Coronavirus company news summary – Australia to begin Covid-19 vaccinations for children in January - US FDA approves booster shots for 16- and 17-year-olds

Australia is set to start Covid-19 vaccination for children aged between 5 and 11 years from 10 January 2022. In a statement, Australian Prime Minister Scott Morrison said that the decision to expand the vaccination programme was taken after the Australian Technical Advisory Group on Immunisation recommended the use of the Comirnaty (Pfizer) vaccine on all children in the age group. Australian agencies are also assessing the Moderna vaccine for 6–11-year-olds, with a decision expected in the coming weeks.

The US Food and Drug Administration (FDA) has approved a single Pfizer-BioNTech Covid-19 booster shot for 16- and 17-year-olds. The regulator amended the Emergency Use Authorisation for the vaccine, thereby authorising the booster dose. Individuals from the age group can receive the third shot at least six months after completing primary vaccination. Last month, FDA authorised the single booster dose of the Pfizer-BioNTech COVID-19 Vaccine for adults.

Cytodyn has submitted protocol to the FDA to conduct a Phase III, randomised, double-blind, placebo-controlled trial of leronlimab in critically ill patients with Covid-19 pneumonia. The trial will assess the safety and efficacy of leronlimab in combination with standard of care in patients requiring invasive mechanical ventilation or extracorporeal membrane oxygenation. It comes after the FDA acknowledged that the development of CCR5 antagonist-leronlimab for severely ill Covid-19 patients is feasible.