A Sept. 16 Senate hearing revisited the Trump administration’s response to the COVID-19 pandemic, and the CDC took the opportunity to post a vaccine distribution plan. CDC director Robert Redfield advised the committee, however, that sufficient quantities of vaccine to cover everyone in the U.S. might not be available until the third quarter of 2021, adding that now is the time to stand up a distribution network for a vaccine that will require cold-chain storage.

The outline for the vaccine distribution plan acknowledges that U.S. FDA approval of a vaccine is a rate-limiting factor in deployment, but points to a need for an IT system to track distribution. An HHS contract taken with McKesson Corp., of Irving, Texas, can be used to handle distribution of refrigerated doses at 2°-8° C and frozen vaccines at -20° C., but operators of distribution points and end clinics may be stalled at making equipment purchases until they have more information about the first FDA-approved or authorized vaccine to go into distribution.

Redfield urged everyone to obtain a flu vaccine for what he predicted is likely to be “a very difficult fall flu season.” Redfield said face masks are the most important public health tool available in the pandemic, adding that these masks may well provide more protection from the SARS-CoV-2 virus than any vaccine that may become available. However, he said a vaccine may not be available in sufficient quantities to inoculate the entire nation until the second or third quarter of 2021.

Redfield defended the previous CDC plan for production and distribution of supplies for vaccine injection, stating that a worst-case scenario may be that a vaccine becomes available without the supplies needed to administer the vaccine. While the latest vaccine distribution plan was panned in the hearing, Redfield countered that McKesson will have to start now to obtain licensing agreements from vaccine manufacturers, and thus time is of the essence, given that the first vaccine may win the nod from the FDA as early as November.

Redfield also said it is urgent that these distribution plans be formulated and publicized now, given that the first wave of vaccinations will have to handle as many as 6 million citizens with a 30-day booster shot requirement. However, he said that CDC has no prior experience with distribution of a vaccine with a cold-chain requirement, and thus there may be some unanticipated problems, which suggests a need to put the infrastructure in place as early as possible.

‘Like trying to build the plane while flying the plane’

Sen. Roy Blunt (R-Mo.), chairman of the Senate Appropriations Committee’s subcommittee for the Department of Health and Human Services, said 6.6 million Americans have tested positive and more than 195,000 have died of the COVID-19 pandemic. “Even after nine months, we still know relatively little” about the disease, he said, adding that the past half year has been “a lot like trying to build the plane while flying the plane.”

Blunt said his remarks were not offered “to fully exonerate the way the [Trump] administration has dealt with it or how it has been funded” by Congress, but said neither the Trump nor the Obama administrations have emphasized research the way the committee has. Blunt pointed to the 40% boost in NIH funding over the past few years as evidence of the committee’s support for life science research,

Sen. Lamar Alexander (R-Tenn.) said Congress “has had a hard time … preparing for the next pandemic” over the past few decades. Alexander remarked that the ease of access to air travel may be the most conspicuous difference between the SARS-CoV-2 virus and previous pandemic-driving pathogens, adding, “the next pandemic could be next year.”

“We go from panic to neglect to panic” in the national response to pandemics, Alexander said, adding that sustained funding for pandemic preparedness has repeatedly challenged the House and Senate. Budget cuts have in the past taken a bite out of the Strategic National Stockpile, but Congress can reverse that trend.

“I don’t think we’re talking about lots of money, but sustained funding for a period of years,” Alexander said. Robert Kadlec, assistant secretary for preparedness and response at HHS, seconded the notion of sustained funding for domestic manufacturing for biologics and vaccines. He advised that there is a need to manage stockpiles of therapies and other products, adding that Congress may have to mandate that hospitals keep a baseline level of inventory immediately on hand to ensure availability.

Kadlec said that roughly $2 billion a year may be a realistic starting figure for an annual appropriation, but he also said that such a program “does require a business model to support that” kind of inventory accumulation and management.

Test availability not the same as tests conducted

Brett Giroir, assistant secretary for health at the Department of Health and Human Services, said that new cases, intensive care admissions and fatalities are all down significantly in recent weeks, but added, “these gains could be fleeting or even reversed” if mitigations are dropped.

Giroir said the cumulative volume of molecular tests will surpass 100 million this week, adding that the availability of all types of tests will run to three million per day going forward. This includes rapid antigen tests deployed at the point of care, while testing done via next-generation sequencing will soon enter the fray.

However, Giroir emphasized that the number of tests available is not the same as the number of tests conducted. “This is not a supply chain problem. We had double the availability of tests that were done in August,” he said, adding that he never vowed that a specific number of tests would actually be conducted.

Regarding the controversy over the ventilator contract with Royal Philips BV, of Amsterdam, Kadlec said that when the pandemic started, there were 17,000 ventilators in the Strategic National Stockpile and another 10,000 on order. The assumption after the pandemic began to sweep across the U.S. was that 170,000 total units may be needed, and there was briefly some concern that even more might be needed. Officials at HHS contacted companies with an eye toward a total volume of 200,000 units, but as the clinical picture emerged, it appeared that significantly fewer units were needed.

Kadlec noted that the total volume of ventilators is not a great measure as higher acuity devices were not uniformly required by patients, and ultimately HHS significantly cut back on its estimate of the presumed need. He agreed that there was a significant cost associated with cancellation of the agreement with Philips, but pointed out that maintenance of excess inventory also comes with costs.