Covid-19 vaccines used across the UK are safe, new MHRA analysis shows
By Jane Kirby, PA Health Editor
Covid-19 vaccines being rolled out across the UK are safe, with the “overwhelming majority” of suspected side-effects being mild, the drugs regulator has said.
The Medicines and Healthcare products Regulatory Agency (MHRA) said its analysis showed a reporting rate of three suspected side-effects for every 1,000 doses of vaccine administered – with the issues reported being similar to those for the annual flu vaccine.
Professor Sir Munir Pirmohamed, chairman of the expert working group of the Independent Commission on Human Medicines, told a media briefing that Covid-19 vaccines were “extremely safe”.
He added: “The benefits far outweigh the risks. I say that to my family as well.”
It is the first time data on side-effects for jabs in use in the community has been scrutinised, including for the newer Pfizer/BioNTech mRNA vaccine.
From December 9 to January 24, the MHRA received 22,820 reports of suspected side-effects, with the vast majority being mild and in line with most other types of vaccine, the MHRA said.
These included sore arms and mild flu-like symptoms (such as headache, chills, fatigue and aching muscles) that are short-lived, reflecting the body’s normal immune response to vaccines.
Dr June Raine, chief executive of the MHRA, said: “Vaccines are the most effective way to protect against Covid-19 and save lives and prevent serious complications from this terrible virus.
“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.
“Our priority is to ensure the public have safe and effective vaccines and we will continue to analyse, monitor and review all the safety data for these vaccines.
“I’d like to thank everyone who has reported a potential side effect to us – every report matters.”
In its report, the MHRA said its analysis covered a period when an estimated 5.4 million first doses of the Pfizer/BioNTech vaccine and 1.5 million doses of the AstraZeneca/Oxford vaccine had been administered, and around half a million second doses.
As of January 24 across the UK, 16,756 Yellow Cards had been reported for Pfizer/BioNTech alongside 6,014 for AstraZeneca/Oxford vaccine, and 50 where the brand of the vaccine was not specified.
The overwhelming majority of reports were for mild suspected side-effects.
The MHRA said data showed that severe allergic reactions to the Pfizer/BioNTech vaccine were very rare (less than one in 10,000 people receiving the jab), with a rate of one to two cases per 100,000 doses administered.
Overall, the MHRA received 101 reports of severe allergic reactions – associated with anaphylaxis or anaphylactoid reactions – for the Pfizer jab, and 13 for the Oxford vaccine. All the people recovered as far as the MHRA was aware.
The regulator said anaphylaxis can be a very rare side-effect to many types of vaccines.
The regulator also received 69 reports of facial paralysis or weakness with the Pfizer/BioNTech vaccine and six for the AstraZeneca jab.
When it compared such reports with the rate at which facial paralysis can occur naturally, it said the rate was similar and does “not currently suggest an increased risk following the vaccines”.
Some 107 reports involved patients who died shortly after vaccination with the Pfizer/BioNTech jab, alongside 34 reports for the Oxford vaccine.
“The majority of these reports were in elderly people or people with underlying illness,” the MHRA said in its study.
“Review of individual reports and patterns of reporting does not suggest the vaccine played a role in the death.”
Of other suspected reactions, the MHRA said “there are currently no indications of specific patterns or rates of reporting that would suggest the vaccine has played a role”.
Side-effects overall appeared to be more common in younger age groups, but the MHRA suggested there may be biases in reporting, with younger people more likely to report side-effects.
It said other strands of data being monitored had not thrown up any safety concerns.