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Q&A: How are vaccination side effects being tracked?

Q&A: How are vaccination side effects being tracked?

Thursday 18 March 2021

Q&A: How are vaccination side effects being tracked?

Thursday 18 March 2021


Amid global discussions about possible side effects to covid-19 vaccines, Express looks at common reactions and the process for logging concerns.

Today, Europe’s medicines agency is due to announce its findings of a review into the safety of Oxford/AstraZenca vaccine after concerns that it caused blood clots.

A number of European countries - including France, Germany, Italy, Ireland and the Netherlands - suspended their rollout of the vaccine this week while they wait for today’s European Medicines Agency report.

However, the agency is standing by its original decision to approve the vaccine and has reiterated there is “no indication” the jab causes clots.

The UK’s medicine and vaccine regulator, the Medicines and Healthcare products Regulatory Agency, has also said the vaccine is safe, there is no evidence to suggest it causes clots, and any reported side effects are within expected parameters. 

Following the MHRA’s advice, Health authorities in Jersey have echoed the agency's position and continue to administer the Oxford/AstraZeneca jab.

This week, the Government also announced its plans to rollout its vaccination programme to the under 50s.

Express looks further into the issue of vaccine side effects and how they are reported...

Are side effects common?

The Government advice is that, yes, side effects are common but most of these are mild and short-term, and not everyone gets them. They say that these are evidence the vaccine is working in the body.

Very common ones include:

  • Having a painful, heavy feeling and tenderness in the arm where you had your injection. This tends to be worst around one to two days after the vaccine
  • Feeling tired
  • Having a headache
  • General aches, or mild flu-like symptoms
  • Feeling feverish for two to three days

However, having a high temperature is unusual and could mean the person having covid itself or another infection. Swollen glands is also uncommon. The official advice in these cases is to rest and take a normal dose of paracetamol.

bed_bedroom_bed_sheets_sleep.jpg

Pictured: A common side effect is fatigue.

If symptoms get worse or last longer than a week, islanders are advised to contact their GP or other healthcare professional. 

It is then that islanders are encouraged to report any side effects - either personally or via their GP - to the Yellow Card Scheme.

Are the side effects different depending on which vaccine is given?

Jersey is currently issuing two types of vaccine: Pfizer/BioNTech and Oxford/AstraZeneca.

When it comes to the former, the MHRA reports that the most frequent adverse reactions in trials were pain at the injection site, fatigue, headache, myalgia (muscle pains), chills, arthralgia (joint pains), and fever; these were each reported in more than one in then people. 

These reactions were usually mild or moderate in intensity and resolved within a few days after vaccination. Adverse reactions were reported less frequently in older adults (over 55 years) than in younger people.

For the Oxford/AstraZeneca vaccine, MHRA reports that the most frequently reported adverse reactions in these trials were injection-site tenderness, injection-site pain, headache, fatigue, myalgia, malaise, pyrexia (fever), chills, arthralgia, and nausea; these were each reported in more than one in 10 people. 

paracetamol-painkiller.jpg

Pictured: Headaches are a common side effect and islanders are advised to take paracetamol if they experience one.

The majority of adverse reactions were mild to moderate in severity and usually resolved within a few days of vaccination. Adverse reactions reported after the second dose were milder and reported less frequently than after the first dose. 

Adverse reactions were generally milder and reported less frequently in older adults (65 years and older) than in younger people.

What is the Yellow Card scheme?

It’s a UK-wide scheme run by the MHRA, which is part of the UK Department of Health. 

The scheme is the only UK system for collecting and monitoring information on medicine or vaccine side effects or medical device incidents. It relies on voluntary reporting by health professionals and the public, either via its website or app.

Yellow Card.jpeg

Pictured: The MHRA has a special section on its website for reporting the side effects of coronavirus vaccines.

The MHRA say that the purpose of the scheme is to provide an early warning that the safety of a medicine or a medical device may require further investigation. 

Reports can be made for all medicines including vaccines, blood factors and immunoglobulins, herbal medicines and homeopathic remedies, all medical devices available on the UK market and reports of safety concerns associated with e-cigarette products . 

The MHRA is also able to investigate counterfeit or fake medicines or devices and if necessary, take action to protect public health.

The agency has created a separate section on its website for people to report side effects specific to covid-19.

How many reports from Jersey have been made?

Because Jersey is basing its vaccine advice on the UK MHRA, it is also feeding into the Yellow Card scheme. This means that it is not known how many reports have been specifically submitted by islanders, be they members of the public or health care professionals.

