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SAGE published the highlights from their meeting held on 20-22 March 2023
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WHO updated the working definitions and monitoring system for SARS-CoV-2 variants of interest and concern.
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EMA updates the information on the Comirnaty vaccine product and adds "dizziness" to the list of adverse drug reactions with
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FDA authorizes bivalent Pfizer-BioNTech COVID-19 Vaccine as a booster dose for children 6 months through 4 years of age at least 2 months after completion of primary vaccination with the monovalent Pfizer-BioNTech COVID-19 Vaccine
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FDA approves Janssen's COVID-19 vaccine to be administered as a heterologous booster dose.
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EMA's CHMP recommended authorizing COVID-19 Vaccine Valneva as a booster in adults aged 18 to 50 who have received this vaccine or an adenoviral vector-based COVID-19 vaccine as their primary vaccination
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SAGE published an updated good practice statement on the use of variant-containing COVID-19 vaccines
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EMA published updated information for COVID-19 Vaccine Valneva, with an increase in its approved shelf life of up to 21 months when stored between 2°C to 8°C.
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EMA's CHMP recommended authorising both Spikevax vaccine and Spikevax bivalent Original/Omicron BA.1 for use as a booster in children aged 6 to 11 years
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EMA published the last monthly safety report on COVID-19 vaccines. From January 2023, relevant changes to the product information of COVID-19 vaccines will be communicated via the PRAC highlights
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EMA's CHMP recommended authorizing the COVID-19 vaccine VidPrevtyn Beta for use as a booster in adults vaccinated with an mRNA or adenoviral vector vaccine
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Health Canada authorizes second bivalent COVID-19 booster: Moderna Spikevax COVID-19 vaccine (original + Omicron BA.4/BA.5)
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The PRAC/EMA recommended adding heavy menstrual bleeding as a side effect of unknown frequency to the Comirnaty and Spikevax vaccine information
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EMA recommends approval of second adapted Spikevax vaccine (Original/Omicron BA.4-5)
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EMA recommends approval of Comirnaty and Spikevax COVID-19 vaccines for children from 6 months of age
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China National Medical Products Administration approves inhaled COVID-19 vaccine CanSino
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EMA’s human medicines committee has recommended authorizing the vaccines adapted against COVID-19, Comirnaty Original/Omicron BA.1 and Spikevax Bivalent Original/Omicron BA.1 for use as a booster in people aged 12 years and older
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Good practice statement on the use of second booster doses for COVID-19 vaccines
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EMA published a revised safety update for COVID-19 vaccines
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The CHMP recommended extending the use of COVID-19 vaccine Spikevax as a booster in adolescents from 12 to 17 years of age
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Global regulators agree on key principles on adapting vaccines to tackle SARS-COV-2 variants
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EMA published new safety updates for COVID-19 vaccines
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SAGE/WHO published an interim statement on decision-making considerations for the use of variant updated COVID-19 vaccines
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Meeting of the Strategic Advisory Group of Experts on Immunization (SAGE), April 2022: conclusions and recommendations.
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EMA adopts the first list of critical medicines for COVID-19 (includes vaccines)
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SAGE/WHO published updated interim recommendations for the use of the Janssen Ad26.COV2.S (COVID-19) vaccine
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SAGE/WHO published an interim statement on hybrid immunity and increasing population seroprevalence rates
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The CHMP/EMA recommended authorizing a booster dose (third dose) of Vaxzevria for adults who completed the primary vaccination course with this vaccine or an approved mRNA COVID-19 vaccine
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SAGE/WHO published Interim statement on the use of additional booster doses of Emergency Use Listed mRNA vaccines against COVID-19
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International regulators and WHO: released a statement to support healthcare professionals to enhance public confidence in COVID-19 vaccines
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EMA published new safety updates for COVID-19 vaccines
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SAGE published April 2022 meeting highlights
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mRNA COVID-19 vaccines: PRAC/EMA finds no link with autoimmune hepatitis. Available
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ECDC and EMA issue advice on fourth doses of mRNA COVID-19 vaccines of Pfizer’s Comirnaty and Moderna’s Spikevax
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SAGE updated recommendations for use of the Bharat Biotech, Sinovac, Sinopharm/BIBP and AstraZeneca Covid-19 vaccines
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EMA published new safety updates for COVID-19 vaccines
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Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 7-10 March 2022
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WHO published the interim statement on the composition of COVID-19 vaccines in the context of the circulation of the Omicron variant
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EMA published updated product information for COVID-19 Vaccine Janssen, with an extension of the authorized shelf life, stored at 2-8°C from 4.5 months to 11 months Date: 28/02/2022
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EMA's Committee for Medicinal Products for Human Use approved increased manufacturing capacity for COVID-19 vaccine Spikevax
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EMA's Committee for Medicinal Products for Human Use recommended reducing the interval between primary and booster dose vaccination with COVID-19 vaccine Spikevax from six to three months
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EMA's Committee for Medicinal Products for Human Use recommended authorizing the use of Spikevax vaccine as a booster dose for adults who have had another COVID-19 vaccine
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EMA's Committee for Medicinal Products for Human Use recommended extending the use of COVID-19 vaccine Spikevax to include children aged 6 to 11 24/02/2022
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EMA's Committee for Medicinal Products for Human Use recommended authorizing booster doses of Pfizer-BioNTech's COVID-19 vaccine Comirnaty in adolescents from 12 years of age
