WASHINGTON — Gustave Perna, the four-star Army general overseeing the task of distributing coronavirus vaccines, said Saturday that he was responsible for the “miscommunication” with states causing them to get fewer doses of the Pfizer-BioNTech vaccine in the second wave of shipments this week than they had been anticipating.
“I want to assure everybody, and I want to take personal responsibility for the miscommunication,” Perna, who is chief operating officer for the Trump administration’s Operation Warp Speed, told reporters. “I know that’s not done much these days, but I am responsible. … This is a Herculean effort, and we are not perfect.”
In another development, the federal government says in guidelines that employers can require workers to get covid-19 vaccines and bar them from the workplace if they refuse.
So far, 2.9 million doses of the Pfizer vaccine have been delivered across all 50 states. As of Saturday morning, 272,001 doses had been administered, according to the Centers for Disease Control and Prevention.
The distribution problem stemmed from mistakes in forecasts that Perna initially gave state officials, which did not account for steps involved in actually clearing available vaccine for release, he said. “There is a delay between what is available and what is releasable,” he said, “because we’re talking about hundreds and thousands and millions of doses that we want to make sure are right.”
But he was not clear about the scope of quality assurance, or about why it would delay the release of doses, saying only that the Food and Drug Administration “does a fantastic job doing that.”
The FDA does not review batches of vaccine before their distribution, an agency spokesperson said Saturday in response to requests to explain the process. Under the terms of the agency’s authorization for the Pfizer-BioNTech vaccine, the company is required to submit “certificates of analysis for each drug product lot at least 48 hours before vaccine distribution.” But the FDA does not review the information before the product is shipped.
FDA Commissioner Stephen Hahn confirmed that later in a tweet, saying, “they can distribute without waiting for FDA’s ok.”
Asked about the steps involved in clearing doses for release, Perna said he didn’t know “the exact details on that.” He did stress that there had been “zero problems” with Pfizer’s product.
Governors and state health departments have spoken with alarm of how few vaccines they have received compared with what had been promised.
“This is disruptive and frustrating,” Gov. Jay Inslee of Washington wrote on Twitter on Thursday. “We need accurate, predictable numbers to plan and ensure on-the-ground success.”
Dr. Mark Levine, commissioner of the Vermont Department of Health, said in a Friday briefing that “all my colleagues in the region are reporting a 25 to 35% decrease in their allocation for next week.”
“As we were walking in, I learned as many as 975 doses out of an expected 5,850 doses would not be coming in when we expected,” he said. “What everyone around the country is upset about, in addition to just the number, is there’s been no communication, so there’s no understanding of what this really means.”
In Michigan, where the Pfizer vaccine is produced, Democratic Gov. Gretchen Whitmer on Friday accused the White House of “slow-walking the process.”
“We have Michigan hospitals and nursing homes ready to administer this vaccine,” she said.
EMPLOYERS’ ROLES
Public health experts see employers as playing an important role in vaccinating enough people to reach herd immunity and get a handle on a pandemic that has killed more than 316,000 Americans. Widespread vaccinations would keep people from dying, restart the economy and usher in a return to some form of normalcy, experts say.
Employers had been waiting for guidance from the U.S. Equal Employment Opportunity Commission, the agency that enforces laws against workplace discrimination, because requiring employees be tested for the coronavirus touches on thorny medical and privacy issues covered by the Americans with Disabilities Act of 1990.
The guidance, issued Wednesday, confirmed what employment lawyers had expected. Businesses and employers are uniquely positioned to require large numbers of Americans who otherwise would not receive vaccinations to get them because their employment depends on it.
The Americans with Disabilities Act limits employers’ ability to require medical examinations like blood tests, breath analyses and blood-pressure screening. These are procedures or tests, often given in a medical setting, that seek information about an employee’s physical or mental conditions.
The administration of a covid-19 vaccine doesn’t fit that definition, the commission said. “If a vaccine is administered to an employee by an employer for protection against contracting COVID-19, the employer is not seeking information about an individual’s impairments or current health status,” it stated, “and, therefore, it is not a medical examination.”
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The commission said requiring an employee to show proof of having gotten a vaccination would not amount to a disability-related inquiry. “There are many reasons that may explain why an employee has not been vaccinated, which may or may not be disability-related,” the commission said.
The guidance comes amid skepticism about covid-19 vaccinations among large swaths of the public. A recent poll of about 2,000 New York City firefighters found that nearly 55% said they would not get a vaccine if offered one by their department, according to CNN.
Only 42% of Black Americans said they intended to be vaccinated, according to a Pew Research poll. And 58% of Americans overall indicated that they would get vaccinated, according to a Gallup Panel survey from November.
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SHIPMENTS CONFUSION
The confusion about the size of shipments was compounded by the move to notify states earlier — on Tuesday rather than Friday — of the number of doses on hand for them to order for the following week, Perna said. Before that notification, states were operating based on a “forecasted worksheet that laid out what we thought might be possible in eventual distribution,” he said.
Asked to explain in simpler terms what happens to make doses releasable, he said, “I am not going to spend any more time talking about the details between fill-finish and releasable.”
