Warp Speed's Slaoui Says COVID Spread Speeding Vaccine Development

Alicia Ault

December 01, 2020

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Moncef Slaoui, PhD

The rapid spread of SARS-CoV-2 is helping speed the development of vaccines and therapeutics for COVID-19 by increasing the number of infected candidates needed for trials, said Moncef Slaoui, PhD, the chief science adviser for the federal government's Operation Warp Speed program.

Two additional vaccine candidates that are part of Operation Warp Speed are deep into phase 3 trials, Slaoui said at a livestream event sponsored by the Washington Post

"We expect that we will be reading out the efficacy of those vaccines in the month of January," said Slaoui. "Unfortunately, there is so much transmission of this virus currently that's very likely to happen early in January."

Two more vaccines should be entering phase 3 trials within a few weeks, he said.

Slaoui didn't mention the names of the candidates that will report out in January or start phase 3 trials.

One is likely to be Janssen Pharmaceutical's viral vector vaccine (JNJ-78436725), which began phase 3 trials in late September. Warp Speed, through the US Department of Health & Human Services (HHS), provided Janssen's parent company Johnson & Johnson $456 million in March for development. The company aimed to enroll 60,000 volunteers at some 215 sites in the United States and globally.

The other readout might be from AstraZeneca and Oxford University's viral vector vaccine. The company said in late November that the vaccine had 90% efficacy, but many questioned those results. AstraZeneca's CEO later said the company would conduct further trials to get a clearer read on its effectiveness.

Novavax reported in early November that it expected to begin phase 3 studies of its protein subunit vaccine (NVX-CoV2373) by the end of the month. By November 30, the Gaithersburg, Maryland-based company said trials would likely start within weeks.

HHS gave Novavax $1.6 billion in July to support large-scale manufacturing, which guaranteed the US government 100 million doses.

Another Warp Speed candidate, a two-dose protein subunit vaccine from GlaxoSmithKline (GSK) and Sanofi, will also likely start phase 3 trials in December. The company started phase 1/2 studies in September and said it expected to move into phase 3 in December.

Sanofi and GSK entered into an agreement with HHS in July to supply up to 100 million doses. The $2 billion agreement gave the United States an option to buy up to 500 million more doses over the long term.

Transition 'Should Be Seamless'

Slaoui also said he doesn't anticipate any problems with Operation Warp Speed's continuing success, despite what has been a rocky transition to a new administration.

"The transition for this operation should be a seamless eventless event," he said, adding that most of the decisions have already been made, vaccines are in trials and being produced, and states are gearing up to receive allocation recommendations from the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices.

"I hope by January 20 we will have immunized quite a large number of fragile...Americans," Slaoui said.

"I'm 100% committed to making sure the operation continues to be successful," he said, adding that because he's within reach of goals he set for himself — including approval and use of two vaccines and two medications — he expects to reduce his role after Christmas.

The decision to step back has nothing to do with the change in administration, said Slaoui. "I said publicly everywhere that I wasn't aligned with the current administration and much more aligned with the future administration," he explained, adding that he has tried to steer clear of politics.

His mission, he said, "was about helping the country and the world." Once his "added value" has receded, "it's time for me to move on and go back to my nonpublic life."

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