GAITHERSBURG, Md. , Nov. 28, 2023 /PRNewswire/ — Novavax, Inc. (Nasdaq: NVAX), a global company advancing protein-based vaccines with its Matrix-M adjuvant, announced that the Nuvaxovid XBB. 1. 5 COVID-19 vaccine (NVX-CoV2601) has received the World Health Organization (WHO) Emergency Use Listing (EUL) for active immunization to save COVID-19 in Americans aged 12 years and older. The EUL supports WHO Member States in comparing vaccines with the WHO Member States. The WHO Food and Drug Administration (WHO) aims to accelerate their availability and enables the 194 WHO Member States to accelerate regulatory approvals to import and administer the vaccine.
“WHO’s Emergency Use Listing for our protein-based, mRNA-free COVID-19 vaccine is helping to accelerate regulatory approvals for its 194 Member States and United Nations procurement agencies, such as UNICEF, supporting equitable access to our vaccine around the world,” said John C. Jacobs, president and CEO of Novavax. Rural or hard-to-reach spaces can benefit from the ease of shipping and storage of our vaccine. As part of a diverse portfolio of vaccines, our vaccine can play a vital role in helping others around the world in the face of the latest variants.
The Novavax vaccine can be stored between 2 and 8 degrees Celsius and has a shelf life of 12 months, simplifying delivery, reducing carbon footprint and reducing waste. 1-4
The EUL was based on non-clinical knowledge that appeared that the Novavax COVID-19 vaccine induced functional immune reactions opposite to the XBB. 1. 5, XBB. 1. 16, and XBB. 2. 3 variants. Additional non-clinical knowledge demonstrated that the Novavax vaccine induced neutralizing antibody reactions against the BA. 2. 86, EG. 5. 1, FL. 1. 5. 1, and XBB. 1. 16. 6 subvariants, as well as polyfunctional CD4 cellular (T-cell) reactions against EG. . 5. 1. and XBB. 1. 16. 6. These data imply that the Novavax vaccine can stimulate either arm of the immune formula and induce a broad reaction against newly circulating variants. 5,6
In clinical trials, the most common adverse reactions related to Novavax’s COVID-19 vaccine prototype (NVX-CoV2373) included headache, nausea or vomiting, muscle pain, joint pain, tenderness when injecting, injection pain, fatigue, and malaise.
Novavax’s updated COVID-19 vaccine is also authorized in the U.S. and the European Union, and is under review in other markets.
US Industry Call Nuvaxovid Industry Call has been approved through the US Food and Drug Administration (FDA).
NOVAVAX COVID-19 VACCINE, ADJUVANT (FORMULA 2023-2024) AUTHORIZED USES The Novavax COVID-19 vaccine, adjuvanted (Form 2023-2024) has not been approved or legal through the FDA, however, it has been legal for emergency use through the FDA, as a component of an emergency use. Authorization (EUA) to save you coronavirus disease 2019 (COVID-19) for use in Americans 12 years of age and older. See the full fact sheet for facts about the Novavax COVID-19 adjuvanted vaccine.
Emergency use of this product is permitted for the duration of the declaration that there are cases justifying emergency use authorization of the medical product under Section 564(b)(1) of the FD Act.
What do you tell your immunizer before you or your child receives the Novavax COVID-19 adjuvanted vaccine?Tell your immunizer about any fitness disorders you or your child have, and add if you or your child:
Who is not receiving the Novavax COVID-19 adjuvanted vaccine?A user does not receive the Novavax COVID-19 adjuvanted vaccine if they have:
What are the threats of the adjuvanted Novavax COVID-19 vaccine?There is a small threat that the vaccine will cause a severe allergic reaction. A severe allergic reaction occurs within a few minutes to an hour after a dose is given. For this reason, the vaccinator may ask you or your child to stay at the location where you or your child got the vaccine to follow up after vaccination. Signs of a severe allergic reaction may include:
Some other people who received the vaccine developed myocarditis (inflammation of the central muscle) and pericarditis (inflammation of the outer lining of the central muscle). In most of those other people, symptoms appeared within 10 days of vaccination. The likelihood of this decreasing is very low. Seek immediate medical attention if you or your child experience any of the following symptoms after receiving the vaccine:
Side effects that have been reported in trials with the Novavax COVID-19 adjuvanted vaccine include:
Side effects that have been reported following the use of the authorization of the Novavax COVID-19 adjuvanted vaccine include:
These may not be all side effects imaginable. Serious and unexpected side effects are possible. Possible side effects are still being investigated.
