The US Food and Drug Administration has approved the Pfizer-BioNTech coronavirus vaccine for emergency use.
The organization said authorization was “the most important thing” in the pandemic, which has affected more than 295,000 people in the United States.
The vaccine, which provides up to 95% protection against Covid-19, has been considered safe and effective by the FDA.
President Donald Trump has said the first vaccination will take place “within 24 hours”.
“Today our nation has achieved a medical miracle,” Mr. Trump said. “We have delivered a safe and effective vaccine in just nine months.”
Prior to the announcement Friday night, the FDA was under intense pressure from Trump officials to approve the use of the vaccine.
The organisation’s head, Stephen Hahn, has been told to authorize it to be used by paramedics on Friday or to stop working, American media reported, although he called it “untrue”.
Health and Labor Secretary Alex Azar told reporters on Friday that his department would work with Pfizer to launch a mass vaccination program on Monday or Tuesday.
Pfizer vaccine has received official approval in the UK, Canada, Bahrain and Saudi Arabia. Like those countries, the US will give older seniors, health workers and emergency workers their first doses of vaccines.
Coronavirus mortality has risen sharply since November in the US. On Wednesday, the country recorded more than 3,000 people – the highest number in a single day anywhere in the world.
“The FDA’s approval of the urgent use of the first Covid-19 vaccine is a milestone in the fight against this devastating epidemic that has affected many families in the United States and around the world,” said Mr Hahn.
He said the accreditation comes after an “open and transparent review process” that ensures the vaccine meets “strict, FDA scientific standards for safety, efficacy, and production quality”.
On Thursday, medical experts advised the FDA to recommend approval for emergency use. The 23-member panel concluded that the benefits of the vaccine outweigh its risks.
Emergency use, says the FDA, is not the same as full approval, which would require Pfizer to apply separately for protection.
“While not a FDA permit, today’s official use of the Pfizer-BioNTech Covid-19 vaccine has the promise of changing the course of the epidemic in the United States,” said Peter Marks, Director of FDA’s Center for Biologics Evaluation and Research.
Pressure On The FDA
On Friday, President Trump sent an angry tweet calling the FDA a “big, old, slow-moving tortoise”, adding: “Get rid of the dam’s goals NOW, Dr. Hahn. Stop playing games and start saving lives.”
The Washington Post said White House chief of staff Mark Meadows had instructed Mr Hahn to either approve the policy on Friday or submit a letter of resignation, citing three sources.
During reports of pressure on the White House, President-elect Joe Biden said he wanted to make it clear to the public that they should trust the vaccine, adding: “There is no political influence.”
About The Vaccine
The Pfizer / BioNTech vaccine was the first jab of coronavirus to show promising results in the final stages of the testing process.
It is a new type called mRNA vaccine that uses a small piece of genetic code from the epidemic virus to teach the body how to fight Covid-19 and build up the immune system.
“The vaccine contains a small amount of mRNA virus [Covid-19] that directs cells in the body to make a different ‘spike’ protein for the virus,” the FDA said.
“When a person receives this vaccine, his or her body produces copies of spike protein, which do not cause the disease, but cause the immune system to learn the immune response, producing antibodies against [Covid-19].”
The vaccine is given in two injections, separated for 21 days, and the second dose is a stimulant. The immune system begins to enter after the first dose but reaches its full potential seven days after the second dose.
Operation Warp Speed says the delivery of the vaccine will begin within 24 hours of approval.
“We have assured that this policy will be free, for all Americans,” Mr. Trump said in a video posted on Twitter.
“We have started distributing the vaccine in all countries with a zip code in the country. The first vaccine will be given in less than 24 hours.”
Pfizer plans to have 6.4 million volumes ready for the US in its first round of release by the end of December.
Because two injections are needed per person, that’s enough for three million people, 330 million US people.
Government officials at the Centers for Disease Control and Prevention (CDC) say 21 million national workers should be prioritized, as well as three million American adults living in long-term care.
But there is little agreement on how provinces should distribute it to other parties. An estimated 87 million national workers are expected to follow suit, but it will be up to them to decide which industries to prioritize.
Mr Trump said the vaccine would “overcome the virus and restore health to its condition”. But officials say the vaccination of the most vulnerable groups is expected to take place in the spring of 2021.
A second vaccine, developed by Moderna and the National Institutes of Health, also requires urgent approval in the US. As a vaccine Pfizer requires a second injection.