FDA authorizes Novavax Covid booster for Americans 12 and up
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The FDA and CDC have approved a third dose of the Novavax COVID-19 vaccine, despite declining interest in the shots among Americans.
The agency issued emergency clearance for the booster on Wednesday, making it the third available to people ages 12 and older — participating in the Pfizer-BioNTech and Moderna shots.
It is available to those who are at least six months away from receiving the primary series of two doses of one of the three shots.
The Novavax booster injection is designed to combat 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 Omicron’s BA.5 and BA.4 strains, which are now invent about 68 percent and 0.6 percent of cases, respectively.
The Omicron variant has been shown to be able to evade some of the protection afforded by vaccinations, although the injections remain effective against serious illnesses requiring hospitalization and death.
Adoption of the newly approved bivalent boosters was minimal, and Americans decided not to get them despite calls from the Biden administration.
Novavax said the booster elicited a robust antibody response against Omicron subvariants BA.1, BA.2 and the dominant BA.5 subvariant in adults who had received the primary series of shots eight to 11 months earlier.
The move by US officials comes as European officials approve shots for children as young as six months old – matching the US for the first batch of shots.
Demand for COVID-19 booster shots was slow when they were first approved in September 2021 (red line), and only increased with the emergence of the Omicron variant in late November. Officials have also struggled to get Americans to receive the recently-approved bivalent booster as well
The Food and Drug Administration on Wednesday granted Novavax’s booster dose an Emergency Use Authorization, but the Centers for Disease Control and Prevention must give final approval before the shots can be taken into battle.
Still, Novavax has not yet presented any real efficacy data on how its shots perform against the BA.5 subvariant.
“We have ongoing studies further exploring the potential of the Novavax COVID-19 vaccine as an effective booster against these variants, including BA.4/5, and we look forward to sharing this data,” said Dr. Gregory Glenn, president of research and development at Novavax.
Moderna and Pfizer-BioNTech also have not provided real-world data indicating the efficacy of the bivalent shot in targeting the omicron offshoots.
The Novavax injection provides an alternative to the mRNA technology that supports the Pfizer-BioNTech and Moderna vaccines.
The Novavax vaccine is based on protein-based technology similar to what is used to make flu, hepatitis B, and shingles vaccines.
The Novavax booster is designed to protect against the ‘wild-type’ strain of Covid, or the strain that caused the global pandemic. But the company’s management said the shot also elicited a strong antibody response against the dominant BA.5-omicron subvariant.
Spike proteins developed in the lab mimic those of the coronavirus pathogen that binds to cells and infects humans.
The engineered spike protein is linked to an adjuvant — in this case derived from a tree native to South America — that boosts the immune response to the real thing.
Novavax aims to reach the population that has yet to be boosted with an mRNA vaccine.
Many people abstained from the mRNA injections because of mistrust of the technology and/or fear of the safety of a vaccine that was being developed at such an accelerated pace.
The development of mRNA technology dates back to the 1990s, although Pfizer-BioNTech’s mRNA vaccine was the first example of how the technology works to create a consistently reliable, safe vaccine.
The technology on which Novavax’s injections rely is considered more traditional than the science that underpins the mRNA vaccines.
The Novavax booster would also be a suitable alternative for people with an allergy to components in the mRNA vaccines.
The protein-based injections were heralded early on as a boon to the federal campaign to vaccinate hesitant people who mistrusted the speed at which mRNA vaccines were being developed.
Early in the pandemic, Novavax was shortlisted by companies that quickly began developing a vaccine for the little-understood novel coronavirus.
The former Trump administration has invested more than $1.5 billion in development as part of the multi-billion dollar Operation Warp Speed initiative, a sweeping federal effort to accelerate the development and distribution of vaccines and treatments for Covid.
But the Maryland-based company faced numerous stumbling blocks early on, including difficulties meeting FDA purity standards and building its manufacturing infrastructure virtually from scratch.
The company hopes the introduction of its booster will increase adoption. Less than half of Americans five years and older who are eligible for a booster have received one.
‘Offering a different vaccine choice could help increase COVID-19 booster vaccination for these adults’ said Novavax CEO Stanley C Erck.
But whether its introduction will have a positive effect on uptake remains uncertain, given the lack of enthusiasm for Moderna and Pfizer-BioNTech’s booster shots specifically targeting omicron offshoots.
The Biden administration began rolling out booster shots amid a delta variant wave last September. They were initially authorized for seniors, health professionals and nursing home residents.
In November, Pfizer and Moderna boosters were approved for all American adults.
Still, the public didn’t immediately grab the chance to get their third shot.
But after Thanksgiving, the brewing of fears about the new Omicron variant forced people to get boosted in greater numbers.
About 682,000 people received an average booster injection in the week leading up to November 25 last year, compared with more than a million injections in the week leading up to December 8.
On December 3 alone, more than 1.4 million adults received a booster injection.
However, demand for boosters declined rapidly in early 2022, and once again officials are struggling to convince Americans to get an extra chance.
Enthusiasm for the new bivalent booster shots remains relatively low.
Since getting clearance on August 31, fewer than 15 million Americans have received the updated recording. They are currently recommended for all adults 18 years and older.