Wednesday 19 October 2022 08:25 PM FDA approves Novavax Covid booster for Americans 12 and up trends now
The FDA has signed off on a third dose of the Novavax COVID-19 vaccine despite waning interest in the jabs among Americans.
The agency issued the emergency use authorization for the booster Wednesday, making it the third available to people 12 and older - joining the Pfizer-BioNTech and Moderna shots.
It is available to those who are at least six months removed from receiving the two-dose primary series of any of the three jabs.
The Novavax booster shot was designed to fight the 'wild type' strain of the coronavirus that first emerged in late 2019 and early 2020.
In August regulators approved bivalent boosters from Pfizer and Moderna targeting the BA.5 and BA.4 strains of Omicron, which now make up about 68 per cent and 0.6 per cent of cases respectively.
The omicron variant has proven capable of evading some of the protection conferred through vaccinations, though the shots remain effective against severe illness requiring hospitalization and death.
Novavax said its booster triggered a robust antibody response against omicron subvariants BA.1, BA.2 and the dominant BA.5 subvariant in adults who received the primary series of shots eight to 11 months prior.
The Food and Drug Administration granted Novavax's booster dose an Emergency Use Authorization on Wednesday, but the Centers for Disease Control and Prevention must give final approval before shots can go into arms.
The Novavax booster was designed to protect against the 'wild type' strain of Covid, or, the strain that prompted the global pandemic. But company leadership said the shot also prompted a strong antibody response against the dominant BA.5 omicron subvariant.
Still, Novavax has not yet presented real-world efficacy data on how its shots perform against the BA.5 subvariant.
'We have ongoing trials further exploring the Novavax COVID-19 vaccine's potential as an effective booster against these variants, including BA.4/5, and look forward to sharing these data,' said Dr Gregory Glenn, President of Research and Development at Novavax.
Moderna and Pfizer-BioNTech also have not provided real-world data pointing to the bivalent shot's efficacy in targeting the omicron offshoots.
The Novavax shot offers vaccine holdouts an alternative to the mRNA technology that supports the Pfizer-BioNTech and Moderna vaccines.
The Novavax vaccine relies on protein-based technology similar to what is used to create the flu, hepatitis B, and shingles vaccines.
Lab-engineered spike proteins mimic the one on the coronavirus pathogen that binds to cells and infects people.
The engineered spike protein is coupled with an adjuvant - in this case derived from a tree native to South America - which turbocharges the immune response to the real thing.
Novavax aims to reach the population who have yet to be boosted with an mRNA vaccine.
