The Novavax vaccine is legal in the U. S. and is recently being studied in the markets.
NOVAVAX COVID-19 VACCINE, ADJUVANT (FORMULA 2023-2024) AUTHORIZED USES The Novavax COVID-19 COVID-19 Vaccine, with Adjuvant (Form 2023-2024) has not been approved or legal through the FDA, however, it has been legal for emergency use through the FDA, under an EUA to save you from 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:
What are the risks of the Novavax COVID-19 adjuvanted vaccine?There is a small risk 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 immunizer may ask you or your child to stay in the position where you or your child received 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:
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 immunizer or your health care provider if you have any side effects that concern you or your child or that 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 toll-free number for VAERS is 1-800-822-7967 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 may report side effects to Novavax, Inc. with the following tactile information: Website: www. NovavaxMedInfo. com, Fax Number: 1-888-988-8809, Phone Number: 1-844-NOVAVAX (1-844-668-2829).
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.
See the Beneficiary and Caregiver Fact Sheet for information. Reporting of Adverse Events and Vaccine Administration Errors
About Nuvaxovid™ XBB. 1. 5, COVID-19 Vaccine Injectable Dispersion (Recombinant, Adjuvanted) (NVX-CoV2601)NVX-CoV2601 is an updated edition of Novavax’s prototype COVID-19 vaccine (NVX-CoV2373) formulated to target Omicron XBB . 1. 5. subvariant. It is a protein-based vaccine that is made by creating copies of the SARS-CoV-2 surface spike protein that causes COVID. Using Novavax’s unique recombinant nanoparticle technology, the non-infectious spike protein serves as an antigen that primes the immune formula to recognize the virus, while Novavax’s Matrix-M™ adjuvant complements and expands the immune response. The vaccine is packaged as ready-to-use liquid formulas and stored between 2° and 8°C, allowing the use of existing vaccine origin chains and the bloodless chain.
When added to vaccines, Novavax’s patented saponin-based Matrix-M™ adjuvant supplements the immune system’s response, making it broader and more sustainable. The Matrix-M adjuvant stimulates the access of antigen-presenting cells at injection and improves antigen presentation in local lymph nodes.
Forward-Looking StatementsStatements contained herein relating to Novavax’s long-term, operating plans and prospects, the scope, timing and effects of long-term filings and regulatory actions, including the availability of its Novavax COVID-19 vaccine, RecombinantArray with adjuvant (formula 2023-2024). ) (NVX-CoV2601), its coordination with certain countries and the delivery and distribution schedule of its vaccine, including the expected availability of its vaccine in Europe in the coming weeks, 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 insecurities include, among others, demanding situations in assembly, alone or with partners, various needs for safety, effectiveness 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, to discuss those and other threats and insecurities. 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 insecurities, in addition to those discussed above. Investors, potential investors and others deserve to pay close attention to those threats and insecurities.
Contacts:InvestorsErika Schultz240-268-2022ir@novavax. com
MediaAli Chartan240-720-7804media@novavax. com
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SOURCE: NOVAVAX, INC.