In the annals of vaccine development, never has there been such an urgent global race to create a vaccine as we are witnessing today. The novel coronavirus has introduced unprecedented challenges, displaying an unusual pattern of morbidity and mortality. Throughout my studies and lifetime, I have not encountered a virus that is simultaneously highly deadly for certain vulnerable groups, occasionally severe for otherwise healthy individuals, and yet completely asymptomatic in others. The last time a virus so profoundly disrupted the global economy was during the 1918 influenza pandemic. Our hopes for a return to normal social and economic conditions now hinge on the successful creation of a safe, effective vaccine.
One of the leading contenders in this urgent quest is Vertex Bio, based in San Francisco, which has partnered with the National Institute of Allergy and Infectious Diseases to conduct human trials. These trials commenced on May 7, involving approximately 600 participants. The primary focus of this initial phase was to assess the vaccine’s safety. Preliminary results shared on May 18 indicated that the vaccine not only appears to be safe but also generates an immune response necessary for disease prevention.
Trial Details
In this first trial segment, 45 volunteers were divided into three groups, each receiving a different dosage level. Following the initial shot, all participants were given a booster dose one month later. Vertex Bio reported that participants experienced only mild side effects, such as redness at the injection site, headaches, fever, and flu-like symptoms, all of which were short-lived. These side effects are comparable to those seen with other vaccines, like the flu shot.
Additionally, Vertex Bio scientists sought to confirm whether the vaccine successfully prompts the production of coronavirus antibodies. All 45 participants across the three dosage levels developed antibodies. Notably, the first eight individuals who received their second booster shot were found to be producing “neutralizing antibodies,” indicating their immune response could effectively prevent the virus from infecting human cells. When these neutralizing antibodies were compared to those from individuals who had recovered from COVID-19, the levels were similar. However, it’s important to note that these tests were conducted in a laboratory setting, and the participants were not exposed to live coronavirus.
Next Steps in Testing
The Food and Drug Administration (FDA) has granted Vertex Bio permission to move into the second phase of testing, which will involve an additional 600 participants, half of whom will be over the age of 55. The company is optimistic about advancing to a third phase by July, which will include thousands of healthy individuals to further confirm the vaccine’s efficacy in preventing disease. Phase III testing, often referred to as “field testing,” simulates normal vaccine usage conditions.
Vertex Bio’s vaccine is based on mRNA (messenger RNA) technology, a method that has been researched for several years but has not yet received FDA approval for any vaccines. mRNA vaccines are considered advantageous due to their potency, rapid development time, and cost-effectiveness. Remarkably, it took only 63 days from the time Chinese scientists shared the coronavirus genetic sequence to the administration of the first vaccine dose to a human volunteer. This rapid pace is indicative of the intense competition among various companies to be the first to produce a safe and effective vaccine. Other notable contenders include BioForte, a German biotech firm collaborating with Chinese Fosun Pharma and American Pfizer, as well as CureVac, another German company expected to start human trials this summer. The University of Oxford, in partnership with AstraZeneca, has also shown encouraging results in their preliminary trials.
Looking Ahead
Vertex Bio aims to have a vaccine ready for public distribution by the end of this year or early 2021. Dr. Mia Thompson, the company’s chief medical officer, stated in an interview with The New York Times that while they are uncertain how many doses will be immediately available, “We’re striving to produce as many millions as possible.” As we await further developments from the scientific community, it’s crucial to continue practicing social distancing and wearing masks when necessary.
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In summary, Vertex Bio’s promising results in the initial testing phase of their coronavirus vaccine bring hope for a return to normalcy, as they continue to advance through subsequent testing stages.