Doses of the first coronavirus vaccine authorized in the United States were shipped to hospitals on Saturday morning after the country’s drug regulator gave the green light late Friday evening.
Stephen Hahn, the chief of the Food and Drug Administration, said on Saturday that doses of the vaccine manufactured by Pfizer and its German partner BioNTech had left the manufacturing facilities following his organization’s decision to give it emergency approval.
Dr Hahn called the move “an important milestone in the fight against a devastating pandemic” as the United States endured its worst week in the pandemic with deaths exceeding 3,000 per day.
Donald Trump, the outgoing US President, said Friday night that it was a “medical miracle”.
Emergency approval makes the United States the sixth country to give the green light to the Pfizer / BioNTech vaccine, following similar decisions taken by the United Kingdom, Bahrain, Canada, Saudi Arabia and Mexico .
Dr Hahn said FDA scientists have undertaken a rigorous review of the data, denying that the regulator has been rushed into a decision by White House pressure.
“We worked quickly based on the urgency of this pandemic, and not due to any other outside pressure,” he said. He called reports that his work was threatened by the White House on Friday unless he issues an approval that day “bogus.”
He admitted, however, that the speed with which the vaccine had been developed and approved could lead some people to doubt its safety.
“The agency is very concerned about the reluctance to get vaccinated,” said Dr Hahn. “We are also aware that some feel that the speed with which this process of development and then regulation has taken place may cause them concern about the vaccine. But that’s why we have been very transparent.
The vaccine will be available to everyone in the United States aged 16 and over, although people with allergies to any of the ingredients have been recommended not to receive it.
The FDA has decided not to completely ban the vaccination of people with severe allergies, as happened in the UK after two people, there were allergic reactions following their injections.
Peter Marks, the head of the FDA division that approves vaccines, said: “About 1.6% of the population has had a serious allergic reaction of some sort to a food or aspect. environmental. And we really wouldn’t like that many people could not get the vaccine.
“We have taken a very close look at the databases and are confident in telling people that unless they have had a serious allergic reaction to the vaccine or one of its ingredients, they can receive it.”
The regulator said it is monitoring around 20 potential adverse events and will release information if something goes wrong.
The FDA has decided to grant emergency use authorization for people over 16, despite concerns from some scientific experts that there was insufficient evidence for the vaccine in 16 and 17 year olds.
The agency said it was “very comfortable” that the benefits outweighed the risks for these older teens.
Dr Marks said that while the disease was generally mild in this group, it could kill and the parents of these children could be “quite upset.”
He added that there might be an added benefit to vaccinating 16 and 17-year-olds who are in the community – working in jobs such as cashiers where they could spread the coronavirus.
Pregnant women will also be allowed to receive the vaccine, although the FDA has recommended that they do so only after talking to their doctors about the relative benefits and risks. Dr Marks said: “This person can decide if the benefits outweigh the risk because Covid-19 and a pregnant woman is definitely not a good thing.”
Over the next few months, regulators will study whether the vaccine prevents infection and the spread of the virus, rather than simply preventing people from developing Covid-19 disease.