Tower Mains Weekly Newsletter
FDA issues EUA for COVID-19 treatment
On 24th June 2021, the U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorisation (EUA) for the drug Actemra for the treatment of hospitalised adults and paediatric patients (2 years of age and older). In clinical trials of hospitalised patients with COVID-19, Actemra, in addition to the routine care patients receive for the treatment of COVID-19, was shown to reduce the risk of death, reduce the risk of patients being placed on ventilators and decrease the amount of time patients remained in hospital.
ICH issues information paper regarding the use of ISO IDMP standards in ICH E2B(R3) messages
On 25th June 2021, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) issued an information paper explaining the International Organisation for Standardisation (ISO) standards related to the identification of medicinal products (IDMP) that are used in E2B(R3) messages.
EMA issues SME report covering the period 2016 to 2020
On 28th June 2021, the EMA published a report highlighting its support for micro, small and medium-sized enterprises (SMEs) that develop and market medicines for human or veterinary use in the EU. The report features key facts and figures of companies that are registered as SMEs with EMA. The publication of the report also marks the 15th anniversary of the adoption of the SME Regulation that promotes innovation and the development of new medicines in Europe.
EMA issues an update of EU recommendations for 2021-22 seasonal flu vaccine composition
On 28th June 2021, the EMA issued an update of the EU recommendations for the influenza virus strains that vaccine manufacturers should include in vaccines for the prevention of seasonal influenza from autumn 2021. The update also includes a decision on suitable H1N1 and H3N2 viruses for seasonal live attenuated influenza vaccines and the updated list of reagents for vaccine standardisation.
A joint report by EFSA, EMA, and ECDC finds the use of antibiotics in animals is decreasing
On 30th June 2021, a joint report published by the European Food Safety Authority (EFSA), the European Medicines Agency (EMA), and the European Centre for Disease Prevention and Control (ECDC), found the use of antibiotics has decreased and is now lower in food-producing animals than in humans. Taking a One Health approach, the report from the three EU agencies presents data on antibiotic consumption and development of antimicrobial resistance (AMR) in Europe for 2016-2018.
MHRA updates guidance on joining its phase I accreditation scheme
On 30th June 2021, the MHRA updated its guidance on how to join its phase I accreditation scheme, which aims to ensure trials are as safe as possible and to create public confidence in the regulation of phase I clinical trials. This includes updates to scheme requirements and guidance, and new forms including the phase I accreditation compliance checklist.
FDA revokes EUAs for imported, non-NIOSH-approved respirators and decontamination systems
On 30th June 2021, the FDA announced it is revoking EUAs of all non-NIOSH (National Institute of Occupational Safety and Health)-approved disposable respirators, which includes imported respirators such as KN95s, along with revoking EUAs for decontamination and bioburden reduction systems. This is due to the increase in domestically manufactured NIOSH-approved N95s available throughout the country.
COVID-19 Vaccine Updates
FDA announces revisions to the patient and provider fact sheets for Moderna and Pfizer-BioNTech vaccines
On 25th June 2021, the FDA announced it had revised the patient and provider fact sheets for the Moderna and Pfizer-BioNTech COVID-19 vaccines to include a warning on the increased risks of myocarditis and pericarditis following vaccination. The FDA and CDC are monitoring the reports, collecting more information, and will follow up to assess longer-term outcomes.
MHRA updates Product Characteristics and the Patient Information Leaflet of COVID-19 vaccines
On 25th June 2021, the Medicines and Healthcare products Regulatory Agency (MHRA) added a warning on myocarditis to the information for healthcare professionals and the public for the Moderna, Pfizer/BioNTech, and AstraZeneca vaccines.
Indian government issues EUA for Moderna COVID-19 vaccine
On 29th June 2021, it was announced that the Indian government had issued an Emergency Use Authorisation (EUA) for Moderna’s COVID-19 vaccine. Moderna has also received emergency (or other conditional, interim, or provisional) authorisation for use of its vaccine from health agencies in more than 50 countries and an Emergency Use Listing (EUL) from the World Health Organisation (WHO).
Issue Number: WN00017