Ex-FDA commissioner analyzes Johnson & Johnson’s Mega Vaccine Trial


J&J will likely look to oversee major threads in many regions at the same time to make it easier to register for regulatory approval, he said.

To obtain legal approval from foreign agencies, a vaccine maker must conduct investigations in that specific region, Gottlieb said.

Even at half the size of J & J’s study, Pfizer’s vaccine study is still very robust, he said.

If successful, the U.S. government could use the vaccine as an emergency authorization for a select high-risk population group, Gottlieb said, adding that the vaccine maker would still need to gather information at this point.

A few fax makers have made recent announcements that they are seeing success in the enrollment phase.

“These subjects look enrolled pretty well,” Gottlieb said.

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