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Novavax 2023-2024 COVID-19 Vaccine Now Authorized and Recommended for Use in the U.S.

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  • This Emergency Use Authorization and CDC recommendation makes Novavax’s vaccine the only protein-based non-mRNA COVID vaccine option in the U.S.
  • Novavax expects doses will be available in thousands of locations across the U.S. in the coming days, including CVS Pharmacy and Rite Aid
  • Find Novavax’s vaccine at us.novavaxcovidvaccine.com or vaccines.gov

GAITHERSBURG, Md., Oct. 3, 2023 /PRNewswire/ — Novavax, Inc. (Nasdaq: NVAX), a global company advancing protein-based vaccines with its novel Matrix-M™ adjuvant, today announced that the Novavax COVID-19 Vaccine, Adjuvanted (2023-2024 Formula) (NVX-CoV2601) has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for active immunization to prevent COVID-19 in individuals aged 12 and older. Immediately upon authorization, Novavax’s vaccine has also been included in the recommendations issued by the U.S. Centers for Disease Control and Prevention (CDC) on September 12, 2023.

Doses will be available nationwide at thousands of locations, including national and local retail pharmacies and physicians’ offices, following the Center for Biologics Evaluation and Research release of vaccine batches, expected in the coming days.

“COVID-19 is once again on the rise with infections and hospitalizations increasing, so it’s important that individuals get vaccinated to protect themselves and their loved ones,” said John C. Jacobs, President and Chief Executive Officer, Novavax. “Novavax’s authorization today means people will now have the choice of a protein-based non-MRNA option to help protect themselves against COVID-19, which is now the fourth leading cause of death in the U.S. In the coming days, individuals in the U.S. can go to pharmacies, physicians’ offices, clinics and various government entities to receive an updated Novavax vaccine.”

The EUA was based on non-clinical data showing that Novavax’s COVID-19 vaccine induced functional immune responses against XBB.1.5, XBB.1.16 and XBB.2.3 variants. Additional non-clinical data demonstrated that Novavax’s vaccine induced neutralizing antibody responses to newly emerging subvariants BA.2.86, EG.5.1 FL.1.5.1 and XBB.1.16.6 as well as robust CD4+ polyfunctional cellular (T-cell) responses against EG.5.1 and XBB.1.16.6. These data indicate Novavax’s vaccine can stimulate both arms of the immune system and may induce a broad response against currently circulating variants.1,2

In clinical trials, the most common adverse reactions associated with Novavax’s prototype COVID-19 vaccine (NVX-CoV2373) included headache, nausea or vomiting, muscle pain, joint pain, injection site tenderness, injection site pain, fatigue and malaise.

The EUA aligns with globally harmonized guidance from the FDA, European Medicines Agency and the World Health Organization to target the XBB strain this fall.3-5 Novavax is working with these and other global regulatory authorities on authorizations for its vaccine.

AUTHORIZED USE IN THE U.S.

Novavax COVID-19 Vaccine, Adjuvanted (2023-2024 Formula) has not been approved or licensed by FDA, but has been authorized for emergency use by FDA, under an EUA to prevent Coronavirus Disease 2019 (COVID-19) for use in individuals 12 years of age and older. Refer to the full Fact Sheet for information about the Novavax COVID-19 Vaccine, Adjuvanted.

The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564(b)(1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner.

IMPORTANT SAFETY INFORMATION

What should you mention to your vaccination provider before you or your child get the Novavax COVID-19 Vaccine, Adjuvanted?

Tell your vaccination provider about all of your or your child’s medical conditions, including if you or your child:

  • have any allergies
  • have had myocarditis (inflammation of the heart muscle) or pericarditis (inflammation of the lining outside the heart)
  • have a fever
  • have a bleeding disorder or are on a blood thinner
  • are immunocompromised or are on a medicine that affects your immune system
  • are pregnant or plan to become pregnant
  • are breastfeeding
  • have received another COVID-19 vaccine
  • have ever fainted in association with an injection

Who should not get the Novavax COVID-19 Vaccine, Adjuvanted?

A person should not get the Novavax COVID-19 Vaccine, Adjuvanted if they had:

  • a severe allergic reaction after a previous dose of any Novavax COVID-19 Vaccine, Adjuvanted
  • a severe allergic reaction to any ingredient of these vaccines

What are the risks of the Novavax COVID-19 Vaccine, Adjuvanted?

