Gaithersburg, Maryland-based Novavax will supplement its global regulatory filings for its COVID-19 vaccine with new data that shows its vaccine is effective for protecting teenagers.
Novavax said it achieved 80% efficacy in adolescents aged 12 through 17 in clinical trials across 73 sites in the U.S. The trials were conducted when the Delta variant was the predominant strain in the U.S.
The trials involved about 2,500 adolescents. There were no significant safety concerns, it said.
The two-dose, protein-based Novavax vaccine differs from the mRNA vaccines approved from Pfizer, Moderna and the vector vaccine from Johnson & Johnson.
“We believe the Novavax vaccine offers a differentiated technology option for this younger population given its established protein-based technology already used in other vaccines, and the positive responses demonstrated against variants,” said Dr. Filip Dubovsky, chief medical officer at Novavax.
Novavax said it expects to start additional studies globally to evaluate younger age groups in the second quarter.
Novavax formally applied for emergency use authorization from the U.S. Food and Drug Administration earlier this month.
It has received conditional approval for the vaccine from U.K. regulators. It had previously received conditional approvals from the European Union and the World Health Organization, and authorization in India. The vaccine is already being distributed in Indonesia and the Philippines.
Earlier this month, Israel’s Ministry of Health agreed to purchase up to 10 million doses of the Novavax vaccine.
