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People with a history of “significant” allergic reactions have been told not to get the Pfizer / BioNTech Covid-19 vaccine after two NHS workers who received the injection had “adverse” reactions.
Both workers, who had a history of “significant allergic reactions”, are understood to be on the mend.
After the incident, the Medicines and Health Products Regulatory Agency (MHRA) told the NHS Trusts that anyone with a history of “significant” allergic reactions should not currently receive the vaccine.
This includes reactions to medications, foods, or vaccines.
Dr. June Raine, executive director of the MHRA, which approved the Pfizer / BioNTech jab, told the Commons Science and Technology Committee that regulators had known since Tuesday night that two people who had received the vaccine had experienced allergic reactions. He added that similar reactions “were not a feature” of the vaccine trials.
He said careful plans had been made for “real-time surveillance” when monitoring the side effects of vaccines and that any updates to patient advice would be communicated “immediately.”
“The role is before, during and after, and there is a real look from start to finish from the scientific laboratory to the patient who received the vaccine for the first time yesterday,” he said.
“As an illustration of this, I can share with the committee that even last night we were looking at two case reports of allergic reactions.
“We know from very large clinical trials that this was not a feature, but if we need to strengthen our advice now that we have had this experience in vulnerable populations … we will send that advice to the field immediately.”
The NHS in England said that all trusts involved with the vaccination program had been informed.
Professor Stephen Powis, National Medical Director of the NHS in England, said: “As is common with new vaccines, the MHRA has advised as a precaution that people with a significant history of allergic reactions should not receive this vaccine after two people with a The history of major allergic reactions responded negatively yesterday.
“They are both recovering well.”
Launch of the vaccine began Tuesday.
/ Jeremy selwyn )Professor Chris Whitty, England’s chief medical officer, said the NHS and the Medicines and Healthcare Products Regulatory Agency (MHRA) are in a “very good position” to detect problems with any vaccine.
He said that “inevitably more information accumulates over time.”
“The NHS to MHRA is in a very good position to make sure we can collect things quickly, identify them, communicate them widely and make sure we improve the practice,” he added.
Dr. Raine also said that regulators in the United States are looking to wrap up their review of the vaccine shortly.
“My understanding is that the Food and Drug Administration will be waiting this week to complete their review, and the European Medicines Agency shortly after,” he told the Commons Science and Technology Committee.
Dr Raine added that she was unable to give a “firm date” on when the UK’s “homegrown” Oxford / AstraZeneca vaccine review would be completed.
“The data packages for the AstraZeneca / Oxford vaccine have been arriving, we expect an additional package in the next few days,” he told the Commons Science and Technology and Health and Welfare committees.
“I couldn’t give the committees a firm date, because the review is clearly a very active review.
“There will be questions and deliberations that we will conduct in exactly the same way that we have done for Pfizer / BioNTech.
“Therefore, I cannot give a firm date, but I can assure the committees that the work is progressing intensively and with great scientific rigor.”
Meanwhile, Pfizer said the vaccine was “well tolerated” during trials without “serious safety concerns.”
A spokeswoman said: “The MHRA has informed us of two reports of yellow cards that may be associated with an allergic reaction due to the administration of the Covid-19 BNT162b2 vaccine.
“As a precautionary measure, the MHRA has issued temporary guidance to the NHS while conducting an investigation in order to fully understand each case and its causes. Pfizer and BioNTech support 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 more than 44,000 participants to date, more than 42,000 of whom have received a second vaccine. “
The people were vaccinated in 70 hospitals across the UK on Tuesday, what Health Secretary Matt Hancock called “V-Day.”
Among the healthcare staff, nursing home workers and the elderly who received the vaccine was Margaret Keenan, 90, who said she felt “so privileged” to be the first person in the world to receive the Pfizer Covid vaccine. -19 out of clinical trials.
Amid the jubilation, Hancock cautioned that the guidelines still need to be followed, as the vaccine will be released in the coming months.
He told MPs in the Commons that people should “temper our joy and enthusiasm” at the beginning of the launch “with the need to keep each other safe.”
And he added: “Let’s not screw it up as we can see the answer is on the horizon.”
The government’s top science adviser Sir Patrick Vallance has said the UK is unlikely to return to a semblance of normalcy before spring, and that we may still need face masks next winter.
