The UK has become the first country to approve a COVID vaccine that targets both the original strain and the Omicron BA.1 variant. The Medicines and Healthcare products Regulatory Agency (MHRA) and the Commission on Human Medicines(the government's independent science advisory body) granted approval to Moderna’s Spikevax bivalent Original/Omicron vaccine. It remains to be disclosed by the Joint Committee on Vaccination and Immunisation how the deployment of the vaccine will be managed. The decision from the MHRA is based on clinical trial data from a phase 2/3 trial, in which mRNA-1273.214 met all primary endpoints, including superior neutralising antibody response against Omicron (BA.1) when compared to a 50 µg booster dose of mRNA-1273 in baseline seronegative participants. A booster dose of mRNA-1273.214 increased neutralising geometric mean titres against Omicron approximately 8-fold above baseline levels. In addition, mRNA-1273.214 elicited potent neutralising antibody responses against the Omicron sub-variants BA.4 and BA.5 compared to the currently authorised booster (mRNA-1273) regardless of prior infection status or age.
The Medicines and Healthcare products Regulatory Agency (MHRA) has granted approval to Small Pharma to initiate clinical trials for SPL026, the company’s lead candidate. SPL026 is a N, N-dimethyltryptamine (DMT) candidate developed for patients with major depressive disorder (MDD). DMT is a naturally-occurring psychedelic tryptamine found in some plants and in the brain of mammals. The trial will asses the interaction between serotonin re-uptake inhibitors (SSRIs) and SPL026 regarding safety, tolerability, pharmacokinetics and pharmacodynamics. These endpoints will be assessed in patients with MDD currently being treated with SSRI but that such is ineffective in fully relieving their depression, compared with patients not currently on a prescribed SSRI. The trial is expected to begin in the third quarter of 2022.
Bloomberg News has reported AstraZeneca has asked a London court to enforce and extend a noncompete agreement signed by Chris Sheldon, former Vice President of Investor Relations, who recently moved to GSK to become Senior Vice President of Commercial Portfolio. The company told Bloomberg the noncompete agreement bars Sheldon from facilitating competition in respiratory, oncology and COVID-19-related therapy work for six months after leaving. Recently Garrett Rhyasen (former AZ’sexecutive director and Global Head of Oncology Search and Evaluation, Business Development and Licensing) has also joined GSK as Vice President of Search and Evaluation for Oncology.
GSK and UNICEF have signed a $170 million contract for 18 million doses of malaria vaccines to be distributed over the next 3 years. The vaccine (Mosquirix or RTS,) was first approved by the EMA in 2015 but concerns arose due to 50% efficacy of the shot in clinical trials and its ability to prevent death. However, in 2019, a WHO pilot program in Ghana, Kenya and Malawi showed that more than two thirds of the children not sleeping under a bed net where benefiting from the vaccine. Mosquirix must be administered in four doses, from 5 months to 3 years old.