Pharmacies about to administer multiple vaccines are worried about waste, and cash-strapped state and local health departments say they need more money and direction from the federal government. The Federal Department of Health says states have what they need and the government will support any shortages that arise.
“We really don’t want to waste a drop of this stuff, so that’s a concern. And I don’t have all the answers yet on how we’re going to do it, ”said Paul Cieslak, Oregon’s medical director for communicable diseases and vaccinations.
The vaccine, if authorized urgently, should first be administered to health workers and the elderly, further complicating planning efforts.
Most of the concerns stem from the Covid-19 vaccine requirements Pfizer submitted to the FDA on Friday. It should be stored in ultra-cold conditions and will be shipped in specially designed pizza-shaped boxes containing a minimum of 975 doses in 195 glass vials. Once a vial is thawed and diluted to give five injections, health workers will be in a real ‘use it or lose it’ situation: if there are not enough people ready for it. in less than six hours, the vaccine spoils, slowing efforts to eliminate hot spots and save lives.
“It will not be acceptable,” said Douglas Hoey, CEO of the National Community Pharmacists Association. “Especially at the beginning, it will be practically liquid gold.”
Some waste is inevitable in any large-scale immunization program. But it’s not the seasonal flu: All Covid-19 vaccines allowed for use will land during a devastating global pandemic that has killed nearly 1.4 million people worldwide – including more than a quarter of a million in the United States – with no sign of stopping. Analysts predicting that it would take months to vaccinate all Americans, minimizing waste will be crucial.
The first vaccinations will be concentrated in hospitals, according to federal health officials. Even they might find it difficult to minimize the number of spoiled doses by vaccinating staff. But the waste problem are growing in importance as pharmacies are gradually added to the mix – especially those in rural areas where there are fewer people.
Maryland health officials told the Centers for Disease Control and Prevention that up to 5% of the vaccine allocated to the state could go bad and go unused.
Some rural counties might not be able to use 975 doses on their own, said Kurt Seetoo, who runs the state health department’s vaccination center. Maryland plans to create regional clinics, bringing together high-priority groups from different rural counties to immunize all at the same time.
HHS Secretary Alex Azar told Sirius XM on Friday that Pfizer’s more demanding storage requirements made it a better choice for large institutions like hospitals and large retail pharmacies. Another Covid-19 vaccine maker, Moderna, will soon seek emergency clearance from the FDA for its vaccine – which can be stored in the refrigerator for up to 30 days and at room temperature for up to 12 hours.
Earlier this week, General Gustave Perna, who heads Operation Warp Speed, the Trump administration’s initiative to bring a vaccine to market, said CVS and Walgreens know how to do this and his team had worked with states to “make sure that no vaccine is wasted.” “
But Paul Offit, a vaccine researcher at the Children’s Hospital of Philadelphia and a member of the panel of experts advising the FDA on Covid-19 vaccines, told reporters on Friday he was “very concerned” about the risk of waste doses of Pfizer vaccine. if it is allowed.
“It’s going to be very difficult, I think there is going to be a steep learning curve here,” Offit said. “I think there’s going to be a lot of waste, and I think we’ll figure that out over time. There are going to be a lot of stumbles. … You have six hours once reconstituted, it’s unprecedented.
In Oregon, the state can contract with emergency medical providers to drive and distribute the vaccine to remote areas – an attempt to avoid having any leftover vaccines.
And North Dakota wants to repackage the vaccine in smaller-quantity boxes, while encouraging suppliers to be able to quickly identify people from the next priority group to come in for the vaccine if there is any vaccine left. The state is also asking facilities to pre-register patients to ensure that no vaccine needs to be thrown away. His vaccination plan recognizes that this could delay the distribution by a day but it is necessary to keep precious vials. Pfizer says it’s working on a smaller package size, but it won’t be ready until early next year, and it’s unclear whether that will solve the need to deliver at least five injections in a matter of hours.
The various plans highlight concerns that public health experts have long raised about the hands-off approach the Trump administration has maintained throughout the pandemic. This is true even for the final leg of the vaccine race, which the president has made the centerpiece of his response to the coronavirus.
“There is a huge leadership vacuum,” said Georges Benjamin, executive director of the American Public Health Association.
Meanwhile, the Trump administration is refusing to share its planning with President-elect Joe Biden’s transition team, who said on Wednesday that lack of access could hamper vaccine distribution. Instead, the Biden team has been in contact with Pfizer and other drugmakers; a spokesperson for Pfizer declined to share details of the communication.
“There’s no excuse not to share the data and let’s start planning,” Biden said Thursday at a press conference. “If we don’t have access to all this data, it will put us behind the eight ball by a month or more. And that’s life.
Azar disputed this claim on CBS’s “This Morning” Friday, saying it was “absolutely incorrect.”