Tuesday, December 14, 2021

Fierce Pharma Politics—Biden aims to release all available COVID-19 shots in departure from Trump strategy


Welcome to the Fierce Pharma political roundup, where each Monday we’ll highlight developments in Washington, D.C., and elsewhere that could affect drug pricing and how drugmakers operate. 

President Donald Trump’s Operation Warp Speed promised 20 million COVID-19 vaccines administered to Americans by the end of 2020. Halfway into January, the rollout is still lagging behind those expectations.  

But President-elect Joe Biden’s team is planning to shake up how doses are delivered after he takes office next week. Rather than holding back supply to ensure people can get their second doses, the Biden administration plans to release all available doses, CNN reports. It’s a departure from the Trump team’s approach at a time when the coronavirus vaccine rollout is failing to meet the pace needed to stem the pandemic. 

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So far, about a month after the first vaccines were given in the U.S., about 6.7 million people have received shots, according to the New York Times. About 151,000 people have received the full two-dose course. That’s far short of the 22 million doses the government has delivered to states. 

While the decision will allow many more people to access a first dose, it poses risks as both the authorized shots—from Pfizer-BioNTech and Moderna—require two doses. The FDA authorized both programs as two-dose regimens based on strong phase 3 data, and the agency has warned against changes to dosing. 

RELATED: Not so fast: FDA warns of ‘premature’ changes to COVID-19 vaccine dosing in clash with Slaoui 

Former FDA commissioner Scott Gottlieb, who’s also served as an important independent voice on the pandemic, supports the Biden plan. In a tweet last week, he called the decision a “prudent move.” 

During a Sunday interview on CBS’ News’ Face the Nation, Gottlieb said health officials have to “hit the reset and adopt a new strategy” to dramatically increase the number of doses administered. Speaking at a time when cases and deaths are surging, Gottlieb said that the 40 million doses currently available could be prioritized to protect the 50 million people 65 and older in the U.S. 

RELATED: As Pfizer’s first COVID-19 vaccine doses roll across the U.S., analysts size up the hurdles ahead 

He called for an “all-of-the-above approach” to administer vaccines through “big box stores” and federal facilities “that the Biden administration is talking about standing up.” 

“We need to try everything right now to create multiple distribution points,” Gottlieb said. 

That seems to be happening in at least one state. Certain Publix locations in Florida are offering appointment-only vaccinations.

While Biden is set to be inaugurated Jan. 20, the New York Times reports his team is planning to unveil their vaccination strategy this week, including an effort to give doses in places like sporting stadiums and high schools, the Times reports





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