UK regulators stated today that they have received two reports of potential allergic reactions linked to the COVID-19 vaccine from Pfizer and BioNTech.
UK regulators stated today that they have received two reports of potential allergic reactions linked to the COVID-19 vaccine from Pfizer and BioNTech, according to the Associated Press. The individuals who received the vaccine were a part of Britain’s coronavirus vaccination program.
Dr. June Raine, head of the UK’s medical regulatory agency, revealed the news while testifying to a Parliamentary committee on Wednesday. She stated that researchers are still looking into the two alleged reports of allergic reactions, and that clinical trials did not initially reveal these reactions to be a potential problem. Now, regulators are claiming that individuals who have a history of serious allergic reactions should not receive the vaccine.
The news comes after data released on Tuesday showed that out of Pfizer’s 44,000 trial volunteers, there were no participants with a “history of severe adverse reaction associated with a vaccine and/or severe allergic reaction to any component of the study intervention(s).”
Pfizer and BioNTech announced in early November that their Phase III study data showed the vaccine was more than 90% effective in preventing COVID-19 in participants who had not been previously infected. The trial enrolled more than 43,000 subjects at the time, 42% of whom had diverse backgrounds. At the time, no serious safety concerns were reported.
“Today is a great day for science and humanity,” said Dr. Albert Bourla, Pfizer Chairman and CEO, at the time of the announcement. “The first set of results from our Phase III COVID-19 vaccine trial provides the initial evidence of our vaccine’s ability to prevent COVID-19. We are reaching this critical milestone in our vaccine development program at a time when the world needs it most with infection rates setting new records, hospitals nearing over-capacity and economies struggling to reopen. With today’s news, we are a significant step closer to providing people around the world with a much-needed breakthrough to help bring an end to this global health crisis. We look forward to sharing additional efficacy and safety data generated from thousands of participants in the coming weeks.”
When the Phase III trial concluded in the middle of November, the companies stated that they believe the vaccine is 95% effective against COVID-19, beginning 28 days after the first dose. The efficacy was consistent across age, gender, race and ethnicity demographics.
Furthermore, the Data Monitoring Committee did not report any serious safety concerns related to the vaccine. A review of unblinded reactogenicity data from the final analysis suggested that the vaccine was well-tolerated in subjects, with most solicited adverse events resolving themselves shortly after the vaccination process.
The only severe solicited adverse events greater than or equal to 2% in frequency after the first or second dose was fatigue (3.8%) and headache (2%).
“The study results mark an important step in this historic eight-month journey to bring forward a vaccine capable of helping to end this devastating pandemic,” Bourla said at the time of the announcement. “We continue to move at the speed of science to compile all the data collected thus far and share with regulators around the world. With hundreds of thousands of people around the globe infected every day, we urgently need to get a safe and effective vaccine to the world.”
Based on current projections, Pfizer and BioNTech predict that they will be able to globally produce up to 50 million vaccine doses before the end of the year. This number is expected to rise to 1.3 billion doses by the end of 2021. The companies have created specially designed, temperature-controlled thermal shipping units utilizing dry ice to get the vaccines to their specified destinations.
