With at least eight COVID-19 vaccines in human testing and headlines touting their progress each day, a top U.S. health official voiced some optimism about one or more of them working.
At a Tuesday Senate hearing about the path forward from pandemic lockdowns, NIAID director Anthony Fauci said there’s “no guarantee” any of the vaccines in testing will be effective, but he has “cautious optimism” one or more might work.
Researchers have “multiple shots on goal” and should know more about whether the programs can provide protection against the novel coronavirus in the late fall or early winter, he added.
There are unknowns, Fauci cautioned, including whether any of the vaccines might actually make infections worse. Other experts, such as SVB Leerink analyst Geoffrey Porges, have argued that current COVID-19 vaccine development timelines and expectations are overly optimistic.
Even as scientists work to learn more about the virus and potential vaccines, officials are taking steps to assist the programs along the development path and prep for a possible rollout if any succeed.
During the hearing, FDA Commissioner Stephen Hahn testified that regulators are looking at a common preclinical development pathway for early projects and a “master trial protocol” to simultaneously test numerous candidates.
Regulators plan to review about 10 vaccine programs through phase 2, Hahn said, and advance four or five of them into phase 3 testing, where researchers look for efficacy in a large group of trial participants.
Multiple teams are also preparing a manufacturing scale-up “at risk” to reduce time to distribution if any of the vaccine programs succeed. Pfizer has detailed its plans on that subject, and Novavax on Monday picked up a major grant to help with manufacturing and testing costs.
During the hearing, Hahn also offered details of the Operation Warp Speed project that taps an “all of government” approach to accelerate the vaccine programs. Officials with NIH, FDA, HHS, the Department of Defense and more are involved, and part of the effort includes scouting for potential supply chain hurdles for a rollout. The Warp Speed project aims to deliver 100 million doses of a vaccine by the end of the year, Bloomberg previously reported, which would mark an unprecedented achievement in vaccine development.
Hearing witnesses further faced questions about potential vaccine pricing from frequent pharma critic Sen. Bernie Sanders. The Vermont senator said it would “not be helpful” if vulnerable people have to pay for a vaccine while pharma companies reap profits. Some companies, such as Johnson & Johnson and AstraZeneca, have pledged to provide vaccine doses at cost during the pandemic.
While Hahn didn’t have specific answers about pricing, he said he shares the concern. HHS Assistant Secretary for Health Brett Giroir said it’s important that a potential vaccine “reaches all segments of society regardless of ability to pay.”
Aside from the at least eight vaccines in human testing, there are dozens of projects in earlier stages of research.