Moderna’s shares fell nearly 5% ahead of Thursday’s long holiday weekend, after a Stat report said biotechnology would have to delay the start of its main phase 3 pandemic vaccine trial.
Shares fell as much as 10% on Thursday before the end of the day with a 4.9% drop, increasing slightly after hours. An anonymous researcher spoke to health care publication Stat saying that heavily funded biotechnology had changed the trial protocol, delaying its timing. He did not say how long or what the original start date was.
These changes are not uncommon, but the reaction shows how closely these tests are observed. “I understood that they wanted to receive the first vaccines in July, and they say they are still committed to doing so,” an investigator told Stat. “The best I can say is that they are close to being the target for that.”
Moderna, seeing her actions fade, launched a Twitter launch on Thursday essentially confirming that, saying she was still on track to begin testing this month as planned. The company did not directly address Stat’s delay allegations, but said: “We have worked closely with NIH / OWS to align the final protocol to start the trial on time.”
Last month, Moderna said it had finalized the design and dosage of its phase 3 COVID-19 vaccine trial, keeping it on track to begin the fundamental test next month. Work to launch the Phase 3 trial of 30,000 subjects is proceeding in parallel to the ongoing enrollment in earlier phases of development.
The messenger RNA biotech set its expectations for the phase 3 trial when it shared a first look at the clinical data of its mRNA-1273 vaccine in May. At that time, Moderna expected the phase 3 trial to test a dose between 25 µg and 100 µg, reflecting the adverse events observed in the 250 µg cohort, and to start in July.
Modern seems ready to respond to these proposals. Having spoken to the FDA, Moderna plans to randomize 30,000 people in the US individually to receive 100 µg of mRNA-1273 or placebo. It is unclear what the protocol has changed since this last update.
In its June update, Moderna said the primary goal of the trial is to assess the ability of mRNA-1273 to prevent symptomatic COVID-19 disease. Secondary endpoints will assess the ability of 1273 mRNA to prevent hospitalization and SARS-CoV-2 infection.
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