Thursday, October 21, 2021

Warp Speed chief Slaoui resigns at Biden’s request as COVID-19 shots are unleashed: report

Despite the slower-than-promised rollout of the Pfizer and Moderna COVID-19 vaccines, the tenure of Moncef Slaoui, Ph.D., as co-leader of the government’s Operation Warp Speed effort has largely been deemed a success. Slaoui, after all, is credited with fostering a speedy R&D process so the companies could get their mRNA vaccines on the market so quickly.

But now, Slaoui reportedly has one foot out the door as the inauguration of president-elect Joe Biden draws near.

Slaoui submitted his resignation at Biden’s request, CNBC reported Tuesday, citing anonymous sources. He plans to stay for 30 days to ease the transition, the sources said. The U.S. Department of Health and Human Services did not immediately respond to a request from Fierce Pharma to confirm Slaoui’s plans.

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The report comes just one week after Slaoui told reporters he had decided to stay on as a consultant to the Biden administration. The change of plans is hardly surprising, though. Slaoui originally planned to leave Warp Speed after two COVID-19 drugs and two vaccines were on the market—a milestone reached with the emergency use authorization of Moderna’s vaccine in December.

And Biden hasn’t exactly been singing Slaoui’s praises, given that Warp Speed had promised 20 million doses of the coronavirus vaccines would be administered by the end of 2020. As of today, only about 9.3 million people have received their first dose of the two-shot regimen, according to the Centers for Disease Control and Prevention.

RELATED: The 22 most influential people in the fight against COVID-19 | Moncef Slaoui

Slaoui, who previously headed up GlaxoSmithKline’s vaccine division, joined Warp Speed last May to develop a plan for speeding COVID vaccines to market. He put together a portfolio of eight companies pursuing four different vaccine technologies.

Although the two mRNA vaccines proved the quickest to develop, they aren’t so easy to manufacture. So the demand for the vaccines has so far outstripped supply.

Slaoui anticipated that problem. In fact, in December, he said that non-replicating viral vector vaccines from Johnson & Johnson and AstraZeneca would need to succeed in order for the U.S. to reach its goal of vaccinating all Americans by this summer.

AstraZeneca’s vaccine has been cleared for marketing in the U.K., but the path to a U.S. approval is murky because of safety concerns and a mixup with dosing that occurred during clinical trials.

J&J’s vaccine program, meanwhile, is nearing the finish line, CEO Alex Gorsky said during the J.P. Morgan Healthcare Conference. The company is nearly ready to unveil data from its phase 3 trial of the vaccine, which could offer a major benefit over the two mRNA vaccines in that it only requires one shot. The New York Times reported Tuesday, however, that the pharma giant is falling behind on manufacturing its shot.

RELATED: AstraZeneca, J&J COVID-19 shots must succeed to meet U.S. vaccination goal: Slaoui

In a bid to end the pandemic as quickly as possible, Biden said Monday he would release all available Pfizer and Moderna doses immediately, rather than holding back shots to ensure patients could receive their boosters, as President Donald Trump’s administration had been doing. Trump changed course shortly thereafter, releasing all available doses and suggesting states broaden availability of the vaccines.

As for Slaoui, his most recent idea for speeding up the vaccination effort wasn’t exactly met with widespread applause. He proposed cutting the dose of Moderna’s vaccine in half, citing clinical data showing the smaller dose elicited the same immune response as the full dose did.

But the half dose wasn’t tested in phase 3 trials, leading FDA Commissioner Stephen Hahn, M.D., and biologics chief Peter Marks, M.D., Ph.D., to dash out a scathing statement last week. Changing the authorized dosing regimen would pose a “significant risk of placing public health at risk,” they said.

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