GAITHERSBURG, Md., Nov. 1, 2023 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), a global company developing protein-based vaccines with its Matrix-M™ adjuvant, today announced that the European Commission has granted approval of COVID-19 vaccine (recombinant, adjuvanted) (NVX-CoV2601) Nuvaxovid™ XBB.1.5 injectable dispersion for active immunization to prevent COVID-19 caused by SARS-CoV-2 in people 12 years or older. This decision follows the positive opinion for approval from the Committee for Medicinal Products for Human Use of the European Medicines Agency.
"Today's approval of the only updated non-mRNA protein-based COVID-19 vaccine in the EU is an important milestone as the need for vaccination continues," said John C. Jacobs, President and CEO of Novavax. "Novavax is working closely with national authorities to have our updated vaccine delivered and available in Europe in the coming weeks."
Novavax is working closely with EU member states that have ordered doses through the advance purchase agreement to confirm the timing of delivery of doses on a country-by-country basis.
The approval was based on non-clinical data showing that Novavax's updated COVID-19 vaccine induced functional immune responses against the XBB.1.5, XBB.1.16 and XBB.2.3 variants. Additional nonclinical data demonstrated that the Novavax vaccine induced neutralizing antibody responses to emerging subvariants BA.2.86, EG.5.1 FL.1.5.1, and XBB.1.16.6, as well as multifunctional cellular (T cell) CD4 responses against EG. . 5.1 and XBB.1.16.6. These data indicate that the Novavax vaccine can stimulate both arms of the immune system and can induce a broad response against 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 , pain at the injection site, fatigue and discomfort.
Novavax's vaccine is authorized for use in the US and is currently under review in other markets.
AUTHORIZED USES OF NOVAVAX COVID-19 VACCINE, ADJUVATED (FORMULA 2023-2024)Novavax COVID-19 Vaccine, Adjuvanted (Formula 2023-2024) has not been approved or cleared by the FDA, but has been authorized for emergency use by FDA, under an EUA to prevent Coronavirus Disease 2019 (COVID-19) for use in people over 12 years of age. Please see the full SmPC for information on Novavax COVID-19 Vaccine, Adjuvanted.
Emergency use of this product is authorized only for the duration of the declaration that circumstances exist justifying authorization of emergency use of the medical product under Section 564(b)(1) of the FD Act.
IMPORTANT SAFETY INFORMATION What should you tell your vaccination provider before you or your child receives the Novavax COVID-19 Vaccine, Adjuvanted? Tell your vaccine provider about all of your or your child's medical conditions, including if you or your son:
Who should not receive the Novavax COVID-19 vaccine, adjuvanted? A person should not receive the Novavax COVID-19 vaccine, adjuvanted if they have had:
What are the risks of the Novavax COVID-19 Vaccine, Adjuvanted? There is a remote chance that the vaccine may cause a serious allergic reaction. A serious allergic reaction usually occurs within a few minutes to an hour after receiving the dose. For this reason, the vaccinator may ask you or your child to stay at the place where you received the vaccine to monitor you after vaccination. Signs of a serious allergic reaction may include:
Myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the outer lining of the heart) have occurred in some people who have received the vaccine. In most of these people, symptoms began within 10 days of vaccination. The probability of this happening is very low. You should seek medical attention immediately if you or your child develop any of the following symptoms after receiving the vaccine:
Side effects that have been reported in clinical trials with the Novavax COVID-19 Vaccine, Adjuvanted include:
Side effects that have been reported in post-authorization use with the Novavax COVID-19 Vaccine, adjuvanted include:
These may not be all possible side effects. Serious and unexpected side effects may occur. 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 vaccine provider or your doctor if any side effects 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). VAERS' toll-free phone number is 1-800-822-7967 or submit a report online at https://vaers.hhs.gov/reportevent.html. Please include "Novavax COVID-19 Vaccine, Adjuvanted (2023-2024 Formula) USA" on the first line of the box
Additionally, you may 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 daughter are pregnant or breastfeeding, discuss options with your healthcare professional.
There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to the adjuvanted Novavax COVID-19 Vaccine during pregnancy. Women vaccinated with the Novavax COVID-19 Vaccine, Adjuvanted during Pregnancy are encouraged to enroll in the registry by visiting https://c-viper.pregistry.com.
For more information, see the information sheet for recipients and caregivers. Reporting of adverse effects and errors in vaccine administration
About Nuvaxovid™ XBB Injectable Dispersion attack the Omicron XBB.1.5 subvariant. It is a protein-based vaccine made by creating copies of the spike surface protein of SARS-CoV-2 that causes COVID. Using Novavax's unique recombinant nanoparticle technology, the non-infectious spike protein serves as an antigen that primes the immune system to recognize the virus, while Novavax's Matrix-M™ adjuvant enhances and amplifies the immune response. The vaccine is presented in a ready-to-use liquid formulation and is stored at a temperature between 2º and 8º C, allowing existing vaccine supply channels and the cold chain to be used.
About Matrix-M™ Adjuvant When added to vaccines, Novavax's patented saponin-based Matrix-M adjuvant enhances the immune system's response, making it broader and longer-lasting. Matrix-M adjuvant stimulates the entry of antigen-presenting cells at the injection site and enhances antigen presentation to local lymph nodes.
About Novavax Novavax, Inc. (Nasdaq: NVAX) promotes improved health by discovering, developing and commercializing innovative vaccines that help protect against serious infectious diseases. Novavax, a global company headquartered in Gaithersburg, Maryland, United States, offers a differentiated vaccine platform that combines a recombinant protein-based approach, innovative nanoparticle technology and Novavax's patented Matrix-M adjuvant to enhance the immune response. Focused on the world's most pressing health challenges, Novavax is currently evaluating COVID-19, influenza, and combined COVID-19 and influenza vaccines. For more information visit novavax.com and LinkedIn.
Forward-Looking Statements The statements contained herein about 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 Novavax COVID-19 vaccine, recombinant, adjuvanted (2023-2024 Formula ) (NVX-CoV2601), its coordination with certain countries and the delivery and distribution schedule of its vaccine, are future estimates. 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, but are not limited to, the difficulty in satisfying, alone or in collaboration with other partners, various safety, efficacy and product characterization requirements, including those related to process qualification and assay validation, necessary to satisfy applicable regulatory authorities; the difficulty in obtaining raw materials and scarce supplies; limited resources, including human capital and manufacturing capacity, on Novavax's ability to pursue anticipated regulatory pathways; challenges or delays in obtaining regulatory authorization for its product candidates, including the updated XBB version of its COVID-19 vaccine in time for the fall 2023 vaccination season or for future variant strain changes COVID-19; challenges or delays in clinical trials; delays or challenges in manufacturing, distribution or export; Novavax's sole dependence on Serum Institute of India Pvt. Ltd. for co-formulation and filling and the impact of any delay or disruption in its operations on the delivery of customer orders; challenges in 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 Analysis and Discussion 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 the forward-looking statements contained in this press release. We encourage you to read our filings with the SEC, available at www.sec.gov and www.novavax.com, to discuss these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date hereof and we undertake no obligation to update or revise any statements. Our business is subject to substantial risks and uncertainties, including those mentioned above. Investors, potential investors and others should carefully consider these risks and uncertainties.
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