F.D.A. Clears Pfizer Vaccine, and Millions of Doses Will Be Shipped Right Away

The Four Percent


The Food and Drug Administration authorized Pfizer’s Covid-19 vaccine for emergency use on Friday, clearing the way for millions of highly vulnerable people to begin receiving the vaccine within days.

The authorization is a historic turning point in a pandemic that has taken more than 290,000 lives in the United States. With the decision, the United States becomes the sixth country — in addition to Britain, Bahrain, Canada, Saudi Arabia and Mexico — to clear the vaccine. Other authorizations, including by the European Union, are expected within weeks.

The F.D.A.’s decision followed an extraordinary sequence of events on Friday morning when the White House chief of staff, Mark Meadows, told the F.D.A. commissioner, Dr. Stephen Hahn, to consider looking for his next job if he didn’t get the emergency approval done on Friday, according to a senior administration official who spoke on condition of anonymity because he was not authorized to discuss the matter. Dr. Hahn then ordered vaccine regulators at the agency to do it by the end of the day.

The authorization set off a complicated coordination effort from Pfizer, private shipping companies, state and local health officials, the military, hospitals and pharmacy chains to get the first week’s batch of about three million doses to health care workers and nursing home residents as quickly as possible, all while keeping the vaccine at ultracold temperatures.

Pfizer has a deal with the U.S. government to supply 100 million doses of the vaccine by next March. Under that agreement, the shots will be free to the public.

Every state, along with six major cities, has submitted to the federal government a list of locations — mostly hospitals — where the Pfizer vaccine is to ship initially. In populous Florida, the first recipients will be five hospitals, in Jacksonville, Miami, Orlando, Tampa and Hollywood. In tiny, rural Vermont, only the University of Vermont Medical Center and a state warehouse will get supplies.

Even though the F.D.A. was going to approve the Pfizer vaccine in any case, some experts warned that the pressure from the White House could undermine public trust in the agency’s decision-making.

“This may actually do more harm than good, because all it will do is inject more politics into a scientific process,” said Dr. Aaron S. Kesselheim, a professor at the Brigham and Women’s Hospital and Harvard Medical School.

A similar vaccine, developed by Moderna, is also under review by the F.D.A. and could soon be cleared for emergency use. On Friday, the federal government announced it had ordered another 100 million doses from Moderna, adding to a deal this summer for an initial supply of 100 million doses. Other vaccines, including ones developed by Johnson & Johnson and AstraZeneca, are in late-stage trials and could be authorized in the next few months.

In anticipation of the vaccine arriving across the country, Americans expressed both hope and anxiety.

Dr. Samu Queen, a physician in Portland, Ore., said her geriatric patients are especially eager to receive the vaccine. “They are all very anxious,” she said. “Pretty much everyone, at every appointment, is ready to get it.”

Dr. Queen said she was watching closely to see how initial subjects in Britain were responding. She described herself as “somewhat apprehensive about how safe it is, versus not.”

Joshua Ball, the associate executive director of Shaping Our Appalachian Region, an economic development group in eastern Kentucky, has been a primary caretaker for his father, who had a stroke earlier this year and has other health issues. During the pandemic, he has had to try and help remotely as much as possible.

A vaccine could change that. It could also allow him to go back to church, and to attend the seasonal festivals that are cultural staples for many small towns in his region.

“I miss the fellowship of shaking hands, and seeing people, and celebrating birthdays and church meals and vacation bible school,” he said.

Still, state health officials remain deeply concerned about what they describe as insufficient funding for the biggest immunization campaign the country has ever embarked on. State health officials have asked Congress for at least $8.4 billion to do the job well. But so far, they have received only about $350 million from the Centers for Disease Control and Prevention for vaccine distribution and administration tasks. Those tasks include expanding online systems to track and share information about who has been vaccinated; recruiting and training doctors, nurses and pharmacists to administer the shots; and convincing the public of the importance of getting immunized.

Supplying enough of the vaccine has also proven to be a challenge without a clear resolution. Pfizer had to scale back earlier estimates because of manufacturing setbacks, and has said it will be able to supply up to 25 million doses before the end of the year, and 100 million total vaccines by March.

This week, federal officials said that rather than using all 6.4 million doses that the government initially ordered from Pfizer to vaccinate people, it is holding back half of the supply for a booster shot to recipients three weeks after their first vaccination. But even though only about three million people will receive a vaccine in the first week, officials have held firm on their estimate that, between the Pfizer and Moderna vaccines, which each require two shots, they hope to give at least 20 million people their first dose of a vaccine by the end of the year.



Source link Most Shared

Be the first to comment

Leave a Reply

Your email address will not be published.


*