Moderna’s Covid-19 vaccine candidate mRNA-1273, also known as Spikevax, has triggered a strong immune response in children aged between six and 12 years, according to data presented by the company. The assessment is based on interim data received from the Phase II/III study of mRNA-1273. The study showed that two doses of mRNA-1273 at the 50µg dose level were generally well tolerated and generated neutralising antibody response among the participants. Moderna plans to submit the study data to various global regulators including the US Food and Drug Administration (FDA) and European Medicines Agency (EMA).
The Serum Institute of India (SII) has reportedly applied for a regular marketing authorisation for its Covid-19 vaccine Covishield in India. According to a PTI news report, the application has been sent to the Drugs Controller General of India (DCGI) for approval. If approved, Covishield will become the second vaccine in the world after Pfizer-BioNTech’s Covid-19 vaccine, which was granted full approval by the US Food and Drug Administration in August, to be approved beyond emergency authorisation. Covishield uses the same formulation as the Vaxzevria jab developed by AstraZeneca and Oxford University, and is produced by SII under licence.
South Africa’s Aspen Pharmacare is working to increase the production of Covid-19 vaccines. In an interview with Reuters, Aspen CEO Stephen Saad said the firm aims to achieve an annual manufacturing capacity of 1.3 billion doses by February 2024 from the current output of around 250 million. Currently, Aspen is supplying Johnson & Johnson’s Covid-19 vaccine under a fill-and-finish contract but it is working on a broader deal that will enable the company to produce J&J’s shot under licence.