- The Washington Times - Sunday, April 4, 2021

The federal government is putting Johnson & Johnson in charge of a Baltimore vaccine facility to avoid the type of mix-up that spoiled up to 15 million doses.

J&J confirmed it is “assuming full responsibility” for the Bayview facility run by contractor Emergent BioSolutions, where workers conflated ingredients for the one-shot vaccine with AstraZeneca’s two-dose version.

“Specifically, the company is adding dedicated leaders for operations and quality and significantly increasing the number of manufacturing, quality and technical operations personnel to work with the company specialists already at Emergent,” J&J said.

The move will allow J&J to focus on its vaccine at the plant while nudging AstraZeneca production out of the facility.

Emergent said it received a contract modification to purchase equipment specifically for J&J production and will work with the U.S. government and AstraZeneca on a “mutually agreed” plan to ramp down production of AstraZeneca’s drug substance.

“Emergent’s top priority continues to be the strengthening of the supply chain for Johnson & Johnson’s vitally needed COVID-19 vaccine,” Emergent President and CEO Robert G. Kramer said. “We have been working closely with Johnson & Johnson and welcome the additional oversight and support at our Bayview facility.”

The AstraZeneca vaccine has not been approved for use in the U.S., while officials are banking on the J&J shots to speed up the nation’s vaccine campaign in the face of aggressive variants and a U.S. death toll that has surpassed 550,000.

Michael Osterholm, an infectious diseases expert at the University of Minnesota, said the increasingly prevalent B.1.1.7, or “U.K.,” variant is “a brand-new ballgame” because of its ability to spread and infect younger persons.

“I give the administration great credit for how it’s bringing forward vaccine as quickly as possible. But at the same time, we’re not going to have nearly enough in the next six to eight weeks to get through this surge, and we’re gonna have to look at other avenues to do that, just as every other country in the world who has had a B.1.1.7 surge has had to do,” he told NBC’s “Meet the Press” Sunday.

Even as Biden administration officials ask people to double down on basics such as mask-wearing and physical distancing, they are under pressure to let fully vaccinated Americans do what they can in society.

The Centers for Disease Control and Prevention said Friday that fully vaccinated people may travel within the U.S. without getting tested or quarantining after their trips because they are less likely to get and spread the virus.

They also can travel to other countries without getting tested first, unless it is required by their destination. And they don’t need to self-quarantine when they return to the U.S., unless their locality demands it.  

However, fully vaccinated Americans should present a negative test before boarding a flight back to the U.S. and get tested three to five days after returning home. 

They also should wear masks while traveling, the CDC said. The COVID-19 vaccines are effective but not 100%, and scientists are studying the degree to which a vaccinated person can spread the virus.

A person is considered fully vaccinated two weeks after receiving the second shot of the two-dose Pfizer-BioNTech or Moderna vaccines or one shot of the J&J version.

Nearly 20% of Americans are fully vaccinated, and close to a third have received at least one dose of a COVID-19 vaccine.

The rollout is accelerating — more than 4 million shots were administered on Saturday alone — and is the envy of much of the world, but the mix-up in Baltimore was a black eye for the effort.

Prashant Yadav, a senior fellow at the Center for Global Development, said having the 15 million doses likely would have moved up appointments for some people to a few weeks earlier, “but it doesn’t impact the overall plan that much.”

“It is more than a blip but not a major setback,” said Mr. Yadav, who studies health care supply chains.

He said this kind of mix-up has happened in the past but it is not common.

“Contract manufacturers routinely manufacture more than one similar product, and we don’t see mix-ups happen frequently,” he said.

J&J says it still plans to meet its goal of supplying 100 million doses to the U.S. government by the end of May

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