The on-camera explanation came two days after reports of widespread confusion in the states yielded conflicting explanations from the Trump administration and from Pfizer, which are locked in negotiations over additional vaccine doses for the United States. A Health and Human Services spokesman initially denied any changes to state allocations, while questions about Pfizer’s manufacturing capacity prompted the pharmaceutical giant to put out a statement saying it faced no production issues.
“We have millions more doses sitting in our warehouse but, as of now, we have not received any shipment instructions for additional doses,” the statement said.
Across the country, governors and top health officials said their expected supply for this week had been cut by as much as 40% or 50% without explanation, forcing them to change their plans.
Already, they were making agonizing decisions about how to allocate a sharply limited share of shots, choosing between ICU nurses and respiratory therapists and emergency medicine residents. Some states had been intending to use the second shipment to begin vaccinating residents of long-term-care facilities, where nearly 40% of covid-19 deaths have occurred.
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The faulty forecasts described by Perna were part of planning assumptions that had been built into Tiberius, a data system developed with Palantir, a Denver-based software company.
The assumptions shared with states using that system were not updated, according to a federal health official who spoke on condition of anonymity to share internal discussions. States have reported varying levels of comfort with the brand-new data system.
“Everyone assumed that was the final count,” the federal official said. When it came time to order doses in a separate system operated by the CDC, state officials found there were fewer doses available.
That led to confusion because state officials were not immediately given an explanation by the Trump administration.
Perna said he has since had conversations with numerous state officials, including Washington Democratic governor.
An added layer of complexity, Perna noted, was the need to have certainty about the availability of a second dose for each initial shot dispatched by the federal government.
The Trump administration has opted to hold back booster shots to be delivered 21 days later in the case of the Pfizer-BioNTech vaccine, rather than sending out all doses for states and other jurisdictions to divide into first and second shots. The decision has baffled people close to Pfizer and surprised some state officials, who said it made their planning more difficult.
Still, state officials said they were rolling with the punches.
“When we get projections from the federal government, we use those but also know it could change,” said Jinlene Chan, Maryland’s acting deputy health secretary.
MODERNA VACCINE
The FDA’s Friday-night authorization of Moderna’s two-dose regimen for emergency use also means more doses will be available and scheduled for delivery across the U.S. as soon as Monday. Between Pfizer and Moderna, 7.9 million doses of vaccine will be shipped this week, Perna said. They will arrive at more than 3,700 locations, he said.
Perna noted that boxes of the Moderna vaccine were being packed and loaded, and that truckloads would begin rolling out today. He said workers were packing containers with 100 vials each, a relatively small number that also eases transportation. “This allows jurisdictions ways to reach small and hard-to-reach rural areas,” he said.
Perna said the government remained on track to allocate about 20 million vaccine doses across the country by the end of December and that the distribution of those doses would be “pushing into the first week of January.”
“There is no problem with the process,” he said. “There is no problem with the Pfizer vaccine. There is no problem with the Moderna vaccine.”
“It was a planning error, and I am responsible,” he said.
He also expressed confidence that “we will have the agility to correct ourselves and get things right, so that the next time it will go flawlessly.”
In other developments, an independent vaccine advisory panel to the CDC voted to recommend Moderna’s vaccine for use in people age 18 and older, paving the way for inoculations to begin as shipments arrive.
The move follows Friday’s authorization from the FDA, which permitted the vaccine to be administered. An endorsement by the CDC immunization panel signals that the vaccine should be administered to the populations included in its guidance.
The United States added a record 249,709 new cases of covid-19 in one day, with California’s 48,000 new cases leading the way, Johns Hopkins University reported Saturday. The death toll now stands at more than 315,000.
Texas, Florida, New York and Tennessee each recorded more than 10,400 new cases.
Cases were on the rise before Thanksgiving, and holiday gatherings since have sent them even higher. Health officials fear the increase will be compounded through Christmas and New Year’s. In many places, health officials say, people tired of wearing masks and staying away from others are simply disregarding advised precautions.
Gallery: Coronavirus scenes, 12-19-2020
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In Louisiana, the state’s newest member of Congress was admitted to a hospital Saturday, a day after announcing that he had been diagnosed with covid-19. Republican Rep.-elect Luke Letlow was admitted as a precaution, a spokesman said.
He is the third high-profile Louisiana politician in two days to say he had been infected. Democratic U.S. Rep. Cedric Richmond, who is leaving to become a member of President-elect Joe Biden’s White House staff, and Republican Lt. Gov. Billy Nungesser both said Thursday that they had tested positive.
Two Republicans in Louisiana’s congressional delegation — U.S. Sen. Bill Cassidy and U.S. Rep. Mike Johnson — have recovered from the disease.
Information for this article was contributed by Isaac Stanley-Becker, Laurie McGinley, Lena H. Sun, Derek Hawkins and Lateshia Beachum of The Washington Post; by Vimal Patel, Giulia McDonnell, Nieto del Rio, Noah Weiland and Sharon LaFraniere of The New York Times; and by Ed White, Jill Colvin, Alanna Durkin Richer, Jay Reeves and staff members of The Associated Press.
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