The United Kingdom drug regulator released on Wednesday that persons who have a history of significant allergic reactions should not receive the COVID-19 vaccine, which was developed by Pfizer and BioNTech.
According to the National medical director for the National Health Services, the Medicines and Healthcare Products Regulatory Agency of U.K. updated its guidance to British health service trusts on who will be receiving the vaccine onwards after two members of Britain's NHS experienced allergic reactions to the shot.
Based on the latest report of USA Today, both are recovering well after displaying allergic reactions.
The regulatory agency stated that any person with a history of a significant allergic reaction to a vaccine, food, or medicine which involves a previous history of anaphylactoid reaction or those who were advised to bring an adrenaline autoinjector should not receive the vaccine from Pfizer BioNtech.
National Medical Director for the NHS, Stephen Powis, shared that the mentioned precautionary measure is standard, especially with new vaccines.
The United Kingdom was the first country that had approved and administered the vaccine of Pfizer-BioNTech.
The massive vaccination drive has begun on Tuesday, where it started in hospitals, with health and care home workers and those over the age of 80 were the first in line to be inoculated, NBC News reported.
Head of the MHRA, Dr. June Raine, shared that the U.K. government selected a committee on Wednesday that the regulator will be maintaining real-time vigilance regarding the vaccine after it is being deployed.
She also mentioned that even last evening, they were looking at two case reports of allergic reactions.
Raine also added that they know from the extensive clinical trials that this was not a feature. Still, they need to strengthen their advice now that they have had this experience in vulnerable populations, the groups selected as a priority. They get the advice to the field immediately, The Wall Street Journal reported.
Earlier this month, Pfizer and BioNTech shared that they have applied to the European Medicines Agency or EMA for the conditional marketing authorization of their vaccine for COVID-19.
BioNTech mentioned a week ago that if the authorization is granted, it will enable them to distribute the vaccine within the European continent this month before the year ends.
On their website, EMA shared that such authorization is granted to medicines that address patients' unmet medical needs based on less comprehensive information compared to normally required.
EMA also added that in the interest of public health, applicants also have a chance that they might be granted conditional marketing authorization for such medicines where the benefit of immediate availability outweighs the risk of less comprehensive information than usually required.
Another requirement of EMA is the applicant's flexibility as there is a need to provide comprehensive clinical information in the future.
Dr. Albert Bourla, the Chairman and CEO of Pfizer shared in a statement a week ago that the announcement they made marks another milestone in their efforts in fulfilling their promise to do everything that they can in addressing the ongoing global health crisis that the public health needs.