SINGAPORE: The Health Sciences Authority (HSA) has granted interim authorisation for Novavax’s Nuvaxovid COVID-19 vaccine to be used in Singapore, it announced on Monday (Feb 14).
The vaccine was authorised for use in individuals aged 18 and above on Feb 3 this year. The vaccination regimen comprises two doses of 5 micrograms administered three weeks apart.
The first batch of the vaccine is “expected to arrive in Singapore in the next few months”, HSA said. Last June, Health Minister Ong Ye Kung announced that Singapore signed an advance purchase agreement with Novavax in January.
The interim authorisation was granted under the Pandemic Special Access Route (PSAR).
The PSAR allows HSA to grant interim authorisation for critical novel vaccines, medicines and medical devices during a pandemic.
The only COVID-19 vaccines currently approved under PSAR are the mRNA vaccines Pfizer-BioNTech and Moderna, as well as Sinopharm’s Sinovac vaccine, an inactive type.
The Sinovac vaccine was originally authorised under a Special Access Route.
“HSA has reviewed that the vaccine meets the quality, safety and efficacy standards, and that the benefits outweigh the risks for the Singapore population,” it added.
“Two groups of experts from HSA’s Medicines Advisory Committee and Panel of Infectious Diseases Experts were also consulted and agreed with HSA’s recommendation for PSAR authorisation.”
Novavax’s COVID-19 vaccine is a protein-based vaccine candidate engineered from the genetic sequence of the first strain of SARS-CoV-2, the virus that causes COVID-19.
The vaccine is stored at 2 degrees Celsius to 8 degrees Celsius, enabling the use of existing vaccine supply and cold chain channels, said Novavax previously.
HSA’s clinical review was based on two Phase 3 clinical studies conducted in the United States, Mexico and the United Kingdom, comprising more than 40,000 clinical trial participants aged between 18 and 95, it said.
“The results showed that Nuvaxovid demonstrated a vaccine efficacy of approximately 90 per cent against symptomatic COVID-19 and 100 per cent in preventing severe COVID-19,” HSA said.
“It showed consistent efficacy against the Alpha variant, but there was no data on the Delta and Omicron variants, as these variants were not prevalent at the time Novavax conducted the clinical trials.”