CAMBRIDGE (CBS/AP) — A Cambridge biotech company said Thursday that it is preparing to move to Phase 3 in its development of a potential vaccine against the coronavirus. Moderna said that after getting feedback from the FDA, testing on 30,000 humans is set to begin in July.
Last month, Moderna reported “great” results among a small group given the mRNA-1273 vaccine. All eight participants produced antibodies “at or above levels” seen in recovered coronavirus patients.
— Moderna (@moderna_tx) June 11, 2020
Moderna said it already has made enough doses for the pivotal late-stage testing. Still needed before those injections begin: results of how the shot has fared in smaller, earlier-stage studies.
“We look forward to beginning our Phase 3 study of mRNA-1273 with some 30,000 participants in July,” Moderna Chief Medical Officer Tal Zaks said in a statement. “Moderna is committed to advancing the clinical development of mRNA-1273 as safely and quickly as possible to demonstrate our vaccine’s ability to significantly reduce the risk of COVID-19 disease.”
Moderna said it has determined that 100 micrograms is the optimal dosage level. Some volunteers will be given the real shot and some a dummy shot.
The company said it is on track to be able to produce between 500 million to 1 billion doses by the start of 2021.
Worldwide, about a dozen COVID-19 potential vaccines are in early stages of testing. The NIH expects to help several additional shots move into those final, large-scale studies this summer, including one made by Oxford University.
There are no guarantees any of them will pan out.
But if all goes well, “there will be potential to get answers” on which vaccines work by the end of the year, Dr. John Mascola, who directs NIH’s vaccine research center, told a meeting of the National Academy of Medicine on Wednesday.
Governments are beginning to stockpile hundreds of millions of doses of different vaccine candidates so they can be ready to start vaccinating as soon as scientists learn that one works. In the U.S, a program called “Operation Warp Speed” aims to have 300 million doses on hand by January.
(© Copyright 2020 CBS Broadcasting Inc. All Rights Reserved. The Associated Press contributed to this report.)