SINGAPORE (CNA) – United States (US) biotechnology company Novavax announced it has filed for interim authorisation of its COVID-19 vaccine under Singapore’s Pandemic Special Access Route (PSAR).
In a statement on Wednesday, Novavax said it has made the submission for its protein-based COVID-19 vaccine, NVX-CoV2373, for regulatory evaluation by the Health Sciences Authority (HSA).
The PSAR allows HSA to grant interim authorisation for critical novel vaccines, medicines and medical devices during a pandemic.
Pfizer-BioNTech, Moderna and Sinovac’s COVID-19 vaccines are currently approved under PSAR.
Responding to CNA’s queries, HSA said Novavax had submitted its data for its PSAR application for its vaccine on November 22.
“HSA has commenced a careful and thorough rolling review of the data to ensure that the vaccine meets the requirements for quality, safety and efficacy for interim authorisation before it is approved for use in Singapore,” it said.
HSA added the time taken for the review would depend on the “completeness” of the data submitted for evaluation, as well as the time taken by Novavax to respond to its queries on issues that may surface during the evaluation.
“The review timeline may vary from several weeks, if the data is complete and meets the stipulated standards, to months, if there are data gaps and inconsistencies in the dossiers,” said HSA.
An update will be provided once a regulatory decision is made, it added.
In June, Health Minister Ong Ye Kung said Singapore had signed an advance purchase agreement with Novavax in January 2021.
Senior Minister of State for Health Janil Puthucheary has also said in Parliament that Singapore was studying the possibility of using non-mRNA vaccines as booster shots.
The filing includes clinical data from two Phase 3 clinical trials. One trial included 30,000 participants in the US and Mexico and showed 100 per cent protection against moderate and severe disease, as well as an efficacy of 90.4 per cent.
Another trial involving 15,000 participants in the United Kingdom (UK) showed an efficacy of 96.4 per cent against the original COVID-19 strain, 86.3 per cent against the B117 or Alpha variant and 89.7 per cent efficacy “overall”.
“In both trials, NVX-CoV2373 demonstrated a reassuring safety and tolerability profile,” said Novavax.
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 packaged in a vial containing 10 doses, and its vaccination regimen calls for two 0.5ml doses injected 21 days apart.
The vaccine is stored at two degrees to eight degrees Celsius, enabling the use of existing vaccine supply and cold chain channels, said Novavax.