Tower Mains Weekly Newsletter
Tower Mains is pleased to announce the following senior appointments:
Rhona McAteer has been promoted to Senior Associate Director;
Shona Ross and Lianne Roeling have been promoted to Associate Directors as Head of QA and Head of Operations, respectively;
Marina Freiberga, MD, MSc, MRQA has re-joined Tower Mains as Associate Director and Head of Clinical and Quality Management.
Managing Director, Dr Andrew Waddell, commented, “These appointments significantly strengthen our senior management team and provide the platform for continuity and growth of our services.”
MHRA issues December time-based performance measures
On 4th January, the Medicines and Healthcare products Regulatory Agency (MHRA) issued the time-based performance statistics for December.
FDA shortens interval for booster dose of Moderna COVID-19 vaccine to five months
On 7th January, the US Food and Drug Administration (FDA) amended the emergency use authorisation (EUA) for the Moderna COVID-19 Vaccine to shorten the time between the completion of a primary series of the vaccine and a booster dose to at least five months for individuals 18 years of age and older.
FDA adds organ preservation solutions to the medical device shortage list
On 7th January, the FDA added organ preservation solutions (product codes KDL and KDN) to the medical device shortage list. The presence of a device type on the shortage list does not necessarily indicate that patient care has been affected. There may be certain facilities that may not be able to perform transplants or process donor organs if they are unable to obtain these products. The FDA is working with manufacturers, distributors, organ procurement organisations, and government partners to support the availability of these products to affected facilities and minimise any impact on patients.
EMA receives application for conditional marketing authorisation for Paxlovid for patients with COVID-19
On 10th January, the European Medicines Agency (EMA) announced it had started evaluating an application for a conditional marketing authorisation for the oral antiviral medicine Paxlovid (PF-07321332 and ritonavir). The application (made by Pfizer Europe MA EEIG) is for the treatment of mild-to-moderate COVID 19 in adult and adolescent patients (12 years of age and older weighing at least 40 kg) who are at high risk of progression to severe COVID 19. The agency will assess the benefits and risks of Paxlovid under a reduced timeline and could issue an opinion within weeks, depending on whether the data submitted are sufficiently robust and whether further information is required to support the evaluation.
MHRA Inspectorate: Pharmacovigilance Inspection Metrics April 2020 to March 2021
On 10th January, the MHRA published the GPvP Inspection Metrics report for the period April 2020 to March 2021.
Preliminary data indicates COVID-19 vaccines remain effective against Omicron variant, accordingly to EMA
Preliminary data indicates COVID-19 vaccines remain effective against severe disease and hospitalisation caused by the Omicron variant. The EMA continues to monitor emerging data on the effectiveness of vaccines against COVID-19, including disease caused by the Omicron variant which is now spreading rapidly across the EU. Although Omicron appears to be more infectious than other variants, studies from South Africa, the UK, and some EU countries show a lower risk of being hospitalised after infection with Omicron; based on these studies, the risk is currently estimated to be between a third and half of the risk with the Delta variant. EMA will continue to review data on vaccine effectiveness and severity of the disease, as well as the evolving landscape in terms of circulating variants and natural exposure to Omicron, as they become available. The outcome of these assessments may impact future vaccination strategies recommended by experts in EU/EEA Member States.
European Commission defines rules and procedures for the cooperation in safety assessment of clinical trials
On 10th January, the European Commission published a document defining the rules for the application of Regulation (EU) No 536/2014 of the European Parliament and of the Council as regards setting up the rules and procedures for the cooperation of the Member States in safety assessment of clinical trials.
FDA revises fact sheets for Janssen COVID-19 Vaccine
On 11th January, the FDA announced revisions to the Janssen COVID-19 Vaccine Fact Sheet for Health Care Providers Administering Vaccine (Vaccination Providers) and the Fact Sheet for Recipients and Caregivers. These revisions are in response to new safety information regarding the serious risk of Immune Thrombocytopenia (ITP), a disorder that can cause easy or excessive bruising and bleeding due to very low levels of platelets, following administration of the Janssen COVID-19 Vaccine.
MHRA updates information for healthcare professionals and the public about Paxlovid
On 11th January, the MHRA updated the Summary of Product Characteristics and Patient Information Leaflet for Paxlovid. Approved in December 2021, Paxlovid is a new combination treatment found to be safe and effective at reducing the risk of hospitalisation and death in people with mild to moderate COVID-19 infection who are at an increased risk of developing severe disease. Developed by Pfizer, Paxlovid is an antiviral medicine with a combination of active ingredients, PF-07321332 and ritonavir, that works by inhibiting a protease required for virus replication.
Registration opens for EMA’s virtual event on ‘Research in regulatory science – addressing the needs’
EMA announces that registration is now open for its virtual event on ‘Research in regulatory science – addressing the needs’, which will be held on Tuesday, 18 January 2022, 10:00 to 12:00 AM CET. The event aims to launch the ‘Regulatory science research needs’ initiative of the European Medicines Agency. With this initiative, the Agency seeks to stimulate researchers and funding organisations to consider addressing these needs in their research work and funding programmes, respectively.
Issue Number: WN00043