Moderna’s COVID-19 vaccine will start arriving in states on Monday, with patients immediately due to start receiving the newly approved product, which has now joined Pfizer’s vaccine in the nation’s arsenal against the pandemic.
U.S. Centers for Disease Control and Prevention (CDC) Director Dr. Robert Redfield gave the final stamp of approval to Moderna’s vaccine on Sunday after the Food and Drug Administration (FDA) issued its emergency use authorization on Friday, paving the way for shipping to begin.
FedEx and UPS began shipping Mordena’s vaccine on Sunday, with Operation Warp Speed officials saying that nearly 6 million doses have been earmarked for distribution to over 3,000 locations across the country.
“The first wave of Moderna COVID-19 vaccines are now making their way from the FedEx World Hub to their final destinations throughout the US along with kits of medical supplies,” FedEx wrote in a post on Twitter, which included a video of some of the logistical processes underway.
“This is a critically important initiative for UPS, and we are committed to delivering what matters for as long as it takes,” said UPS CEO Carol Tome in a post on Twitter that included photos of trucks shipping the vaccine under police escort.
“Approximately 20 million doses will be delivered to the U.S. government by the end of December 2020,” Moderna said in a statement, adding that that number will grow to between 85-100 million doses in the first quarter of 2021.
Operation Warp Speed lead Moncef Slaoui told CNN in an interview on Sunday that patients are expected to begin receiving the first doses of Moderna’s vaccine on Monday.
The vaccine, called mRNA-1273, was jointly developed with scientists from the National Institute of Allergy and Infectious Diseases (NIAID), which is part of the National Institutes of Health (NIH).
“It has been less than a year since the world first learned of SARS-CoV-2 and the terrible disease it can cause,” said NIH Director Dr. Francis Collins, in a statement. “To have not one but two safe and highly effective COVID-19 vaccines ready for deployment to the American public is truly a remarkable scientific achievement, and a significant step toward ending the pandemic that has caused so much suffering.”
The Trump administration struck a $1.5 billion deal with Moderna in August to secure 100 million doses of its vaccine. The government secured another 100 million more doses of the vaccine on Friday for around $1.68 billion. The 200 million doses is enough to vaccinate 100 million people. Like the Pfizer vaccine, the Moderna vaccine requires two doses. The doses are administered about 28 days apart.
Documents prepared by FDA scientists and released ahead of a meeting of panel advisers who on Thursday voted to recommend emergency use authorization said that a two-dose regimen of the Moderna vaccine was highly effective in preventing COVID-19 and did not raise any specific safety issues.
The FDA released an analysis of Moderna’s COVID-19 vaccine last week (pdf), concluding it is highly effective and safe. The document was issued ahead of a Thursday meeting with a panel of independent medical advisers that discussed whether scientific evidence supports the view that the vaccine is effective in preventing COVID-19 in people aged 18 and older, and if the known benefits outweigh potential risks.
The advisers voted 20-0 with one abstention, in agreement that the benefits of the vaccine outweighed its risks.
While serious reactions to the vaccine were rare, side effects were common, the analysis found. People who took part in the clinical trial complained of injection site pain (91.6 percent), fatigue (68.5 percent), headache (63.0 percent), muscle pain (59.6 percent), joint pain (44.8 percent), and chills (43.4 percent).
The analysis noted that there is insufficient data to make conclusions about the safety of the vaccine in children, pregnant and breast-feeding women, and immunocompromised individuals. Also, there is a lack of data about both long-term effectiveness and long-term safety of the vaccine, the FDA’s briefing document said.
The review also found that the vaccine had an overall efficacy of 94.5 percent in preventing COVID-19 two weeks after the second dose. The vaccine regimen involves an initial inoculation, followed by a booster shot 28 days later. The vaccine is less effective in older people, however, with an effectiveness of 86 percent for those aged 65 and older.