June 08, 2022
Moderna has developed a COVID-19 booster shot designed to provide stronger protection against the omicron variant, with the hope that it will be available by the end of the summer.
Early data on its effectiveness has been promising, the company said Wednesday. The bivalent vaccine – a shot designed to address two virus strains – also protects against the original form of the coronavirus.
The news came one day after a U.S. Food and Drug Administration advisory committee recommended a COVID-19 vaccine developed by Novavax be authorized for people ages 18 and older. Health officials hope that vaccine, which uses more traditional technology, appeals to unvaccinated people who have remained wary about the other available vaccines.
The Moderna booster produced an eightfold increase in neutralizing antibody levels against the highly contagious omicron variant. It also boosted antibody levels against all other known variants of concern, the company said.
In a Phase 2/3 clinical trial of 437 people, the shot had a safety profile similar to the booster dose of its existing vaccine. Study participants received a 50 microgram dose; it was generally well-tolerated.
Moderna also has developed another bivalent booster that targets nine mutations found in the beta variant. Four of the mutations also are found in the omicron variant. But CEO Stéphane Bancel said the latest booster is the company's "lead candidate" for a fall booster.
Moderna said it soon will submit data from the trial to the FDA as part of the authorization process. The data has not yet been peer-reviewed or published in a scientific journal.
An FDA advisory committee voted 21-0, with one abstention, Tuesday to recommend Novavax’s COVID-19 vaccine for emergency use authorization. The FDA is not required to follow the committee's recommendations, but it usually does. Its decision could come as soon as later this week.
If authorized, Novavax's shot would be the fourth COVID-19 vaccine available in the U.S following those developed by Pfizer-BioNTech, Moderna and Johnson & Johnson.
About 27 million U.S. adults have not received a COVID-19 vaccine dose, Heather Scobie, a member of the U.S. Centers for Disease Control and Prevention's COVID-19 emergency response team, told CNBC. The Novavax vaccine could appeal to those who are more comfortable with traditional vaccine technology.
The vaccine uses a traditional, protein-based technology to generate an immune response. It contains a full-length spike protein mixed with adjuvant, but the protein can neither cause COVID-19 nor replicate. The same technology has been used for decades in vaccines against hepatitis B and HPV.
By contrast, the COVID-19 vaccines made by Pfizer-BioNTech and Moderna rely on a new technology – synthetic mRNA – to provide protection. The technology sends cells instructions for producing a spike protein that will train the body to recognize and attack the coronavirus.
The Johnson & Johnson shot also takes a traditional approach, using a disabled adenovirus to generate an immune response. This technology has been used in flu shots. But the J&J shot has been restricted due to its association with a rare but serious blood clotting disorder.
Novavax's two-dose vaccine was 90% effective at preventing infection and 100% effective at preventing severe illness during a clinical trail. However, the study occurred before omicron and its subvariants emerged. Despite this, scientists say it most likely will protect against severe illness from omicron.
Though the two-dose regimen induced a lower immune response against omicron, a third shot restored its prior efficacy level, Novavax Chief Medical Officer Dr. Filip Dubovsky told the FDA advisory committee. If the primary series is authorized, he said Novavax will ask the FDA to authorize a third dose.
The side effects associated with the Novavax vaccine are similar to the other COVID-19 shots — injection site pain, fatigue, headache and muscle pain. However, committee members raised concerns about a risk of heart inflammation. Of 40,000 Novavax recipients, four men, ages 16-28, developed myocarditis or pericarditis within 20 days of being vaccinated.
The Pfizer and Moderna vaccines also have a similar risk. Dr. Cody Meissner, a pediatrician at Tufts University, who is also a committee member, told CNBC that there is not enough data to determine whether the risk is higher in one vaccine.
Novavax’s vaccine is based on more traditional vaccine technology unlike Pfizer's and Moderna's which rely on synthetic mRNA technology. It