Tower Mains Weekly Newsletter

Industry Updates

FDA warns public to stop using the Innova SARS-CoV-2 Antigen Rapid Qualitative Test for diagnostic use

On 10th June 2021, the U.S. Food and Drug Administration (FDA) issued a safety communication warning the public to stop using the Innova SARS-CoV-2 Antigen Rapid Qualitative Test for diagnostic use. This follows concerns that the performance of the test has not been adequately established, presenting a risk to health, and that the performance claims do not accurately reflect the performance estimates observed during the clinical studies of the tests.

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Moderna files for an emergency use authorisation in the US for its COVID-19 Vaccine in adolescents

On 10th June 2021, Moderna announced it has requested an emergency use authorisation (EUA) for its COVID-19 vaccine in adolescents with the FDA. This follows the company’s announcement in May that the Phase 2/3 TeenCOVE study of its COVID-19 vaccine in adolescents met its primary immunogenicity endpoint, successfully bridging immune responses to the adult vaccination.

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FDA takes steps to increase availability of the Janssen COVID-19 vaccine

On 11th June 2021, the FDA announced it was taking steps to increase the supply of the Janssen COVID-19 vaccine. It is authorising for use – under the emergency use authorisation (EUA) for the vaccine – two batches of vaccine drug substance manufactured at the Emergent BioSolutions facility in Baltimore. Before making this decision, the FDA conducted a thorough review of facility records and the results of quality testing performed by the manufacturer. Additionally, the FDA has extended the expiration dating for the refrigerated Janssen vaccine after determining that it can be stored at 2-8 degrees Celsius for 4.5 months instead of 3 months.

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EMA issues update on ongoing evaluation of myocarditis and pericarditis in people following COVID-19 vaccines

On 11th June 2021, the European Medicines Agency (EMA) announced its safety committee (PRAC) is continuing its review of reports of myocarditis and pericarditis in a small number of people following vaccination with COVID-19 vaccines. Currently, further analysis is required to conclude on whether there is a causal relationship with the vaccines, and the PRAC is requesting additional data from the companies marketing them.

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EMA advises against use of Vaxzevria in people with history of capillary leak syndrome

On 11th June 2021, the EMA’s safety committee (PRAC) concluded that people who have previously had capillary leak syndrome must not be vaccinated with Vaxzevria (formerly COVID-19 Vaccine AstraZeneca). The Committee also concluded that capillary leak syndrome should be added to the product information as a new side effect of the vaccine, together with a warning to raise awareness among healthcare professionals and patients of this risk. The PRAC will continue to monitor for cases of the condition and will take any further actions necessary.

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ICMRA and WHO address need to boost COVID-19 confidence

On 11th June 2021, the International Coalition of Medicines Regulatory Authorities (ICMRA) and the World Health Organization (WHO) issued a joint statement to help healthcare professionals increase trust and confidence in COVID-19 vaccines and answer questions.

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ICH issues updates from virtual assembly meeting held on 2nd-3rd June

On 11th June 2021, the International Council for Harmonisation (ICH) issued updates from its virtual assembly meeting on the 2nd-3rd June. Updates include progress on existing ICH guidelines, further expansion of ICH membership, and new areas of ICH harmonisation. The next ICH assembly meeting is planned as a virtual meeting on 17-18 November 2021.

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EMA publishes its 2020 report

On 14th June 2021, the EMA published its annual 2020 report that provides an overview of the agency’s major achievements and contributions to public health in the EU. The report outlines the most important highlights of the evaluation and monitoring of human and veterinary medicines, the European medicines regulatory network’s rapid response to COVID-19, and a high-level overview of key figures. Additional topics covered by the report include the EMA’s response to other public health challenges, such as antimicrobial resistance, and EMA’s relocation to a new permanent headquarters in Amsterdam, and Brexit.

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MHRA updates its guidance on applying for the early access to medicines scheme (EAMS)

On 15th June 2021, the Medicines and Healthcare products Regulatory Agency (MHRA) updated its guidance on applying for the early access to medicines scheme (EAMS). The EAMS aims to give patients with life threatening or seriously debilitating conditions access to medicines that do not yet have a marketing authorisation when there is a clear unmet medical need. The dates for submission – Day 1 and Day 45, for the end of 2020 and into 2021 – have been updated.

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Issue Number: WN00015

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