The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has approved the use of Moderna’s Covid-19 vaccine, Spikevax, in adolescents aged 12 to 17 years. This Conditional Marketing Authorisation (CMA) extension is valid only in Great Britain. The vaccine received authorisation in this age group in Northern Ireland under the CMA extension approved by the European Medicines Agency on 23 July. The UK’s Joint Committee on Vaccination and Immunisation will now advise on whether this age group should be vaccinated with Moderna’s jav as part of the country’s vaccine rollout, noted MHRA chief executive Dr June Raine.
A study by University of Washington Medicine has shown that pregnant and lactating individuals who were inoculated with the Covid-19 vaccine had symptoms with severity comparable to those seen in non-pregnant individuals. Of a total of more than 17,000 surveyed individuals, 62% were vaccinated with the Pfizer Covid-19 vaccine and most resided in the US. Symptoms reported were pain at the injection site (91%) and fatigue (31%), and a mean temperature of 100˚F. A small number (5-7%) experienced a reduction in milk supply after vaccination. Based on the findings, researchers concluded that the vaccine is well tolerated in women and they should be part of trials for other relevant vaccines.
Gritstone Bio has signed a funding agreement of up to $20.6m with the Coalition for Epidemic Preparedness Innovations (CEPI) to progress the development of its CORAL Covid-19 vaccine programme. The programme is progressing a second-generation vaccine platform offering spike and other SARS-CoV-2 T cell epitopes for broad and long-lasting protection against viral variants. CEPI will provide funds for a multi-arm Phase I trial of CORAL’s SAM vaccine in naïve, convalescent and HIV+ patients. The funds will also be used for pre-clinical studies, scale-up and development of a formulation to allow a stable drug product.