EMA investigating link between Pfizer and Moderna vaccines and three new conditions

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The vast majority of the UK population have now received at least one dose of a coronavirus vaccine and the fruits of this effort are boldly apparent. Restrictions have been lifted across the board and the economy has roared back to life. This dramatic turn of events is all down to the vaccines reducing the severity of the disease, which has stopped the NHS from becoming overwhelmed. However, side effects of the vaccines continue to be reported. Although the risk of developing a complication post-vaccination remains extremely low, the European Medicines Agency (EMA) is currently investigating the link between the Pfizer and Moderna vaccines and three new conditions.

On Wednesday, it emerged in a report published by the EMA revealed that the European drug regulator is investigating a possible link between the mRNA vaccines and new conditions reported by a few recipients of the shots.

The health body is trying to establish a causal link between the vaccines and an allergic skin reaction called erythema multiforme or two kidney disorders.

It has requested additional data from Pfizer, BioNTech and Moderna.

In response to the development, Pfizer released the following statement: “We take adverse events that are potentially associated with our COVID-19 vaccine, BNT162b2, very seriously.

“We closely monitor all such events and collect relevant information to share with global regulatory authorities.”

Emphasising the infinitesimal risk, the company’s spokesperson pointed out that hundreds of millions of people have received the vaccine without experiencing any adverse effects.

“Serious adverse events that are unrelated to the vaccine are unfortunately likely to occur at a similar rate as they would in the general population,” the company representative said.

What are the conditions?

The skin condition is called erythema multiforme. According to the EMA, it causes round skin lesions which may also affect mucous membranes in internal body cavities.

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The two kidney disorders are nephrotic syndrome and glomerulonephritis.

Nephrotic syndrome causes the kidneys to leak too much protein into the urine.

Glomerulonephritis causes inflammation of the tiny filters in the kidneys.

Symptoms of the kidney disorders are fatigue, bloody or foamy urine, and oedema – a swelling of the eyelids, feet or abdomen.

Some of the patients under examination had pre-existing kidney ailments.

The EMA also is looking into menstrual side effects with all of the available adenovirus and mRNA COViD-19 vaccines.

Pfizer said that it and BioNTech are supporting the EMA’s Pharmacovigilance Risk Assessment Committee investigation with data and analyses.

Safety checks

COVID-19 vaccines have to go through several stages of clinical trials before they can be approved for use.

Clinical trials are where a vaccine or medicine is tested on volunteers to make sure it works and is safe.

The approved COVID-19 vaccines have been tested on millions of people in the UK and around the world, including:

  • People from different ethnic backgrounds
  • People aged between 18 and 84
  • Children and young people aged between 12 and 17
  • People with different health conditions.

All vaccines used in the UK must be approved by the independent Medicines and Healthcare products Regulatory Agency (MHRA).

The MHRA makes sure the vaccines meet strict international standards for safety, quality and effectiveness. Once a vaccine is approved, it’s closely monitored to continue to make sure it is safe and effective.

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