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New NIH Program to Speed Vaccine, Antibody Upgrades to Variants

Jan. 25, 2021, 5:25 PM

Covid-19 vaccines and monocolonal antibodies will adapt quickly to fight off new strains of the virus—if that need emerges—under a new NIH program.

Leaders at the National Institutes of Health told Bloomberg Law they’re using ACTIV, the public-private partnership for accelerating Covid-19 therapeutic interventions and vaccines, to coordinate data from industry, government, and academia to determine whether the new strains make a vaccine or monoclonal antibody less responsive.

“We may not ever need to go to an upgraded version in order to address the mutants. But we might,” Anthony S. Fauci, director of the National Institute of Allergy and Infectious Diseases in the NIH and President Joe Biden‘s chief medical adviser for Covid-19, said in an interview. “Rather than sitting around waiting for the need, we’re anticipating the need.”

Vaccines produced by Moderna Inc. and Pfizer-BioNTech appear to protect against strains such as B.1.1.7, the strain first identified in the U.K., along with variants in South Africa and Brazil. But vaccine makers said they could adjust their shot in about six weeks to work on the new strains.

Fauci said Sunday on CBS’s Face the Nation “a little bit more concerning” is the strain that’s prevalent in South Africa. That strain appears to have a negative impact on monoclonal antibodies and has some effect on the vaccine. But there’s what he calls a “cushion effect” that means the vaccines still appear to work, even if they are slightly less efficacious against these newer strains.

As cases of the B.1.1.7 strain have emerged in more than 20 U.S. states, NIH Director Francis S. Collins said he’s concerned there needs to be a more coordinated way to look at these emergency variants and understand their effects on a vaccine or monoclonal antibody therapy.

“Right now, that data is kind of scattered around, and it’s not always immediately accessible,” Collins said in an interview. “So we are working hard on coming up with a clearinghouse that could be quickly assembled where all that data could be deposited. And all that’s being done through this ACTIV partnership.”

The responsibility for tracking the emerging variants in the U.S. rests with the Centers for Disease Control and Prevention, which is boosting its surveillance efforts, CDC Director Rochelle P. Walensky said on Fox News Sunday.

“But that’s not sufficient,” Collins said. “That will tell you that something’s emerging. Then you want to know: Does it matter?”

With a variant emerging out of California “that everyone’s getting a little worried about,” the ACTIV program will quickly figure out who has the assays ready to go to indicate whether that strain would be less responsive to a particular monoclonal antibody or might be a virus to which our current vaccines don’t provide effective antibodies. “And you probably even want to think about doing that in animal models as an even more compelling way to understand the answer,” Collins said.

Both Moderna and Pfizer rely on a new technology known as messenger RNA to deliver the vaccine, which allow upgrades to happen much more quickly than conventional vaccines. “That was one of the original reasons why we were enthusiastic about the mRNA platform is its exquisite adaptability to these types of things,” Fauci said in an interview.

Fauci said if the work started now, new vaccines could produced in just a couple of months. “You won’t have enough vaccine to make the change in a couple of months, but you could at least start getting it made in a couple of months.”

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

To contact the editors responsible for this story: Fawn Johnson at fjohnson@bloombergindustry.com; Karl Hardy at khardy@bloomberglaw.com

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