There is a remote chance that the vaccine could cause a severe allergic reaction. A severe allergic reaction would usually occur within a few minutes to one hour after getting a dose. For this reason, the vaccination provider may ask you or your child to stay at the place where you or your child received the vaccine for monitoring after vaccination. Signs of a severe allergic reaction can include:

  • Difficulty breathing
  • Swelling of the face and throat
  • A fast heartbeat
  • A bad rash all over your body
  • Dizziness and weakness

Myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining outside the heart) have occurred in some people who have received the vaccine. In most of these people, symptoms began within 10 days following vaccination. The chance of having this occur is very low. You should seek medical attention right away if you or your child have any of the following symptoms after receiving the vaccine:

  • Chest pain
  • Shortness of breath
  • Feelings of having a fast-beating, fluttering, or pounding heart

Side effects that have been reported in clinical trials with the Novavax COVID-19 Vaccine, Adjuvanted include:

  • Myocarditis (inflammation of the heart muscle)
  • Pericarditis (inflammation of the lining outside the heart)
  • Injection site reactions: pain/tenderness, swelling, redness and itching
  • General side effects: fatigue or generally feeling unwell, muscle pain, headache, joint pain, nausea, vomiting, fever, chills
  • Allergic reactions such as hives and swelling of the face
  • Swollen lymph nodes

Side effects that have been reported in post-authorization use with the Novavax COVID-19 Vaccine, Adjuvanted include:

  • Severe allergic reactions
  • Myocarditis (inflammation of the heart muscle)
  • Pericarditis (inflammation of the lining outside the heart)
  • Paresthesia (unusual feeling in the skin such as tingling or a crawling feeling)
  • Hypoesthesia (decreased feeling or sensitivity, especially in the skin) 

These may not be all the possible side effects. Serious and unexpected side effects may occur. The possible side effects are still being studied.

What should I do about side effects?

If you or your child experience a severe allergic reaction, call 9-1-1, or go to the nearest hospital.

Call the vaccination provider or your healthcare provider for any side effects that bother you or your child or do not go away.

Report vaccine side effects to the FDA and the Centers for Disease Control and Prevention (CDC) Vaccine Adverse Event Reporting System (VAERS). The VAERS toll-free number is 1–800–822–7967 or report online to https://vaers.hhs.gov/reportevent.html . Please include “Novavax COVID-19 Vaccine, Adjuvanted (2023-2024 Formula) EUA” in the first line of box #18 of the report form.

In addition, you can report side effects to Novavax, Inc., using the following contact information: Website: www.NovavaxMedInfo.com, Fax Number: 1-888-988-8809, Telephone Number: 1-844-NOVAVAX (1-844-668-2829).

What about pregnancy or breastfeeding?

If you or your child are pregnant or breastfeeding, discuss the options with your healthcare provider.

There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to the Novavax COVID-19 Vaccine, Adjuvanted during pregnancy. Women who are vaccinated with the Novavax COVID-19 Vaccine, Adjuvanted during pregnancy are encouraged to enroll in the registry by visiting https://c-viper.pregistry.com.

Please see the Fact Sheet for Recipients and Caregivers for more information.

Reporting Adverse Events and Vaccine Administration Errors

  • Adverse events can also be reported to Novavax, Inc. using the following contact information or by providing a copy of the VAERS form to Novavax, Inc. Website: https://www.novavaxmedinfo.com/, Fax Number: 1-888-988-8809, Telephone Number: 1-844-NOVAVAX (1-844-668-2829).

About Novavax

Novavax, Inc. (Nasdaq: NVAX) promotes improved health by discovering, developing and commercializing innovative vaccines to protect against serious infectious diseases. Novavax, a global company based in Gaithersburg, Md., U.S., offers a differentiated vaccine platform that combines a recombinant protein approach, innovative nanoparticle technology and Novavax’s patented Matrix-M adjuvant to enhance the immune response. Focused on the world’s most urgent health challenges, Novavax is currently evaluating vaccines for COVID-19, influenza and COVID-19 and influenza combined. Please visit novavax.com and LinkedIn for more information.

