FDA, Approve Novavax Covid-19 Booster For Americans
Despite Americans’ declining interest in the vaccines, the FDA has approved a third dose of the Novavax COVID-19 vaccine.
The Pfizer-BioNTech and Moderna shots are now joined by the emergency use authorization for the booster, which was granted by the government on Wednesday.
A minimum of six months must have passed since receiving the two-dose primary series of any of the three vaccinations in order to receive it.
The ‘wild type’ coronavirus strain that initially appeared in late 2019 and early 2020 was the target of the Novavax booster shot.
Bivalent boosters from Pfizer and Moderna targeting the BA.5 and BA.4 strains of Omicron, which now account for roughly 68 percent and 0.6% of cases, respectively, were approved by regulators in August.
The omicron form has demonstrated the ability to circumvent some of the protection provided by immunizations, but the shots continue to be effective against serious sickness that results in hospitalization and death.
According to Novavax, adults who had gotten the initial set of shots eight to 11 months earlier developed a significant antibody response against the omicron subvariants BA.1, BA.2, and the dominant BA.5 subvariant after receiving the booster.
On Wednesday, the Food and Drug Administration approved the emergency use of Novavax’s booster dose; but, the Centers for Disease Control and Prevention must still approve it before shots can be administered.
The Covid “wild type” strain, or the one that started the pandemic, is what the Novavax booster was created to guard against. However, according to company executives, the shot also triggered a potent immune response against the predominant BA.5 omicron subvariant.
However, Novavax has not yet provided actual effectiveness data demonstrating how well its vaccines work against the BA.5 subvariant.
According to Dr. Gregory Glenn, President of Research and Development at Novavax, “We have ongoing trials evaluating further the possibility of the Novavax COVID-19 vaccine as a successful booster against various variations, including BA.4/5,” and look forward to releasing this data.
Additionally, Moderna and Pfizer-BioNTech have not offered any actual evidence demonstrating the bivalent shot’s effectiveness in focusing on the omicron offshoots.
The Pfizer-BioNTech and Moderna vaccines’ mRNA technology is an alternative to the Novavax shot for anti-vaccine individuals.
The Novavax vaccine is produced using protein-based technology, much as the vaccinations for the flu, hepatitis B, and shingles.
Spike proteins created in the lab mirror the coronavirus pathogen’s protein that binds to cells and infects people.
The artificial spike protein is combined with an adjuvant, in this case, one made from a South American tree, to boost the immune response to the real spike protein.
The target market for Novavax is the population that hasn’t had a booster dose of an mRNA vaccination.
Due to mistrust of technology and/or concern over the safety of a vaccine manufactured at such a rapid pace, several people choose not to receive the mRNA doses.
Though mRNA technology has been around since the 1990s, Pfizer-mRNA BioNTech’s vaccine represents the first instance of the technology being used to produce a consistently dependable, secure vaccination.
The science supporting the mRNA vaccines is thought to be more cutting-edge than the technology Novavax’s shots rely on.
Why now, and what distinguishes the Novavax shot from the others?
The vaccine is produced using protein-based technology, just like the flu, hepatitis B, and shingles shots.
On the other hand, mRNA technology is used in the Moderna and Pfizer-BioNTech vaccines.
The business wants to reach the group of people who have not yet received a boost from an mRNA vaccine.
Contrary to the modern Moderna and Pfizer boosters, the Novavax booster was created against the original Covid strain rather than the currently prevalent BA.5 omicron subvariant.
Additionally, compared to mRNA vaccines, protein-based vaccinations are simpler to store and carry.
People who are allergic to any of the ingredients in the mRNA vaccines could potentially use the Novavax booster.
Early on, the protein-based shots were hailed as a success for the federal push to immunize people who were reluctant and mistrustful of how quickly mRNA vaccines were being developed.
Early in the pandemic, Novavax was among a select group of businesses that started working on a vaccine for the new coronavirus that was still little understood.
As part of Operation Warp Speed, a massive federal effort to hasten the research and dissemination of Covid vaccines and treatments, the former Trump administration invested more than $1.5 billion in its development.
But the Maryland-based company encountered several difficulties in the beginning, including challenges in passing the FDA’s purity standards and basically starting over while developing its production infrastructure.
The business anticipates that the launch of its booster will enhance adoption. Less than half of eligible Americans aged five and older have received a booster.
According to Stanley C. Erck, CEO of Novavax, “offering another vaccine option may assist enhance COVID-19 booster immunisation rates for these individuals.”
Given the lack of enthusiasm for booster shots developed by Moderna and Pfizer-BioNTech that particularly target omicron offshoots, it is unclear whether its release will have a favorable impact on uptake.
In the midst of a delta variant wave, the Biden administration started administering booster doses in September of last year. Seniors, healthcare professionals, and residents of nursing homes were initially the intended recipients.
Pfizer and Moderna boosters had been approved for all US adults by November. However, the public did not instantly seize the opportunity to receive their third shot. However, following Thanksgiving, growing apprehensions regarding the new omicron variety forced people to be boosted in greater numbers.
In the week prior to November 25 of last year, an average of about 682,000 persons received a booster shot, as opposed to the week prior to December 8 when more than a million shots were administered.
On December 3 alone, about 1.4 million adults received a booster dose.
The new bivalent booster shots continue to receive only moderate levels of enthusiasm.
Less than 15 million Americans have received the revised vaccine since they gained authorization on August 31.