US Buys Extra 100M Doses of Moderna’s COVID-19 Vaccine

The Trump Administration, through HHS and the Department of Defense (DoD), will purchase an additional 100 million doses of Moderna’s COVID-19 vaccine candidate, mRNA-1273. 

mRNA-1273 would be shipped immediately following emergency use authorization from FDA. 

“Securing another 100 million doses from Moderna by June 2021 further expands our supply of doses across the Operation Warp Speed portfolio of vaccines,” HHS Secretary Alex Azar, said in the announcement. “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.”

Under the agreement with the Trump Administration, Moderna will leverage its US-based manufacturing capacity to fill, finish, and ship doses of mRNA-1273 as the candidate is produced.

The additional 100 million doses will allow for continuous delivery through the end of 2021, which will help meet the anticipated demand for the vaccine candidate and boost the delivery for the now 200 million doses the US government is purchasing. 

In mid-August, HHS and the DoD announced an agreement with Moderna to manufacture and deliver 100 million doses of mRNA-1273. Under the agreement, Moderna manufactured the vaccine doses while clinical trials were underway. 

The federal government will own the doses and will be able to acquire up to an additional 400 million doses of mRNA-1273.

Manufacturing in parallel with clinical trials increases the speed of vaccine development and furthers the Operation Warp Speed efforts to deliver safe and effective vaccines to Americans by the end of 2020, the government said in the August announcement. 

The Biomedical Advanced Research and Development Authority (BARDA) collaborated with the DoD Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense and Army Contracting Command to provide nearly $3.2 billion to expand the manufacturing capacity reserved for mRNA-1273 and deliver the vaccine doses to government-designated locations across the country.

This federal funding brings the total provided to Moderna for this vaccine, including vaccine development, clinical trials, and manufacturing to $4.1 billion, HHS said.  

The vaccine will be free for Americans and vaccine administration costs for private-sector administration partners will be covered by private insurance, Medicare, or Medicaid An HHS program will cover COVID-19 costs for the uninsured by reimbursing the provider at Medicare rates from the Provider Relief Fund. 

Moderna’s Phase 3 clinical trial began at the end of July and was the first government-funded Phase 3 clinical trial for a COVID-19 in the US. It enrolled nearly 30,000 adult volunteers who did not have COVID-19. 

In mid-November, researchers reported that mRNA-1273 was 95 percent effective in the Phase 3 trial and met statistical criteria pre-specified in the study protocol in a majority of US participants. 

The first analysis was based on 95 cases and showed a point estimate of vaccine efficacy of 94.5 percent. The second endpoint analyzed was severe COVID-19 cases; there were 11 severe cases. All 11 cases occurred in the placebo group and not in the group that received the mRNA-1273 injections. 

Moderna is the second company to apply for FDA emergency use authorization (EUA) for a coronavirus vaccine that uses messenger RNA. 

Just recently, FDA issued an EUA to Pfizer-BioNTech for their mRNA COVID-19 vaccine, BNT162b2, based on the Phase 3 trial results reported in November. The government has already started shipping doses of the Pfizer-BioNTech vaccine to states and local governments, which have agreed to prioritize vaccination of healthcare providers and nursing home residents.