London – Britain hailed “V-Day” when it became the first country to roll out the Pfizer-BioNTech COVID-19 vaccine. Yet, as first mover, it has also become the first to report cases of adverse reactions, allowing other nations to watch and learn.
Officials from around the world are keen for British authorities to give them as much information as possible about the two reported cases of anaphylaxis among thousands of people inoculated since mass-vaccination began on Tuesday.
Anaphylaxis is an over-reaction of the body’s immune system, which health specialists describe as severe and sometimes life-threatening. While such allergic reactions are rare in any individual vaccine recipient, they are not unusual during large-scale rollouts, scientists, experts and industry figures said.
The reports nonetheless led to Britain’s Medicines and Healthcare products Regulatory Agency (MHRA) beefing up its guidance for the shot at midnight leading into Thursday, specifically warning that anyone with a history of anaphylaxis should not take it.
In the United States, regulators and public health officials are determining whether to approve the vaccine from Pfizer and BioNTech, and what advice to issue.
William Schaffner, an infectious disease expert at Vanderbilt University Medical Centre, said the British regulator was being cautious in its approach to the shot, which uses new genetic mRNA technology.
“They’re being very, very careful. These are new vaccines using a new technology. They’ve gotten a signal here that they need to investigate,” he said.
“We’ll benefit from their investigation.”
Schaffner, who is a non-voting member of Centres for Disease Control and Prevention’s Advisory Committee on Immunisation Practices, said the group would likely discuss the topic when it discusses the use of Pfizer’s vaccine on Friday.
Stephen Hahn, commissioner of the US Food and Drug Administration, said his agency was trying to learn from the UK experience.
“We’re working very closely with our UK partners to understand what went on with respect to those allergic reactions,” he told CBS News ahead of a meeting of outside advisers to weigh whether to recommend approval of the vaccine.
Canada’s health ministry, which approved the vaccine on Wednesday, also said it would look at the reported reactions in Britain, but added that adverse events were to be expected and would not necessarily change the risk/benefit of the shot.
‘Benefits outweigh risks’
The MHRA, which last week became the first regulator in the world to approve the vaccine, said it was looking into the reports of anaphylaxis as a matter of priority.
“Anaphylaxis is a known, although very rare, side effect with any vaccine,” the watchdog said. “Most people will not get anaphylaxis and the benefits in protecting people against COVID-19 outweigh the risks.” (Reuters)
