Novavax applies to have non-mRNA COVID-19 vaccine approved for use in Singapore
The Health Sciences Authority says the review may take several weeks to months.
SINGAPORE: 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 (Nov 24), 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 Nov 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.
SEVERAL WEEKS TO MONTHS
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 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 ten doses, and its vaccination regimen calls for two 0.5ml doses injected 21 days apart.
The vaccine is stored at 2 degrees to 8 degrees Celsius, enabling the use of existing vaccine supply and cold chain channels, said Novavax.
According to Novavax, the company and Serum Institute of India recently received emergency use authorisation for the vaccine in Indonesia and the Philippines.
The companies have also filed for emergency use authorisation in India and for the Emergency Use Listing with the World Health Organization.
Novavax also announced regulatory filings for its vaccine in the UK, Australia, New Zealand as well as the European Union.
It is also expected to submit the "complete package" to the US Food and Drug Administration by the end of the year, said the company.
Editor’s note: This story has been amended to include Sinovac in the list of COVID-19 vaccines approved under Singapore's Pandemic Special Access Route.