The United Kingdom has issued a warning against individuals with severe allergic reactions from taking the Pfizer/BioNTech coronavirus vaccine after two people developed severe reactions after the country initiated a mass vaccination programme.
The two staff members, who both carried an adrenaline auto injector and had a history of allergic reactions, developed symptoms of anaphylactoid reaction after receiving the vaccine on Tuesday.
An anaphylactoid reaction is a severe and potentially life threatening allergic reaction by the body’s immune system.
“Medicines and Healthcare Products Regulatory Agency (MHRA) have advised on a precautionary basis that people with a significant history of allergic reactions do not receive this vaccination.” Said Stephen Powis, the National Medical Director for UK’s National Health Service.
The statement from NHS has also confirmed that the two are recovering well.
MHRA said it is investigating the two reports that have been reported as a matter of priority. Once the investigation is complete and all the information has been reviewed, MHRA said it will communicate updated advice.
In the meantime, the new advice to persons with significant allergic reactions to vaccine, medicine or food that they should not receive the Pfizer/BioNTech vaccine stands.
The advice also states that vaccines should only be carried out in facilities where resuscitation measures are available.
Britain’s government had secured 800,000 doses of the vaccine, enough to give 400,000 people two doses each.
Top in the priority list are old people and those in care homes together with health care workers and other frontline workers. Thousands overall were vaccinated in the UK on Tuesday, NHS England said.
Britain banked on the vaccines efficacy data that showed that in the pivotal phase 3 clinical trial, the 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.
However, documents released on Tuesday by the U.S. Food and Drug Administration (FDA) said the Pfizer/BioNtech trial data indicated that there were potentially slightly more adverse responses thought to be allergic reactions among the vaccine group compared with the placebo group, at 0.63 percent.
Pfizer’s trial protocol also shows that people with a history of severe allergic reaction such as anaphylaxis to any component of the study intervention were not able to take part.
This new revelation and development comes barely 24 hours after the FDA said the first COVID-19 vaccine being considered for U.S. distribution “met the prescribed success criteria” in a clinical study. This was major milestone in paving the way for the agency to green-light distribution as early as this weekend.