The US Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for Novavax’s adjuvanted Covid-19 vaccine, NVX-CoV2373, as a booster for use in people aged 18 years and above.
The booster is indicated for use after a minimum of six months following a vaccine regimen with an authorised or approved Covid-19 shot.
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NVX-CoV2373 can be given to people for whom an mRNA bivalent Covid-19 booster vaccine, authorised by the FDA, is either not clinically appropriate or accessible.
The regulatory agency based its decision on findings from the Phase III Prevent-19 clinical trial, as well as from the COV-BOOST trial, sponsored by the UK.
In the Phase III trial, the vaccine booster was given to healthy adult subjects nearly eight or 11 months following the primary regimen.
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According to the findings, antibody levels following a booster shot rose substantially compared with pre-boost levels, growing above levels associated with protection in the Phase III studies.
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By GlobalDataAdditionally, a 34 to 27-fold rise in neutralising antibodies was seen versus pre-boost levels on administering booster at eight or 11 months.
NVX-CoV2373 elevated antibody titers when administered as a third shot after a preliminary regimen with an authorised Covid-19 vaccine in the COV-BOOST trial.
Novavax president and CEO Stanley Erck said: “The US now has access to the Novavax Covid-19 vaccine, adjuvanted, the first protein-based option, as a booster.
“According to CDC data, almost 50% of adults who received their primary series have yet to receive their first booster dose.
“Offering another vaccine choice may help increase Covid-19 booster vaccination rates for these adults.”
In July this year, the company received FDA EUA for the NVX-CoV2373 vaccine for use as a two-dose primary regimen in adults.
