The U.S. Food and Drug Administration on Monday approved Pfizer’s (PFE.N) respiratory syncytial virus (RSV) vaccine for use in women during the middle of the third trimester of pregnancy to protect their babies.
The biotech will supply Canada with fewer doses of its coronavirus vaccine while reaching a financial agreement for the forfeiting of certain doses previously scheduled for delivery.
The Medicines and Healthcare products Regulatory Agency (MHRA) authorized GSK’s shot, called Arexvy, for active immunization to prevent lower respiratory tract disease caused by RSV in adults 60 years and older.
Germany’s BioNTech said it was on track to introduce a COVID-19 shot by the early fall in the northern hemisphere that is adapted to currently dominant virus variants in line with recommendations by the World Health Organization.
Ghana has become the first country in the world to approve a new malaria vaccine from Oxford University, a potential step forward in fighting a disease that kills hundreds of thousands of children each year.
“We plan to continue investing in our transformation with a focus on building commercial capabilities in oncology and working towards registrational trials,” said CEO and Co-Founder Ugur Sahin.
On February 28, Novavax issued a candid warning to investors: it may not be able to continue operations beyond February 2024.
The meeting is also a chance to discuss the risk of animal viruses spilling over to humans and causing a pandemic.
The decision could delay the time to approval of a vaccine that Valneva expects could become a blockbuster shot as infections rise globally due to a burgeoning population of ticks, which usually cause Lyme disease.
BioNTech on Friday initiated an early-stage study to evaluate its experimental malaria vaccine in humans, the German drugmaker said.