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Initial trials should also be evaluated by an International Scientific Advisory Panel—yet to be established—for safety and efficacy before receiving the final go-ahead.
These trials allow scientists to determine the vaccines’ efficacy and identify side effects that may not have appeared in phase 1 or phase 2 trials.
We need to assess safety, and we won’t know the efficacy part until much later.
Meanwhile, other experts have questioned the efficacy of Hong Kong’s mass testing as a preventative measure since people are still free to circulate around the city.
Just last week, FDA commissioner Stephen Hahn cited misleading statistics about the efficacy of using blood plasma to treat severe Covid-19.
“The psychiatrists I talk with say that they want to see much stronger efficacy data,” Widge said.
If any of them pan out, larger clinical trials would be needed to establish efficacy.
Without a sense of efficacy—the feeling of having control over the conditions of their lives—I fear some may give up on the difficult process of making change.
According to the statement, the Phase 1 trial will investigate the safety and efficacy of a product the company calls AGT 103-T, “a genetically modified cell product made from a person’s own cells.”
The announcement came even though no published information is available about the vaccine’s safety and efficacy, and scientists have yet to complete the final phase of clinical testing to determine whether it works.