Forward-Looking Statements

Statements herein relating to the future of Novavax, its operating plans and prospects, the scope, timing and outcome of future regulatory filings and actions, including the availability of its updated XBB version of its Novavax COVID-19 Vaccine, Adjuvanted (2023-2024 Formula) (NVX-CoV2601) and the timing of delivery and distribution of its vaccine are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include, without limitation, challenges satisfying, alone or together with partners, various safety, efficacy, and product characterization requirements, including those related to process qualification and assay validation, necessary to satisfy applicable regulatory authorities; difficulty obtaining scarce raw materials and supplies; resource constraints, including human capital and manufacturing capacity, on the ability of Novavax to pursue planned regulatory pathways; challenges or delays in obtaining regulatory authorization for its product candidates, including its updated XBB version of its COVID-19 vaccine in time for the fall 2023 vaccination season or for future COVID-19 variant strain changes; challenges or delays in clinical trials; manufacturing, distribution or export delays or challenges; Novavax’s exclusive dependence on Serum Institute of India Pvt. Ltd. for co-formulation and filling and the impact of any delays or disruptions in their operations on the delivery of customer orders; challenges in obtaining commercial adoption of our updated protein-based non-mRNA XBB COVID-19 vaccine, NVX-CoV2373 or any COVID-19 variant strain-containing formulation; challenges meeting contractual requirements under agreements with multiple commercial, governmental, and other entities; and those other risk factors identified in the “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of Novavax’s Annual Report on Form 10-K for the year ended December 31, 2022 and subsequent Quarterly Reports on Form 10-Q, as filed with the Securities and Exchange Commission (SEC). We caution investors not to place considerable reliance on forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at www.sec.gov and www.novavax.com, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.

Contacts:

Investors

Erika Schultz

240-268-2022

[email protected]

Media

Ali Chartan

240-720-7804

[email protected]

References

  1. Wherry EJ, Barouch DH. T cell immunity to COVID-19 vaccines. Science. 2022;377(6608):821-822. doi:10.1126/science.add2897.
  2. Markov PV, Ghafari M, Beer M, et al. The evolution of SARS-CoV-2. Nat Rev Microbiol. 2023;21(6):361-379. doi:10.1038/s41579-023-00878-2.
  3. U.S. Food and Drug Administration (FDA). Updated COVID-19 vaccines for use in the United States beginning in fall 2023. June 16, 2023. https://www.fda.gov/vaccines-blood-biologics/updated-covid-19-vaccines-use-united-states-beginning-fall-2023.
  4. European Medicines Agency (EMA). EMA and ECDC statement on updating COVID-19 vaccines to target new SARS-CoV-2 virus variants. June 6, 2023. https://www.ema.europa.eu/en/news/ema-ecdc-statement-updating-covid-19-vaccines-target-new-sars-cov-2-virus-variants.
  5. World Health Organization (WHO). XBB.1.5 updated risk assessment. June 20, 2023. https://www.who.int/docs/default-source/coronaviruse/20230620xbb.1.5.pdf?sfvrsn=fff6f686_3.
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Press Release

New Study Reveals Majority of Indians Prioritize Nutrition Over Taste, Surpassing Global Average

Published

11 months ago

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May 31, 2024

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Based on a recent survey of urban Indian consumers: 


  • Nine out of 10 consumers are searching for protein-rich food compared to seven out of 10 global shoppers.


  • The top four qualities consumers look for when buying snacks are (1) natural, (2) heart-healthy, (3) protein-rich and (4) energy-source, all of which come before satisfying cravings.


  • Nuts have emerged as one of the most popular snacking choices, with 86% of Indian shoppers report having purchased them in a span of 6 months.


  • Urban Indians read nutrition labels more than the global average, reflecting a growing trend towards informed purchasing.


  • 69% of urban dwellers surveyed have the opinion that plant-based protein is just as good as meat-based protein, exceeding the global average of 55%.


 


Wonderful Pistachios, the world’s largest grower and processor of pistachios and distributor of California Pistachios in India, released today, World Nutrition Day, the findings of a new global study that sheds light on the snacking habits of urban Indians. The study, commissioned with Material, a leading global research consultancy, included 10 countries and over 12,400 respondents, revealed a new behavioural trend that urban Indian consumers prioritize nutrition over taste when it comes to snacking. This growing preference for healthy snacking emphasizes the importance of good nutrition for overall well-being.


 


For the India market specifically, the study delved into the snacking habits of 2,415 shoppers across six Indian cities, which represented a population of approximately 35.9 million consumers. Remarkably, a majority of urban Indians (58%) reported basing their food purchasing decisions on nutritional benefits more than taste, exceeding the global average of 52%. Delhi and Ahmedabad lead with over 60% of urban shoppers preferring nutrition in their food. Bengaluru and Chennai follow closely, indicating a nationwide shift towards smarter snacking preferences. In India, Millennials and Gen Z are leading the charge in health-conscious purchasing decisions, with more than 83% of consumers in these age groups reading nutritional labels before buying.


 


Indian consumers prioritize four key factors when shopping for nutritional snacks: natural (free of artificial colours and preservatives), heart-healthy, protein-rich, and provides energy. Nine out of 10 urban shoppers consciously seek protein-rich food options, compared to the global average of seven out of 10. The focus on nutrition has fueled the rise of nuts as a preferred snack choice, becoming essential to daily eating habits. The study found a staggering consumption of nuts, with 86% of Indian shoppers report purchasing them in a span of 6 months, compared to just 75% globally. With 6g of protein in per 28g serving, California Pistachios are a smart snack choice that provides benefits without sacrificing taste.


