COVID-19: latest updates (archive)
COVID-19 vaccines
COVID-19 vaccines
ECDC-EMA statement on booster vaccination with Omicron adapted bivalent COVID-19 vaccines
COVID-19 Vaccine Valneva
Spikevax (previously COVID-19 Vaccine Moderna)
on developing COVID-19 therapeutics for all populations
EMA’s CHMP concluded that an extra dose of Comirnaty and Spikevax may be given to people with severely weakened immune systems, and that for Comirnaty a booster dose may be considered at least 6 months after the second dose in adults
Regulatory expectations and flexibility (human medicines)
Regulatory expectations and flexibility (veterinary medicines)
EMA evaluating data on booster dose of COVID-19 vaccine Spikevax
17/09/2021
EMA's PRAC is assessing whether there is a risk of rare multisystem inflammatory syndrome following COVID-19 vaccination
EMA issued a new update on COVID-19 vaccination jointly with the European Centre for Disease Prevention and Control
EMA’s CHMP approved additional manufacturing sites for Comirnaty and Spikevax
EMA published new safety updates for Comirnaty, COVID-19 Vaccine Janssen, Spikevax and Vaxzevria
EMA’s PRAC reviewed the latest safety data on COVID-19 vaccines and recommended listing immune thrombocytopenia, dizziness and tinnitus as new side effects in the product information for COVID-19 Vaccine Janssen
EMA issued a new update on COVID-19 vaccination jointly with the European Centre for Disease Prevention and Control
EMA published the clinical data supporting the authorisation of Vaxzevria
EMA's CHMP approved an increase in active substance production at the manufacturing sites in the United States for Moderna's COVID-19 vaccine, Spikevax
EMA published the clinical data supporting the authorisation of COVID-19 Vaccine Janssen. Health Canada also published these data at the same time
EMA's CHMP recommended extending the use of Spikevax to include children aged 12 to 17
EMA’s PRAC considered that a causal relationship between COVID-19 Vaccine Janssen and Guillain-Barré syndrome is possible, after assessing the available data
EMA’s CHMP started the rolling review of Vidprevtyn, a COVID-19 vaccine developed by Sanofi Pasteur
EMA’s CHMP will hold an extraordinary meeting on 23 July to evaluate the extension of Spikevax to include children aged 12 to 18
EMA published the updated product information for Vaxzevria, following CHMP’s approval of PRAC’s recommendation to include a warning about the potential, small risk of Guillain-Barré syndrome
EMA published a direct healthcare professional communication (DHPC) on the risk of capillary leak syndrome occurring after vaccination with COVID-19 Vaccine Janssen
EMA published a direct healthcare professional communication (DHPC) on the risk of myocarditis and pericarditis occurring after vaccination with Comirnaty and Spikevax
EMA's CHMP started evaluating an application to extend the use of Kineret (anakinra) for the treatment of COVID-19
At their workshop on 24 June 2021, ICMRA members discussed the development of second-generation COVID-19 vaccines and booster doses. A report is available
EMA published new safety updates for Comirnaty, COVID-19 Vaccine Janssen, Spikevax and Vaxzevria
EMA issued an update on COVID-19 vaccination jointly with the European Centre for Disease Prevention and Control
EMA’s PRAC recommended that people who have previously had capillary leak syndrome must not be vaccinated with COVID-19 Vaccine Janssen
EMA’s PRAC recommended listing myocarditis and pericarditis as new side effects in the product information for Comirnaty and Spikevax
EMA updated the mandate, objectives and rules of procedure of its COVID-19 pandemic Task Force (COVID-ETF)
EMA's CHMP approved a scale-up of the active substance manufacturing process for COVID-19 Vaccine Janssen in the Netherlands
EMA provided procedural guidance on updating the composition of an authorised COVID-19 vaccine to address SARS-CoV-2 variants
EMA’s CHMP approved a new manufacturing site for COVID‑19 Vaccine Janssen in Italy
EMA’s CHMP approved new manufacturing sites for Comirnaty in Germany and Switzerland
EMA published new safety updates for Comirnaty, COVID-19 Vaccine Janssen, COVID-19 Vaccine Moderna and Vaxzevria
Authorities in the EU took precautionary steps to safeguard the quality of COVID-19 Vaccine Janssen
EMA published the assessment report for its review of sotrovimab in COVID-19 patients
