AS THE ROLLOUT of vaccines against Covid-19 progresses, public health regulators around the world are continuing to monitor potential side effects or adverse reactions.
Agencies in both the UK and Ireland are operating systems where healthcare professionals and people who have received a vaccine can log any negative health experience they observe after being inoculated, whether or not they know if it was due to the vaccine.
Clinical trials that the vaccines were put through before they were authorised for use in the public identified possible side effects, which continue to be monitored on a national and international level.
A recent article in the Westmeath Topic, which was reshared by other users on social media, suggested that this information is being hidden.
“We haven’t seen the story on the newspapers, but the official UK government data revealse [sic] that up tok [sic] April 16, Covid-19 injections wre [sic] followed by 847 deaths, and over 626,000 adverse effects, including over 11,000 psychiatric disorders, and 771 seizures.”
The Westmeath Topic is a weekly local newspaper based in Mullingar, Co Westmeath.
It printed the article under a section labelled “what it doesn’t say in the papers”. A photo of the article was uploaded to Instagram by a user and reshared on other social media platforms.
In a followup segment, the unidentified columnist last week wrote that adverse reactions to the vaccines in Ireland are “being kept quiet about and covered up”.
Both the UK and Ireland have health regulatory authorities which are closely monitoring any negative health experiences that people report after receiving a vaccine.
There have been suspected adverse reactions, including some deaths, recorded in people who have received Covid-19 vaccines – however, the figures recorded in the UK and Ireland include any reports that the regulators receive from people who were vaccinated (or their doctors or carers), whether or not it’s known if the experience was caused by the vaccine or if it happened to occur around the same time.
These figures are publicly available and regularly updated. It is incorrect to suggest that they’re being covered up.
Public health experts on a national and international level are continuing to monitor Covid-19 vaccines that are in use and it remains their stance that the vaccines are safe and effective.
So – where can you find information on side effects and suspected reactions, and what’s the difference? What suspected reactions have been recorded so far? What side effects have been identified?
The Westmeath Topic talks about the UK, where the Medicines and Healthcare Products Regulatory Agency (MHRA) runs a “Yellow Card” scheme that allows people to report if they experience a suspected adverse reaction or side effect to a vaccine, or for healthcare professionals or carers to make a report about a patient.
The MHRA asks for any suspicions to be reported, even if the person who reports the reaction isn’t sure if it was due to the vaccine.
Because of this, it is “very important to note that a Yellow Card report does not necessarily mean the vaccine caused that reaction or event”, the agency says.
“Many suspected ADRs [suspected adverse reactions] reported on a Yellow Card do not have any relation to the vaccine or medicine and it is often coincidental that they both occurred around the same time,” the MHRA says.
“The reports are continually reviewed to detect possible new side effects that may require regulatory action, and to differentiate these from things that would have happened regardless of the vaccine or medicine being administered, for instance due to underlying or undiagnosed illness,” it says.
“It is therefore important that the suspected ADRs described in this report are not interpreted as being proven side effects of Covid-19 vaccines.”
Over 34 million people have received a first dose of a vaccine against Covid-19 across England, Wales, Scotland and Northern Ireland, while a further 14 million have received a second dose as of 28 April.
The three vaccines in use in the UK are Pfizer/BioNTech, Oxford/AstraZeneca, and Moderna.
The MHRA has received and analysed Yellow Cards from 215,939 people after they received a vaccine, which is around 6.4% of the number of people in the UK who have received at least one dose.
One report can include more than one symptom, and in total, 755,757 suspected adverse reactions have been reported under the scheme.
The agency receives around three to six Yellow Cards per 1,000 doses of Pfizer/BioNTech and Oxford/AstraZeneca vaccines administered (the rollout of Moderna only began during April).
“It is known from the clinical trials that the more common side effects for both vaccines can occur at a rate of more than one in 10 doses (for example, local reactions or symptoms resembling transient flu-like symptoms),” the agency says.
The “overwhelming majority” of these reports relate to a reaction at the side of the injection, like a sore arm, or “generalised” symptoms, such as a headache, nausea, or fatigue.
These usually happen shortly after the person is vaccinated and are resolved within a day or two.
The MHRA has received 364 reports where a person died shortly after receiving the Pfizer/BioNTech vaccine, 722 reports after the Oxford University/AstraZeneca vaccine, two after the Moderna vaccine and 14 where the brand of vaccine was unspecified in the report.
The MHRA weekly report with the figures states that the “majority of these reports were in elderly people or people with underlying illness”.
“Usage of the Covid-19 Vaccine AstraZeneca has increased rapidly and as such, so has reporting of fatal events with a temporal association with vaccination however, this does not indicate a link between vaccination and the fatalities reported,” it says.
“[A] review of individual reports and patterns of reporting does not suggest the vaccine played a role in the death.”
Speaking to The Journal, a spokesperson for the MHRA explained that the agency reviews the Yellow Card reports regularly to allow it to differentiate between side effects of the vaccines and experiences which simply happened to occur around the same time the person was vaccinated.
“In regards to the COVID-19 vaccines, we now have a lot of data on safety and it’s really encouraging that people are reporting their experiences with the vaccine to us,” the spokesperson said.
