Covid-19 vaccine deficiencies attributable to confusion about FDA necessities

Employees move boxes of Pfizer-BioNTech Covid-19 vaccine as they prepare for shipment at Pfizer Global Supply’s Kalamazoo manufacturing facility in Kalamazoo, Michigan on December 13, 2020.

Morry Gash | AFP | Getty Images

Officials at Operation Warp Speed, the U.S. government’s program to distribute Covid-19 vaccines to Americans, had to cut doses for several states due to confusion over the U.S. Food and Drug Administration’s certificate of analysis for rounds of vaccination.

The federal government’s mistake disrupted vaccination distribution plans in at least 14 states and frustrated governors and state health officials who said they were surprised to learn of shipping shortages.

Operation Warp Speed ​​has put 2 million Pfizer vaccine doses ready for delivery next week, after the US shipped 2.9 million doses last week. Officials also plan to ship 5.9 million doses of Moderna’s vaccine this week.

Dr. Moncef Slaoui, chief advisor to Operation Warp Speed, said the agency mistakenly assumed that Pfizer’s vaccine was ready to ship when there was actually a two-day delay in which the FDA required a certificate of analysis for each batch of vaccines.

“This delay has led to differences in the plan and in the actual measures,” Slaoui said in an interview on CNN’s State of the Union on Sunday. “We’ve looked at it and optimized what we’re doing every day.”

The FDA requires a certificate of analysis for each round of Pfizer vaccines at least 48 hours prior to distribution, but does not require the certificate to be verified prior to shipment. The certificate contains quality control test results and is required when Pfizer uses an emergency approval under the FDA.

Former GlaxoSmithKline pharma executive Moncef Slaoui, who will serve as the chief advisor in the search for a vaccine against the coronavirus disease (COVID-19) pandemic, speaks while President Donald Trump during a coronavirus response event Illness in the rose garden at the White Hearts House in Washington.

Kevin Lamarque | Reuters

Operation Warp Speed’s Chief Operating Officer, General Gustave Perna, who is responsible for the logistics for shipping the vaccines, repeatedly apologized for smaller vaccine shipments on Saturday and took responsibility for the “planning error”.

“The mistake I made is not really understanding – again my responsibility – what steps are needed to make sure the vaccine is releasable,” Perna said at a press conference.

States where fewer than expected numbers occur include Washington state, New Jersey, Virginia, Idaho, Michigan, Connecticut, California, Nevada, Minnesota, Wisconsin, Vermont, Massachusetts, Iowa, and Oregon.

Washington Governor Jay Inslee said Thursday that the Centers for Disease Control and Prevention had told him that vaccine allocations for his state had been cut by 40% and that other states had similar deficits.

General Gustave Perna, Chief Operating Officer for the Department of Defense’s Warp Speed ​​Project, speaks during a White House Coronavirus Task Force press conference in the James Brady Press Room at the White House in Washington, DC on November 19, 2020.

Tasos Katopodis | Getty Images News | Getty Images

“It’s disruptive and frustrating. We need accurate, predictable numbers to plan and ensure on-site success,” wrote Inslee in a tweet. “No explanation was given.”

Pfizer spokeswoman Kim Bencker told CNBC in an email after Perna apologized that the company had millions of cans in warehouses ready to ship once the company received confirmation from Operation Warp Speed.

“We remain confident that we can dispense up to 50 million doses worldwide this year and up to 1.3 billion doses next year,” said Bencker.

U.S. Surgeon General Jerome Adams said the introduction of the vaccine will be the toughest vaccination program in history, warning that there will be inconsistencies in the number of planned doses and the doses actually allocated.

“This will be the technically and logistically most difficult vaccination project of all time,” said Adams on Sunday in an interview with CBS ‘”Face The Nation”. “We started slowly and will continue to grow. The American people should be hopeful about the vaccines, but we also need to remain vigilant.”

– CNBC’s Noah Higgins-Dunn contributed to the coverage

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