The Trump administration plans to buy another 100 million doses of Moderna’s COVID-19 vaccine, according to the Department of Health and Human Services (HHS).
The purchase agreement, announced by HHS in a press release on Friday, will bring the total number of doses of Moderna’s vaccine owned by the federal government to 200 million, with a further option to buy an additional 300 million doses.
“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, in a statement.
Called mRNA-1273, the Moderna vaccine is pending approval for emergency use, with a review by the Food and Drug Administration (FDA) expected on Dec. 17. Once it is approved, the vaccine will begin shipping immediately and will be provided at no cost to Americans.
“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,” Azar said.
The Trump administration previously ordered 100 million doses of Moderna’s vaccine, which the company began manufacturing while clinical trials were still underway. Running development and manufacturing processes in parallel was part of the strategy to make COVID-19 vaccines and therapeutics available in record time.
The vaccine was co-developed by Moderna and scientists from the National Institute of Allergy and Infectious Diseases (NIAID), the agency headed by Dr. Anthony Fauci.
An independent data safety monitoring board overseeing the clinical trial of Moderna’s vaccine candidate reviewed the trial data and concluded that the vaccine was safe, prevented disease in 94 percent of the volunteers who received the vaccine, and was generally well tolerated.
Moderna is the second company to apply to the FDA for emergency use authorization, with the Pfizer/BioNTech vaccine receiving the final go-ahead on Saturday.
Army Gen. Gustave Perna, who is part of the Trump administration’s Operation Warp Speed initiative, said Saturday that trucks will roll out on Sunday as shipping companies UPS and FedEx begin delivering the Pfizer/BioNTech vaccine to nearly 150 distribution centers across the country, with the nation’s first COVID-19 vaccine starting to arrive in states on Monday morning.
An additional 450 or so distribution centers will get the vaccine between Tuesday and Wednesday, with around 3 million doses expected to be shipped nationwide at the outset.
Perna said health authorities would decide who gets priority access to the vaccine, which is administered in two doses, around three weeks apart.
Ahead of the FDA’s approval, the agency issued a detailed analysis (pdf) that concluded the Pfizer-BioNTech vaccine “met the prescribed success criteria.”
Regarding safety, the FDA reviewed data from some 38,000 participants aged 16 and older, and found “a favorable safety profile, with no specific safety concerns identified that would preclude issuance of an EUA [emergency use authorization],” according to the analysis.
The analysis did note, however, that, “there are currently insufficient data to make conclusions about the safety of the vaccine in subpopulations such as children less than 16 years of age, pregnant and lactating individuals, and immunocompromised individuals.”
People who took part in the study did experience a number of side effects after taking the vaccine, with the FDA noting the most common were injection site reactions (84.1 percent), fatigue (62.9 percent), headache (55.1 percent), muscle pain (38.3 percent), chills (31.9 percent), joint pain (23.6 percent), and fever (14.2 percent).
Several experts who sit on an advisory panel that voted on Thursday to recommend the Pfizer-BioNTech COVID-19 vaccine for emergency use authorization have expressed concern about the vaccine’s potential effects on teenagers, arguing that there is not enough safety data to conclude it is safe for those aged 16–17.