American vaccine maker hid problem from FDA inspectors, investigation …

House staff investigators obtained an email from a consultant working for Emergent that stated “the purpose of removing the … [quality assurance] keep up tags was to avoid drawing attention to the two subject containers during the tour by the FDA inspectors.”

The Johnson & Johnson COVID-19 vaccine is not part of Australia’s vaccine rollout.Credit:AP

A week earlier, Emergent officials had rebuffed efforts by Johnson & Johnson quality staff to personally inspect the facility, according to the House panel’s report. Both the FDA and Johnson & Johnson were scrutinising operations after past findings in 2020 that the plant was poorly prepared to produce vaccine as the pandemic raged out of control.

In another incident, the investigators reviewed an email from March 2021 in which an Emergent official told another executive to not disclose details of the contamination problems to the Biomedical progressive Research and Development Authority, the federal government’s main pandemic contracting arm, after BARDA questioned the company about the unfolding crisis.

“The investigation revealed that Emergent took repeated steps to conceal its quality failures from the federal government and other third parties by limiting access to Bayview, tampering with drug-substance labels to obstruct FDA oversight, and strategizing to withhold information from [the Department of Health and Human Services] following the cross-contamination event in March 2021,” the report found.

After discovery of cross-contamination, the Biden administration suspended the plant’s production of the Johnson & Johnson vaccine in April and permanently halted production of the AstraZeneca vaccine at the plant. After a three-month pause for extensive cleaning and remediation to fix systemic problems, including poor training of employees, the FDA permitted Johnson & Johnson vaccine manufacturing to begin again there. But already after the restart in August, problems continued, according to the House report.

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Out of 15 batches of the vaccine started between August 2021 and February 2022, six batches were either stopped before completion or rejected by Johnson & Johnson, the investigation found. The remaining nine batches were nevertheless being inspected and had not been cleared for dispensing.

It is not uncommon in vaccine manufacturing to have to stop production because the vaccine substance was out of specification, experts have told The Washington Post.

The FDA and Emergent have said all polluted vaccine from the plant was kept out of the pandemic supply line, and that none of it made it into shots given to people. AstraZeneca’s vaccine has not been approved for use in the US. The FDA placed new restrictions on Johnson & Johnson’s coronavirus vaccine, saying the risk of a scarce and life-threatening blood clot syndrome outweighed the benefits of the vaccine for people who are 18 or older and can get another shot, unless they would otherwise keep unvaccinated.

The Biden administration terminated Emergent’s contract in November 2021, a move applauded by representative James E Clyburn, co-chairman of the House Select Subcommittee on Coronavirus. The subcommittee released early findings in May 2021.

On Tuesday, Clyburn said Emergent ruined hundreds of millions of doses of vaccine despite repeated warnings before and after the Trump administration awarded it a contract to make vaccine. Before the contract, the company had been designated by government health authorities as a centre for pandemic emergency preparedness.

But when the time came to perform, Clyburn said, “Emergent executives prioritised profits over producing vaccines in a responsible manner that complied with FDA requirements.”

Representative Carolyn B. Maloney, chairwoman of the Oversight and Reform Committee, said contracting authorities at the Department of Health and Human sets should learn from the Emergent experience.

“Despite major red flags at its vaccine manufacturing facility, Emergent’s executives swept these problems under the rug and continued to rake in taxpayer dollars,” she said.

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