The Food and Drug Administration (FDA) approved the Pfizer / BioNTech coronavirus vaccine on Friday for emergency use.
President Donald Trump hailed the “medical miracle” and said the first injections would be given in less than 24 hours.
The development marks a turning point in the United States where the
the pandemic has killed more than 295,000 people.
Millions of vulnerable people will begin receiving the vaccine in the days and months to come, especially if a second vaccine from Moderna Inc is quickly approved.
With the approval of the Pfizer vaccine, the United States became the sixth country in the world to allow the vaccine for use.
The first country to approve the vaccine earlier this month was the United Kingdom, where residents started receiving their first vaccines on Tuesday, December 8.
Canada has also cleared the vaccine and plans to start vaccinations next week.
Mexico and Bahrain have also approved the vaccine.
The United States Food and Drug Administration has granted emergency use authorization for the vaccine, developed with German partner BioNTech, which was found to be 95% effective in preventing disease in a stage trial. advanced.
The FDA has said the vaccine can be given to people 16 years of age and older.
Health workers and the elderly in long-term care facilities are expected to be the main beneficiaries of a first round of 2.9 million doses.
Three people spoke anonymously to the New York Times about the development because they were not authorized to discuss it.
The approval came hours after White House Chief of Staff Mark Meadows told FDA Commissioner Dr Stephen Hahn to consider finding another job if the emergency approval was not not done by Friday.
The authorization of the vaccine marks a turning point in the United States where the pandemic has killed more than 292,000 people.
Donald Trump has spoken to confirm the news that the vaccine has been approved for use.
He said in a video statement on Twitter: “Today our nation has achieved a medical miracle.
“We delivered a safe and effective vaccine in just nine months, which is one of the greatest scientific achievements in history.
“It will save millions of lives and soon end the pandemic once and for all.
“I’m delighted to report that the FDA cleared the Pfizer vaccine, we gave Pfizer and other companies a lot of money hoping that would be the result – and it did. ”
He added, “On behalf of the American people, I would like to thank all of the brilliant scientists, technicians, doctors and workers who made this all possible. ”
Trump also reassured Americans that the Pfizer and Moderna vaccines are “very safe” because the clinical trials in which the volunteers participated were “much larger than normal.”
He added that people who participated in clinical trials did not experience significant side effects.
Trump said the vaccine will be free for all Americans.
“I am proud to say that we have made sure this vaccine is free for all Americans,” he added.
The US president said the vaccine is already shipped to all states and zip codes in the United States.
It will then be up to the governor of each state to decide where the vaccines go and who gets them first.
The government has ordered 100 million doses of the Pfizer vaccine – enough to inoculate 50 million people – as part of its Operation Warp Speed virus development program and could negotiate for more.
The Trump administration has said it will have enough to supply all the 330 million U.S. residents who want to be vaccinated by mid-2021.
He concluded, “The pandemic may have started in China, but we are ending it here in America. ”
BioNTech began developing the vaccine in January, using a technology called synthetic messenger RNA (mRNA) that had yet to produce an approved product.
The technology uses a chemical messenger to instruct cells to make proteins that mimic part of the new coronavirus, which the immune system learns to recognize as an invader.
BioNTech entered into a development agreement with Pfizer in March.
The vaccine is given in two doses, 21 days apart.
It presents complex distribution challenges as it has to be shipped and stored at -70 Celsius, which requires specialized ultra-cold freezers or dry ice supplies.
Moderna’s vaccine uses the same technology but does not need to be stored at extremely low temperatures.