Two allergic reactions to Pfizer vaccine lead to warning in UK
December 9, 2020
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Margaret Keenan, 90, who was the first patient in the United Kingdom to receive the first of two doses of the Pfizer-BioNtech Covid-19 vaccine, reacts as she talks with Healthcare assistant Lorraine Hill, while preparing to leave University Hospital Coventry, in Coventry on December 9, 2020, a day after receiving the vaccine.
Enlarge / Margaret Keenan, 90, who was the first patient in the United Kingdom to receive the first of two doses of the Pfizer-BioNtech Covid-19 vaccine, reacts as she talks with Healthcare assistant Lorraine Hill, while preparing to leave University Hospital Coventry, in Coventry on December 9, 2020, a day after receiving the vaccine.

Johnny Weeks | Getty Images

People with a significant history of allergies should not receive the Pfizer/BioNTech coronavirus vaccine, the UK medical regulator has said, after two NHS staff experienced an adverse reaction.

June Raine, chief executive for the Medicines and Healthcare products Regulatory Agency (MHRA), told a UK parliamentary committee that the two individuals had the allergic reaction shortly after receiving the vaccine and that the regulator was investigating. Both people had a history of serious allergies and carried adrenalin pens.

“We know from the very extensive clinical trials that this wasn’t a feature but if we need to strengthen our advice . . . we get that advice to the field immediately,” Dr. Raine said.

Experiencing an allergic reaction to a vaccine is not uncommon and independent scientists stressed that there was no need for immediate alarm.

Professor Stephen Powis, national medical director for the NHS in England, said: “As is common with new vaccines, the MHRA have advised on a precautionary basis that people with a significant history of allergic reactions do not receive this vaccination after two people with a history of significant allergic reactions responded adversely yesterday.”

Prof. Powis added that the two NHS workers were recovering well.

Pfizer confirmed the temporary change in guidance while a probe was under way. “We have been advised by MHRA of two yellow card reports that may be associated with allergic reaction due to administration of the Covid-19 BNT162b2 vaccine,” said the drugmaker.

The company said it was supporting the MHRA in the investigation with its partner BioNTech.

Stephen Evans, professor of pharmacoepidemiology at the London School of Hygiene & Tropical Medicine, said: “For the general population, this does not mean that they would need to be anxious about receiving the vaccination…  Allergic reaction occurs with quite a number of vaccines and perhaps even more frequently with drugs, so it is not unexpected.”

Prof. Evans added that data from the BioNTech/Pfizer trial showed that 0.5 percent of participants who received the placebo had experienced an allergic reaction compared with 0.6 percent of those who received the real vaccine.

Pfizer said its phase 3 clinical trials showed the vaccine was “generally well tolerated” with no serious safety concerns. More than 44,000 patients had taken part in trials, 42,000 of whom had received a second jab, it said. However, the companies’ trial had excluded participants with a “history of severe adverse reaction associated with a vaccine.”

The vaccine uses breakthrough mRNA technology and was the first Covid-19 shot to win approval for use in either Europe or North America earlier this month. On Wednesday it was also approved for use in Canada, where the regulator has been reviewing the shot on a rolling basis. It has also gained regulatory approval in Bahrain.

Data released on Tuesday by the US Food and Drug Administration, which is still assessing the vaccine, showed that it had worked well on trial participants whatever their race, age or weight.

In the most detailed public report yet on the results of the trials, the US regulator’s scientists did not raise any significant concerns about safety. However, the report said there was not enough evidence about how safe it was in children, pregnant and breastfeeding women, and people with compromised immune systems, such as those with HIV. The most common side effects were pain at the injection site, fatigue and headache.

© 2020 The Financial Times Ltd. All rights reserved Not to be redistributed, copied, or modified in any way.

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