Moderna vaccine one step closer. At FDA. May ship this weekend. US reserves 100 million more doses.

The U.S. Food and Drug Administration released a 54-page document outlining Moderna’s (MRNA) request for an emergency use authorization (EUA) Tuesday, bringing the biotech one step closer to the finish line.

Though it is widely anticipated that an EUA is issued by the weekend, based on the precedent set by Pfizer (PFE) and BioNTech (BNTX) last week, the exact timeline still remains unclear. The FDA’s vaccine advisory committee is slated to meet December 17 to vote on recommending authorization of the vaccine in adults 18 and older.

The Food and Drug Administration said Tuesday that the Covid-19 vaccine developed by Moderna Inc. was “highly effective,” setting the stage for an emergency authorization later this week that would add a second vaccine to the arsenal against the pandemic.

The agency posted online documents, prepared by its staff and by Moderna, analyzing the safety and effectiveness of the vaccine in a large clinical study. The findings will go before an independent advisory panel that will vote Thursday on whether to recommend FDA authorization.

Barring complications, the FDA is aiming to authorize emergency use of the Moderna vaccine Friday, following the same timetable as last week with the first Covid-19 vaccine from Pfizer Inc. and BioNTech SE.

The FDA Finds Moderna Covid-19 Vaccine Highly Effective

Doses of Moderna’s vaccine could be shipped this weekend, with vaccinations starting early next week. Which vaccine people get will be decided by factors including availability, with the Centers for Disease Control and Prevention and the Trump administration’s Operation Warp Speed overseeing distribution. Federal officials have said the Moderna vaccine will be more suitable for smaller hospitals in rural areas because it is shipped in smaller quantities than Pfizer’s.

FDA analysts found that the Moderna vaccine was effective “across age groups, genders, racial and ethnic groups, and participants with medical co-morbidities [underlying conditions] associated with high risk of severe Covid-19.”

Similarly encouraging, FDA scientists also found that the research “suggested benefit of the vaccine in preventing severe Covid-19.” The issue of effectiveness against severe disease has been raised about the studies of Covid-19 vaccines. The study found 30 cases of severe disease in the placebo group, versus zero in the vaccine group.

The FDA analysis found the Moderna vaccine appeared somewhat more effective in younger people than in seniors. Vaccine efficacy was 95.6% among people 18 to 64, and 86.4% among those 65 and older.

Moderna studied its vaccine in people 18 and older, and is seeking authorization for use in that population. The FDA cleared Pfizer’s vaccine in people 16 and older because the study included that age group.

The FDA’s Vaccines and Related Biological Products Advisory Committee will discuss the Moderna data Thursday. The same panel reviewed the Pfizer data at an all-day meeting last week, after which it voted 17-4, with one abstention, in favor of granting emergency-use authorization.

The FDA did so one day later and is expected to move quickly to approve the Moderna vaccine if there is a favorable recommendation.

U.S. Government Exercises 1st Option for Additional 100 Million Doses of Moderna’s COVID-19 Vaccine Candidate

Total of 200 million doses ordered by the U.S government to date. Additional doses ordered today will be delivered in Q2 2021. U.S. government retains option to purchase up to an additional 300 million doses

Moderna announced that the U.S. government has exercised its option to purchase an additional 100 million doses of mRNA-1273, Moderna’s COVID-19 vaccine candidate, bringing its confirmed order commitment to 200 million doses.

Of the first 100 million doses purchased by the U.S. government, approximately 20 million doses will be delivered by the end of December 2020 and the balance will be delivered in the first quarter of 2021. Today’s new order of 100 million doses will be delivered in the second quarter of 2021. These deliveries are subject, in each case, to receipt of an Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for the vaccine.

Under the terms of the agreement, Moderna will continue to leverage the Company’s U.S.-based manufacturing infrastructure to supply mRNA-1273 to the U.S. government. As part of Operation Warp Speed, the U.S. government has the option to purchase up to an additional 300 million doses of mRNA-1273 from Moderna. The Company expects the U.S. government will provide the vaccine to Americans at no cost as previously announced.

“We appreciate the confidence that the U.S. government continues to have in mRNA-1273, our COVID-19 vaccine candidate, demonstrated by this increased supply agreement,” said Stéphane Bancel, Chief Executive Officer of Moderna. “We continue to scale up our manufacturing capability in the U.S. and outside of the U.S. In parallel, we have filed for an Emergency Use Authorization with the U.S. FDA and a Conditional Marketing Authorization with the European Medicines Agency, and we will continue to work with regulatory agencies around the globe to continue the rolling review process. We remain committed to helping address this global pandemic with our vaccine.”

“Securing another 100 million doses from Moderna by June 2021 further expands our supply of doses across the Operation Warp Speed portfolio of vaccines,” said HHS Secretary Alex Azar. “This new federal purchase can give Americans even greater confidence we will have enough supply to vaccinate all Americans who want it by the second quarter of 2021.”