U.S. Vaccinations to Start Today Following FDA’s Emergency Clearance for Pfizer/BioNTech Vaccine

The first U.S. COVID-19 vaccinations are to be given today using Pfizer/BioNTech’s vaccine, following the announcement late Friday that the FDA had granted the first emergency clearance for a coronavirus vaccine, a pivotal and unprecedented moment in the battle against the pandemic.

Pfizer is employing its own strategy for distribution due to its experience in cold-chain shipping and existing infrastructure. The initial roll-out of its vaccine consists of 2.9 million doses, with the other 2.9 million doses — the second round of shots — to be shipped later, HHS Secretary Alex Azar said Sunday.

Pfizer’s vaccine needs to be shipped with dry ice at the extremely cold temperature of -94 Fahrenheit (F), a requirement that presents serious logistical considerations. The drugmaker is delivering special packaging and storage technology to vaccination sites that will keep doses safe for 10 days (DID, Nov. 4). Pfizer will deliver the vaccine doses to state health authorities, who will distribute it to frontline healthcare workers and the elderly (DID, Dec. 9).

Gen. Gustave Perna, chief operating officer of Operation Warp Speed (OWS), said over the weekend that the government expects nearly 150 vaccination sites to receive the first vials of the two-dose vaccine today, with more to get supplies as the week goes on. By mid-week the initial vaccine deliveries, which total 2.9 million doses, are due to be completed.

“When the decision occurred [on Friday], we immediately went into action,” Perna said. “We expect 145 sites across all the states to receive vaccine on Monday, another 425 sites on Tuesday, and the final 66 sites on Wednesday, which will complete the initial delivery of the Pfizer orders for vaccine,” he said.

Deliveries of BNT162b2 — from a Pfizer plant in Kalamazoo, Mich. — started over the weekend, said Nancy Messonnier, director of the Center for Disease Control and Prevention (CDC)’s Center for Immunization and Respiratory Diseases, and CDC Director Robert Redfield on Sunday approved the recommendation of the CDC’s immunization practices panel in support of the vaccine. The panel voted Saturday in favor of the vaccine.

President Trump had pressured the FDA and Commissioner Stephen Hahn to get the Emergency Use Authorization (EUA) for the Pfizer vaccine signed by Friday night, calling the agency “money drenched but heavily bureaucratic” and “still a big, old, slow turtle.” White House Chief of Staff Mark Meadows reportedly warned Hahn he would have to resign if the EUA wasn’t done Friday, an allegation Hahn disputes, though the agency did end up meeting the administration’s timeline.

“There was a desire for us to move as quickly as possible,” Hahn said. “We have. We had to get this right and I believe we did.”

The EUA for the two-dose Pfizer vaccine came a day after the agency’s vaccine advisory committee voted 17-4, with one abstaining vote, in favor of awarding an EUA for use of the highly effective vaccine in patients ages 16 and above. At least two ‘no’ voters had expressed hesitancy toward the EUA due to a lack of data for 16- and 17-year-old patients (DID, Dec. 11).

Moncef Slaoui, OWS’ chief adviser, said Sunday that the federal government plans to have about 40 million Pfizer and Moderna vaccine doses distributed in the U.S. by the end of the year. It should have approximately 50 million to 80 million doses of vaccines distributed in January and plans to distribute the same amount in February, he said.

“We hope to have immunized 100 million people, which would be the long-term care facility people, the elderly people with comorbidities, the first-line workers, the healthcare workers … we will have immunized about 100 million people by the first quarter of 2021,” Slaoui said.

Moderna on Friday announced that the U.S. has exercised its option to order 100 million additional vaccine doses, bringing its total amount ordered to 200 million shots.

The vaccine advisory committee meets again on Dec. 17 to discuss an EUA for Moderna’s promising two-dose COVID vaccine, and a recommendation in favor of an EUA is expected. — James Miessler