The US Food and Drug Administration (FDA) has expanded the emergency use authorisation (EUA) for Pfizer and BioNTech’s Covid-19 vaccine, which will now include adolescents aged between 12 and 15 years. It is the first Covid-19 vaccine to be approved in the US for administration in children in this age group. The vaccine showed 100% efficacy in a Phase III trial that enrolled 2,260 participants aged between 12 and 15 years, and was also found to be well tolerated by the age group.
Egyptian generic drugmaker Eva Pharma has signed an agreement with the Indian Ministry of Health and Family Welfare to provide 300,000 doses of remdesivir, a potential treatment for Covid-19. Signed at the Indian embassy in Cairo, the agreement is intended to help India fight the recent surge in Covid-19 infections in the country. In June 2020, Eva Pharma received a licence from US biotech Gilead Sciences to manufacture remedisivir in Egypt for distribution to 127 countries.
Niche pharmaceutical services company Open Orphan has announced that its subsidiary hVIVO has signed a $4.2m contract with Imperial College London to manufacture a SARS-CoV-2 challenge virus, as part of the Wellcome Trust-funded effort. hVIVO is expected to develop the challenge virus based on new emerging variants of the virus, which will be used in future human challenge trials to allow direct comparisons of vaccines or antivirals against different Covid-19 variants. The UK has already launched a human challenge trial for SARS-CoV-2, in which healthy volunteers will be infected with the virus.