Johnson & Johnson COVID-19 vaccine batch fails quality check

Coronavirus Vaccine

BALTIMORE (NewsNation Now) — Johnson and Johnson reported that one of their factories, which was not yet fully authorized to produce their one-shot COVID-19 vaccine, had a batch that did not meet quality standards and was thrown out.

The drugmaker didn’t say how many doses were lost, and it was not immediately clear how the problem would impact future deliveries.

A vaccine ingredient made by Emergent BioSolutions — one of about 10 companies that Johnson & Johnson is using to speed up manufacturing of its recently approved vaccine — did not meet quality standards, J&J said.

In a statement released by J&J, the company said, “This is an example of the rigorous quality control applied to each batch of drug substance. The issue was identified and addressed with Emergent and shared with the United States Food & Drug Administration.”

J&J had pledged to provide 20 million doses of its vaccine to the U.S. government by the end of March, and 80 million more doses by the end of May. Its statement on the manufacturing problem said it was still planning to deliver 100 million doses by the end of June and was “aiming to deliver those doses by the end of May.” A federal official said Wednesday evening the administration’s goal can be met without additional J&J doses.

J&J said the Emergent BioSolutions factory involved had not yet been approved by the U.S. Food and Drug Administration to make part of the vaccine.

Emergent, which has been producing bulk drug substance at one of its factories in Baltimore, declined to comment.

Emergent, a little known pharmaceutical company granted a major role in the federal government’s response to coronavirus pandemic, has been repeatedly cited by the FDA for problems ranging from poorly trained employees to cracked vials and mold around one of its facilities, according to records obtained by The Associated Press through the Freedom of Information Act.

The records cover inspections at Emergent facilities, including Bayview, since 2017. Following a December 2017 inspection at an Emergent plant in Canton, Massachusetts, the FDA said the company hadn’t corrected “continued low level mold and yeast isolates” found in the facility. Nearly a year later, agency investigators questioned why Emergent had “an unwritten policy of not conducting routine compliance audits” at a separate plant in Baltimore, known as Camden, where an anthrax vaccine is filled into vials.

Emergent’s revenues skyrocketed during the Trump administration, jumping from around $523 million in 2015 to more than $1.5 billion in 2020. The company has invested heavily in lobbying the federal government, according to disclosure records, which show the company spent $3.6 million on lobbying in 2020 alone.

J&J, which created the only currently approved single-shot vaccine in the U.S., has faced manufacturing issues in both America and Europe.

Last month, Merck and Co. agreed to team up with rival J&J to distribute the 1 shot vaccine in order to speed up production. Merck’s collaboration with J&J comes after Merck scrapped the development of its own COVID-19 vaccine candidates in January.

President Joe Biden has pledged to have enough vaccines for all U.S. adults by the end of May. The U.S. government has ordered enough two-dose shots from Pfizer and Moderna to vaccinate 200 million people to be delivered by late May, plus the 100 million shots from J&J.

As of Wednesday, J&J had provided about 6.8 million doses, according to the U.S. Centers for Disease Control and Prevention’s online vaccine tracker. Some additional doses may not yet have been recorded as delivered, and the CDC said Wednesday that another 11 million doses of the vaccine would be available for shipments starting on Thursday.

It was not immediately clear where those 11 million doses originated, but Johnson & Johnson has been shipping finished vaccines from its factory in the Netherlands to the U.S.

The FDA said it was aware of the situation but referred questions to Johnson & Johnson.

About 54.6 million people, or 16.4% of the U.S. population, have been fully inoculated with COVID-19 vaccines made by Pfizer Inc/ BioNTech SE, Moderna Inc and Johnson & Johnson, according to CDC data. 29.4% of the U.S. population, or 97.5 million adults had received at least one dose of a COVID-19 vaccine.

The Full Johnson and Johnson Statement is below:

Since January of 2020, Johnson & Johnson has been working directly with governments, health authorities and other companies to help end the global pandemic. We continue to expect to deliver our COVID-19 vaccine at a rate of more than one billion doses by the end of 2021.

We are pleased we have met our commitment to deliver enough single-shot vaccines by the end of March to enable the full vaccination of more than 20 million people in the United States. This is part of our plan to deliver 100 million single-shot vaccines to the U.S. during the first half of 2021, aiming to deliver those doses by the end of May.

As with the manufacturing of any complex biologic medication or vaccine, the start-up for a new process includes test runs and quality checks to ensure manufacturing is validated and the end product meets our high-quality standards. This approach includes having dedicated specialists on the ground at the companies that are part of our global manufacturing network to support safety and quality.

This quality control process identified one batch of drug substance that did not meet quality standards at Emergent Biosolutions, a site not yet authorized to manufacture drug substance for our COVID-19 vaccine. This batch was never advanced to the filling and finishing stages of our manufacturing process.

This is an example of the rigorous quality control applied to each batch of drug substance. The issue was identified and addressed with Emergent and shared with the United States Food & Drug Administration (FDA).

Quality and safety continue to be our top priority. Therefore, as we continue to work with FDA and Emergent toward the Emergency Use Authorization of the Emergent Bayview Facility, Johnson & Johnson 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. In coordination with the U.S. Department of Health & Human Services, these steps will enable us to safely deliver an additional 24 million single-shot vaccine doses through April.

Associated Press reporters Matt Perrone and Zeke Miller in Washington contributed to this report.

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