EMA’s CHMP approved a new manufacturing site for COVID-19 Vaccine Moderna in France
EMA’s PRAC is continuing its assessment of reports of myocarditis and pericarditis in a small number of people following vaccination with COVID-19 vaccines
EMA’s PRAC concluded that people who have previously had capillary leak syndrome must not be vaccinated with Vaxzevria
ICMRA and the World Health Organization (WHO) updated their statement intended to increase trust and confidence in COVID-19 vaccines
EMA started evaluating an application to extend the use of COVID-19 Vaccine Moderna to include people aged 12 to 17
EMA advised healthcare professionals to consider recommendations by learned societies to manage suspected symptoms of thrombosis with thrombocytopenia syndrome
At their workshop on 10 May 2021, ICMRA members discussed global collaboration and information sharing on COVID-19 real-world evidence and observational studies. A report is available
The EU Executive Steering Group has provided recommendations to help EU Member States forecast demand for medicines during this pandemic and similar global health emergencies
EMA recommended approving additional manufacturing capacity for Comirnaty in Belgium
EMA advised healthcare professionals that there is not enough evidence on whether inhaled corticosteroids benefit non-hospitalised people with COVID-19
EMA published a new assessment report for its review of reported cases of blood clots with COVID-19 Vaccine Janssen
EMA published the assessment report for its review of reported cases of blood clots with COVID-19 Vaccine Janssen
EMA implemented additional measures to allow experts to focus on COVID-19 medicines
EMA is holding a press briefing on Wednesday 12 May to provide an update on its most recent activities in the context of the COVID-19 pandemic
EMA started evaluating an application to extend the use of Comirnaty to include people aged 12 to 15
EMA's CHMP started evaluating an application to extend the use of immunosuppressant Olumiant (baricitinib) for the treatment of COVID-19
EMA updated the product information for Vaxzevria in all EU languages to include a new manufacturing site
EMA published a new safety update for COVID-19 Vaccine Janssen
EMA published new safety updates for Comirnaty, COVID-19 Vaccine Janssen and Vaxzevria
EMA published the assessment report for its review of reported cases of blood clots with AstraZeneca’s COVID-19 vaccine, Vaxzevria
EMA updated the direct healthcare professional communication (DHPC) on how to monitor and report any suspected adverse reactions with AstraZeneca’s COVID-19 vaccine, Vaxzevria
EMA’s PRAC is continuing its review of reported cases of blood clots with AstraZeneca’s COVID-19 vaccine; its preliminary assessment report is available
meeting on COVID-19 vaccines on 26 March 2021
EMA updated the product information for AstraZeneca’s COVID-19 vaccine, to include the Halix manufacturing site and the new name of the product, Vaxzevria
EMA concluded that regdanvimab can be used in COVID-19 patients not requiring oxygen and at high risk of progressing to severe disease
EMA published an open letter in response to questions it had received about COVID-19 vaccines
EMA’s safety committee (PRAC) is continuing its assessment of reported cases of blood clots with COVID-19 Vaccine AstraZeneca
EMA published the assessment report for its review of the antibody combination bamlanivimab / etesevimab in COVID-19 patients
EMA published updated product information for COVID-19 Vaccine AstraZeneca in all EU languages, following its review of a signal of blood clots
EMA will hold a third public meeting on 26 March 2021 to provide an update on the assessment, approval and safety monitoring of COVID-19 vaccines
EMA's CHMP endorsed PRAC’s recommendations following review of a signal of blood clots and agreed to update the product information of COVID-19 Vaccine AstraZeneca
EMA’s safety committee (PRAC) concluded its preliminary review of a signal of blood clots in people vaccinated with COVID-19 Vaccine AstraZeneca.
EMA and Health Canada published the full clinical data supporting their authorisations of COVID-19 Vaccine Moderna.
At their workshop on 10 February 2021, ICMRA members discussed surveillance activities and data requirements for updating available vaccines against new virus strains. A report is available.