Express has asked the MHRA if it can provide any Jersey-specific data and is waiting for a reply.

However, speaking this week, the island’s Deputy Medical Officer of Health, Dr Ivan Muscat, did say that he was unaware of any reports of people in Jersey having a blood clot that was linked to the vaccine.

He added that the MHRA had said that, to the end of last month, there had been 37 reports of clots out of 10.7m doses of Pfizer/BioNTech vaccine given across the British Isles, and 32 out of 9.7m Oxford/AstraZeneca doses.

The agency had made it “very clear” there currently is no signal to indicate a relationship between a covid vaccine and blood clotting, he said.

vaccineastrazeneca1.jpg

Pictured: The MHRA says there is currently is no signal to indicate an AstraZeneca vaccine will cause blood clotting.

He added that there is around one case of DVT (deep vein thrombosis) per 1,000 every year, and that it may be that some of these expected cases may be occurring in people who have recently had the vaccine.

Nationally, as at the end of February, 33,207 Yellow Cards were reported for the Pfizer/BioNTech, 54,180 have been reported for the Oxford/AstraZeneca vaccine, and 251 have been reported where the brand of the vaccine was not specified.

For both vaccines, the overall reporting rate is around three to six Yellow Cards per 1,000 doses administered.

Will my doctor fill out a Yellow Card for me?

It is the responsibility of any healthcare professional to complete a Yellow Card report if they come across a condition in a patient which they think might have been caused by a vaccine, medicine or device. 

Doctors have told Express that, while GPs have not been specifically briefed by the Health Department on possible vaccination side effects or given a reminder about the Yellow Card system, they are keeping up to date with data and information as it is released.

If a person fills in a Yellow Card form themselves, there is a tick box to allow the MHRA to send the information to a person’s GP. If filled in by a healthcare professional, the form does not ask for the personal details of the patient. 

What happens to the information?

Information is entered into a database that allows the MHRA to process and analyse the reports on a weekly basis. Taken with all other reports relating to that medicine or vaccine, the agency say they will look for trends, in conjunction with research from around the world.

If enough evidence is found from multiple reports, the agency would initiate more research and discussion that could lead to more guidance and regulation - or even a suspension or ban - of any medicine or vaccine if it is deemed unsafe.

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Comments

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Posted by Anthony Webber on
We have a major health and safety issue with the reporting of any harmful effects of the covid-19 vaccines.
The reports we have here should have stated that only between 3 and 6 yellow card report forms are filled in per 1000 patients given a covid -19 vaccine.
These MHRA reports are based on those which are obviously inadequate.
Let us look at the initial trials the covid-19 vaccine manufacturers did. They had 100% reporting.
So why is between 0.3% and 0.6% deemed satisfactory ?! it simply isn't, especially when all these covid-19 vaccines are officially still in the trials stage.
Yes, that is right, they have only been approved by the MRHA for emergency use.
The problem is the authorities have gone over the top with the emergency use and are now giving it to millions of people who do not even need it !
The same applies in Jersey in a smaller scale.
These covid -19 vaccines will not be considered for licsensing by the MHRA until about 2023 !
Until the licensing is granted all those taking these covid-19 vaccines are effectively guinea pigs- and they should be told the truth about this.
In the UK there have been just under a 1000 deaths post covid-19 vaccine.
But this is based on not knowing what the results of over 99% of the covid-19 vaccines which have been given.
In Scotland a Freedom of Information request revealed that 2000 people in Scotland alone had died within a month of having a covid-19 vaccination. As Scotland's population is minute compared with the whole of the UK, that figure would have to be increased about ten times to get an idea of the UK figure.
So in the UK and in Jersey it is important for the authorities to follow up on every patient who has had a covid-19 vaccine. To not do so is nothing short of negligence.
Even with the limited reporting, there are numerous side effects. Others are being reported in the national and international media every day.
It is not acceptable to continue to roll out these covid-19 vaccines now. There has to be a pause, so that all the results can be assessed and so that the medium and longer term effects can be assessed too. These are all things which are normally done in trials for other vaccines before they are actually licensed but the authorities are misusing these covid-19 vaccines as if they have been fully licensed when they have not been.
To emphasise that they have been "approved" but not tell the public they have not been licensed is deceptive beyond belief.
These covid-19 vaccines cannot be described glibly as "safe" when they have yet to prove that.
Let us end this charade and use some medical common sense, please !
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