Moderna COVID-19 vaccine authorized for use by FDA

The U.S. Food and Drug Administration authorized Moderna’s (MRNA) COVID-19 vaccine for emergency use Friday evening, after an independent advisory panel voted overwhelmingly to recommend the EUA.

The EUA marks an important moment in the company’s history, as the vaccine is its first product to emerge from clinical trials. It also marks the second vaccine using a new platform, messenger RNA or mRNA, to deliver protection.

“It has been a 10-year scientific, entrepreneurial and medical journey, and I am thankful to all those who have helped us get here today. We remain focused on scaling up manufacturing to help us protect as many people as we can from this terrible disease,” said Moderna CEO Stéphane Bancel in a statement late Friday.

Moderna was the first company to begin clinical trials, beginning 63 days after the virus was sequenced from China.

“On January 7, before China had reported even one death from the novel coronavirus or confirmed human-to-human transmission, NIH scientists and innovators at Moderna agreed to begin work on the vaccine that received FDA authorization today,” said Heath and Human Services Secretary Alex Azar.

The authorization makes Moderna’s the second vaccine to be available in the U.S., following that of Pfizer’s (PFE) and BioNTech’s (BNTX).

“With the availability of two vaccines now for the prevention of COVID-19, the FDA has taken another crucial step in the fight against this global pandemic that is causing vast numbers of hospitalizations and deaths in the United States each day,” said FDA Commissioner Stephen Hahn in a statement.

The 20-0 vote in favor of authorization Thursday evening paved the way for what was widely expected to be a sprint to the finish line for Moderna.

Experts including National Institute of Allergy and Infectious Diseases Director Dr. Anthony Fauci say the platform holds promise for the future of vaccines, as well as treatments.

Originally, Moderna had been working on mRNA for cancer treatments. It has also announced efforts to begin working on a flu vaccine.

The company began as a small biotech at the start of the year, but became the first to be approved for clinical trials in March. It’s valuation has spiked, from trading at $17 per share in January, to a high of nearly $170 per share this month — pushing its market cap to $56 billion.

Moderna's logo is reflected in a drop on a syringe needle in this illustration taken November 9, 2020. REUTERS/Dado Ruvic/Illustration
Moderna's logo is reflected in a drop on a syringe needle in this illustration taken November 9, 2020. REUTERS/Dado Ruvic/Illustration

In a statement following the conclusion of Thursday’s meeting, the FDA said in a statement that the agency “will rapidly work toward finalization and issuance of an emergency use authorization.”

Similar to last week’s process, when Pfizer (PFE) and BioNTech (BNTX) clinched the first authorization in the U.S., the FDA also notified Operation Warp Speed officials to ready the first shipments.

Pfizer’s EUA came shortly before midnight Saturday, after pressure from the White House for Commissioner Stephen Hahn to do so or resign.

President Donald Trump incorrectly tweeted Friday that the vaccine had been approved. Neither Pfizer nor Moderna will receive full approval for their vaccines at this stage.

Moderna’s vaccine was shown to be 94.1% efficacious in clinical trials, and had a far more diverse trial population than Pfizer. The company also has a less demanding cold storage process for the vaccine, giving hope for greater reach throughout the U.S. — especially to rural areas and territories.

Moderna’s trial was smaller than Pfizer’s, with about 30,000 participants compared to 44,000. Both vaccines have similar side effects, including pain at the injection side, headache and fatigue.

The vaccines are first being distributed to frontline health workers and nursing home residents and staff. An advisory committee to the U.S. Centers for Disease Control and Prevention (CDC) will vote on subsequent priority groups as vaccine production ramps up.

Between Pfizer and Moderna, the U.S. expects to deliver 40 million doses by the end of the year. Moderna expects nearly 6 million — double that of Pfizer— to be included in its initial shipment.

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