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Get Ready to Ramp Up Production When Vaccine Comes, HHS Advises

March 24, 2020, 6:04 PM

Biotech companies should prepare now to ramp up production for Covid-19 vaccines and treatments to prevent manufacturing delays that could hinder patient access, a key HHS official said.

Federal authorities want to “ensure that when we have a vaccine or drug available, there are multiple facilities able to scale up and manufacture and produce and fill and finish and deliver those vaccines and drugs and reagents as quickly as possible,” Rick A. Bright said Tuesday during a Biotechnology Innovation Organization virtual summit on the novel coronavirus.

Bright is the director of the Biomedical Advances Research and Development Authority (BARDA), which helps companies get new medical countermeasures onto the market and into the Strategic National Stockpile.

“No single manufacturer that I’m aware of has the full capacity needed to make a large-scale, full-response supply as quickly as possible out of a single facility,” said Bright, who is also the deputy assistant secretary for preparedness and response for the Department of Health and Human Services.

There are no approved vaccines or treatments available for Covid-19, the respiratory disease caused by the new coronavirus. Companies such as Gilead Sciences Inc. and Moderna Inc. have potential treatments and vaccines in clinical trials. BARDA is also working with Sanofi S.A., Johnson & Johnson, Janssen Research & Development, Regeneron Pharmaceuticals, and other companies on Covid-19 products.

Not Too Soon to Stock Up

A vaccine won’t be on the market for at least a year to 18 months, but Bright called on the biotech industry to begin working now on how to make and distribute an approved product.

In a span of just over 30 seconds, he said “now” four times, emphasizing that manufacturers should start gathering raw materials and getting agreements in place with others in the industry to prevent any production delays.

Bright acknowledged the risk involved in buying necessary materials because none of these therapies have proven to work yet and there’s no guarantee the Food and Drug Administration will approve them.

“We must also plan for success, and plan for success today in parallel, to initiating phase I clinical studies,” he said.

‘Vaccine for the World’

Bright isn’t alone in his concerns about scaling up potential Covid-19 countermeasures. Julie L. Gerberding, who led the Centers for Disease Control and Prevention during the 2003 SARS outbreak, said that manufacturing a vaccine of this scale would be an unprecedented effort.

“We have never made a vaccine for the world,” Gerberding said in an earlier interview. “Even with influenza, there is no influenza vaccine sufficient to vaccinate the entire world.”

Gerberding is now an executive vice president Merck & Co. Inc., which developed the Ebola vaccine that the FDA approved in December.

“We thought we would have a licensed vaccine much faster than we did but it took a long time because of all the testing and safety and regulatory monitoring etc. that had to go on,” she said of Ebola. Likewise, a potential Covid-19 vaccine raises questions of: When will a vaccine be available? How many doses can be made quickly? Will it work and will it be safe?

“It’s a really tall order,” she said. “So we have to be careful not to overpromise.”

To contact the reporter on this story: Jeannie Baumann in Washington at jbaumann@bloomberglaw.com

To contact the editors responsible for this story: Fawn Johnson at fjohnson@bloomberglaw.com; Peggy Aulino at maulino@bloomberglaw.com

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