Baltimore Sun

Baltimore NAACP demands meeting

Request is of inspector general’s oversight board

- By Tim Prudente

The Baltimore chapter of the NAACP is calling on city leaders to convene a meeting of the board that oversees the inspector general’s office after its recent investigat­ion of State’s Attorney Marilyn Mosby.

The Rev. Kobi Little, president of the local NAACP, circulated a letter to board members in which he writes that he’s troubled after reading that the oversight board has never met. The Baltimore Sun reported in February the lack of meetings.

“The public must have the confidence that there is effective oversight of the OIG [Office of the Inspector General] which will prevent runaway investigat­ions and hold the OIG accountabl­e to the highest levels of impartiali­ty and competence,” Little wrote on March 1.

He released his letter publicly Monday, saying he has received no response from city leaders.

“Here you have an agency that is given a great amount of authority to investigat­e and report findings on many, many aspects of life in Baltimore around fraud, waste and abuse, “he said in an interview, “and for two years it hasn’t been operated according to the law.”

Authority for the office was moved two years ago from the mayor to an independen­t oversight board that’s supposed

product, and officials have said all the Johnson & Johnson vaccine distribute­d in Maryland is made in Europe.

But an official with the U.S. Department of Health and Human Services told The Baltimore Sun Thursday that Johnson & Johnson expects to provide “a relatively low level of weekly dose delivery” until the East Baltimore plant gets federal authorizat­ion to distribute.

The vaccine maker still expects to fulfill its 100 million-dose commitment to the U.S. around the end of May, the official said.

Gaithersbu­rg-based Emergent BioSolutio­ns, a crucial cog in the global vaccine manufactur­ing network, has received hundreds of millions in federal dollars to boost production of COVID-19 therapies and vaccines, including at its East Baltimore factory. Johnson & Johnson said in a statement that a 15-million dose batch of urgently needed COVID-19 vaccine had to be destroyed because it did not meet the company’s quality standards.

Johnson & Johnson has assumed control of the plant, and vaccine maker AstraZenec­a has stopped its production line there.

Records obtained by The Baltimore Sun through a public records request show numerous problems inside the Bayview facility dating back to at least a year ago, including “deficient” areas to prevent contaminat­ion or mixup of rejected components; insufficie­nt employee training in manufactur­ing; a lack of standardiz­ation of quality-control measures; and a non-adherence to test procedures and laboratory control mechanisms.

Johnson & Johnson also has a contract with the European Union, for 200 million doses. . The company is expected to deliver as many as 50 million doses to Europe by the end of the second quarter of 2021.

All doses distribute­d in the United States so far have been shipped from Europe.

Tinglong Dai, an associate professor at the Johns Hopkins University Carey Business School who studies vaccines, said the East Baltimore mishap is likely to cause some short-term shipment delays. Beyond the bad batch, the Bayview facility made millions more doses, whose fate is unclear. They surely will undergo additional quality checks, along with the plant itself, by the FDA, and that will take time, Dai said.

Emergent operates another plant in Baltimore near the Camden Yards profession­al baseball and football stadiums, where it has helped package a crucial COVID-19 monoclonal antibody therapy.

Emergent did not respond to a request for comment about either Baltimore facility. And Johnson & Johnson has not addressed the latest shortages, with its last statement April 3 saying that the company was working with the FDA on authorizat­ion for the

Bayview facility.

Dr. Joshua Sharfstein, a vice dean at the Johns Hopkins Bloomberg School of Public Health and a former FDA official, said the federal agency’s job is to ensure that the manufactur­ing itself is of high quality.

“I’m sure the focus is not only on this facility but other facilities so the public can have confidence in the products made,” he said.

In an appearance Thursday morning on WBAL Radio, Gov. Larry Hogan said he and the rest of the nation’s governors were blindsided Tuesday night when White House officials told them the nationwide distributi­on of Johnson & Johnson vaccines would be reduced by about 85% this week.

For Maryland, that meant going from about 90,000 of the single-shot immunizati­ons to roughly 11,000, Hogan said, calling it a “big hit.”

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