“What this is telling us is that the side effect profile is as we expected it to be based on the clinical trial data that supported the authorisations – all vaccines and medicines have some side effects and these need to balanced against benefits,” they said.
“Yellow Card reports are continually reviewed to detect possible new side effects that may require regulatory action, and to differentiate these from things that would have happened regardless of the vaccine or medicine being administered, for instance due to underlying or undiagnosed illness.”
The MHRA encourages doctors and patients to report any negative health experience they observe after receiving a vaccine so that it can “continually appraise the safety of vaccines and medicines”.
“Vaccination and surveillance of large populations means that, by chance, some people will experience and report a new illness or events in the days and weeks after vaccination,” the MHRA says.
“A high proportion of people vaccinated early in the vaccination campaign were very elderly, and/or had pre-existing medical conditions. Older age and chronic underlying illnesses make it more likely that coincidental adverse events will occur, especially given the millions of people vaccinated.”
A detailed breakdown of the reports for possible reactions received by the MHRA are available for the Pfizer, Moderna, and AstraZeneca vaccines, and for cases where the vaccine brand was not specified.
13,930 psychiatric disorders have been reported as possible reactions to the vaccines, of which two were fatal.
There have been 1017 reports of seizures, as well as some other cases of specific types of seizures or epilepsy. Two of the seizures were fatal.
Ireland
In Ireland, the Health Products Regulatory Authority operates a similar system where the public and healthcare professionals can log suspected side effects from a Covid-19 vaccine.
It also includes any reports it receives from the companies responsible for the vaccines.
The HPRA publishes regular updates that include “an overview of reports of suspected side effects notified to the HPRA safety monitoring system and is provided as an enhanced transparency measure for members of the public and healthcare professionals”.
The latest figures from the HPRA show that it has received 6,616 reports of suspected side effects up to 15 April.
At that time, 814,470 first doses and 341,129 second doses of Covid-19 vaccines had been administered in Ireland.
“All vaccines have some side effects, the vast majority of which are mild to moderate in nature,” the HPRA said in its latest update last week.
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“These side effects need to be continuously balanced against the benefits in preventing Covid-19 illness. Overall, the national reporting experience continues to support the favourable assessment that the benefits of Covid-19 vaccines outweigh the risks.”
The HPRA’s updates detail limitations with the system similar to that in the UK, which include that:
- It receives reports “based on suspicion that an adverse experience may be associated with vaccination”, which “does not mean the vaccine caused the adverse experience”
- “Reports may describe coincidental events, which have occurred post-vaccination, but would have occurred even if vaccination had not taken place (e.g. they may be due to an underlying medical condition, or be signs and symptoms of another illness)”
- Because reporting a suspected side effect is voluntary, “not all suspected side effects will be reported”
- “An increased number of reports is expected for Covid-19 vaccines, given public interest as well as HPRA calls encouraging reporting. This is known as stimulated reporting.”
The most common suspected side effects that the HPRA has received reports of include nausea, headaches, and a fever.
The HPRA has received 40 reports that described an individual who was vaccinated and has later passed away.
“The types of events reported mainly include fatalities often seen in the general population, such as those due to natural causes or progression of underlying disease,” the HPRA stated.
“In all cases, those concerned had underlying conditions and/or concurrent illness, with a small number having tested positive for Covid-19,” it said.
“Reports describing a death are carefully reviewed. However, it can be expected that fatalities due to progression of underlying disease or natural causes will continue to occur, including following vaccination. This does not mean that the vaccine caused the deaths.”
Side effects
The three vaccines that are currently in use in Ireland – Pfizer/BioNTech, Moderna, and Oxford/AstraZeneca – were put through several phases of clinical trials before they were approved for use, which included identifying potential side effects.
Information about the side effects or suspected adverse reactions that were identified during clinical trials and through ongoing monitoring are publicly available.
Patients, and their doctors and carers, are encouraged to report any side effect or suspected reaction that they experience after receiving a vaccine.
There is no evidence to suggest that this information is being hidden or covered up.
The HSE has a full list available of the side effects that can be experienced from the vaccines.
Common side effects for all three of the vaccines can be tenderness in the arm where the person was injected, a headache, and feeling tired.
The most common side effects identified during the trial of the Pfizer vaccine were “usually mild or moderate and got better within a few days after vaccination,” the European Medicines Agency has said.
“They included pain and swelling at the injection site, tiredness, headache, muscle and joint pain, chills and fever.”
The HSE says that “serious side effects, like a severe allergic reaction, are extremely rare”.
Some rarer side effects after the AstraZeneca vaccine that may affect 1 in 1,000 people include reduced appetite, dizziness, and sleepiness.
For the Moderna and Pfizer vaccines, 1 in 10,000 people may develop Bell’s palsy, which is a weakness or paralysis of the facial muscles. Most people start to recover from Bell’s palsy around two weeks after the symptoms first appear and continue to improve over the following three to six months.
Serious side effects in the Pfizer and AstraZeneca vaccines are seen in around 1 in 100,000 people, and 1 in a million people for the Moderna vaccine.
“Your vaccinator is trained to treat any serious allergic reactions,” the HSE says.
Earlier this month, the EMA said that unusual blood clots should also be listed as a “very rare side effect” of the Astrazeneca vaccine after a review of evidence by its safety committee.
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