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allergic reaction

Irish regulator says appropriate advice will be given if Pfizer vaccine approved after UK allergy warning

The adverse reactions which prompted the allergy warning in the UK are likely to be taken into the consideration by the EU regulatory body.

IRISH REGULATORS HAVE said comprehensive advice will be given if the Pfizer/BioNTech Covid-19 vaccine is approved in Ireland, following the UK’s warning that people who have a history of “significant” allergic reactions should not currently receive the jab.

The Health Products Regulatory Authority (HPRA) said Ireland will align with the guidance offered by the European Medicines Agency (EMA) when it makes a decision on the vaccine’s authorisation later this month. 

“Should a recommendation to authorise the vaccine be made, both the EMA and the HPRA will give comprehensive advice on any special warnings or restrictions in use, including for people who have a history of significant allergic reactions,” an HPRA spokesperson said. 

“That advice will take into consideration information emerging from use of the vaccine, outside of the context of clinical trials.”

In the UK, the Medicines and Healthcare products Regulatory Agency (MHRA) issued precautionary advice that anyone who has a history of “significant” allergic reactions to medicines, food or vaccines should not receive the vaccine currently.

The adverse reactions which prompted the allergy warning from the MHRA are likely to be taken into the consideration by the EMA when it comes to making any decision on authorisation and guidance for populations.

The warning came after two NHS staff members who received the jab on Tuesday had allergic reactions after being given the Pfizer/BioNTech vaccine.

Two health workers, who are understood to both have a history of severe allergic reactions, were among thousands to receive the vaccine on the first day of the Covid-19 mass vaccination programme.

In response to the warning, Pfizer said the vaccine was “well-tolerated” during the trials with “no serious safety concerns”.

A spokeswoman said: “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.

“As a precautionary measure, the MHRA has issued temporary guidance to the NHS while it conducts an investigation in order to fully understand each case and its causes.

“Pfizer and BioNTech are supporting the MHRA in the investigation.

“In the pivotal phase three clinical trial, this vaccine was generally well tolerated with no serious safety concerns reported by the independent Data Monitoring Committee.

“The trial has enrolled over 44,000 participants to date, over 42,000 of whom have received a second vaccination.”

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The EMA says it will hold a special meeting by 29 December at the latest to decide on whether to grant conditional approval for the vaccine, with a decision on the Moderna vaccine also potentially happening a couple of weeks later.

The EMA has insisted it has the “most appropriate” method to approve a Covid-19 vaccine after the UK fast-tracked its process. 

Once approval is given by the EU regulatory body, the rollout of the vaccine could start in the Republic as early as next month. Speaking at Fine Gaels parliamentary party last night, Tánaiste Leo Varadkar he was hopeful that the EMA may make their approval sooner than planned. 

The government has signed up to six advance purchase agreements of vaccines from Moderna, AstraZeneca, Jansen, Sanofi, CureVac and Pfizer.

The HPRA said that with any injectable vaccine, appropriate supervision should always be readily available following administration, in case of a rare significant allergic reaction.

“People that have a history of severe allergic reaction may be more susceptible to a reaction to a vaccine. As with the introduction of any new vaccine, the reactions are closely scrutinised and carefully monitored,” an HPRA spokesperson said.

- With reporting from PA

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