On May 28, 2020, Ha Kung Wong was quoted in Bloomberg Law regarding the regulatory challenges involved in producing a COVID-19 vaccine. According to the article, roughly a half-dozen vaccine candidates are being readied for human testing in the U.S. by the end of 2020, but regulatory and logistical hurdles will affect the timeline for when average Americans can get the shot.
The FDA’s process for inspecting and approving new vaccine production facilities is complex, “but there’s a danger when you cut corners,” Wong said. As biologic products, most vaccines are dead or weakened viral strains, which can be dangerous if they aren’t manufactured responsibly, he said.
Even more dangerous are newer mRNA vaccines, which use messenger RNA—a single-strand molecule that is complementary to a DNA strand in a gene, Wong said. Those mRNA vaccines make the body produce an antigen, and then the body will create antibodies against the virus. If handled improperly, they could be harmful to humans, Wong said.
“The FDA is the gold standard when it comes to approving products,” Wong said. “As much as we like to hate on them for taking too much time, we forget that drugs get approved faster in other jurisdictions and they have problems.”
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