The European Agency for Medicines and Medical Products updates information on the safety of COVID-19 vaccines

In line with the conclusions from the meeting of the Pharmacovigilance Risk Assessment Committee (PRAC) held from 31 August to 2 September 2021, the European Medicines Agency (EMA) updated safety information for the following vaccines, as summarized below:

• Pfizer-BioNTech Comirnaty Vaccine: The Pharmacovigilance Risk Assessment Committee (PRAC) evaluated safety data, including the latest report submitted by the manufacturer, and concluded that no updated product safety information was needed. In relation to the following events, PRAC indicated the following:
  • Myocarditis and pericarditis: These were added in July 2021 to the product information sections on side effects and warnings, and at present there are no updates.
• Janssen COVID-19 Vaccine: PRAC evaluated safety data, including the latest report submitted by the manufacturer, and noted the following:
  • Multisystem Inflammatory Syndrome (MIS) in children and adolescents coinciding chronologically with COVID-19 (MIS-C): No reports have been received for this vaccine.
  • Venous thromboembolism (VTE) (blood clots in the veins): This event is different from thrombosis with thrombocytopenia syndrome (TTS) (blood clots with low platelet levels). This was included, in Janssen's COVID-19 vaccine risk management plan, as a safety issue to be investigated, based on a higher proportion of VTE cases in the vaccinated group versus the placebo group in the clinical studies used to authorize this vaccine. PRAC will evaluate additional data from two large clinical trials currently in progress.
  • Lymphadenopathy (swollen lymph nodes): PRAC concluded that this should be added as a very lowfrequency side effect (less than 1 in 1,000 people vaccinated) of the Janssen COVID-19 vaccine. o Paresthesia (unusual sensation in the skin, such as tingling) and hypoesthesia (decreased sensation or sensitivity, especially in the skin): These were added as side effects of the Janssen COVID-19 vaccine.Multisystem Inflammatory Syndrome (MIS) in children and adolescents coinciding chronologically with COVID-19 (MIS-C): PRAC is evaluating a possible relationship between this condition and administration of this vaccine, in light of the case, reported on 19 August 2021, of a 17-year-old in Denmark. To date, there are no safety updates related to this event.
    The frequency of paresthesia has been determined to be uncommon (less than 1 in 100 people vaccinated), and hypoesthesia as rare (less than 1 in 1,000 people vaccinated).
  • Tinnitus (persistent ringing in the ear): This was added as a rare side effect of Janssen's rare COVID-19 vaccine (less than 1 in 1,000 vaccinated people). In addition, PRAC requested more information from the authorization holder, in order to better characterize the nature of the cases, symptoms, and duration.
  • Diarrhea and vomiting: These were added as side effects of Janssen's COVID-19 vaccine; the frequency of diarrhea has been determined to be uncommon (less than 1 in 100 people vaccinated), with vomiting as rare (less than 1 in 1,000 people vaccinated).
• Moderna Spikevax COVID-19 Vaccine: PRAC evaluated safety data, including the latest report submitted by the manufacturer, and noted the following:
  • Myocarditis and pericarditis: These were added, in July 2021, to the product information sections on side effects and warnings, and at present there are no updates. o Multisystem Inflammatory Syndrome (MIS) in children and adolescents coinciding chronologically with COVID-19 (MIS-C): No reports have been received for this vaccine.
  • Anaphylaxis and other hypersensitivity reactions: This is a known side effect of the Spikevax COVID-19 vaccine, and is included in the product information, along with recommendations for the clinical management of anaphylaxis. There are no updates on this.
  • Delayed injection-site reactions: The information has been updated to include delayed injection-site reactions (rash, redness, or hives) as a common side effect (less than 1 in 10 people vaccinated). PRAC requested further information from the vaccine's authorization holder, in an effort to specify the characteristics of this side effect, including details such as time of onset, duration, and severity of the reaction.
  • Diarrhea: PRAC, continuing its May 2021 assessment, requested that the vaccine's authorization holder add diarrhea as a side effect of the vaccine, including information on frequency, based on data from the latest clinical trials.
• AstraZeneca Vaxzevria Vaccine: PRAC evaluated safety data, including the latest report submitted by the manufacturer, and noted the following:
  • Guillain-Barré syndrome (GBS): PRAC, in consultation with experts in neurology, after evaluating the additional data requested from the vaccine's authorization holder and reviewing the scientific literature, concluded that there is at least a plausible possibility of a causal relationship between Vaxzevria and GBS, and determined that it should be added to the product information as a side effect of Vaxzevria, with the frequency of occurrence designated as "very rare" (less than 1 in 10,000 people vaccinated). In addition, PRAC recommended updating the warning included in the vaccine's package insert, so that patients can notify healthcare personnel if they contracted GBS after being vaccinated with the Vaxzevria vaccine, with the additional warning that people should seek immediate medical attention if they develop weakness and paralysis in the extremities, which can progress to the chest and face. o Capillary leak syndrome (CLS): PRAC evaluated the available data and concluded that it was insufficient to definitively establish the mechanism involved. There is a continued warning remains in place that people with a previous diagnosis of CLS should not be vaccinated with Vaxzevria, and that people should seek immediate medical attention if they experience rapid swelling of the arms and legs, sudden weight gain, and feeling faint (low blood pressure) in the days following vaccination with the Vaxzevria vaccine.
  • Thrombosis with thrombocytopenia syndrome (TTS): PRAC concluded that the product information should be updated, to remove the indication that cases occur primarily in women under the age of 60, since the most recent analysis indicates that 43% of TTS cases occurred in males, and 37% in vaccinated individuals over the age of 60, with no significant difference between men and women. The warning remains in place that people should seek immediate medical attention if they experience severe or persistent headache, blurred vision, confusion, seizure, shortness of breath, chest pain, swelling of the legs, persistent pain in the legs, abdominal pain, unusual bruising of the skin, or round dots outside of the vaccination site, within three weeks following vaccination.
  • Cerebral venous sinus thrombosis (CVST) without thrombocytopenia: PRAC has asked the vaccine's authorization holder for more information on cases of CVST, so that it can conduct the necessary evaluation. CVST is a rare form of stroke, involving the formation of a blood clot in the bran's venous sinuses without thrombocytopenia (low levels of platelets in the blood), reported after vaccination with the Vaxzevria vaccine.
  • Multisystem Inflammatory Syndrome (MIS) in children and adolescents coinciding chronologically with COVID-19 (MIS-C): No reports have been received for this vaccine.
  • Menstrual disorders: PRAC concluded that there is no evidence of a causal relationship between this condition and administration of the Vaxzevria vaccine.

Source: https://www.ema.europa.eu/en/human-regulatory/overview/public-health-threats/coronavirus-disease-covid-19/treatments-vaccines/vaccines-covid-19/safety-covid-19-vaccines#latest-safety-information-section