US FDA grants permission to Pfizer’s COVID-19 vaccine for emergency use, ready for 2.9 million doses

The Food and Drug Administration authorised 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 FDA has granted emergency use authorization for the vaccine, developed with German partner BioNTech, which is said to be 95% effective in preventing the disease in a late-stage trial. It said the vaccine can be given to people aged 16 and above.

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Healthcare workers and elderly people in long-term care facilities are expected to be the main recipients of the first round of 2.9 million doses.

The action 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 authorisations, including by the European Union, are expected within weeks.
Delivery companies United Parcel Service and FedEx Corp plan to ship millions of the Pfizer doses across the country, giving top priority to the vaccines on the aeroplanes and trucks.

The authorisation 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

The FDA’s decision followed an extraordinary sequence of events on 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 on 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 United States is the first nation in the world to produce a verifiably safe and effective vaccine. Today’s achievement is a reminder of America’s unlimited potential,” Trump said.

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.

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.

Others with vaccines in advanced development include Moderna, which could win emergency U.S. authorization as soon as next week, AstraZeneca Plc with Oxford University, and Johnson & Johnson.