Gen. Gustave Perna, MD, the chief operating officer of Operation Warp Speed (OWS) expects more than 40 million doses of the two vaccines to be ready by the end of 2020. Vaccination of the general population must be right around the corner, right?
Not so fast. While the development of the Pfizer and Moderna vaccines in 11 months took just one-quarter the time of the previous fastest developed vaccine, meeting the needs of the largest vaccination campaign in history will take some time.
Thanks to OWS, a collaboration between the U.S. Department of Health and Human Services and the Department of Defense, Moderna, Pfizer and four other vaccine developers have been able to mass produce their vaccine prior to approval by the FDA. OWS provided more than $1 billion for manufacturing costs in trade for guaranteed access to between 100 and 300 million doses if the vaccines received FDA approval.
How long the FDA will take to review and potentially approve the vaccines remains unclear. The agency could authorize the vaccines immediately after their scheduled review meetings, but it might take a few days—or even a few weeks—to dig into the data and discuss the results, according to Peter Marks, head of the FDA’s Center for Biologics Evaluation and Research.
OWS plans to distribute any approved vaccine in 24 hours and expects vaccinations of the highest priority groups to begin within 3 days of the FDA’s ok. Exactly who will be considered the highest priority remains unclear and may ultimately vary by state and vaccine, but initial doses are expected to go healthcare workers, long-term care residents, essential workers, individuals with preexisting conditions, and people over age 65 years without other risk factors.
Because five of the six vaccines supported by OWS require two doses spaced 3 or 4 weeks apart, the 40 million doses available in late December will not cover the 21 million healthcare workers in the country. Another 3 million elderly people live in congregate housing and 87 million are considered essential workers, including police, firefighters, wastewater management workers, food processing employees, individuals in the transportation industry, and teachers. In addition, 100 million have underlying conditions that put them at risk of worse outcomes from the coronavirus and nearly 50 million Americans are over age 65 years.
For the first several months of 2020, officials expect to have enough doses to vaccinate about 25 million to 30 million individuals each month, if production goes according to the OWS plan. Additional vaccines may be approved during this timeframe as well.
Pharmacy staff might also be called upon to vaccinate residents in local long-term care facilities and help employers of essential workers immunize their workforce in the first few months of 2021. High-risk and other older people could receive vaccinations starting in March or April and the general population in late spring or early summer.
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