What do I do if I have appearance effects? If you or your child has 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’s (CDC) Vaccine Adverse Event Reporting System (VAERS). The VAERS toll-free number is 18008227967 or report it online at https://vaers. hhs. gov/ reportevent. html. Include “Novavax COVID-19 Vaccine, EUA Formula with Adjuvant (2023-2024)” in the first row of Table 18 of the reporting 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 features with your health care provider.
There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to the Novavax COVID-19 vaccine, adjuvanted pregnancy. Women vaccinated with the Novavax COVID-19 vaccine, adjuvanted pregnancy, are encouraged to sign up for 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
About Nuvaxovid XBB.1.5 2023-2024 Formula (NVX-CoV2601)NVX-CoV2601 is an updated version of Novavax’s prototype COVID-19 vaccine (NVX-CoV2373) formulated to target the Omicron XBB.1.5 subvariant. It is a protein-based vaccine made by creating copies of the surface spike protein of SARS-CoV-2 that causes COVID-19. With Novavax’s unique recombinant nanoparticle technology, the non-infectious spike protein serves as the antigen that primes the immune system to recognize the virus, while Novavax’s Matrix-M adjuvant enhances and broadens the immune response. The vaccine is packaged as a ready-to-use liquid formulation and is stored at 2° to 8°C, enabling the use of existing vaccine supply and cold chain channels.
About the Matrix-M adjuvant? When added to vaccines, Novavax’s patented saponin-based Matrix-M adjuvant complements the immune system’s response, making it broader and longer-lasting. The Matrix-M adjuvant stimulates the access of antigen-presenting cells at injection and improves antigen presentation in local cells. lymph nodes.
About Novavax? Novavax, Inc. (Nasdaq: NVAX) promotes improved health by discovering, developing and commercializing cutting-edge vaccines to help protect against serious infectious diseases. Novavax, a global company headquartered in Gaithersburg, Maryland, USA, is a global company based in Gaithersburg, Maryland, USA. The U. S. Centers for Disease Control and Prevention offers a differentiated vaccine platform that combines a recombinant protein approach, cutting-edge nanoparticle technology, and Novavax’s proprietary Matrix-M adjuvant for the immune response. Focused on the world’s most pressing health challenges, Novavax is recently comparing COVID-19, influenza and COVID-19 vaccines and combined influenza. Visit novavax. com and LinkedIn to learn more.
Forward-Looking StatementsThe following statements relate to Novavax’s long-term operating plans and prospects, adding the availability of its updated delivery and distribution of your vaccine are forward-looking statements. Novavax cautions that such forward-looking statements are subject to threats and uncertainties that may cause actual effects to differ materially from those expressed or implied by such statements. These threats and uncertainties include, among others, demanding situations in assembly, alone or with partners, various needs for safety, efficacy and product characterization, adding those similar to the qualification of procedures and validation of tests, mandatory to satisfy the authorities. applicable regulations; difficulty obtaining scarce raw materials and fabrics; resource limitations, human capital addition and production capacity, to Novavax’s ability to pursue expected regulatory pathways; difficulties or delays in obtaining regulatory approval for its product candidates, adding its updated XBB edition of its COVID-19 vaccine in time for the fall 2023 vaccination season or for long-term COVID-19 variant strain changes; demanding situations or delays in clinical trials; delays or difficulties in production, distribution or export; Novavax’s sole dependence on Serum Institute of India Pvt. Limited. Ltd. for the co-formulation and filling and the effect of any delay or interruption of its operations in the delivery of visitor orders; difficulties in meeting contractual needs under agreements with multiple commercial, governmental and other entities; and other known threat points 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 the next quarterly reports in the form. 10-Q, filed with the Securities and Exchange Commission (SEC). We caution investors not to place significant reliance on the forward-looking statements contained in this press release. We encourage you to read our SEC filings, available at www. sec. gov and www. novavax. com, for a discussion of those and other threats and uncertainties. The forward-looking statements contained in this press release speak only as of the date hereof and we undertake no legal responsibility to update or revise such statements. Our business is subject to significant threats and uncertainties, in addition to those discussed above. Investors, potential investors and others deserve to pay close attention to those threats and uncertainties.
Contacts: Investors Erika Schultz240-268-2022ir@novavax. com
MediaAli Chartan240-720-7804media@novavax. com
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