A healthcare worker at the Bartlett Regional Hospital in Juneau, Alaska, has reportedly developed a severe allergic reaction after getting the Pfizer-BioNTech COVID-19 vaccine on Tuesday (15 Dec) despite not having a history of allergic reactions.
The middle-aged woman had to be hospitalised overnight for observation due to the symptoms, as reported by NBC.
Dr Lindy Jones, the emergency physician who treated the woman, said on Wednesday (16 Dec) that the woman had no history of allergies, but she had an anaphylactic reaction about 10 minutes after receiving the vaccine.
Her reactions include feeling flushed and shortness of breath.
“She had a red, flushed rash over her face and torso,” said the physician.
Dr Jones noted that the patient’s symptoms subsided for a while but then re-emerged, adding that the symptoms resolved after being administered with allergy treatment epinephrine.
The woman’s reaction is believed to be similar to the two cases of anaphylaxis reported in Britain last week.
Following the two reports, the Medicines and Healthcare Products Regulatory Agency (MHRA) warned that anyone with a history of anaphylaxis to medicine or food should not get the Pfizer-BioNTech COVID-19 vaccine.
“Any person with a history of anaphylaxis to a vaccine, medicine or food should not receive the Pfizer BioNTech vaccine,” said June Raine, chief executive of the MHRA.
“A second dose should not be given to anyone who has experienced anaphylaxis following administration of the first dose of this vaccine,” she added.
The Pfizer-BioNTech vaccine has already received conditional approvals or emergency authorisations from four regulatory agencies, including the UK’s Medicines and Healthcare products Agency (MHRA), Health Canada, the US’ Food and Drug Administration (FDA), and Singapore’s Health Sciences Authority (HSA).
Meanwhile, the European Medicines Agency’s (EMA) Human Medicines Committee (CHMP) has set a date for the Pfizer-BioNTech COVID-19 vaccine assessment meeting, which set to be scheduled on 21 December, following the data it received from the company and its pending evaluation outcome.
“The CHMP will conclude its assessment at the earliest possible timepoint and only once the data on the quality, safety and effectiveness of the vaccine are sufficiently robust and complete to determine whether the vaccine’s benefits outweigh its risks,” it asserted.
S’pore expects delivery of Pfizer-BioNTech vaccine by December-end
Over in Singapore, the HSA has recently granted an authorisation for the Pfizer-BioNTech COVID-19 vaccine to be used in the city-state, with the first shipment due to arrive in Singapore by the end of December.
“HSA’s review of the available clinical data found that the benefits of the Pfizer-BioNTech COVID-19 vaccine outweigh the known risks. The vaccine demonstrated a high vaccine efficacy of 95%,” it said in a statement on Monday (14 Dec).
The vaccine was granted interim authorisation under the Pandemic Special Access Route (PSAR), which facilitates access to critical novel vaccines, medicines and medical devices during a pandemic, said HSA.
“Using PSAR, HSA can start evaluating new vaccines, medicines and medical devices from the early stages of clinical studies, as and when real-time data is submitted by companies on a ‘rolling’, or staggered basis, instead of waiting for the full data set to be submitted before starting our evaluation,” it added.
Citing the vaccination regime submitted by Pfizer-BioNTech, HSA said two doses are required to be administered 21 days apart, in people aged 16 years and above.
“Pregnant women, immunocompromised persons and those under the age of 16 should also not receive the Pfizer-BioNTech vaccine as the safety and efficacy data on this group of persons is not available yet,” it stated.
Additionally, people with a history of anaphylaxis or the rapid onset of severe allergic reactions should not receive the Pfizer-BioNTech vaccine as a precautionary measure.
Noting that the safety profile of the vaccine is “generally consistent” with other registered vaccines, HSA explained that some people may experience side effects such as pain, redness, swelling at the injection site, as well as fatigue, headache and muscle ache after vaccination.
While not everyone will experience these side effects, they are “common and expected” as part of the body’s natural response to build immunity against the COVID-19, it further noted.
Update: Another healthcare worker from Alaska suffers allergic reaction to Pfizer-BioNTech vaccine
A second healthcare worker, a male, has reportedly suffered an allergic reaction 10 minutes after getting the Pfizer-BioNTech vaccine at Bartlett Regional Hospital on Wednesday (16 Dec).
Bartlett hospital said in a statement that the man experienced “eye puffiness, lightheadedness, and scratchy throat” but it was not considered as anaphylaxis, as reported by CNN.
He was treated in the emergency department with epinephrine, Pepcid and Benadryl, according to the hospital.
It added that the worker felt “completely back to normal within an hour and was released.”
“Both incidents were reported to the CDC’s [Centers for Disease Control and Prevention] Vaccine Adverse Event Reporting System (VAERS) database. Bartlett Regional Hospital and the State of Alaska Department of Health and Social Services are in close communications with the CDC, and the agency is providing guidance and support,” said the hospital.