The UK’s medicines regulator today confirmed that the Pfizer/BioNTech and Oxford/AstraZenecaCovidvaccines are safe, with few adverse reactions among the first 7.4m doses given across the country.
The Medicines and Healthcare products Regulatory Agency (MHRA) said the benefits of having the jab “far outweighed” the risks and their safety was as high as had been suggested in clinical trials.
The MHRA said it had received 22,820 “yellow card” reports of suspected side effects from doses administered between December 9 and January 24, a reporting rate of three per 1,000 doses.
For both vaccines, the overwhelming majority of reports related to “mild and short-lasting” complaints about a sore arm or "flu-like” illness, headache, tiredness, nausea or fever.
The yellow card system is a safety-monitoring scheme where anyone who has received the vaccine can report a side-effect, even if only suspected. It is also used by GPs and other healthcare professionals.
The “reassuring” reports included 49,472 suspected reactions or symptoms after people received the Pfizer jab and 21,032 after the Oxford jab, which has been in use for less time. It said the number of incidents reflected a normal immune reaction to vaccines and were short-lasting.
Dr June Raine, MHRA chief executive, said: “The data we have collected provides further reassurance that the Covid-19 vaccines are safe and continue to meet the rigorous regulatory standards required for all vaccines. We remain confident that the benefits of these vaccines outweigh any risks.”
The MHRA said some events happened regardless of vaccination, especially when jabs were being given to elderly people with underlying illness.
There were 16,756 yellow cards reported for the Pfizer jab, 6,014 for the Oxford jab and 50 where it was not clear which vaccine had been used.
The MHRA currently recommends that people with a history of severe allergic reaction to any of the ingredients of the Pfizer jab should not receive it. Everyone who get a Pfizer jab should be monitored for 15 minutes afterwards.
The MHRA said that severe allergic reactions to the Pfizer jab could now be shown to be “very rare”, occurring in fewer than one in every 10,000 people receiving it.
It said it had received 101 reports of anaphylaxis or severe allergic reaction to the Pfizer jab. All patients have recovered. Thirteen reports of anaphylaxis have been received for the Oxford vaccine.
It has received 69 reports of Bell’s Palsy facial paralysis but said “association with the vaccine is not yet confirmed”.
The MHRA has received 107 UK reports of adverse drug reactions to the Pfizer jab in which the patient died shortly after vaccination, 34 reports for the Oxford vaccine and two where the brand of vaccine was unspecified.
It said: “The majority of these reports were in elderly people or people with underlying illness. Review of individual reports and patterns of reporting does not suggest the vaccine played a role in the death.”