COVID Vaccine Delivery Proceeding Smoothly, Officials Say

WASHINGTON -- "Expect the unexpected" applies to many things -- including distribution of the Pfizer/BioNTech COVID-19 vaccine.

At a press briefing Wednesday, Gen. Gustave Perna, chief operating officer of Operation Warp Speed, the Trump administration's effort to speed up development of COVID-19 vaccines and therapeutics, said that two trays of vaccines headed for delivery to two separate places in California had to be returned to Pfizer -- because they got too cold.

"As we were tracking the temperature, we noted that the temperature got colder than -80° C; they went to -92°," he said. "We locked those trays down; they never left the truck. We returned them immediately back to Pfizer and we sent immediate shipments to replace those two trays."

The staff "is working with the CDC, FDA, and Pfizer to determine if that anomaly is safe or not, but we were taking no chances," he said, adding that a similar incident occurred with two trays going to a facility in Alabama. "Again, we were able to stop and quarantine the vaccine and get a replacement shipped immediately to Alabama ... We're learning; the key is we could see ourselves and we were able to take action."

Other than such relatively minor issues, things are generally going as planned, with vaccines delivered to 145 sites on Monday, 425 on Tuesday, and 66 on Wednesday. "Tomorrow, we're going to 886 additional locations in the United States," Perna said.

Also at the briefing, Moncef Slaoui, PhD, chief advisor to Operation Warp Speed, discussed the expected emergency use authorization of a COVID-19 vaccine from Moderna; like the Pfizer/BioNTech vaccine, it requires two doses and uses mRNA, but it doesn't need to be kept quite as cold. In total, Moderna will deliver 20 million doses of the vaccine to the federal government by the end of the month, he said. The Moderna vaccine will be discussed Thursday by an FDA advisory committee, which is expected to recommend it for emergency use authorization.

Slaoui also discussed the progress of the adenovirus-vector vaccine developed by Johnson & Johnson subsidiary Janssen. "Tomorrow we will close recruitment in the phase III trial with about 43,000 to 44,000 subjects," he said. "The trial is accruing cases very quickly; we hope we may be able to assess efficacy for the first time early in January and maybe for the final time late in January." Officials are hoping to have doses of that vaccine available in February and March. And AstraZeneca expects to finish recruitment for the phase III trial of its COVID-19 vaccine by the end of this year or very early in January, he said.

Slaoui gave an update on the progress in COVID-19 therapeutics as well. He lamented "a disappointing level of usage of the monoclonal therapies in the hospital setting for patients that are infected but not hospitalized. We really hoped to see a much, much higher level of usage of the doses that are delivered to the healthcare facilities -- our surveys for now, they are not yet fully complete, but they show anywhere between 5% and 20%, which for a hospital-preventing lifesaving intervention in this setting is not acceptable, so we look forward to that improving."

During a question-and-answer session, a reporter asked why the Trump administration didn't buy more doses of the Pfizer vaccine earlier on, even though they were available. Operation Warp Speed committed in July to purchase 100 million doses with an option to buy 500 million more, but has yet to pick up that option.

"Any reasonable person would understand that we built a portfolio of vaccines and took them into development in order to ensure that one of them, at least, makes it to the finish line, and if more than one makes it to the finish line, we can accumulate vaccine doses faster than if we were relying on a single provider," said Slaoui. "It wouldn't make sense whatsoever to pre-order more from one vaccine manufacturer than from any other one before we knew if a vaccine works."

Secondly, "in order to ensure we'd be in position to acquire more vaccine doses if and when a vaccine had first signs of performance, we built options in each and every one of our agreements," he said. "That's the right thing to do; it's a thoughtful way to allocate resources and taxpayers' money. As soon as we knew that the vaccine worked, negotiations started."

However, as summer turned to fall without the government exercising its option for more doses, Pfizer committed all its remaining production through early 2021 to other countries.

Pfizer was unable to specify when more vaccine doses would be delivered in the U.S.; speculation has centered on June. Nevertheless, "I think there are enough vaccine doses," Slaoui said. "With the first option agreement with Moderna, now doubling the amount of vaccine doses we have, and with the Janssen vaccine coming in, and AstraZeneca after it, and the Novavax vaccine, I think the strategy is really happening exactly as we planned it. Of course we would welcome another 100 million doses of the Pfizer vaccine and we are negotiating with them appropriately. Our expectation is for that to complete shortly."

According to Health and Human Services Secretary Alex Azar, "we now have 900 million doses of vaccine that we have contracted for delivery of; we have options that increase that to a total of 3 billion doses of vaccine ... We have 100 million of Moderna set between now and March 31, and 100 million of Pfizer between now and March 31. We have 100 million additional Moderna in the second quarter. We are working actively with Pfizer and I am very optimistic we'll conclude a successful result there. We have Johnson & Johnson with 100 million in active production -- single-dose, so that's 100 million people right there. We have 300 million of AstraZeneca."

With 330 million people in the U.S. and subtracting 70 million people below age 16 who are not authorized for vaccination, "if you just do the math on that ... we believe that we will have surplus supplies of vaccine, and that's why the president signed an executive order that made the commitment that we'll take that surplus capacity -- not just surplus vaccine but also surplus manufacturing capacity -- and use that for the benefit of the world community," he said.

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