Feds Reach Agreement With Mass.-Based Moderna On Vaccine Candidate

The federal government has reached an agreement with Cambridge-based Moderna to manufacture and deliver 100 million doses of the company's COVID-19 vaccine candidate, President Donald Trump announced early Tuesday evening.

"The federal government will own these vaccine doses," Trump said. "We're buying them."

Moderna estimated the value of Tuesday's award at $1.525 billion, including incentive payments for timely delivery of the product. Under the agreement, the U.S. government will also have the option to purchase up to 400 million additional doses of the vaccine - mRNA-1273 - from Moderna.

Trump highlighted federal government investments in the development and manufacturing of the top six vaccine candidates "to ensure rapid delivery" and noted previously established vaccine manufacturing partnerships with Johnson & Johnson and Sanofi/GSK.

"Some tremendous things are happening on the vaccine front, on the therapeutic front," Trump said.

U.S. Health and Human Services Secretary Alex Azar said that as part of Operation Warp Speed, the federal government is "assembling a broad portfolio of vaccines to increase the odds that we will have at least one safe, effective vaccine as soon as the end of this year."

Trump said there are three vaccine candidates in Phase 3 studies, the final stage of clinical trials.

The Phase 3 study of Moderna's candidate, being conducted in collaboration with the National Institutes of Health and the Biomedical Advanced Research and Development Authority (BARDA), began on July 27 and enrollment is on track to complete in September, according to Moderna.

Moderna estimated U.S. government commitments for access to its vaccine candidate at $2.48 billion, citing a previous award of up to $955 million. The company also cited a U.S. government announcement that, consistent with its commitment to free access to COVID-19 vaccines, Americans will receive mRNA-1273 at no cost for the vaccine itself, although health care professionals could charge for the cost of administering the vaccine.

"We appreciate the confidence of the U.S. government in our mRNA vaccine platform and the continued support," Moderna CEO Stephane Bancel said. "We are advancing the clinical development of mRNA-1273 with the ongoing Phase 3 study being conducted in collaboration with NIAID and BARDA. In parallel, we are scaling up our manufacturing capability with our strategic partners, Lonza, Catalent and Rovi, to address this global health emergency with a safe and effective vaccine."

Trump on Tuesday also raised the idea of military involvement in distributing vaccines.

"The military is ready to go," he said. "They're ready to deliver a vaccine to Americans as soon as one is fully approved by the FDA and we're moving very close to that approval."