FDA approves first COVID-19 vaccine, clearing the way for states’ rollout

WASHINGTON — The Food and Drug Administration on Friday approved the first COVID-19 vaccine for use in the United States, a decision that serves as the starting gun for the vaccine logistics efforts that states have been preparing for months.

The vaccine approved 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.

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 final approval 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 approval, 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. Colorado this week released an updated vaccination priority plan that places at the front of the line the most at-risk health care works and residents and staff of long-term care facilities.

Colorado’s revised vaccine plan removes priority for incarcerated people, shelter residents

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.

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.