The question of prices for a COVID-19 vaccine have raged in recent days. Gary Disbrow, acting director of the Biomedical Advanced Research and Development Authority (BARDA), told members of a Senate committee that vaccines developed with the help of taxpayer funding will come with an appropriate reduction in price. However, CDC Director Robert Redfield emphasized that the cold-chain distribution system for those products requires the same kind of at-risk investment that is used for vaccine development, the absence of which could significantly impede efforts to deploy a vaccine.
Disbrow and Redfield appeared before the Senate Appropriations Subcommittee on Labor, Health and Human Services, Education, and Related Agencies, along with NIH Director Francis Collins. For his part, Disbrow said BARDA is employing the same taxpayer funding approach to drugs and diagnostics for the pandemic as is in use for vaccine development. He described Operation Warp Speed (OWS) as “an unprecedented collaboration” between the Departments of Defense and Health and Human Services (HHS), adding, “we will not risk the safety of these products,” in reference to concerns that the U.S. FDA may approve a vaccine that carries disproportionate safety concerns. Disbrow added that some of those taxpayer funds will have been applied toward candidate vaccines that will not make it past the FDA review process.
Disbrow noted that under OWS, the presumption is that a five-dose vial of vaccine will have to be packaged with seven each of needles, syringes and alcohol wipes due to the need for spares. He said the assistant secretary for preparedness and response at HHS is spearheading the effort to ensure that vaccine kits are supplied adequately. Meanwhile, Redfield emphasized the need for a beefed-up cold-chain capacity to ensure the vaccine is handled appropriately during shipping and handling. “It is vitally important to ensure” there is redundancy in that system, Redfield said, adding that the monetary needs for ensuring the cold-chain supply infrastructure is up to the task and “is not measured in the millions; it’s measured in the billions” of dollars.
Vaccine development a priority, as is equitability
Chairman Roy Blunt (R-Mo.), noted that roughly 128,000 individuals in the U.S. have died of the SARS-CoV-2 virus as of early July, adding that Pfizer Inc., of New York, has passed an important benchmark for its vaccine effort. Should the Pfizer candidate successfully hurdle clinical trials, production could reach hundreds of millions of doses by the end of this year. Blunt added that vaccine development is a top priority, as is a fair and equitable distribution of a vaccine to communities of need. However, he pointed out that a recent survey suggested that as many as one in five Americans may decline the vaccine.
Blunt said there is consequently a need to emphasize that the term “at risk” means financial risk, not a health risk for patients. He also said it would be no surprise “if somehow we lose $3 billion” in the effort to develop a vaccine. That said, it later could be argued that “if we don’t lose some money, we didn’t try hard enough.” He also requested that Redfield and Disbrow advise Congress in the next couple of weeks on the financial needs associated with their respective tasks.
For his part, Collins said that vaccine development typically has taken as long as 10 years, making this effort a historic one. Vaccine trials will have to enroll roughly 30,000 individuals, randomized evenly to control and study subjects. Collins also said that development of a vaccine that will be available in the millions of doses by January is “a stretch goal” for OWS, but which is nonetheless critical.
The phase III trial of the vaccine candidate by Moderna Inc., of Cambridge, Mass., will commence in July, Collins predicted, but clarified that the two-year time interval to study completion is a standard duration of a pivotal drug study. That duration is needed to tease out information regarding efficacy and adverse events for subpopulations. Collins said this term of follow-up also will elicit information regarding the durability of immunity, leaving open the prospect that booster shots eventually will prove necessary.
Monoclonal antibodies ‘have a lot going for them’
Collins also observed that several therapies are under investigation beyond dexamethasone and remdesivir, adding that monoclonal antibody therapies "have a lot going for them," as was demonstrated with Ebola. However, he advised that production of therapies that are in trial also may have to be scaled up in anticipation of an affirmative nod from the FDA, a consideration that is also on the agenda for the team charged with administering the OWS program.
Sen. Lamar Alexander (R-Tenn.) was one of at least two senators who inquired about the potential resumption of sporting events. Collins said the NIH’s Rapid Acceleration of Diagnostics program is designed in part to speed the development of point-of-care tests that provide quick turnaround. “The path we are on right now – and this is a white-knuckle goal – is to have an additional 1 million tests per day” available later this year, Collins said. In some instances, a test handled by a local lab can provide fairly rapid turn-around as well. However, “the best [scenario] is to have your gadget right there at the front desk,” he added.
Collins said there is a need for a nongovernmental organization to provide a framework for prioritizing vaccine distribution, adding that there are talks with the National Academy of Medicine toward this end. Blunt replied that the actual development of such a framework should perhaps be underway already. However, Collins advised that it may be especially challenging to quickly enroll a phase III trial that represents a diversity of populations. This will require an outreach effort that will include not only historically Black colleges and universities, but also churches. Collins also said there will be an emphasis on pregnant and lactating women in those vaccine trials.