American biotech company Moderna has announced on June 11 that it will start the final stage of a COVID-19 vaccine trial in July. (Photo Illustration by Jakub Porzycki/NurPhoto via Getty Images)
LOS ANGELES - The Trump Administration, through the U.S. Department of Health and Human Services (HHS) and Department of Defense (DoD), will purchase an additional 100 million doses of COVID-19 vaccine candidate from drugmaker Moderna, according to a new press release published Friday.
“If authorized by the U.S. Food and Drug Administration for emergency use as outlined in agency guidance, doses of the vaccine will begin shipping immediately,” the report said.
This announcement would bring the total doses of Modern owned by the federal government to 200 million.
Under the agreement, Moderna will leverage its U.S.-based manufacturing capacity to fill, finish and ship vials of the vaccine as the bulk material is produced.
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“The additional doses ordered today provide for continuous delivery through the end of June 2021. This strategy will help meet the anticipated demand for mRNA-1273 and safely accelerate the delivery schedule for all 200 million doses the U.S. government is purchasing,” the report said.
According to the purchase announcement, the vaccine would be provided at no cost to Americans.
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“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.
”Moderna began manufacturing the first 100 million doses while clinical trials were getting underway, the report explained.
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“Manufacturing in parallel with clinical trials expedited the traditional vaccine development timeline and built toward the U.S. government’s Operation Warp Speed goal to begin delivering safe and effective vaccines to the American people by the end of the year,” according to the report.
This comes as the vaccine produced by Pfizer Inc. and its German partner BioNTech won a critical endorsement Thursday from an FDA panel of outside advisers, and sign off from the agency — which is expected within days — is the next step needed to get the shots to the public.
“This federal funding brings the total provided to Moderna for this vaccine, including vaccine development, clinical trials and manufacturing, to $4.1 billion. The government also has the option to acquire up to an additional 300 million doses of the Moderna vaccine," the report said.
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Participants in Moderna COVID-19 vaccine trial developed antibodies
The vaccine candidate will begin a 30,000-person study on July 27.
The vaccine candidate was co-developed by Moderna and scientists from the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, with NIAID also supporting the vaccine’s nonclinical studies and clinical trials. BARDA supported phase 2/3 clinical trials, vaccine manufacturing scale up and other development activities for this vaccine.
In November, Moderna said its vaccine appeared to be 94.5% effective, according to preliminary data from an ongoing study.
Then earlier this month, the U.S. Food and Drug Administration announced it had scheduled a meeting on Dec. 17 to discuss the request for emergency use authorization (EUA) for a COVID-19 vaccine from Moderna Inc.
“In keeping with the FDA’s commitment to ensuring full transparency, dialogue and efficiency, the Vaccines and Related Biological Products Advisory Committee (VRBPAC), will meet to discuss the totality of the safety and effectiveness data provided by Moderna for their EUA submission,” said FDA Commissioner Stephen M. Hahn, M.D.
Final decisions on whether to authorize the vaccine for emergency use will be made by the FDA, according to the agency.