EMA for Moderna: Possible association with very rare cases of myocarditis

EMA for Moderna: Possible association with very rare cases of myocarditis

F59E4C64 A9BC 4C21 A105 C10B992FB9F2 Moderna, EMA, vaccine

The EMA Safety Committee (PRAC) has concluded that myocarditis and pericarditis can occur in very rare cases after vaccination. COVID-19 Comirnaty and Spikevax (formerly known as COVID-19 Vaccine Moderna).

The Commission therefore recommends the inclusion of myocarditis and pericarditis as new side effects in the information on the products of these vaccines, together with a warning to raise the awareness of health professionals and individuals receiving these vaccines.

Myocarditis and pericarditis are inflammatory conditions of the heart. Symptoms can vary, but often include shortness of breath, a strong heartbeat that may be irregular (palpitations), and chest pain.

At its conclusion, the committee took into account all available information.

This included an in-depth review of 145 cases of myocarditis in the European Economic Area (EEA) among people taking Comirnaty and 19 cases among people taking Spikevax. The PRAC also reviewed reports of 138 cases of pericarditis after using Comirnaty and 19 cases after using Spikevax. As of 31 May 2021, the EEA received approximately 177 million doses of Comirnaty and 20 million doses of Spikevax.

In addition, the PRAC also considered cases received worldwide.

The committee concluded that the cases occurred mainly within 14 days after vaccination, more often after the second dose and in younger adult men. In five cases in the EEA, people died. They were elderly or had co-morbidities. Available data suggest that the course of myocarditis and pericarditis after vaccination is similar to the typical course of these conditions, usually improving with rest or treatment.

Health professionals should be careful about the signs and symptoms of myocarditis and pericarditis. People receiving these vaccines should be told to seek immediate medical attention if symptoms indicative of myocarditis or pericarditis occur. These include shortness of breath, a strong heartbeat that may be irregular, and chest pain.

Health professionals should consult current guidance and / or consult specialists (eg cardiologists) for the diagnosis and treatment of these conditions.

At this point in time, no causal link could be established with myocarditis or pericarditis with the other two vaccines. COVID-19 approved in the EEA, the vaccine COVID-19 Janssen and Vaxzevria, and the committee requested additional information from the companies that supply these vaccines.

The EMA confirms the benefits of all approved vaccines COVID-19 still outweigh their risks, given the risk of disease COVID-19 and related complications and as scientific evidence shows that they reduce deaths and hospitalizations due to COVID-19.

For all vaccines, the EMA will continue to monitor the safety and efficacy of vaccines and provide the public with the latest information, especially as more adolescents and young adults are vaccinated and more second doses are given. The organization will take the necessary measures if new security issues are identified.

Information for the general public

  • Very rare cases of myocarditis and pericarditis (inflammatory conditions of the heart) have occurred in people taking Comirnaty and Spikevax (COVID-19 Vaccine Moderna).
  • The chance of these conditions occurring is very low, but you should be aware of the symptoms so that you can receive immediate medical attention to help you recover and avoid complications.
  • You should seek medical attention immediately if you have any of the following symptoms after vaccination:
    • Shortness of breath
    • strong heartbeat that may be irregular
    • chest pain
    • Talk to your healthcare professional or contact the relevant national health authority if you have any questions about the availability of vaccines in your country.

Information for health professionals

Following a review of very rare cases of myocarditis and pericarditis in individuals receiving Comirnaty and Spikevax (COVID-19 Vaccine Moderna), health professionals should:

  • be careful about the signs and symptoms of myocarditis and pericarditis in people who have received these vaccines.
  • Inform people receiving the vaccine that they should seek immediate medical attention if they have the following symptoms suggestive of myocarditis and pericarditis after vaccination: (acute and persistent) chest pain, palpitations or shortness of breath People with myocarditis or pericarditis may need specialized treatment.
  • consult current guidance and / or consult specialists (eg cardiologists) for the diagnosis and treatment of these conditions.

Product information will be updated to include myocarditis and pericarditis as side effects of unknown frequency.

Direct contact with a healthcare professional (DHPC) will be sent in a timely manner to healthcare professionals who prescribe, dispense or dispense the medicine. DHPC will also be published on a special page on the EMA website.

More about the drug

Comirnaty and Spikevax (COVID-19 Vaccine Moderna) contain a molecule called mRNA and has instructions for the production of pin protein. It is a protein on the surface of the SARS-CoV-2 virus that the virus must enter the cells of the body.

When a person receives one of these vaccines, some of their cells will read the mRNA instructions and temporarily produce the spike protein. The individual's immune system will then recognize this protein as foreign and produce antibodies and activate T cells (white blood cells) to attack it.

If, later, the person comes in contact with the SARS-CoV-2 virus, their immune system will recognize it and be ready to defend the body against it.

More on the process

This review by Comirnaty and Spikevax was part of a security label. A safety signal is information about a new or under-documented adverse event that may be caused by a drug such as a vaccine and that requires further investigation.

The review was carried out by the EMA Pharmacovigilance Risk Assessment Committee (PRAC), the committee responsible for the evaluation of safety issues for human medicines. The PRAC recommendations will be submitted to the EMA Human Medicines Committee, CHMP, for approval.

The PRAC examined the data for Vaxzevria and COVID-19 Vaccine Janssen as part of the review of summary pandemic safety reports submitted each month by marketing authorization holders.