On June 25, the FDA added new warnings for both vaccine providers and recipients over cases of heart inflammation from the Pfizer and Modern Covid vaccines. The warnings came after the Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) met and confirmed a “likely association” between myocarditis and pericarditis and the Pfizer and Moderna jabs, both of which use mRNA.
The FDA says symptoms of myocarditis and pericarditis don’t typically crop up right away, but tend to begin “within a few days following receipt of the second dose”.
The federal agency also urged recipients who’ve experienced myocarditis or pericarditis in the past to tell their vaccination producer.
For providers, the FDA says there’s “increased risks of myocarditis and pericarditis, particularly following the second dose”.
John Greenwood, president of the British Cardiovascular Society and a consultant cardiologist at Leeds Teaching Hospitals NHS Trust, told The BMJ: “Myocarditis is not an uncommon condition 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 benign, self-limiting condition and can be easily treated with NSAIDs. For a very small number of people the heart muscle can become impaired.”
Up to 16 June the MHRA had received 53 reports of myocarditis and 33 reports of pericarditis (including one death) after use of the Pfizer-BioNTech vaccine.
The latest weekly yellow card reporting figures show that 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.
A total of 275 cases of myocarditis were reported in Israel between December 2020 and May 2021 among more than five million vaccinated people.
Most of the cases were in men aged 16-19, usually after the second dose. After the reports the European Medicines Agency started a review, which is expected to report in July.
All vaccines can cause side effects, although not everybody gets them.
Most are mild or moderate and go away within a few days of appearing.
GOV.UK notes the very common side effects that may affect more than one in 10 people:
- injection site: pain, swelling
- muscle pain
- joint pain
It also advises: “If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. If you are concerned about a side-effect it can be reported directly via the Coronavirus Yellow Card reporting site or search for MHRA Yellow Card in the Google Play. When completing a report please include the vaccine brand and batch/Lot number if available.”