Welcome to the FiercePharma political roundup, where each Monday we’ll highlight developments in Washington, D.C., and elsewhere that could affect drug pricing and how drugmakers operate.
About six months into the pandemic and about 130 days until the U.S. presidential election, COVID-19 vaccines are moving ahead at record speeds. Now, a group of analysts predicts “at least one” vaccine will be approved before November 3.
Jefferies healthcare strategist Jared Holz told MarketWatch that “perhaps multiple vaccines” could get FDA authorizations “early in the fourth quarter and quell fears of a second wave of COVID-19.”
The team cited several reasons why an approval, or emergency use authorization, may come before the November election. For one, Trump could push the FDA behind the scenes to issue an approval or emergency authorization. Moderna and AstraZeneca, two vaccine front-runners, have already told the analysts an approval could happen on that timeline, according to the report.
Meanwhile, a vaccine approval might lift the entire industry, rather than just one or two companies, Holz told the publication. If the industry delivers a successful shot, it’d be seen as saving the day amid the pandemic, and that would lift sentiment around all of biopharma. With that lift, there’d be less political pressure to take on drug pricing.
The analysts at Jefferies aren’t the only market watchers who believe vaccines could be approved before the election. In a New York Times op-ed earlier this month, University of Pennsylvania professors Ezekiel Emanuel and Paul Offit warned about a possible “October surprise” in the form of a COVID-19 vaccine approval on political grounds.
FDA commissioner Stephen Hahn, though, said his agency won’t be pressured to approve a shot for political reasons. He told The Guardian that “science and data—not politics—has and will always guide our decision-making, including our work related to vaccines.”
Several vaccines, including those from Moderna and AstraZeneca, are slated for late-stage tests this summer, The Wall Street Journal has reported. Worldwide, about 140 COVID-19 vaccines are in development, and 13 are in human testing, according to the World Health Organization.
Meanwhile, on the subject of drug pricing regulations, several companies scored a win last week against the U.S. Department of Health and Human Services (HHS) when a U.S. appeals court found that the body doesn’t have the authority to compel drugmakers to include prices in TV ads.