Companies say documents relating to their COVID-19 vaccine were hacked in cyberattack on Europe’s medicines regulator.
The UK’s medicine regulator says anyone with a history of anaphylaxis to a medicine or food should not get the Pfizer-BioNTech vaccine, expanding its guidance on an earlier allergy warning about the shot, the first against COVID-19 to have secured approval.
“Any person with a history of anaphylaxis to a vaccine, medicine or food should not receive the Pfizer BioNTech vaccine,” June Raine, chief executive of the Medicines and Healthcare products Regulatory Agency (MHRA) said in a statement. “A second dose should not be given to anyone who has experienced anaphylaxis following administration of the first dose of this vaccine.”
The United Kingdom this week became the first country in the world to begin vaccinations against COVID-19, but after reports of three possible allergic reactions from people who had their shots on the first day of the mass vaccination programme warned those with a “significant allergic reaction” to vaccines, medicines or food should not get the inoculation.
The earlier warning did not mention anaphylaxis, which is a severe and potentially life-threatening reaction to a trigger, usually foods including milk, nuts and shellfish, as well medicines like aspirin. Other triggers include bee stings and latex.
Symptoms of anaphylaxis include feeling faint, having difficulty breathing and a fast heartbeat. A patient may also develop a rash. The reaction requires immediate treatment and many people who suffer severe allergies usually carry adrenaline 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 programme on Tuesday.
The agency said it was updating its guidance after two cases of anaphylaxis and one report of a possible allergic reaction following immunisation.
“Most people will not get anaphylaxis and the benefits in protecting people against COVID-19 outweigh the risks,” Raine stressed.
“You can be completely confident that this vaccine has met the MHRA’s robust standards of safety, quality and effectiveness. The safety data has also been critically assessed by the government’s independent advisory body, the Commission on Human Medicines. No vaccine would be approved unless it meets these stringent standards – on that you can be sure.”
Canada is the latest country to approve the Pfizer-BioNTech vaccine, which showed 95 percent efficacy in late-stage trials, raising hopes that it will help bring an end to the coronavirus pandemic. Bahrain has also authorised the vaccine for public use, while the US Food and Drug Administration is scheduled to consider emergency use authorisation on Thursday.
On Twitter, New York governor Andrew Cuomo said the FDA was expected to give the drug the green light and the state’s own panel would then “review and approve”. Some 170,000 doses could arrive in New York 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 the age of 80.
The UK, which has a population of about 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.
It has ordered 40 million doses of the vaccine, which needs to be shipped and stored at -70 degrees Celsius (-94F), or below. The order is enough to inoculate 20 million people, because the vaccine has to be administered in two injections, 21 days apart.
There are a number of other vaccines in development with US-based Moderna expected to get emergency approval in the coming weeks. The vaccine has been developed in partnership with the United States National Institutes of Health, and uses the same basic approach as the Pfizer-BioNTech shot.
Scientists at the UK’s University of Oxford, meanwhile, expect to report results from the late-stage trials of their COVID-19 vaccine by Christmas. They are working with UK-based pharmaceutical firm AstraZeneca. The experimental vaccine is expected to be cheaper and easier to handle than the Pfizer and Moderna shots.