 


Shail Pancholi, Country Director, India, Wonderful Pistachios, commented on the study, saying, “Nuts were traditionally used as garnishes and consumed during festivals, but have now become a popular snack in India, indicating a notable shift in dietary habits. Pistachio consumption in India has doubled in the last six years, as consumer awareness of the nutritional benefits that pistachios offer has grown. Consumers are discovering that pistachios are naturally cholesterol-free, rich in plant-based protein and dietary fiber, and provide over 30 different vitamins and minerals.” 


 


Interestingly, the study found that nuts are the second most preferred snack among urban Indian consumers, with 64% of Baby Boomers and 59% of Gen Z prioritizing nutrition over taste when selecting food. This indicates a growing focus on health across generations, with Baby Boomers focusing on senior wellness and Gen Z reflecting the rise of mindful purchasing. Though on opposite ends of the age spectrum, these two generations take the lead in seeking protein-rich options, as well as preferring natural snacks. 


 


Mumbai tops most of the consideration sets when choosing a snack. Residents opt for natural ingredients (35% vs. the national average of 30%), heart-healthy options (33% vs. 30%), and protein (33% vs. 29%). Chennai residents look for energy-boosting snacks (31% vs. the national average of 29%). 


 


The fact that 69% of urban Indians surveyed have the opinion that that plant-based protein is just as good as meat-based protein reflects a positive shift towards varied dietary preferences. Pistachios are a good source of high-quality complete protein, containing all nine essential amino acids. A 28g serving of pistachios provides 6g of protein, which is 11% of the recommended daily allowance (RDA) according to FSSAI.


 


The Wonderful Pistachios study unveils a compelling shift in Indian snacking habits. Nuts are evolving from festive treats to a daily snacking staple, fueled by a nationwide preference for more nutritious options. The trend transcends generations, resonating with Gen Z and Baby Boomers alike, underscoring the growing importance of mindful eating in urban India. As consumers increasingly seek natural, heart-healthy, protein-rich, and energy-boosting snacks, the future of Indian snacking appears to be firmly rooted in nutrition and well-being.

 


Wonderful Pistachios

Wonderful® Pistachios is the world’s largest grower and processor of pistachios, with a global presence in over 70 countries. As a vertically integrated operation, they are experts in every step of the process from tree to shelf, ensuring the highest-quality product every time. In tandem with its Grower Partners, Wonderful Pistachios harvests 125,000 sunny acres (50,000 hectares) of land in California that receive warm days and cool nights, which work in harmony with the rich, natural soils to create the perfect growing climate for high-quality pistachios. They ship 600 million pounds (204 million kg) of nuts worldwide from their advanced processing facilities to ensure the highest standards are met. When it comes to pistachios, Wonderful® Pistachios expertise is unmatched in scale and capacity, paired with warehouses and sales teams worldwide that are well-equipped to provide support at every step of the way. 

 


California Pistachios

California Pistachios are grown and distributed by The Wonderful Company, the world’s largest vertically integrated pistachio processor and marketer located in California’s Central Valley. California Pistachios are Non-GMO, providing a smart, healthy choice for consumers around the world. Sun-ripened in the moderate Mediterranean climate of California, these distinctively green nuts pack taste and contain antioxidants and over 30 different nutrients. California Pistachios in India are available under leading brands and private labels at retail outlets, grocery stores, and online platforms.


 


For more information about California Pistachios India, please visit www.b2b.wonderfulpistachios.com 


 



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Press Release

Singapore Prepares Ahead to Leverage Artificial Intelligence for a Better Future

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11 months ago

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May 31, 2024

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SINGAPORE, May 31, 2024 /PRNewswire/ — Senior Minister of State for Communications and Information Tan Kiat How launched the Digital Enterprise Blueprint (DEB) at Asia Tech x Singapore (ATxSG) 2024 today. The Blueprint will enable SMEs to harness technology, optimise the way they work, and strengthen digital resilience and cybersecurity across the ecosystem. 50,000 SMEs are expected to benefit over the next five years through four key focus areas:

  1. Empower enterprises to be smarter by adopting AI-enabled solutions
  2. Enable enterprises to scale faster through cloud-based and integrated solutions
  3. Equip enterprises to be safer through improved cyber resilience
  4. Support enterprises to upskill workers to make full use of digital capabilities

Seven partners have come onboard to pledge their commitment, including Singapore Business Federation, Singapore Computer Society, SGTech, Amazon Web Services, Google, Microsoft and Salesforce.

