Eric Sagonowsky| FiercePharma
Johnson & Johnson's COVID-19 vaccine rollout has been slower than
expected in the U.S., with just 6.8 million doses delivered to states
in the first month. Now, The New York Times has revealed behind-the-scenes
details into an unfortunate mix-up in the production process.
Workers at an Emergent BioSolutions plant in Baltimore mixed up vaccine
ingredients weeks ago and ruined a large batch of the vaccine containing around
15 million doses, the Times reports. The FDA is investigating the mistake, but the episode has led to a
temporary halt of future J&J shot deliveries from the site, according to
the newspaper. In a statement, J&J said it's working with federal authorities to deliver 24
million doses of the vaccine in April.
Federal investigators have ruled that the episode was the result of
"human error," NYT reports.
Moving forward, J&J is moving to implement tighter controls at its
manufacturing partner, the company's statement said. J&J and AstraZeneca,
another leading COVID-19 vaccine player, tapped the contract
manufacturer in their production ramp-up efforts last year.
J&J has met its goal to ship 20 million doses to the U.S.
government by the end of March, the company said in its statement. CDC data
show that just 6.8 million doses have been delivered to states, and 3.3
million doses have been administered.
The company said its manufacturing ramp-up "includes test runs
and quality checks to ensure manufacturing is validated and the end product
meets our high-quality standards." That process identified a batch
that didn't meet standards at the Emergent site, which J&J noted has
not yet been authorized.
Emergent spotted the issue and notified the FDA, J&J said.
Moving forward, as the company and Emergent seek an FDA manufacturing
authorization for the site, J&J is "providing additional experts in
manufacturing, technical operations and quality to be on-site at Emergent to
supervise, direct and support all manufacturing of the Johnson & Johnson COVID-19
vaccine."
Working with officials at HHS, the company plans to ship 24 million doses
of the vaccine in April, the statement said. J&J has leaned on
its vaccine plant in the Netherlands to help with production while its U.S. supply chain comes online. For
the first half of the year, J&J is aiming to deliver 100 million doses to
the U.S.
