The United Kingdom's medical regulator is urgently examining reports of two serious adverse reactions to the Pfizer-BioNTech COVID-19 vaccine.
Key points:
- People with a history of allergic reactions are now being told to not take the vaccine
- Late-stage trials of the vaccine found "no serious safety concerns"
- The medical director of the NHS in England says both affected patients are recovering
The two cases are people with a history of allergies.
The Medicines and Healthcare products Regulatory Agency (MHRA) released a statement on Wednesday saying the investigation had been made a priority.
"Once all the information has been reviewed we will communicate updated advice," the statement read.
The regulator is now warning people who have a history of serious allergic reactions not to receive a vaccine.
Stephen Powis, medical director for the National Health Service in England, said in a statement both affected patients were "recovering well".
"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," he said.
The medical regulatory agency also said vaccinations should not be carried out in facilities that did not have resuscitation equipment.
Pfizer and BioNTech said they were working with investigators "to better understand each case and its causes".
Late-stage trials of the vaccine found "no serious safety concerns," the companies said. More than 42,000 people have received two doses of the shot during those trials.
"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 companies said in a statement.
Documents published by the two companies showed people with a history of severe allergic reactions were excluded from the trials, and doctors were advised to look out for such reactions in trial participants who were not previously known to have severe allergies.
The UK began its mass vaccination program on Tuesday, offering the shot to people over 80, nursing home staff and some NHS workers.
Ninety-year-old grandmother Margaret Keenan was the first to receive the shot.
AP/Reuters
https://news.google.com/__i/rss/rd/articles/CBMiaGh0dHBzOi8vd3d3LmFiYy5uZXQuYXUvbmV3cy8yMDIwLTEyLTEwL3VrLXJlZ3VsYXRvci1pbnZlc3RpZ2F0aW5nLXJlYWN0aW9ucy10by1jb3ZpZC0xOS12YWNjaW5lLzEyOTY4NjA00gEnaHR0cHM6Ly9hbXAuYWJjLm5ldC5hdS9hcnRpY2xlLzEyOTY4NjA0?oc=5
2020-12-09 14:30:00Z
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