A sign at an East Lansing long-term care facility, May 2, 2020 | Susan J. Demas
WASHINGTON — The Food and Drug Administration on Friday authorized for emergency use the first COVID-19 vaccine in the U.S., a decision that serves as the starting gun for the vaccine logistics efforts that states have been preparing for months.
The vaccine authorized for emergency use from Pfizer and German partner BioNTech is expected to begin shipping across the country within 24 hours of Friday’s approval from the FDA.
On Friday afternoon, the Michigan Department of Health and Human Services (DHHS) held a media briefing on the vaccine rollout, as the Advance reported. Michigan is expected to receive an initial 84,825 COVID-19 vaccine doses from Pfizer. Another 173,600 vaccine doses are expected from Moderna, which is slated to arrive by the end of December if approved. The general public may begin to receive the vaccine by the late spring.
“This is great news for our families, frontline workers, small businesses, and economy. In Michigan, a state built on hard work and innovation, a safe and effective COVID-19 vaccine will be manufactured by Michigan workers at a Michigan business,” Gov. Gretchen Whitmer said in a statement Friday evening. “I want to thank all of our dedicated Pfizer employees for their hard work. My administration, led by Dr. Joneigh Khaldun, is developing a plan to distribute the vaccine, with a focus on our most vulnerable populations.”
Nearly 3 million vaccine doses will be headed to states — the first half of two doses required to be administered 21 days apart, according to officials with Operation Warp Speed, the White House-led initiative to develop and distribute vaccines. The second dose will be shipped later, with another 500,000 doses held in reserve.
“It is nothing short of a medical miracle to have FDA authorization of a vaccine for COVID-19 just over 11 months since the virus was made known to the world,” said Health and Human Services Secretary Alex Azar in a statement Friday evening, adding that the vaccine “like any vaccine FDA potentially authorizes, has been through multiple stages of safety review, and it has shown extraordinary effectiveness in protecting people from the virus.”
The authorization comes after a federal vaccine advisory panel voted 17-4 on Thursday to recommend the Pfizer vaccine for those at least 16 years old.
It also follows pressure from the White House for a swift decision. In a tweet Friday morning, Trump criticized the FDA as a “big, old, slow turtle,” and called on Stephen Hahn, the FDA commissioner, to take immediate action.
“Get the dam(n) vaccines out NOW, Dr. Hahn,” Trump posted, adding: “Stop playing games and start saving lives!!!”
The Washington Post and other outlets reported later Friday that White House Chief of Staff Mark Meadows told Hahn to resign if the agency did not give its green light by the end of the day.
At a news conference Friday, before the FDA issued its decision, President-elect Joe Biden urged confidence in the vaccine, saying there’s been “no political influence” in the regulatory review process.
“These are first-rate scientists, taking their time, looking at all of the elements that need to be looked at. Scientific integrity led us to this point,” said Biden, who has set a goal of having 100 million vaccines administered within his first 100 days in office.
Federal officials have not confirmed how many doses each state will receive, saying only that those doses will be distributed based on each state’s adult population.
Each state can determine who is prioritized to receive the initial doses, but most will follow federal recommendations to first inoculate health care workers and those in nursing homes and long-term care facilities.
The two groups prioritized nationally for the initial vaccine doses are estimated to include some 24 million Americans: 21 million health care workers and 3 million in nursing homes and assisted-living centers.
Michigan health officials are planning to distribute the vaccine to 56 hospitals and 16 local health departments in Michigan. For security reasons, Khaldun would not specify which hospitals and health departments will receive the doses.
Michigan’s distribution plan is divided into four priority groups. The first group, Phase1A, is paid and unpaid individuals working in health care settings who have direct or indirect exposure to patients or infectious materials and are unable to work from home, as well as residents of long-term care facilities. Also included are those in long-term care facilities, including skilled nursing staff, assisted living facility workers, psychiatric hospital staff, those in adult foster care, home health care workers and vulnerable residents in these settings. Other health care workers, such as dentists, workers in ambulatory care and urgent care, and staff in pharmacies and labs, among others, also are first up for the vaccine.
The number of people in this initial priority group varies widely across states. A study from Kaiser Family Foundation found seven states in which the number of health care workers who have direct patient contact or who are nursing facility residents is at least 8% of the state’s population: Pennsylvania, Minnesota, Ohio, North Dakota, Massachusetts, New York and Rhode Island.
Federal officials have not yet issued recommendations for who should receive the vaccine in the next stages of the rollout, but the next priority groups are likely to include essential workers not in the health care industry, and then people older than 65 and those with underlying health conditions.
The Pfizer vaccine is one of several in the regulatory pipeline. A second vaccine from U.S. biotech firm Moderna is scheduled to be considered for emergency use next week, and if approved, could begin shipping doses on a similarly quick timeline as the Pfizer vaccine.
The Trump administration announced Friday afternoon that it had purchased another 100 million doses of the Moderna vaccine, for a total of 200 million. Approximately 20 million doses will be delivered by the end of December 2020, pending Moderna’s approval for emergency use.
Federal officials had locked in 100 million doses from Pfizer, with an option to purchase more. Several news outlets have reported that the White House declined this summer to purchase additional doses from Pfizer, which the Trump administration has denied.
Our stories may be republished online or in print under Creative Commons license CC BY-NC-ND 4.0. We ask that you edit only for style or to shorten, provide proper attribution and link to our web site. Please see our republishing guidelines for use of photos and graphics.