Coronavirus vaccine on track for FDA approval by end of 2020, says Operation Warp Speed official

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The United States expects to have four coronavirus candidate vaccines in large-scale clinical trials by the middle of September, a remarkable timeline considering the SARS-CoV-2 virus was only discovered in December.

The government is “very pleased” with the progress, Health and Human Services deputy chief of staff Paul Mango told reporters Friday afternoon. Mango is the agency’s liaison with Operation Warp Speed, the White House-led task force on coronavirus vaccine and treatment development.

“We feel we are absolutely on track — if not a little bit ahead — in terms of our overall objective, which is tens of millions of (doses of) safe and effective vaccines approved for calendar year-end,” Mango said.

Each Phase 3 clinical trial will enroll 30,000 volunteers; the two now underway are about halfway there, he said.

Early data on the vaccines show they are causing volunteers’ bodies to produce significant amounts of neutralizing antibodies, Mango said. That doesn’t necessarily mean a vaccine candidate will protect against COVID-19, but it may.

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