In collaboration with IMDA and the TechSkills Accelerator for ITE and Polytechnics Alliance, SGTech is launching the Tech Apprenticeship Programme to expand the career pathways of graduates by providing access to industry apprenticeships that offer on-the-job training and development opportunities. Over the next two and a half years, SGTech aims to facilitate the placement of at least 300 apprentices who are fresh or mid-career professionals from polytechnic or ITE backgrounds, and drive the adoption of similar practices that promote more inclusive hiring and career agility.

IMDA and the Singapore Academy of Law (SAL) signed an MoU aimed at uplifting the legal sector’s productivity through the use of GenAI. As part of this partnership, GPT-Legal, a new large language model which is contextualised for Singapore’s legal sector, will be co-developed. The model will be integrated into SAL’s research platform LawNet, which is accessible by 75% of Singapore’s lawyers. SAL will also be penning an MoU with the National University of Singapore and AI Singapore to develop its AI capabilities and create a certification to recognise AI specialists in the legal profession.

Additionally, Tribe and Digital Industry Singapore announced a collaboration with NVIDIA to launch the Ignition AI Accelerator for AI startups to create and bring to market the next wave of advancement in AI solutions. This programme will nurture 15 high-potential startups, equipping them with well-rounded support covering business and technical needs. NVIDIA and Tribe will also collaborate with EnterpriseSG to offer qualified AI startups funding support through the Startup SG Tech scheme, and assist them through the IMDA Accreditation process. 

Singapore hosted the final meeting of the UN Secretary-General’s Artificial Intelligence Advisory Body (AIAB) from 28-29 May. As part of the agenda, Singapore facilitated an engagement session between AIAB and the Digital Forum of Small States (Digital FOSS). Digital FOSS Fellows exchanged views with AIAB members on the topic of AI governance, particularly on the implications and challenges faced by small states. Through such efforts, Singapore aims to promote a more inclusive approach towards shaping global AI and digital governance.

Contact:

[email protected]

 

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Press Release

One in Six Globally Concerned About Colorectal Cancer Screening Costs

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May 31, 2024

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SHENZHEN, China, May 31, 2024 /PRNewswire/ — By 2040, the burden of colorectal cancer (CRC) is projected to increase to 3.2 million new cases and 1.6 million deaths per year representing a 66% and 71% rise in new cases and deaths respectively relative to 2020.

To better address the global burden of CRC and reduce its impact, BGI Genomics has launched the second edition of its global CRC awareness report, covering 1,938 respondents from Brazil (306), China (367), Poland (300), Saudi Arabia (300), Thailand (362), and Uruguay (303):  

CRC Screening Gaps Vary Globally: Nearly half (49.3%) of global respondents have never undergone CRC screening, with the highest proportions in Saudi Arabia (62.0%) and Poland (61.0%).

Preference for Fecal Testing Over Colonoscopy: Although colonoscopies are more recognized (33.4%), fecal tests at healthcare facilities are preferred (31.8%), reflecting a trend towards non-invasive methods.

Cost and Fear are Determinants of Screening Choice: Fear of colonoscopy (18.2%) and screening costs (17.7%) are major barriers to CRC screening. Poland (24.7%) and Uruguay (21.0%) show the highest fear of colonoscopy, while Thailand (24.5%) and Brazil (20%) indicate the most concern about costs.

Medical Advice and Family History Drive CRC Screening: Doctor’s recommendations are a major driver for CRC screening (30.5% globally), with Uruguay showing the highest adherence (44.1%). Additionally, those with a family history of CRC are more proactive in screening (64.5%), compared to the general population (35.0%).

Prof. Varut Lohsiriwat from Mahidol University offers his insights to this report. He suggested: “The essence of effective cancer screening lies in the acceptance and adherence of the patient to the screening method. The best screening method is the one that the patient accepts and adheres to because that’s the method that will actually benefit them.”

Dr. Zhu Shida, BGI Genomics Deputy GM, notes: “At BGI Genomics, we focused our efforts on developing advanced molecular biology testing techniques to close the gap [between acceptance and accessibility]. The ultimate goal is to transform colorectal cancer from a life-threatening disease into a manageable condition through widespread, early screening and intervention.”

For more region-level comparisons, access the full BGI Genomics 2024 State of CRC Awareness Report.

All data involved in this report come from the results of an online survey project conducted by BGI Genomics. It only surveys awareness related to colorectal cancer and does not involve personally identifiable data.

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