Gaithersburg Based Novavax Announces Initiation of Phase 2b/3 Hummingbird Global Clinical Trial for the Novavax COVID-19 Vaccine in Children Aged Six Months Through 11 Years

“We are excited to begin the Hummingbird trial to study Nuvaxovid’s efficacy in children as young as six months through age 11,” said Stanley C. Erck, President and Chief Executive Officer, Novavax. “With a successful trial, we may have the opportunity to offer our COVID-19 vaccine to all age groups aged six months and older for protection against this ongoing pandemic.”

The trial will assess the Novavax COVID-19 vaccine in infants (six through 23 months of age), toddlers (two through five years) and children (six through 11 years). The trial is an age de-escalation trial and age groups will be tested sequentially. Participants have begun dosing in the six to 11-year-old age group. The trial will also have sentinel cohorts in each age group and cohort progression and age-de-escalation will occur after safety review.

The trial will seek to enroll 3,600 participants in the US, MexicoColombiaArgentinaSpain, UK, South AfricaPhilippines, and Brazil. Initial results are expected in Q1 2023.

About the Novavax COVID-19 vaccine (NVX-CoV2373)

The Novavax COVID-19 vaccine (NVX-CoV2373) is a protein-based vaccine engineered from the genetic sequence of the first strain of SARS-CoV-2, the virus that causes COVID-19 disease. The vaccine was created using Novavax’ recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and is formulated with Novavax’ patented saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. The Novavax COVID-19 vaccine contains purified protein antigen and can neither replicate, nor can it cause COVID-19.

The Novavax COVID-19 vaccine is packaged as a ready-to-use liquid formulation in a vial containing ten doses. The vaccination regimen calls for two 0.5 ml doses (5 mcg antigen and 50 mcg Matrix-M adjuvant) given intramuscularly 21 days apart. The vaccine is stored at 2°- 8° Celsius, enabling the use of existing vaccine supply and cold chain channels. Use of the vaccine should be in accordance with official recommendations.

Novavax has established partnerships for the manufacture, commercialization and distribution of its COVID-19 vaccine worldwide. Existing authorizations leverage Novavax’ manufacturing partnership with Serum Institute of India, the world’s largest vaccine manufacturer by volume. They will later be supplemented with data from additional manufacturing sites throughout Novavax’ global supply chain.

About Matrix-M™ Adjuvant

Novavax’ patented saponin-based Matrix-M adjuvant has demonstrated a potent and well-tolerated effect by stimulating the entry of antigen-presenting cells into the injection site and enhancing antigen presentation in local lymph nodes, boosting immune response.

About Novavax

Novavax, Inc. (Nasdaq: NVAX) is a biotechnology company that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases. The company’s proprietary recombinant technology platform harnesses the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles designed to address urgent global health needs. The Novavax COVID-19 vaccine, has received authorization from multiple regulatory authorities globally, including the U.S., EC and the WHO. The vaccine is currently under review by multiple regulatory agencies worldwide, including for additional indications and populations such as adolescents and as a booster. In addition to its COVID-19 vaccine, Novavax is also currently evaluating a COVID-seasonal influenza combination vaccine candidate in a Phase 1/2 clinical trial, which combines NVX-CoV2373 and NanoFlu*, its quadrivalent influenza investigational vaccine candidate, and is also evaluating an Omicron strain-based vaccine (NVX-CoV2515) as well as a bivalent Omicron-based / original strain-based vaccine. These vaccine candidates incorporate Novavax’ proprietary saponin-based Matrix-M adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies.

For more information, visit www.novavax.com and connect with us on LinkedIn.

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17th Annual Kensington Day of the Book Festival

Now in its 17th year, the Kensington Day of the Book Festival is a family-friendly street festival featuring 150+ renowned authors, poets, and literary organizations. Enjoy live music on five stages, special guest speakers, military veteran writers and comedians, poetry readings, cookbook demos, children's program, and much more.

Admission is free, and attendees will also be able to explore a marketplace of books and food offerings from local vendors.

Not your average book festival! This festival offers something for everyone!

17th Annual Kensington Day of the Book Festival

Sunday, April 21, 2024, 11am-4pm (held rain or shine!)

Howard Avenue, Kensington, MD 20895

www.dayofthebook.com

Instagram: @kensingtonbookfestival

Contact: Elisenda Sola-Sole, Festival Director

[email protected]

301-949-9416 (text preferred)

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!!!

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