In early February, President Joe Biden announced that the U.S. would have sufficient COVID-19 vaccine supplies to immunize every adult by the end of July, following the purchase of additional doses from Moderna and Pfizer-BioNTech. On March 2, he moved that date back by 2 months, saying the country was on track to have enough doses “for every adult in America by the end of May.”
What happened and what can community pharmacies expect to actually happen, given the rocky rollout to date?
Significant changes make the new date feasible: addressing manufacturing issues for the mRNA vaccines, approving the Johnson & Johnson vaccine, and involving Merck, a pharmaceutical manufacturer whose own vaccine candidates have failed.
From the start, the Pfizer-BioNTech and Moderna vaccines have fallen behind schedule. Difficulty obtaining enough vials to hold doses, raw material shortages, and unexpected production issues resulted in only half of the doses expected being delivered from Pfizer-BioNTech in December, and problems continued to plague both companies through February.
“We ultimately had never–when we were trying to make those estimates — manufactured at this scale, and so we had a lot to learn along the way,” Moderna President Stephen Hoge, MD, said at a Congressional subcommittee hearing in late February. He added that the Cambridge, Massachusetts–based company now had the materials needed, although it was seeking FDA approval to increase the number of doses in each COVID-19 vaccine vial from 10 to 15 to further accelerate delivery. Even without that approval, Moderna said it was on pace to double production levels.
Moderna also announced new capital investments to increase its capacity to further ramp up production in 2022 and meet the need for production of expected boosters to address variants that may impact the effectiveness of currently authorized vaccines.
The two manufacturers committed to having a combined 160 million doses available for shipment by the end of March, 400 million doses by late May, and 600 million doses by the end of July, with production scaling up immediately. Sixty million Americans have already received one dose, and about half of that number have received both, meaning that the increased deliveries from Pfizer-BioNTech and Moderna would be sufficient to meet the May 30 goal for vaccinating all 260 million adult Americans.
However, the challenges seen so far would still give someone pause about committing to a firm date for vaccinating everyone without two other developments. The Johnson & Johnson vaccine received Emergency-Use Authorization from the FDA on February 27 for its one-dose vaccine, and the company pledged to provide 20 million doses by March 31. Johnson & Johnson shipped nearly four million doses the first week of March.
While that sounds promising, it actually represented a significant shortfall in Johnson & Johnson expected stockpile of vaccine prior to authorization. The federal government stepped in to help the company resolve continuing manufacturing issues with logistical help from the U.S. Department of Defense. Johnson & Johnson pledged to begin producing vaccine around the clock to boost its deliveries quickly. Those efforts allowed the company to commit to contributing 94 million doses by the end of May.
The administration also facilitated discussions between Johnson & Johnson and Merck that had begun in 2020. Those talks ultimately resulted in a highly unusual, game-changing agreement for Merck to help produce the Johnson & Johnson vaccine.
“Two of the largest pharmaceutical companies in the world who are usually competitors are working together on the vaccine,” Biden said in remarks delivered at the White House. “This is the type of collaboration between companies we saw in World War II.”
The administration also used the Defense Production Act to provide $268.8 million to help Merck upgrade two plants to produce the vaccine. Bringing Merck online could double the supply of Johnson & Johnson vaccine this year, with real increases seen by late spring. The collaboration could add more than 100 million doses in the next few months.
With volume issues resolved, getting doses into people’s arms now relies on the execution of state and federal distribution programs and the efforts of U.S. pharmacists. The country was jabbing just over two million people each day in early March. To meet the new goals, many more vaccinators—that means pharmacies—must be involved. If you’ve enrolled in the Federal Retail Pharmacy Program, expect to hear more soon about deliveries.
The content contained in this article is for informational purposes only. The content is not intended to be a substitute for professional advice. Reliance on any information provided in this article is solely at your own risk.
Published March 11, 2021
