Operation Warp Speed officials accepted the criticism that the COVID-19 vaccine rollout has not gone as planned, with the program’s chief advisor acknowledging that “it should be better.”
The Trump administration expected to administer 20 million doses of vaccine by the end of December. So far, just over 2 million shots have been given, according to the New York Times.
“We agree that that number is lower than what we hoped for,” said Moncef Slaoui, PhD, chief advisor to Operation Warp Speed, during a press briefing.
Slaoui invited anyone with recommendations for accelerating the process to “put your sleeves up and come help us with specific ideas … We know that it should be better and we’re working hard to make it better.”
U.S. Army Gen. Gustave Perna, Operation Warp Speed chief operating officer, cited multiple factors behind the delay: two holidays; three major snowstorms; understanding how to implement the notification process; adhering to the “cold chain” protocols for the vaccines; and delays in vaccine-count data reporting, which currently is behind by 72 to 96 hours. The CDC updates its vaccine counts every Monday, Wednesday, and Friday morning, according to the agency.
However, Perna noted that jurisdictions were given the “final allocations of doses,” and that by Thursday evening, states can begin placing orders for additional doses.
He pointed out that more than 14 million doses have been shipped to date, and distribution of the second dose of Pfizer vaccines has already begun. Perna highlighted the CDC’s work, along with CVS and Walgreens, to go into long-term care facilities and deliver vaccines to the those residents. He added that the federal government is planning a partnership with 19 pharmacy chains to allow for the necessary distribution capacity across the country as the vaccine rollout progresses from phase 1A to phase 1B.
“I do believe, as has been reported to me, vaccine allocations or uptake usually starts out a little slow, and then it increases exponentially and very rapidly,” Perna said.
Slaoui also responded to the news that U.K. regulators had authorized the AstraZeneca/Oxford vaccine, stating that it is “very good against severe disease,” but its efficacy in the elderly is “effectively unknown.”
“For me, the biggest question mark [with the AstraZeneca vaccine]… is efficacy in the elderly population that needs to be further documented… because there were not enough elderly subjects included in the trial early on,” Slaoui said, noting additional analysis is planned.
While Slaoui said the move by Great Britain’s Medicines and Healthcare Products Regulatory Agency was a “very important step forward, “the FDA will have to makes its own decision “on the basis of the data that [Britain] has used or not.”
The AstraZeneca vaccine is relatively far back in the U.S. pipeline because its trial in this country was halted for several weeks while FDA scrutinized adverse effects that occurred in trials elsewhere. In contrast, trials in Britain and other countries were paused for only a few days.
Asked whether the U.S. might take a page from the U.K. government and lengthen the time between the first and second doses of vaccines in order to increase the number of people who could more quickly receive their first dose, Slaoui said that would entail a tradeoff in efficacy. “One will need to just be very clear in the communication,” he said, “whether it is worth protecting at 95% those most impacted by the disease very quickly, or whether it’s worth immunizing the broader population with the vaccine at 50% efficacy.”
He stressed his strong belief in using vaccines in the manner in which they’ve been studied. “For me, the biggest concern if we were to extend the time period between the first and second dose is what happens to persistence of protection?” he said. Efficacy might be lower, he added, “or will we have some individuals that may have more severe disease? …. I would really advise not to do something that we have no characterization of.”
The AstraZeneca vaccine is still in phase III trials in the U.S., thanks to the earlier delay, but recruitment is near completion, Slaoui said, having enrolled almost all of the roughly 30,000 people the company planned.
Slaoui said data readouts and emergency use authorization (EUA) are expected in April if all goes well.
Slaoui also gave an update on ongoing COVID-19 vaccine studies:
- The Novavax vaccine began a phase III trial on Dec. 27 and has recruited 1,000 participants to date.
- The Johnson & Johnson/Janssen vaccine phase III trial is fully enrolled. Slaoui said experts are “more and more confident” that efficacy data from the trial will be available in January, with an EUA application submitted that same month, and authorization likely by the first half of February.
- The Sanofi/GlaxoSmithKline vaccine phase IIb trial is scheduled to start in February 2021.