Operation Warp Speed Chief Says U.S. Jurisdictions Are Ready for Vaccine Distribution

The U.S. is ready to distribute Pfizer’s COVID-19 vaccine despite its need for extremely cold temperatures, Gen. Gustave Perna, chief operating officer of Operation Warp Speed, said yesterday, adding that the company is taking a “very aggressive approach” to testing the distribution strategy.

Perna announced yesterday in a press briefing that the drugmaker, whose 95 percent effective COVID-19 vaccine is the first being reviewed for Emergency Use Authorization (EUA), has expanded its recently announced distribution pilot program (DID, Nov. 18) from four states to 10 locations and will now conduct tests in 54 remaining jurisdictions that include U.S. states, territories and major metropolitan areas to ensure there’s a successful plan in place to allocate the vaccine.

Overall, the U.S. appears prepared for the initial rounds of Pfizer’s and Moderna’s vaccines should EUAs be granted, and close to 40 million vaccine doses should be distributed by year’s end, the Operation Warp Speed official said. In total, 6.4 million vaccine doses have been allocated for the initial rollout, and allocation numbers were sent out to jurisdictions and federal agencies for planning purposes on Friday, he said.

The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) will meet on Dec. 10 to discuss Pfizer’s vaccine and will discuss Moderna’s vaccine “more or less a week later,” said Operation Warp Speed Chief Adviser Moncef Slaoui.

HHS Secretary Alex Azar said during the briefing that by the second quarter of 2021, he believes “we’d have enough vaccine from all sources” so that any American would be able to get vaccinated if they so choose.

 “Pfizer is really implementing a very aggressive approach to figuring out how to get their product out to the administration sites as designated by the states,” Perna said. “They’re running dry rehearsals, this way they run through the actual process of registering product through a jurisdiction, then they deliver the product, then they walk the administration sites through the actual opening [of the containers] and how [to take] the product out of the container.”

Perna said that Pfizer is documenting its takeaways in training factsheets and providing YouTube-like videos to help ensure a smooth distribution. Though the chief operating officer noted initial hesitation at administration sites, he said confidence has been growing as Pfizer walks them through the process.

To address the significant cold-chain requirements that come with Pfizer’s vaccine, the company has developed a dry ice container that maintains the vaccine for up to 20 days, Perna said, expressing confidence that, should states plan properly, administration of the vaccine is “very doable” within that time period. He said that while the cold temperature requirements are a challenge, they “should not hold us back from administering a very good vaccine.”

Moderna’s vaccine will be easier to administer, as it can be stored at standard refrigerator freezer temperatures for up to 30 days, Perna noted, adding that this will help the government in getting the vaccine to many different areas of the country.

“I believe the jurisdictions are ready. They’ve been well informed on the information of both vaccines, both requirements for cold-chain storage, they have added capability and capacity as required, they have trained people to administer it, they have contacted pharmacies for support,” he said. “We are well on our way to successfully administering both vaccines to the American people in the near future.”

The Centers for Disease Control and Prevention (CDC)’s Advisory Committee on Immunization Practices (ACIP), which met Monday to discuss vaccine prioritization, said that essential healthcare workers, including first responders and nursing home staff, should be at the front of the line to receive the first vaccinations due to their close proximity to patients who have or may have COVID-19.

With vaccines on the way, antibody treatments are already being distributed for emergency use. More than 120,000 doses of Eli Lilly’s EUA-cleared antibody treatment have been distributed to more than 2,400 treatment sites across the country, with another 50,000 doses to be shipped this week, Azar said. And the first 35,000 doses of Regeneron’s antibody cocktail, which also recently received an EUA (DID, Nov. 24), were shipped out on Tuesday, he said.

More than 250,000 COVID-19 patients in the U.S. have received convalescent plasma, the secretary added, calling on people within three months of recovery from the virus to donate plasma in order to bolster supplies of the emergency authorized treatment. — James Miessler