Moderna Could Distribute COVID-19 Vaccine By End Of Year, Phase 3 Trial Nearly Done

Moderna (MRNA) said Thursday it has nearly completed its phase 3 clinical trial of its messenger RNA coronavirus vaccine and could ramp up production by the end of the year, pending government approval.

The company said it had made its phase 3 protocol available online to provide more transparency – something outside scientists had been demanding to increase confidence any vaccine approved by the Food and Drug Administration would be safe and effective.

The announcement came as President Trump clashed with the head of the Centers for Disease Control and Prevention over a timeline for when a vaccine would be widely available.

“We are actively preparing for a potential commercial launch of mRNA-1273, our COVID-19 vaccine, and we continue to expand the breadth of Moderna’s platform,” Moderna CEO Stéphane Bancel said in a press release.

Moderna said it had enrolled 25,296 subjects of the 30,000 subjects called for in its phase 3 trial of mRNA-1273. Nearly half already have received a second dose. Two other vaccines also are being tested with mRNA-1647 ready for a phase 3 trial next year. A fourth vaccine is being developed for children.

The company also plans to develop an mRNA flu vaccine.

In an interview with MSNBC, Bancel said the company cares “deeply that this vaccine is trusted.” He said Moderna will know by November if the vaccine can be readied for commercial use.

"If the infection rate in the country were to slow down in the next weeks, it could potentially be pushed out in a worst-case scenario in December,” he said.

Trump rebuked CDC Director Robert Redfield Wednesday for saying a vaccine won’t be ready until 2021 and also took issue with the doctor’s advice about wearing masks. Trump told reporters a vaccine is much “closer” than that, and likely will debut in October.

Trump’s Democratic rival, Joe Biden, said Wednesday though he’s a fan of vaccines, he’s not sure he would trust one approved before the Nov. 3 election.

"So, let me be clear. I trust vaccines. I trust the scientists, but I don't trust Donald Trump. And at this moment the American people can't either," Biden told reporters during a campaign stop.

At 1:29 p.m. EDT, Moderna stock was trading off $2.59 or 3.76% at $66.25 a share.