Novavax’s Covid vaccine gets US FDA approval as booster dose for adults

Notably, the authorisation is for people who were unable to get updated Omicron-tailored boosters, or those who would choose not to receive any other booster dose.

Novavax’s vaccine is based on an older technology that has been used for decades to combat diseases including hepatitis B and influenza.

Wednesday’s decision is in addition to the earlier clearance for the protein-based vaccine as a primary two-shot regimen for those 12 years and above.

Government authorities hoped that the shot would find wider acceptance among vaccine skeptics who were unwilling to take shots from Pfizer and Moderna, who used the ground-breaking messenger RNA technology.

Novavax, however, has been struggling to boost sales of the vaccine and in August halved its full-year revenue forecast, saying it does not expect further sales of the shot in the United States this year.

Only around 35,000 doses of the vaccine have been administered across the United States so far since the company originally got the regulator’s nod in July, as per CDC data.

However, over half the population in the United States eligible for booster is yet to take it, as per the data.

“Offering another vaccine choice may help increase COVID-19 booster vaccination rates for these adults,” Novavax Chief Executive Officer Stanley Erck said in a statement.

The World Health Organisation has given its Emergency Use Listing green light to nine Covid-19 vaccines and variations — Pfizer/BioNTech, AstraZeneca, Janssen, Moderna, Sinovac, Sinopharm, Bharat Biotech, Novavax and CanSinoBIO.

Meanwhile in India, Novavax which is being manufactured by Pune-based Serum Institute of India said that two large phase-3 trials of its COVID-19 vaccine have shown high levels of protection against mild, moderate, and severe infection.