Recommendations from the CDC’s Advisory Committee on Immunization Practices ultimately may not dictate the coronavirus vaccination process.
Health and Human Services Secretary Alex Azar said on 24 November that the ACIP recommendations on the groups that should receive the vaccine will be important to trigger reimbursement mechanisms, but the final decisions will rest with state and territory governors.
Following US Food and Drug Administration approval, the ACIP is scheduled to meet and recommend the groups that should receive the vaccine first, such as front-line health care workers or nursing home residents. Vaccination generally does not begin until the ACIP issues a favorable recommendation that is accepted by the Centers for Disease Control and Prevention.
Azar was asked during an Operation Warp Speed briefing whether states would have time to adjust vaccine orders following ACIP recommendations, to which he responded that the committee’s actions will not delay distribution.
“We hope that our recommendations will carry weight with them, but at the end of the day, [governors] will make that decision,” Azar said. “We are not dependent on any delay or ACIP in terms of helping to advise states on that prioritization.”
“We are working expeditiously to formulate our recommended prioritization for vaccine distribution based on where we can secure the maximum effect under whatever the current epidemiological circumstances are in the United States at that time,” he added.
ACIP members and CDC staff, as well as other groups, have been working for months to build recommendations for groups that should be the first to receive the coronavirus vaccine because early on supplies will be limited. There appears to be consensus that front-line health care workers will be the first in line, followed by long-term care facility residents and non-health care essential personnel. (See sidebar.)
A final decision on priority groups will depend in part on the clinical trial data. ACIP officials likely will schedule an emergency meeting once the FDA issues an emergency use authorization for a vaccine to vote on recommendations. (Also see "Vaccine Hesitancy May Drive Distribution Priorities For Early COVID-19 Supply" - Pink Sheet, 22 Sep, 2020.)
Multiple EUAs could be granted in December. The FDA has scheduled a Vaccines and Related Biological Products Advisory Committee meeting for 10 December to consider the Pfizer Inc. mRNA vaccine candidate.
Moderna, Inc. also is expected to submit an EUA request for its mRNA vaccine candidate soon and could have an advisory committee meeting scheduled days after the Pfizer meeting. (Also see "US FDA’s COVID Whirlwind: Pfizer Vaccine Adcom Set; Monoclonal EUAs Cleared; Trump Aggrieved" - Pink Sheet, 22 Nov, 2020.) Both reported efficacy of more than 90% in Phase III trials. (Also see "Pfizer Is Ready To File Vaccine, With More Good News On Over-65s Efficacy" - Scrip, 18 Nov, 2020.)
Manufacturing Processes To Be Watched For Production Stability
US officials also will be closely monitoring the Pfizer and other vaccine manufacturing plants to ensure a steady stream of product before fully unleashing the distribution system.
The Pfizer and Moderna vaccine candidates require two shots: Pfizer requires the booster 21 days later, while Moderna schedules the second shot 28 days later. A key part of the nationwide vaccination plan will be ensuring there is enough supply to give the second shot.
Gen. Gustave Perna, Operation Warp Speed’s chief operating officer, suggested during the briefing that distribution may not be as widespread at first in order to ensure the second dose is available.
“We are continuing to assess the manufacturing of the vaccine and we think that once we have a really steady, confident cadence in manufacturing in the very near future, there's potential to just vaccinate at maximum allocation because we have confidence that the second dose will be available accordingly,” Perna said. “We're just starting this way initially to ensure that everybody understands the process.”
Pfizer, Moderna and several other vaccine sponsors are manufacturing at-risk in order to expedite vaccination upon approval. (Also see "Novavax Push For COVID-19 Vaccine Manufacturing Capacity Delays Flu Vaccine Application" - Pink Sheet, 15 Sep, 2020.)
Pfizer Shipping, Storage Plans ‘Doable,’ Perna Says
Each Pfizer vaccine shipping container includes a tray with 975 vaccine doses encased in dry ice. Perna said early in the distribution process, providers will have 20 days to administer those doses and then will receive another tray to provide the second dose.
States and other primary jurisdictions will be expected to tell the government where to send the boxes each week. Perna said the cold-chain storage requirements and other logistical issues will be challenging, but that he was confident everyone was ready.
“I've actually put my hands in the box. I've pulled trays out. I've watched and I've timed myself in execution,” he said. “It is a very, very doable process.”
Pfizer’s vaccine requires storage at -70°C/-94°F. CDC officials have advised against purchasing special freezers, arguing that the shipping containers filled with dry ice can meet storage requirements. (Also see "CDC Bets Vaccine Stability Conditions Will Change, Urges Against Freezer Purchases" - Pink Sheet, 1 Sep, 2020.) Pfizer is practicing distribution at several sites around the country, in part to train local workers and avoid waste. (Also see "COVID Vaccine Distribution: Pfizer Plans ‘Dry Run’ With Four States" - Pink Sheet, 17 Nov, 2020.)