At their workshop on 9 February 2021, ICMRA members discussed issues around COVID-19 medicines in pregnant and breastfeeding women, including knowledge gaps and how to overcome them. A report is available.
Information on COVID-19 from EU / EEA Member States is available in national languages.
The European Commission authorised the second vaccine to prevent COVID-19 in the EU, COVID-19 Vaccine Moderna, following evaluation by EMA.
European Commission authorises first treatment against COVID-19
- 144 potential COVID-19 treatments;
- 35 potential COVID-19 vaccines.
Implications of COVID-19 on methodological aspects of ongoing clinical trials
following a four-week public consultation.- 132 potential COVID-19 treatments;
- 34 potential COVID-19 vaccines.
Rules for the implementation of Council Regulation (EC) No 297/95 on fees payable to the European Medicines Agency and other measures - Revised implementing rules to the Fee Regulation as of 12 June 2020
guidance on remote good-clinical-practice (GCP) inspections
during the pandemic. This is the first in a series of guidance documents on remote inspections for the verification of compliance with EU and international standards during the pandemic.
joint procedural assistance for medicine developers planning to submit a paediatric investigation plan (PIP) to EMA and an initial pediatric study plan (iPSP)
to the FDA for a COVID-19 vaccine or treatment. The aim of the joint document is to make it easier for developers to submit paediatric development plans simultaneously to the regulators.
open letter
to researchers from the Institute for Quality and Efficiency in Health Care (IQWiG) and the Cochrane Collaboration, in response to their call for EMA to make the clinical data submitted as part of COVID-19-related evaluation procedures publicly available rapidly.
business continuity plan
. This sets out principles to ensure that the European medicines regulatory network can continue to operate its core regulatory activities during the COVID-19 pandemic. It covers procedures related to medicines for COVID-19, as well as core procedures for other human and veterinary medicines.- 125 potential COVID-19 treatments;
- 33 potential COVID-19 vaccines.
EMA participated in the third bi-weekly global regulators’ meeting on COVID-19-related policy approaches and regulatory flexibility on Thursday 14 May, under the umbrella of the International Coalition of Medicines Regulatory Authorities (ICMRA). Participants discussed COVID-19 clinical-trial management, focusing in particular on the use of master protocols to help generate the robust evidence needed for regulatory decisions, and measures for mitigating medicine-supply issues.
- 115 potential COVID-19 treatments;
- 33 potential COVID-19 vaccines.
EMA’s CHMP recommended extending the compassionate use of the investigational medicine remdesivir to further groups of patients in Europe, based on preliminary results of studies with the medicine. The updated recommendations cover hospitalised patients who are requiring supplemental oxygen, non-invasive ventilation, high-flow oxygen devices or ECMO (extracorporeal membrane oxygenation), in addition to those on invasive mechanical ventilation.
guidance for developers on the rapid review procedures
it has put in place to speed up development and approval of COVID-19 treatments and vaccines. The rapid procedures can accelerate every step of the regulatory pathway while ensuring that robust evidence on efficacy, safety and quality is generated to support scientific and regulatory decisions. As these procedures require developers to submit well-prepared dossiers, EMA encourages them to contact the Agency as soon as possible to discuss their strategy for evidence-generation, by emailing their proposals to 2019-ncov@ema.europa.eu. EMA and the national competent authorities reminded patients with suspected or confirmed COVID-19 to report any suspected side effects that they are experiencing with any medicine, including medicines taken to treat COVID-19 and pre-existing conditions. Healthcare professionals treating COVID-19 patients should also report the suspected side effects that their patients are experiencing. These reports help regulators understand how medicines act in patients with COVID-19, complementing the knowledge generated in clinical trials and other studies.
additional guidance for qualified persons for pharmcovigilance (QPPV) and marketing authorisation holders
on how to submit COVID-19-related ICSRs to EudraVigilance, including on the use of the correct Medical Dictionary for Regulatory Activities (MedDRA) terms and free-text fields.
mandate of its COVID-19 EMA pandemic Task Force (COVID-ETF).
The Task Force is helping EU Member States and the European Commission to take quick and coordinated regulatory action on the development, authorisation and safety monitoring of treatments and vaccines intended for the treatment and prevention of COVID-19.
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