The United States Food and Drug Administration (FDA) has added new warnings – for vaccine suppliers and those who receive the vaccine.
This comes after the Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) confirmed a “probable association” between myocarditis and pericarditis and the Pfizer and Moderna jabs, which both use l ‘MRNA, reports the Express.
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These cases are said to be rare and treatable, and are generally mild, with the FDA also noting that the risk of heart inflammation is “very low.”
But recipients of Pfizer and Moderna vaccines are warned to “see a doctor immediately if you have any of the following symptoms.”
1. Chest pain
2. Shortness of breath
3. Feeling of having a fast beating, restless or pounding heart
The FDA says symptoms of myocarditis and pericarditis usually don’t appear right away, but tend to start “a few days after receiving the second dose.”
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The federal agency also urged recipients who have suffered from myocarditis or pericarditis in the past to notify their vaccine producer.
For providers, the FDA says there are “increased risks of myocarditis and pericarditis, especially after the second dose.”
John Greenwood, president of the British Cardiovascular Society and consultant cardiologist at Leeds Teaching Hospitals NHS Trust, told BMJ: “Myocarditis is not a rare disease and it can be associated with many different viruses.
“In our hospital, for example, we may have one or more patients per week suspected of having it. “
He added: “For the vast majority of people, myocarditis is a mild, self-limiting disease and can be easily treated with NSAIDs. For a very small number of people, the heart muscle can become impaired.
As of June 16, the MHRA had received 53 reports of myocarditis and 33 reports of pericarditis (including one death) after the use of the Pfizer-BioNTech vaccine.
The latest weekly yellow card figures show there have been 42 reports of myocarditis (and one death) and 77 reports of pericarditis after the Oxford-AstraZeneca vaccine and three reports of myocarditis and one report of pericarditis after the Moderna vaccine.
Pfizer vaccine: Seek immediate medical attention if you experience chest pain (Image: GETTY)
A spokesperson for the MHRA told the British Medical Journal: “The number of reports of myocarditis and pericarditis reported with vaccines in the UK remains at or below the expected baseline rate in different age groups within the general population and does not currently indicate an increased risk after vaccination against COVID-19.
“We will continue to closely monitor these reported events in the UK and overseas. “
The first reports of a small number of cases of heart inflammation after the Pfizer vaccine came from Israel in late April.
On June 1, Israel’s health ministry said there was a “likely link” between the vaccine and cases of myocarditis.
A total of 275 cases of myocarditis were reported in Israel between December 2020 and May 2021 among more than five million people vaccinated.
Most cases were in men aged 16 to 19, usually after the second dose. After the reports, the European Medicines Agency launched a review, which is expected to report in July.
All vaccines can cause side effects, although not everyone gets them.
Most are mild or moderate and go away within days of onset.
GOV.UK notes the very common side effects that may affect more than 1 in 10 people:
- injection site: pain, swelling
- muscle pain
- articular pain
He also advises: “If you get any side effects, talk to your doctor, pharmacist or nurse. This includes all possible side effects not mentioned in this leaflet. If you are concerned about a side effect, you can report it directly through the Coronavirus Yellow Card Reporting Site or search for the MHRA Yellow Card in Google Play. When completing a report, please include the vaccine brand and lot / lot number if available.