EXCLUSIVE: The head of Operation Warp Speed shares his best timeline on the race for a COVID-19 vaccine and predicts a return to normal in the second half of 2021

  • The leading coronavirus vaccine candidates are on track to produce data showing whether or not they work before the end of this year, the Trump administration's coronavirus vaccine czar told Business Insider in a rare phone interview. 
  • Moncef Slaoui is the chief advisor of the US government's Operation Warp Speed, the Trump administration's initiative to accelerate coronavirus vaccine research, manufacturing, and distribution.
  • "I would not be surprised if we have data before the end of the year," Slaoui said, referring to late-stage trials underway testing vaccine candidates developed by Moderna and Pfizer.
  • He expects a vaccine will become widely available to most Americans in the second quarter of 2021 — April, May or June.
  • By then, Slaoui added, the high-risk population of around 70 or 80 million people will have been immunized. 
  • For more stories like this, sign up here for our healthcare newsletter, Dispensed.

The US government's coronavirus vaccine czar said Wednesday late-stage clinical trials are progressing "very well" and anticipates results by the end of this year. 

Speaking in a rare interview with Business Insider, Moncef Slaoui said recruitment in Moderna's vaccine trial is "on track with the plans that we put together." Moderna has said it expects to finish recruiting 30,000 volunteers in the US sometime next month. 

Since mid-May, Slaoui, a former pharmaceutical executive, has served as chief advisor to Operation Warp Speed, the US government's initiative to accelerate progress on a coronavirus vaccine. 

But the exact timing on when we'll know if a vaccine works is too difficult to say, he added.

"It's frankly impossible to predict," Slaoui said, when asked on the timing of crucial readouts for vaccine candidates developed by Moderna and Pfizer. 

That's because the studies depend on two crucial unknowns, Slaoui said. First, if the vaccine winds up to be extremely effective, results should come sooner. A shot that is moderately helpful will require more time to show a benefit. Secondly, trials have to have enough volunteers register coronavirus infections to see if there's a statistically meaningful difference between groups receiving the experimental shots and placebos

Even with the uncertainty on exact timing, Slauoi anticipates results this year.

"I would not be surprised if we have data before the end of the year," Slaoui said. 

Executives from both companies have been more aggressive on their expectations.

Pfizer's chief scientific officer recently said the first look at the data could come in late-September or early October. Moderna's CEO outlined October as the best-case scenario for a study readout.

Read more: Moderna's CEO shared a detailed timeline for when we'll know if its coronavirus vaccine works, and cautions that you might not get a shot until the spring

A widely available shot should be here between April and June 2021

Warp Speed has backed six vaccine candidates developed by Moderna, Pfizer/BioNTech, Johnson & Johnson, AstraZeneca, Novavax, and Sanofi/GlaxoSmithKline. These companies have landed roughly $10 billion in deals that pay for clinical trials, manufacturing, and purchase orders for hundreds of millions of doses in advance. 

Vaccine development typically take several years, oftentimes more than a decade. Warp Speed's premise is for the US government to pick up the financial risk for these companies, allowing them to run studies in parallel while simultaneously mass-producing doses.

It raises the chances that if a shot shows it works in humans, the US will be ready to start vaccinating people. And it also raises the possibility that billions in taxpayer money will be wasted by funding drug companies that ultimately produce a vaccine that falls short of safety and efficacy requirements.

The ambitious program should lead to a widely available vaccine for Americans in April, May or June of 2021, Slaoui said. To be sure, that'll depend on whether roughly two-thirds of the vaccines involved with Warp Speed being able to demonstrate efficacy.

"I feel pretty confident we will be there," he added.

Read more: There are more than 160 research programs hunting for a coronavirus vaccine. Here's how the top drugmakers see the race for a cure playing out and when the first shots might be available.

While late-stage trials are now underway for Moderna and Pfizer — and will also start in a matter of weeks for AstraZeneca and Johnson & Johnson — the logistics on how to distribute the shots are still being discussed and designed, Slaoui said.

Slaoui said he anticipates the US can return to normal in the second half of 2021, but that will also depend on people agreeing to take a vaccine.

"The mission of addressing the hesitancy is absolutely vital for our lives to go back to normal," he said. 

Do you have a personal experience with the coronavirus you’d like to share? Or a tip on how your town or community is handling the pandemic? Please email [email protected] and tell us your story.

Get the latest coronavirus business & economic impact analysis from Business Insider Intelligence on how COVID-19 is affecting industries.

Source: Read Full Article