Public support for vaccines in general is already an issue. Trust in other lifesaving vaccines will be eroded even further if a COVID vaccine goes wrong and many more people—children especially—will be at risk if vaccination rates fall.” 

    Antibodies and Antiviral Drugs May Provide Better Immediate Protection 

    Haseltine believes that a combination of monoclonal antibody treatment and antiviral drug treatment may be a better option for short-term protection against COVID-19.  

    “These drugs could treat those who were ill and prevent further infection,” he explained. Using antibodies and antivirals to slow the path of COVID-19 would allow research teams to pursue an effective vaccination within a realistic timeframe, while also focusing on other promising medical solutions that are quicker to bring to market safely.  

    Sources 

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