The UK’s medicine regulator has advised that people with a significant history of allergies should not receive the Pfizer and BioNTech Covid-19 vaccine, after 2 people experienced adverse reactions from the shots on the first day of rollout.
This warning from the regulator comes a day after UK became the first western country to commence a Covid-19 vaccination programme, after approval of the vaccine last week by Medicines and Healthcare Products Regulatory Agency (MHRA).
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The UK started mass vaccinating its population on Tuesday, starting with the elderly and frontline workers.
What they are saying
The Medical Director, National Health Service, Stephen Powis, said the advice had been changed after 2 NHS workers, who were part of the thousands that received the vaccine on Tuesday, reported anaphylactoid reactions associated with receiving the vaccine.
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- “As is common with new vaccines, the MHRA (regulator) has advised on a precautionary basis that people with a significant history of allergic reactions should not receive this vaccination after two people with a history of significant allergic reactions responded adversely yesterday. Both are recovering well.”
The Chief Executive of the MHRA, June Raine, said that her team took a look at 2 cases of allergic reactions on Tuesday evening and both of the staff members of the NHS are recovering well.
- “Last evening, we were looking at two case reports of allergic reactions. We know from the very extensive clinical trials that this wasn’t a feature.”
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The MHRA said it would seek further information and was investigating as a matter of priority. Pfizer and BioNTech said they were supporting the MHRA’s investigation.
What you should know
It can be recalled that following the certification of the Pfizer and BioNTech Covid-19 vaccine as 95% effective in protecting people of all ages and ethnicities, the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) became the first in the world to approve the vaccine, while the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) continue to assess the data.
- The UK about 2 days ago became the first country to start the mass roll-out of Covid-19 vaccine with the administering of shots on a 90-year-old Margaret Keenan.
- Pfizer has said people with a history of severe adverse allergic reactions to vaccines or the candidate’s ingredients were excluded from their final stage trials, which is reflected in the MHRA’s emergency approval protocol.
