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By DAMIAN GARDE @damiangarde
JULY 2, 2020
30,000-patient trial of Moderna’s coronavirus vaccine candidate, expected to start next week, has been delayed, a potential hurdle in the company’s ambitious effort to deliver key data by Thanksgiving.
Moderna is making changes to the trial plan, called a protocol, which has pushed back the expected start date of the Phase 3 study, according to investigators. The investigators, who spoke on condition of anonymity, emphasized that protocol changes are common but said it’s not clear how long the start will be delayed.
... Investigators at the University of Illinois at Chicago had previously said Moderna’s trial would begin July 9. On Thursday, NIH Director Francis Collins also told lawmakers in Washington that the study would begin this month.
... The intense focus on the exact timing of the trial stems from the tight nature of the race to develop a vaccine for the novel coronavirus — and the fact that any delay could imperil Moderna’s pole position. Pfizer, working with the German firm BioNTech, plans to start a 30,000-patient study of its own later this month. AstraZeneca and Oxford University are slated to begin a similarly sized trial in August, followed by Johnson & Johnson in September.
JULY 2, 2020
30,000-patient trial of Moderna’s coronavirus vaccine candidate, expected to start next week, has been delayed, a potential hurdle in the company’s ambitious effort to deliver key data by Thanksgiving.
Moderna is making changes to the trial plan, called a protocol, which has pushed back the expected start date of the Phase 3 study, according to investigators. The investigators, who spoke on condition of anonymity, emphasized that protocol changes are common but said it’s not clear how long the start will be delayed.
... Investigators at the University of Illinois at Chicago had previously said Moderna’s trial would begin July 9. On Thursday, NIH Director Francis Collins also told lawmakers in Washington that the study would begin this month.
... The intense focus on the exact timing of the trial stems from the tight nature of the race to develop a vaccine for the novel coronavirus — and the fact that any delay could imperil Moderna’s pole position. Pfizer, working with the German firm BioNTech, plans to start a 30,000-patient study of its own later this month. AstraZeneca and Oxford University are slated to begin a similarly sized trial in August, followed by Johnson & Johnson in September.