UK Medicines Regulator Says Anyone With A History Of Drug Or Food Anaphylaxis Should Not Receive The Pfizer-BioNTech Vaccine, Expanding Advice On Earlier Allergy Warning Regarding Shooting, The First Against COVID -19 to have obtained approval.
“Anyone with a history of anaphylaxis to any vaccine, drug, or food should not receive the Pfizer BioNTech vaccine,” said June Raine, executive director of the Medicines and Health Products Regulatory Agency (MHRA ) in a press release. “A second dose should not be given to anyone who has experienced anaphylaxis after the administration of the first dose of this vaccine.”
The UK this week became the first country in the world to start COVID-19 vaccinations, but after reports of three possible allergic reactions from people who were vaccinated on the first day of the mass vaccination program , people suffering from a reaction “to vaccines, drugs or foods should not be vaccinated.
The previous warning did not mention anaphylaxis, which is a serious and potentially fatal reaction to a trigger, usually foods including milk, tree nuts, and shellfish, as well as medications like aspirin. Other triggers include bee stings and latex.
Symptoms of anaphylaxis include feeling faint, difficulty breathing, and rapid heartbeat. A patient may also develop a rash. The reaction requires immediate treatment, and many people with severe allergies usually wear epinephrine auto-injectors.
The MHRA approved the Pfizer-BioNTech vaccine for emergency use last week, paving the way for the start of a UK-wide vaccination program on Tuesday.
The agency said it was updating its guidelines after two cases of anaphylaxis and a report of a possible allergic reaction after the vaccination.
“Most people won’t get anaphylaxis, and the benefits of protection from COVID-19 outweigh the risks,” Raine said.
“You can be completely confident that this vaccine meets the rigorous standards for safety, quality and efficacy of the MHRA. Safety data has also been critically assessed by the government’s independent advisory body, the Commission for Medicines for Human Use. No vaccine will be approved if it does not meet these strict standards – you can be sure. “
Canada is the last country to approve the Pfizer-BioNTech vaccine, which has shown 95% effectiveness in late-stage trials, raising hopes that it will help end the coronavirus pandemic. Bahrain has also cleared the vaccine for public use, while the U.S. Food and Drug Administration is expected to consider emergency use clearance on Thursday.
On Twitter, New York Gov. Andrew Cuomo said the FDA needed to give the drug the green light and the state’s own panel “would review and approve.” Some 170,000 doses could arrive in New York City by the weekend, he said on Twitter.
Seventy UK hospitals are involved in the Pfizer-BioNTech campaign with the first doses given to people over 80.
The UK, which has a population of around 67 million people, has recorded more deaths from COVID-19 than anywhere else in Europe and has confirmed more than 1.7 million cases of the disease.
He has ordered 40 million doses of the vaccine, which must be shipped and stored at -70 degrees Celsius (-94F), or less. The order is sufficient to vaccinate 20 million people, because the vaccine must be given as two injections, 21 days apart.
A number of other vaccines are in development with US-based Moderna expected to get emergency approval in the coming weeks. The vaccine was developed in partnership with the US National Institutes of Health and uses the same basic approach as the Pfizer-BioNTech vaccine.
Scientists at the UK University of Oxford, meanwhile, expect to report results advanced trials of their COVID-19 vaccine before Christmas. They work with the British pharmaceutical company AstraZeneca. The experimental vaccine is expected to be cheaper and easier to handle than the Pfizer and Moderna injections.