Covid-19 roundup: BioNTech prepares for vaccine launch in 5- to 11-year-olds; Sinovac weighs vaccine production site in South Africa — report
As children return to school and youth Covid-19 hospitalizations hit a new high, BioNTech is reportedly prepping a launch for its mRNA vaccine developed with Pfizer in those between 5 and 11 years old.
BioNTech CMO Özlem Türeci told the weekly German magazine Der Spiegel that the company will file the results of its trial in 5- to 11-year-olds with regulators across the world “over the next few weeks,” and that final production steps are being adjusted to bottle a lower-dose pediatric version of the vaccine.
“Things are looking good, everything is going according to plan,” CEO Ugur Sahin told Der Spiegel.
The Pfizer/BioNTech vaccine is currently authorized for children as young as 12 years old, and back in August became the first Covid-19 vaccine fully approved in the US for people 16 years and older.
Moderna’s vaccine is authorized for those 18 years and older. The company began recruiting in March for a trial testing the mRNA jab in kids younger than 12, and said it would enroll in three age brackets: 6 to 11 years old; 2 to 5 years old; and 6 months to 1 year old.
Sinovac weighs vaccine production site in South Africa — report
China’s Sinovac is reportedly considering a new vaccine production site in South Africa, where its Covid-19 vaccine CoronaVac is currently in a Phase III trial in children and adolescents.
“This clinical trial is a precursor to the establishment of a South African vaccine manufacturing facility partnered by Sinovac and Numolux Group that will cover the entire spectrum of vaccinations beyond just the COVID-19 response,” Hilton Klein, CEO of Sinovac’s South Africa-based partner Numolux, said per Reuters.
South Africa’s regulatory authority, SAHPRA, gave conditional authorization to Sinovac’s vaccine back in July for those between 18 and 59 years old.
Sinovac’s vaccine — which was just effective enough to meet regulatory standards — was authorized in China last summer and became the first Chinese Covid-19 vaccine to be considered by the European Medicines Agency back in May. However, the EMA said yesterday that it needs more data on both the Sinovac and Russia’s Sputnik V vaccines before it can progress rolling reviews, according to Reuters.
Sinovac and Numolux are currently enrolling 2,000 participants between the ages of 6 months and 17 years in the South Africa cohort of their global trial.