Per Novavax:
- Trial will assess safety and antibody responses of NVX-CoV2515 to the Omicron variant of COVID-19
- Two-dose primary regimen of NVX-CoV2373 already demonstrated cross-reactive immune responses against Omicron and other variants
Novavax today announced the initiation of its Phase 3 strain change trial to determine if its Omicron variant specific vaccine, NVX-CoV2515 (Omicron BA.1 strain), induces superior antibody responses against the Omicron variant compared to its Wuhan prototype vaccine, NVX-CoV2373, in participants who have received either a primary (two doses) or booster (three doses) series of an mRNA vaccine. The trial will also seek to determine the antibody responses to a bivalent vaccine, containing both NVX-CoV2373 and NVX-CoV2515, administered in participants who have received a booster series of an mRNA vaccine.
The observer blinded, randomized trial, will analyze reactogenicity and immune responses to NVX-CoV2515 and a bivalent vaccine in approximately 1,340 participants in Australia. Two doses of either NVX-CoV2515 or NVX-CoV2373 will be administered following three doses of either the Pfizer-BioNTech and/or Moderna vaccines received at least three months before joining the trial. Similarly, two doses of NVX-CoV2515 or NVX-CoV2373 will be administered following two doses of either mRNA vaccine received at least six months before joining the trial. Two doses of the bivalent vaccine will be administered in participants previously vaccinated with three doses of either mRNA vaccine at least three months before joining the trial. The duration of the trial is 10 months and initial results are expected in the second half of 2022.
Non-clinical animal data has shown NVX-CoV2515 demonstrated robust immune responses against Omicron BA.1 and Omicron BA. 2 spike proteins as measured by IgG, hACE2 receptor inhibition, and neutralizing antibodies. No notable safety findings were observed.
Novavax’ original COVID-19 vaccine, NVX-CoV2373, has demonstrated broad cross-reactivity against Omicron and other circulating variants from a primary two-dose regimen, with responses that increased following a third dose at six months.
Authorization in the U.S.
The Novavax COVID-19 vaccine (NVX-CoV2373) has not yet been authorized for use in the U.S. and the trade name Nuvaxovid™ has not yet been approved by the U.S. Food and Drug Administration (FDA). The U.S. FDA’s Vaccines and Related Biological Products Advisory Committee will review the Novavax COVID-19 vaccine for active immunization against SARS-CoV-2 during a meeting scheduled for June 7, 2022.
Recent Stories
The Office of Governor Wes Moore issued the following news release on Monday, May 7:
On Sunday we reported on Montgomery County Fire and Rescue Services (MCFRS) and Rockville City Police responding to a collision involving a vehicle into a tree at the intersection of…
EDENS, a national retail real estate owner, operator and developer, last year announced its partnership with Domain Fitness & Performance– a new premier fitness facility at Burtonsville Crossing in Burtonsville….
Montgomery County Police Department (MCPD) District 2 Bethesda Commander Capt. Amy Daum shared on Monday afternoon that Corporal Matthew Chamberlain and eight other officers were honored for their role in…
FREE Shred Day
Join us at Lafayette Federal Credit Union for a Free Community Shred Day, an event dedicated to helping you protect your privacy and the environment! Bring your old bank statements, bills, medical records, and any other paper documents that need secure disposal, and we'll take care of them on the spot.
Why You Should Come:
Protect Your Privacy: Safely shred sensitive documents to help prevent identity theft.
Eco-Friendly: All shredded material will be recycled, supporting our commitment to sustainability.
Complimentary Breakfast: Enjoy a free breakfast on us--start your day right with good food and good company!
Exciting Giveaways & Prizes: Don't miss out on giveaways and be sure to enter our drawing for a chance to win one of four $100 gift cards.
This event is open to all! It's a fantastic opportunity to clean out those old documents cluttering up your home, safe in the knowledge that they will be disposed of securely. Plus, it's completely free!
Don't miss out on this chance to declutter safely, enjoy some free treats, and possibly win a great prize. We look forward to seeing you there, rain or shine!
For more information, contact us at www.lfcu.events/shred.
FEST OF SPRING Caribbean Wine Food & Music Festival
Get ready to experience the vibrant colors, tantalizing flavors, and infectious rhythms of the Caribbean at the FEST OF SPRING Caribbean Wine Food & Music Festival! Hosted by RHU LLC, this exciting festival is set to take place on May 18, 2024, at the picturesque 16700 Barnesville Rd in Boyds, MD.
Step into a world where the Caribbean spirit comes alive! From 12:00 PM onwards, immerse yourself in a sensory journey that celebrates the unique culture, cuisine, and music of the Caribbean. Whether you're an African American, a Reggae or Soca music enthusiast, a wine lover, or part of the vibrant Caribbean diaspora, this festival promises to delight and captivate you in every way.
Let the enticing aromas of mouthwatering Caribbean dishes tantalize your taste buds. Feast on traditional delicacies prepared by expert chefs, showcasing the rich and diverse culinary heritage of the Caribbean. Indulge in flavorful jerk chicken, succulent seafood, and delectable plantain dishes that will transport you straight to the islands.
Accompanying the culinary extravaganza is a carefully curated selection of premium wines, ensuring the perfect pairing for your palate. Sip on fine wines from renowned vineyards, each sip a reflection of the Caribbean's vibrant spirit. Discover new flavors, expand your wine knowledge, and savor unforgettable moments with every glass.
As the sun sets, get ready to groove to the infectious rhythms of Caribbean music. Feel the pulsating beats of reggae, soca, dancehall, and calypso, moving your body to the lively melodies. Live performances by talented musicians and performers will keep the energy high, ensuring a night of unforgettable entertainment.
Don't miss this opportunity to embrace the Caribbean spirit and celebrate the arrival of spring in style! Tickets are available on AllEvents, so secure your spot today. Join us at the FEST OF SPRING Caribbean Wine Food & Music Festival, where cultures collide and unforgettable memories are made.
LIVE PERFORMANCES By: CULTURE Feat. Kenyatta Hill, EXCO LEVI, IMAGE BAND, RAS LIDJ REGG'GO with Special Guest SUGAR BEAR FROM E.U. & MORE! & MORE!
MUSIC By: DJ ABLAZE, DJ SMALLY & NAJ SUPREME
2 NIGHT Camping packages available: RV/CAMPER $200 | TENTS $150 Starting on Friday May 17 @ 5pm | 30 RV SPACES | 30+ TENT SPACES
KIDS 12 & UNDER FREE!!!
