More than a dozen states complained this week that they were alerted that their second shipment of the Pfizer-BioNTech vaccine doses next week will be drastically less than initially projected, sparking a row between Pfizer and the federal government about who is to blame.
The situation has prompted “widespread confusion and conflicting statements from Pfizer and federal officials about who was at fault,” the Washington Post reported Thursday.
Federal officials are reportedly holding hundreds of thousands of doses in warehouses on hold in case of unexpected problems.
Citing Trump Administration officials who spoke to the Associated Press (AP) on condition of anonymity, Spectrum News from California, the most populous state and the new pandemic epicenter in America, noted, echoing other news outlets:
States will receive their full allocations, one [unnamed administration] official said, but misunderstandings about vaccine supply and changes to the delivery schedule may be creating confusion.
Another official said the initial numbers of available doses that were provided to states were projections based on information from the manufacturers, not fixed allocations. Some state officials may have misunderstood that, the official said.
The federal officials said Pfizer committed to providing 6.4 million doses of its vaccine in the first week after approval [last Friday]. But the federal Operation Warp Speed had already planned to distribute only 2.9 million of those doses right away.
Another 2.9 million were to be held at Pfizer’s warehouse to guarantee that individuals vaccinated the first week would be able to get their second shot later to make protection fully effective. Finally, the government is holding an additional 500,000 doses as a reserve against unforeseen problems.
Even before U.S. regulators approved the Pfizer vaccine candidate, supply-chain obstacles forced the company to reduce its vaccine rollout target by half, the Wall Street Journal noted on December 3.
Pfizer shifted the blame for several states potentially receiving fewer doses next week to the federal government in a statement issued Thursday that contradicted what named and anonymous officials described as the issue.
The company insisted it has “continuously shared” information about their production process with Operation Warp Speed officials.
Operation Warp Speed refers to the Trump Administration’s multi-billion dollar public-private effort to develop a vaccine and therapeutics in record time. Until last Friday, there were no vaccines approved to combat coronaviruses in humans.
Pfizer “is not having any production issues with our COVID-19 [coronavirus disease] vaccine, and no shipments containing the vaccine are on hold or delayed,” the company declared in the statement, adding:
This week, we successfully shipped all 2.9 million doses that we were asked to ship by the U.S. Government to the locations specified by them. We have millions [of] more doses sitting in our warehouse but, as of now, we have not received any [shipping] instructions for additional doses.
The Pfizer statement is at odds with a message from U.S. Department of Health and Human Resources Secretary Alex Azar, who told reporters on Wednesday the company was facing “manufacturing challenges.”
“Because the company did not accept federal funding for the manufacturing and development of its vaccine,” Azar reportedly said, the administration does not have [a] clear insight into what exactly these problems are.”
“Part of our ongoing discussions is to remediate that and get better visibility into what they’re doing, what challenges they’re facing, because they’ve made significant commitments to us and others,” Azar also said.
The secretary asserted Pfizer has only been able to produce half of the vaccine quantity it initially promised.
On Friday, Azar asserted that Operation Warp Speed would have enough doses of the Pfizer and Moderna vaccines to vaccinate 20 million “of our most vulnerable Americans,” pending approval of the Moderna vaccine by the U.S. Food and Drug Administration (FDA) soon.
“Production, of course, would continue to ramp up after that,” he added. Both the Pfizer and Moderna vaccines require two doses.
Unlike other pharmaceutical companies working with Operation Warp Speed, Pfizer independently funded its vaccine’s research and manufacturing.
The Trump Administration, however, paid nearly $2 billion for the first 100 million doses with the option to buy 500 million more. Pfizer, approved for emergency use by U.S. regulators last Friday, supplies other countries with shots as well.
In its statement, Pfizer claimed it remains confident it will deliver 50 million doses across the world this year and up to 1.3 billion doses next year.
Moderna’s vaccine candidate is on track to be approved soon, potentially allowing shipment early and shots next week.
According to Operation Warp Speed officials, Moderna has produced more vaccines than Pfizer — an estimated six million doses versus Pfizer’s nearly three million will be shipped once the FDA authorizes the Moderna.
The states reportedly told to expect smaller shipments of the vaccines next week than initially projected include Connecticut, Georgia, Illinois, Kansas, Montana, Nebraska, Nevada, New Hampshire, Indiana, Texas, Michigan, Missouri, and Hawaii, among others. The virus has been surging across the country in recent months.
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