Tower Mains Weekly Newsletter
FDA authorises additional COVID-19 vaccine dose for certain immunocompromised individuals
On 12th August 2021, the U.S. Food and Drug Administration (FDA) amended the emergency use authorisations (EUAs) for the Pfizer-BioNTech and Moderna COVID-19 vaccines to allow for the use of an additional dose in certain immunocompromised individuals, specifically, solid organ transplant recipients or those who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise.
MHRA updates report covering adverse reactions to approved COVID-19 vaccines
On 13th August 2021, the Medicines and Healthcare products Regulatory Agency (MHRA) updated its weekly report covering adverse reactions to approved COVID-19 vaccines. The report covers the period from 9th December 2020 to 4th August 2021.
MHRA Inspectorate: Transfer of analytical methods
On 13th August 2021, the MHRA Inspectorate published a blog on the technical transfer of analytical methods, or analytical method transfer (AMT). The blog aims to provide guidance to manufacturers and contract testing laboratories for the process of transferring a method for outsourcing of testing.
ICMRA sets out recommendations to address artificial intelligence challenges
On 16th August 2021, the International Coalition of Medicines Regulatory Authorities (ICMRA) published a report setting out recommendations to help regulators address the challenges that the use of artificial intelligence (AI) poses for global medicines regulation. The report identifies key issues linked to the regulation of future therapies using AI and makes specific recommendations for regulators and stakeholders involved in medicine development to foster the uptake of AI. The implementation of the recommendations will be discussed by ICMRA members in the coming months.
EMA starts evaluating use of RoActemra in hospitalised adult patients with severe COVID-19
On 16th August 2021, the European Medicines Agency (EMA) announced that it had started evaluating the anti-inflammatory medicine RoActemra to extend its use to include treatment of hospitalised adult patients with severe COVID-19. RoActemra is considered a potential treatment for COVID-19 because of its ability to block the action of interleukin-6, a substance produced by the body’s immune system in response to inflammation, which plays an important role in COVID-19. The EMA will communicate the outcome of its evaluation by mid-October unless supplementary information is needed.
MHRA publishes COVID-19 vaccine updates for August 2021
On 16th August 2021, the MHRA issued its most recent information on COVID-19 vaccines. Contents include the review of reports involving menstrual disorders and the safety of COVID-19 vaccines in pregnancy.
ACT-Accelerator launches urgent 7.7-billion-dollar appeal to stem surge of dangerous COVID-19 variants
On 16th August 2021, it was announced that the ACT Accelerator – a global collaboration to accelerate development, production, and equitable access to COVID-19 tests, treatments, and vaccines – had launched a $7.7billion appeal to stem the surge of COVID-19 variants. The Rapid ACT-Accelerator Delta Response (RADAR) has been launched to scale up testing; maintain R&D efforts to stay ahead of the virus; address acute oxygen needs; rollout tools; and protect frontline healthcare workers.
MHRA extends approval of Spikevax vaccine to allow use in 12–17-year-olds
On 17th August 2021, the MHRA announced it had extended the current approval of the Spikevax vaccine (formerly Moderna COVID-19 vaccine) to allow use in 12- to 17-year-olds. This Conditional Marketing Authorisation (CMA) extension granted is valid in the UK only and was approved via the European Commission (EC) Decision Reliance Route.
US public health and medical experts issue joint statement on COVID-19 booster shots
On 18th August 2021, public health and medical experts from the U.S. Department of Health and Human Services (HHS) issued a statement on plans to provide COVID-19 booster shots in order to maximise vaccine-induced protection and prolong its durability.
Issue Number: WN00024