Doses of the first coronavirus vaccine authorised in the US were being shipped to hospitals on Saturday morning after the country’s drugs regulator gave the go-ahead late on Friday night.
Stephen Hahn, the head of the Food and Drug Administration, said on Saturday that doses of the vaccine made by Pfizer and its German partner BioNTech had left manufacturing facilities following his organisation’s decision to give it emergency approval.
Dr Hahn called the move “a significant milestone in battling a devastating pandemic,” as the US endured its worst week of the pandemic with fatalities topping 3,000 a day.
Donald Trump, the outgoing US president, said on Friday night that it was a “medical miracle”.
The emergency approval makes the US the sixth country to give the green light to the Pfizer/BioNTech vaccine, following similar decisions taken by the UK, Bahrain, Canada, Saudi Arabia and Mexico.
Dr Hahn said FDA scientists had undertaken a rigorous review of the data, denying that the regulator had been rushed into a decision by pressure from the White House.
“We worked quickly based on the urgency of this pandemic, not because of any other external pressure,” he said. He called reports that his job had been threatened by the White House on Friday unless he issue an approval that day “untrue”.
He admitted, however, that the speed with which the vaccine had been developed and approved could lead to some people doubting its safety.
“The agency is very concerned about vaccine hesitancy,” said Dr Hahn. “We are also aware that some feel that the speed with which this development and then regulatory process took place might give them concerns about the vaccine. But that is why we were very transparent.”
The vaccine will be available to everyone in the US aged 16 and over, though people with allergies to any of the ingredients have been recommended not to receive it.
The FDA decided not to issue a blanket ban on vaccinating people with severe allergies, as happened in the UK after two people there suffered allergic reactions following their injections.
Peter Marks, the head of the FDA division which approves vaccines, said: “About 1.6 per cent of the population has had a severe allergic reaction of some sort or another to a food or some environmental aspect. And we would really not like to have that many people not be able to receive the vaccine.
“We looked very closely at the databases, and we feel comfortable that we’re telling people that unless they’ve had a severe allergic reaction to the vaccine, or one of its components, they can receive it.”
The regulator said it was monitoring for about 20 potential adverse events and will publish information if it has any concerns.
The FDA decided to issue the emergency use authorisation for people over 16, despite concerns by some scientific experts that there was not enough evidence about the vaccine in 16 and 17 year olds.
The agency said it was “very comfortable” that the benefits outweighed the risks for these older teenagers.
Dr Marks said while the disease was usually mild in this group, it could kill and parents of these children might be “pretty upset”.
He added there could be an added benefit of vaccinating 16 and 17 year olds who are in the community — working in jobs such as checkout cashiers where they might spread coronavirus.
Pregnant women will also be allowed to receive the vaccine, though the FDA has recommended that they do so only after talking to their doctors about the relative benefits and risks. Dr Marks said: “That individual can make a decision about whether the benefits outweigh the risk because certainly Covid-19 and a pregnant woman is not a good thing.”
Over the next few months, regulators will study whether the vaccine prevents infection and spread of the virus, rather than just stopping people from developing the Covid-19 disease.