Novavax Inc. (NASDAQ: NVAX) has announced that Singapore Health Sciences Authority has issued preliminary clearance for the Nuvaxovid COVID-19 vaccine for active immunization against COVID-19 caused by the coronavirus in people above 18 years old. The company’s vaccine, also called NVX-CoV2373, is the first protein-based COVID-19 vaccine to receive approval in Singapore.
Singapore authorizes Novavax’s Nuvacovid vaccine
CEO Stanley Erck stated, “We thank the HSA for its partnership, and we are proud that Singapore is now part of the growing list of regions to have authorized the Novavax vaccine and will have a protein-based option. This authorization demonstrates our commitment to deliver our COVID-19 vaccine, built on a well-understood vaccine platform, worldwide to help combat the evolving pandemic.”
Two pivotal third phase clinical studies were submitted to the HSA for review: PREVENT-19 study, which registered roughly 30,000 subjects aged above18 years in Mexico and the United States and published in the New England Journal of Medicine (NEJM) and a study with nearly 15,000 study subjects in the United Kingdom, which was also published in the NEJM. NVX-CoV2373 showed efficacy as well as favourable tolerability and safety profile in both trials. In addition, the number of severe and serious adverse events was minimal and evenly distributed between the vaccination and placebo groups.
Novavax to continue gathering data on the vaccine
Headache, myalgia, vomiting or nausea, injection site tenderness/pain, arthralgia, exhaustion, and malaise were the most common side effects recorded during clinical investigations (frequency category of very often 1/10). Novavax will continue to gather and evaluate actual data as the vaccine is delivered, including safety monitoring and variation evaluation.
Initial Nuvaxovid doses will arrive in Singapore at the end of March. Interestingly Nuvaxovid is yet to receive approval in the US from the FDA.
The vaccine is contraindicated in individuals with hypersensitivity to the active substance. It is vital to note that anaphylaxis events have been reported with COVID-19 vaccines. Therefore, proper medical supervision is necessary in case of an anaphylactic reaction. For those that have experienced an anaphylactic reaction, a second dose is not advisable.
