Tower Mains Weekly Newsletter
EMA recommends approval for use of Comirnaty COVID-19 vaccine in children aged 5 to 11
On 25th November, the European Medicines Agency (EMA) announced its human medicines committee (CHMP) had recommended granting an extension of indication for the COVID-19 vaccine Comirnaty to include use in children aged 5 to 11. The dose of Comirnaty will be lower than that used in people aged 12 and above (10 µg compared with 30 µg) and it is given as two injections in the muscles of the upper arm, three weeks apart. The safety and efficacy of the vaccine in both children and adults will continue to be monitored closely as it is used in vaccination campaigns in EU Member States through the EU pharmacovigilance system and ongoing and additional studies conducted by the company and by European authorities.
MHRA publishes ABRHP and HMAC annual reports
On 25th November, the Medicines and Healthcare products Regulatory Agency (MHRA) published the 2020 reports of the Advisory Board on the Registration of Homeopathic Products (ABRHP) and the Herbal Medicines Advisory Committee (HMAC).
MHRA updates report covering adverse reactions to approved COVID-19 vaccines
On 25th November, the MHRA updated its report covering adverse reactions to approved COVID-19 vaccines. The report has been updated to include figures up to and including the 17th of November.
ICH issues details on its November Assembly Meeting
On 25th November, the International Council for Harmonisation (ICH) issued details on its virtual Assembly meeting held on 17th and 18th November. Details include the outcome of the Management Committee and Assembly Chair and Vice-Chair elections, new areas of ICH harmonisation, and progress on the following existing ICH Guidelines:
- Step 4 reached for the ICH E8(R1) Guideline on General Considerations for Clinical Studies in October 2021.
- Step 2 reached in November 2021 for the ICH Q9(R1) draft Guideline on Quality Risk Management (QRM).
- Step 2 reached in October 2021 for the ICH M7(R2) draft Guideline and Addendum on Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk
- Step 2 reached for the ICH Q13 draft Guideline on Continuous Manufacturing of Drug Substances and Drug Products in July 2021.
WHO issues update on Omicron
On 28th November, the World Health Organisation (WHO) issued a statement on the Omicron variant following its designation of a variant of concern on the advice of WHO’s Technical Advisory Group on Virus Evolution (TAG-VE). The statement includes a summary of what is currently known about the variant.
FDA approves new imaging drug to help identify ovarian cancer lesions
On 29th November, the US Food and Drug Administration (FDA) approved Cytalux, an imaging drug intended to assist surgeons in identifying ovarian cancer lesions. The drug is indicated for use in adult patients with ovarian cancer to help identify cancerous lesions during surgery. The drug is a diagnostic agent that is administered in the form of an intravenous injection before surgery.
Johnson & Johnson evaluating its COVID-19 vaccine against Omicron
On 29th November 2021, Johnson & Johnson announced it is assessing blood serum from participants in completed and ongoing booster studies to look for neutralizing activity against the Omicron variant. In addition, the company is pursuing an Omicron-specific variant vaccine and will progress it as needed.
MHRA updates guidance on pharmacovigilance system requirements
On 30th November, the MHRA updated its guidance on pharmacovigilance system requirements by providing additional information on requesting a UK PSMF number.
Lynparza granted Priority Review in US for BRCA-mutated HER2-negative high-risk early breast cancer
On 30th November, AstraZeneca announced its supplemental New Drug Application (sNDA) for Lynparza (olaparib) has been accepted and granted Priority Review in the US for the adjuvant treatment of patients with BRCA-mutated (BRCAm) HER2-negative high-risk early breast cancer who have already been treated with chemotherapy either before or after surgery. Lynparza is being jointly developed and commercialised by AstraZeneca and MSD.
FDA announces it is actively working to investigate and address potential impacts of Omicron variant
On 30th November, the FDA announced it is actively collaborating with federal partners, international regulators, and medical product companies to quickly address the potential impact of this variant on the currently available diagnostics, therapeutics, and vaccines.
Issue Number: WN00039