FDA CLEARS PFIZER VACCINE
Broward’s skilled-nursing facilities will be first in line for COVID-19 vaccine The Broward office of the Florida Department of Health will send strike teams into every skilled-nursing facility in the county, likely within days.
Health officials in Broward County announced on Friday that they’ll send COVID-19 vaccination “strike teams” to 35 skilled-nursing facilities shortly after the state receives the Pfizer-BioNTech vaccine.
The state health department offices in Broward and Pinellas counties will each receive about 10,000 doses of the vaccine from the federal government, likely within a few days. From those two offices, teams of health professionals will fan out to skilled-nursing facilities.
During a Friday afternoon virtual news conference, Dr. Paula Thaqi, director of the state health department’s
Broward office, told reporters she expects enough doses to vaccinate all 3,211 resi
— 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 FDA’s decision followed an extraordinary sequence of events Friday morning in which the White House chief of staff, Mark Meadows, told the FDA commissioner, Dr. Stephen Hahn, to consider looking for his next job if he didn’t get the emergency approval done Friday, according to a senior administration official who spoke on condition of anonymity because he was not authorized to discuss the matter. 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 3 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 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.
McKesson Corp., a giant medical supplier, is sending kits of syringes, alcohol pads, face shields and other supplies to the same sites, where they will meet up with the vaccines that Pfizer is shipping in special boxes, packed with dry ice, designed to keep them at minus 94 degrees Fahrenheit.
The Pfizer packaging will include a device that tracks the location of the box, plus a thermal probe that will make sure the deep freeze is maintained throughout the journey from the company’s distribution sites in Michigan and Wisconsin.
The decision is a victory for Pfizer and its German partner BioNTech, which began working on the vaccine 11 months ago. Vaccines typically take years to develop. The companies’ late-stage clinical trial, which enrolled nearly 44,000 people, was found to be 95% effective.
The threat to Hahn’s job was first reported by The Washington Post. In a statement, Hahn denied that Meadows told him he should consider seeking another job, calling it “an untrue representation of the phone call.” Instead, Hahn said, his agency was “encouraged to continue working expeditiously.”
Even though the FDA 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 FDA 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 may be authorized in the next few months.
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 3 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.
Questions also persist about how quickly a vaccine will be available to anyone that wants one. Federal officials have said they expect to be able to vaccinate the bulk of the U.S. population by the middle of next year, but recent setbacks have challenged those estimates. Pfizer has told the federal government that it may not be able to provide an additional 100 million doses to the United States before the middle of next year, because of agreements it has with other countries. And three other experimental vaccines, developed by Novavax, Sanofi and AstraZeneca, have faced delays in their clinical trials.