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Officials with Operation Warp Speed said distribution of a COVID-19 vaccine will begin within 24 hours after FDA authorization.
Operation Warp Speed (OWS) officials announced that about 40 million doses of 2 safe and highly effective vaccines for coronavirus disease 2019 (COVID-19) – made by Moderna and Pfizer – could be available for distribution by the end of December, pending FDA approval.1
The distribution is enough to vaccinate about 20 million Americans at high risk for COVID-19, Department of Health and Human Services (HHS) Secretary Alex Azar, MD, said in a news briefing on Wednesday.2
Both Pfizer and Modera have created messenger RNA (mRNA) vaccine candidates; Pfizers’ showed a 95% efficacy rate in a recent update, whereas Moderna reported meeting its primary end point of efficacy, with 94.5% .
The CDC has moved to facilitate rapid distribution of vaccine to each state, Gen. Gustave Perna, OWS chief operating officer, said in the briefing.3
The CDC has collaborated with commercial industry to produce, store, distribute, and administer the vaccine. Perna mentioned McKesson, in addition to Pfizer and Moderna, as partners in distributing the vaccine.
“We will begin distribution of the vaccine within 24 hours after Emergency Use Authorization [EUA] is approved,” Perna said. The government is planning to deliver COVID-19 vaccine weekly to each state.
Once investigators and the FDA determine the safety and efficacy of the vaccine, “every jurisdiction will have access immediately,” Perna added.
The OWS announcement outlined several things that the government needs from each jurisdiction; first is that there must be “good, solid, expansive provider enrollment,” Perna said. “Only to providers that are enrolled can we distribute to.”
The officials also stressed the importance of data use agreements, which help with the recording of vaccine dosing information, such as what vaccine an individual received and where. The ability to track vaccine uptake among Americans is also critical in order to maintain consistent distribution to all states.
Those administering the vaccine, including pharmacies and hospitals, should also arrange for the initial delivery. Perna recommended tabletop exercises to double check that they are prepared for an influx of responsibility.
Pharmacists administering the vaccine will need to store it, most likely in an ultra-cold storage refrigerator with dry ice. Pfizer has assisted in providing dry ice to locations receiving the vaccine.
Still, the trials evaluating COVID-19 vaccine candidates continue. OWS addressed how investigators will continue collecting data in phase 3 trials following authorization from the FDA.
“From the standpoint of efficacy analysis, trials will have achieved their objective,” said Dr. Moncef Slaoui, chief scientific advisor to OWS. “From the standpoint of long-term follow up into the trials, the trial could still generate substantially important information, such as persistence protection over time and safety over time,” he continued.
Once the EUA is granted, Slaoui projected a 2-month wait until the FDA grants the Biologics License Application (BLA).
“There is light at the end of the tunnel,” Azar said. “But we need people to get there.” Azar said continuing to practice good individual behaviors – washing hands, social distancing, wearing masks, and avoiding crowded spaces – remain critical in protecting against COVID-19.