Tower Mains Weekly Newsletter

Industry Updates

FDA posts update to the SARS-CoV-2 Viral Mutations: Impact on COVID-19 Tests web page

On 3rd June 2021, the U.S. Food and Drug Administration (FDA) posted an update to the SARS-CoV-2 Viral Mutations: Impact on COVID-19 Tests web page. The update added new information about a potential impact on the performance of the Mesa Biotech Inc. Accula SARS-CoV-2 Test due to a genetic mutation at positions 28877-28878 (AG to TC) in patient samples.

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EU regulators develop recommendations to forecast demand of medicines

On 3rd June 2021, the EU Executive Steering Group on Shortages of Medicines Caused by Major Events issued a reflection paper containing recommendations to support forecasting of demand for human medicinal products across the European Union (EU). While it includes practical recommendations and examples specific to the COVID-19 pandemic, many of the general principles are applicable to other emergencies which require to forecast demand for medicines.

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MHRA concludes positive safety profile for Pfizer/BioNTech vaccine in 12- to 15-year-olds

On 4th June 2021, the Medicines and Healthcare products Regulatory Agency (MHRA) announced it had concluded its positive safety profile for Pfizer/BioNTech vaccine in 12 to 15-year-old. This follows a rigorous review of the safety, quality, and effectiveness of the vaccine in this age group by the MHRA and the Government’s independent advisory body, the Commission on Human Medicines (CHM).

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ICMRA issues report from international COVID-19 workshop

On 4th June 2021, the International Coalition of Medicines Regulatory Authorities (ICMRA) published the main findings from the international Covid-19 workshop held on the 10th of May 2021 and chaired by Health Canada and the European Health Agency (EMA). During the workshop, medicines regulators from around the world discussed the importance of global collaboration and information sharing in relation to real-world evidence that can be used to facilitate regulatory decision-making on COVID-19 treatments and vaccines. Meeting participants shared their experiences with using real-world evidence to support decision making in the context of COVID-19.

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EMA raises awareness of clinical care recommendations to manage suspected thrombosis with TTS

On 7th June 2021, the EMA announced its COVID-19 taskforce (COVID-ETF) is advising healthcare professionals in the EU to consider recommendations by learned societies when assessing people with signs and symptoms of thrombosis with thrombocytopenia syndrome (TTS) following vaccination with Vaxzevria and COVID-19 Vaccine Janssen. For the management of suspected TTS, the taskforce recommends that healthcare professionals consider the ISTH interim guidance on vaccine-induced immune thrombotic thrombocytopenia (VITT), which is based on ongoing international collaboration of healthcare professionals. As the management of TTS is evolving, the guidance may be further updated in future.

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EMA evaluating the use of COVID-19 Vaccine Moderna in young people aged 12 to 17

On 8th June 2021, the EMA announced it had started evaluating an application to extend the use of the COVID-19 Vaccine Moderna to include young people aged 12 to 17. EMA’s human medicines committee (CHMP) will carry out an accelerated assessment of data submitted in the application, including results from a large ongoing clinical study involving adolescents from 12 to 17 years of age.

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Issue Number: WN00014

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