Moderna vaccine production timeline11/3/2023 If rich countries monopolize COVID-19 vaccines, it could cause twice as many deaths as distributing them equally “But at the same time, this doesn’t really capture the overall demographic, especially in a heterogeneous country like the United States, where we have fairly diverse groups of people, different age groups, different races.” “Now you’re starting to ask the bigger question: Is it effective, can this vaccine work?” Amiji says. At this point, scientists begin to split people into different testing groups, including people who could be potentially infected. This step increases the number of people involved in order to better assess how the body responds to the vaccine candidate. If it is deemed safe, the product can move to Phase 2. “The purpose is not to try to see if this product works or not-it’s just to see if it’s safe.” “You narrow your choices of individuals who enroll in Phase 1 trials in a much more confined way,” Amiji says. That means this phase of the trial isn’t designed to study a broad demographic. “From the preclinical studies, you’ve identified a range of doses, and now you’re actually testing it in humans to confirm that those doses are going to be safe,” Amiji says.īecause the purpose of Phase 1 is to assess safety rather than the efficacy of the vaccine, the study usually involves a small cohort of participants. The idea is to assess whether small increments of these doses pose a risk for the human body. During this period, a small number of people receive different doses of the vaccine product. The vaccine product also contains a mix of other components to help it navigate the human body.Ī Phase 1 clinical trial can now begin. In this case, the spike protein-or some other genetic material from the coronavirus that helps produce the protein-serves as the active ingredient. Scientists then develop the candidate compound into a vaccine product. Its purpose is to demonstrate that a compound could be a good candidate for a vaccine.ĭuring the preclinical phase, scientists have to compile enough data to show that the compound can generate a response from the immune system, while also providing evidence that the potential benefits of the vaccine are much higher than the risks associated with using it, Amiji says. This happens in the lab and doesn’t involve human test subjects. The global medical supply chain is not immune to COVID-19 A fourth, post-approval phase monitors the safety and efficacy of the vaccine after it reaches the market. The clinical trial process is divided into three phases before a vaccine is approved by the FDA. “Ultimately, the spike protein is what is going to cause the immune cells to produce antibodies and to protect the host from the infection.” Why do clinical trials take so long to complete? “That part of the viral molecule is enough to cause an immune response, but certainly it doesn’t have any infective potential, so it will not harm the patient,” Amiji says. Those proteins help the virus bind to human cells. Vaccines for COVID-19 use a compound based on the spike proteins that adorn SARS-CoV-2 like the Sun’s corona. “There is no magic wand here, we have to go through these studies.” How would a COVID-19 vaccine work?Ī vaccine trains people’s immune systems to recognize and fight off an infection. “I disagree with the President on this point that there is any way that we can expedite the process ,” Amiji says. That’s breakneck speed for a process that usually takes three to five years of rigorous testing for safety and effectiveness, says Amiji, who explained why vaccines take so long to develop and distribute. Some of the most promising vaccine candidates have now entered the last phase of these trials. Several pharmaceutical companies began testing COVID-19 vaccines as early as March and have been working through clinical trials to ensure their vaccines are effective and don’t cause dangerous side effects. Photo by Matthew Modoono/Northeastern University Mansoor Amiji is the University Distinguished Professor of pharmaceutical sciences and chemical engineering.
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