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EMA updated the guidance on preparing risk management plans for COVID-19 vaccines
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EMA updated the guidance on preparing risk management plans for COVID-19 vaccines
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EMA published the full risk management plan for Novavax's COVID-19 vaccine, Nuvaxovid
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Updated Interim recommendations for use of the Pfizer–BioNTech COVID-19 vaccine, BNT162b2, under Emergency Use Listing
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The updated WHO SAGE Roadmap for prioritizing uses of COVID-19 vaccines has been published
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International Coalition of Medicines Regulatory Authorities (ICMRA) published a report on the global regulatory response to the Omicron variant
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CDC publishes updated interim recommendations for the use of the Janssen (Johnson & Johnson) COVID-19 vaccine from the Advisory Committee on Immunization Practices
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Statement on the tenth meeting of the International Health Regulations (2005) Emergency Committee regarding the coronavirus disease (COVID-19) pandemic
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EMA published assessment reports for its review of the risk of myocarditis and pericarditis with Comirnaty and Spikevax
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EMA published updated product information for Vaxzevria to include new data on the known side effect, thrombosis with thrombocytopenia syndrome
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European Medicines Agency (EMA): latest safety data provide reassurance about use of mRNA vaccines during pregnancy
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Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 10 - 13 January 2022
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EMA published an update on the effectiveness of COVID-19 vaccines against the Omicron variant
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Interim Statement on COVID-19 vaccines in the context of the circulation of the Omicron SARS-CoV-2 Variant from the WHO Technical Advisory Group on COVID-19 Vaccine Composition (TAG-CO-VAC)
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WHO Strategic Advisory Group of Experts on Immunization (SAGE) updated recommendations issued on booster doses for COVID-19 vaccination
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EMA recommends Nuvaxovid for authorisation in the EU
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The Committee for Medicinal Products for Human Use (CHMP), of the European Medicines Agency, recommends authorization of the Pfizer-BioNTech Comirnaty vaccine in children ages 5 to 11 years
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Mix-ups between the influenza (flu) vaccine and COVID-19 vaccines
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OFFICIAL REPORTS ON PHARMACOVIGILANCE PROGRAMS - 22 October 2021
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Adverse Events of Special Interest (AESI) and Related Risks: Multisystem Inflammatory Syndrome in Children
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OFFICIAL REPORTS ON PHARMACOVIGILANCE PROGRAMS - 4 October 2021
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Facial nerve palsy following administration of COVID-19 mRNA vaccines: analysis of a selfreporting database
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OFFICIAL REPORTS ON PHARMACOVIGILANCE PROGRAMS - 27 September 2021
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Risk factors and disease profile of post-vaccination SARS-CoV-2 infection in UK users of the COVID Symptom Study app
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OFFICIAL REPORTS ON PHARMACOVIGILANCE PROGRAMS - 20 September 2021
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Update to the Alert on Falsified Covishield COVID-19 vaccine
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Update on SARS-CoV-2 Variants of Concern-6-september
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The European Medicines Agency reviews cases of multisystem inflammatory syndrome
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European Medicines Agency and the European Centers for Disease Prevention and Control highlight considerations for additional and booster doses of COVID-19 vaccines
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Cardiovascular Adverse Events Reported from COVID-19 Vaccines: A Study Based on WHO Database
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New COVID-19 variant of interest, named “Mu”
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OFFICIAL REPORTS ON PHARMACOVIGILANCE PROGRAMS - 6 September 2021
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India
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CECMED grants emergency use authorization to the Soberana 02 and Soberana Plus vaccines
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FDA Approves First COVID-19 Vaccine
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OFFICIAL REPORTS ON PHARMACOVIGILANCE PROGRAMS - 23 August 2021
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Adverse Events of Special Interest (AESI) and related risks: facial palsy/Bell
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WHO alert on falsified Covishield COVID-19 vaccine
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Allergic reactions after vaccination with COVID-19 vaccines
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Updated recommendations by the WHO Strategic Advisory Group of Experts on the use of ChAdOx1-Sbased (recombinant) COVID-19 vaccines
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U.S. Food and Drug Administration (FDA) authorizes export of batches of the active ingredient in AstraZeneca
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Reports of menstrual disorders and unexpected vaginal bleeding following administration of COVID-19 vaccines of Pfizer-BioNTech, Moderna, and AstraZeneca
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U.S. Food and Drug Administration Authorizes Extending the Shelf-life of Janssen
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Adverse Events of Special Interest (AESI) and related risks
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The European Medicines Agency authorizes use of the Spikevax COVID-19 vaccine for children ages 12 to 17
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OFFICIAL REPORTS ON PHARMACOVIGILANCE PROGRAMS 19 July 2021
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COVID-19 vaccine traceability initiative
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The European Medicines Agency adds capillary leak syndrome as a contraindication to Janssen
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Warning about possible risk of myocarditis/pericarditis with mRNA vaccines
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CECMED grants emergency use authorization (EUA) to the Cuban vaccine candidate Abdala
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Update on SARS-CoV-2 variants of interest
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AEFI and serious adverse events reported for vaccines being used in the Region of the Americas, by doses administered, as of 30 June 2021
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OFFICIAL REPORTS ON PHARMACOVIGILANCE PROGRAMS - 12 July 2021
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European Medicines Agency guidance for variant strain(s) update to COVID-19 vaccines
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