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Pending a decision from the European Commission, the Novavax vaccine will be the only updated non-mRNA protein-based COVID-19 vaccine available in Europe for people aged 12 and over.
GAITHERSBURG, Md. , Oct. 31, 2023 /PRNewswire/ — Novavax, Inc. (Nasdaq: NVAX), a global company advancing protein-based vaccines with its Matrix-M™ adjuvant, today announced that Nuvaxovid™ XBB. 1. 5 The committee recommended approval of the COVID-19 dispersal injectable vaccine (recombinant, adjuvanted) (NVX-CoV2601) for active immunization to save COVID-19 caused by SARS-CoV-2 in Americans aged 12 years and older in the European Union. of the European Medicines Agency (CHMP). The European Commission will follow the advice of the CHMP and is expected to adopt a final resolution in the coming days.
“Following the CHMP’s positive opinion and pending the European Commission’s resolution, Novavax will work intensively with EU Member States on our shared purpose to deliver an updated protein-based, mRNA-free COVID-19 vaccine in Europe,” said John C. Jacobs, chairman and chief executive officer of Novavax.
The CHMP’s positive opinion was based on non-clinical knowledge that appeared that Novavax’s updated COVID-19 vaccine induced functional immune reactions opposed to the XBB. 1. 5, XBB. 1. 16 and XBB. 2. 3 variants. Additional non-clinical data demonstrated that Novavax vaccine induced neutralizing antibody reactions opposite to the emerging subvariants BA. 2. 86, EG. 5. 1, FL. 1. 5. 1, and XBB. 1. 16. 6, as well as CD4 polyfunctional cellular reactions (T cells) opposed to EG. 5. 1 and XBB. 1. 16. These data imply that the Novavax vaccine can stimulate either arm of the immune formula and induce a broad reaction against circulating variants. 1,2
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.
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 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. under an EUA. to protect 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 a 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 vaccine provider before you or your child receives the Novavax COVID-19 adjuvanted vaccine?Tell your immunization provider about any fitness disorders you or your child have, and add if you or your child:
having allergies
have had myocarditis (inflammation of the central muscle) or pericarditis (inflammation of the outer lining of the central muscle)
have a fever
you have bleeding or are taking a blood thinner
are immunocompromised or are taking a medication that affects their immune system
are pregnant or plan to become pregnant
You’re breastfeeding
have won the COVID-19 vaccine
You’ve already passed out from an injection
Who is not receiving the Novavax COVID-19 adjuvanted vaccine?A user does not receive the Novavax COVID-19 adjuvanted vaccine if they have:
severe allergic reaction after one dose of any Novavax adjuvanted COVID-19 vaccine
a severe allergic reaction to any of the ingredients in those vaccines
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:
Labored breathing
Swelling of the face and throat.
A Rapid Heartbeat
A rash all over the body.
Dizziness and weakness.
Some other people who received the vaccine suffered 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 probability 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:
Chest pain
Shortness of breath
Feeling like your core is beating fast, throbbing, or pounding too hard
Side effects that have been reported in trials with the adjuvanted Novavax COVID-19 vaccine include:
Myocarditis (inflammation of the central muscle)
Pericarditis (inflammation of the outer lining of the heart)
Injection reactions: pain/tenderness, swelling, redness, and itching.
General effects: tiredness or malaise, muscle aches, headache, joint pain, nausea, vomiting, fever, chills.
Allergic reactions such as hives and facial swelling.
Swollen lymph nodes
Side effects that have been reported after the use of the authorization of the Novavax COVID-19 vaccine with adjuvant include:
Severe allergic reactions
Myocarditis (inflammation of the central muscle)
Pericarditis (inflammation of the outer lining of the heart)
Paresthesia (unusual sensation such as tingling or tingling)
Hypoesthesia (decreased sensation or tenderness in the skin)
These may not be all imaginable side effects. 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 your immunizer or health care provider if you have any side effects that worry 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 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 may report side effects to Novavax, Inc. with the following tactile information: Website: www. NovavaxMedInfo. com, Fax: 1-888-988-8809, Phone 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, pregnancy with adjuvant. Women vaccinated with the Novavax COVID-19 vaccine, pregnancy with adjuvant, are advised to enroll in the registry by visiting https:/ /c-viper. pregistry. com.
See the fact sheet for beneficiaries and caregivers for information. Reporting of adverse events and errors in vaccine administration
Adverse events may also be reported to Novavax, Inc. by using the touch form below or by providing a copy of the VAERS form to Novavax, Inc. Website: https://www. novavaxmedinfo. com/, Fax: 1-888-988-8809, Phone Number: 1-844-NOVAVAX (1-844-668-2829).
About Nuvaxovid™ XBB. 1. 5 2023-2024 (NVX-CoV2601) NVX-CoV2601 is an updated edition of Novavax’s COVID-19 vaccine prototype (NVX-CoV2373) formulated to target the Omicron XBB. 1. 5 subvariant. It is a vaccine protein based on 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 amplifies the immune response. The vaccine is packaged in 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.
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. Food and Drug Administration offers a vaccine platform that combines a recombinant protein approach, state-of-the-art nanoparticle technology, and Novavax’s proprietary Matrix-M adjuvant for the immune response. Focused on the world’s most pressing health challenges, Novavax is lately comparing COVID-19, influenza, and COVID-19 vaccines. 19 and influenza combined. Visit novavax. com and LinkedIn to learn more.
Forward-Looking Statements Statements contained herein relating to Novavax’s long-term, operating plans and prospects, the scope, timing and effects of long-term regulatory filings and actions, including the availability of its Novavax COVID-19 vaccine. 19, recombinant, with adjuvant (2023-2024). Formula) (NVX-CoV2601), its coordination with certain countries and the delivery and distribution schedule of its 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 insecurities 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, 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 Schultz 240-268-2022 ir@novavax. com
MediaAli Chartan 240-720-7804media@novavax. com
References
Wherry EJ and Barouch DH. T-cell immunity to COVID-19 vaccines. Science. 2022; 377(6608):821-822. com what I:10. 1126/science. add2897.
Markov PV, Ghafari M, Beer M et al. The evolution of SARS-CoV-2. Nat Rev Microbiol. 2023; 21(6):361-379. com what I:10. 1038/s41579-023-00878-2.
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SOURCE NOVAVAX, INC.