The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has issued updated guidance, warning people with a history of allergic reactions not to get the Pfizer/BioNTech COVID-19 vaccine.
The UK began administering the vaccine, BNT162b2, on Tuesday after the MHRA gave the vaccine a green light for emergency use last week.
Since then, the MHRA has received two reports of anaphylaxis – severe allergic reactions – and one report of a possible allergic reaction following immunisation with the Pfizer/BioNTech vaccine.
The individuals who experienced the reactions are now recovering after receiving ‘prompt’ treatment, said the MHRA.
The MHRA is now recommending that anyone with a history of anaphylaxis, whether as a reaction to a vaccine, medicine or food, should not receive the recently approved vaccine.
In addition, people who have experienced anaphylaxis after receiving the first dose of BNT162b2 should not be given a second dose.
The MHRA added that those who are due to receive the vaccine should still continue with their appointment and discuss any concerns or their medical history with a healthcare professional prior to receiving the vaccine.
“You can be completely confident that this vaccine has met the MHRA’s robust standards of safety, quality and effectiveness. The safety data has also been critically assessed by the government’s independent advisory body, the Commission on Human Medicines. No vaccine would be approved unless it meets these stringent standards – on that you can be sure,” said June Raine, chief executive of the MHRA.
“We have in place a robust and proactive safety monitoring strategy for COVID-19 vaccines which allows for rapid, real-time safety monitoring at population level. The fact that these incidents were picked up and reviewed shows that to be the case,” she added.
It is expected that 800,000 doses of the Pfizer/BioNTech vaccine will be administered in the coming weeks, with up to four million more vaccines to be administered by the end of December in the UK.
Anaphylaxis is a very rare side effect with any vaccine, the MHRA added in a statement.
“Most people will not get anaphylaxis and the benefits in protecting people against COVID-19 outweigh the risks,” said Raine.