Updated Version of Novavax's COVID-19 Vaccine Now Approved in the EU
Friday, November 03, 2023
Novavax, Inc. (Nasdaq: NVAX ), a global company advancing protein-based vaccines with its Matrix-M ™ adjuvant , today announced that the Commission European Union has approved the dispersion of Nuvaxovid™ people aged 12 and over. This decision follows the favorable opinion of the Committee for Medicinal Products for Human Use of the European Medicines Agency.
“Today’s approval of the only updated protein-based RNA-free COVID-19 vaccine in the EU is an important milestone as the need for vaccination continues,” said John C. Jacobs, President and CEO general of Novavax. “Novavax is working closely with national authorities to ensure that our updated vaccine is delivered and available in Europe in the coming weeks. »
Novavax is working closely with EU member states that have requested doses under the Advance Purchase Agreement to confirm the dose delivery schedule on a country-by-country basis.
The approval is based on non-clinical data showing that the updated version of the Novavax COVID-19 vaccine induces functional immune responses against the XBB.1.5, XBB.1.16 and XBB.2.3 variants. Other non-clinical data demonstrated that Novavax's vaccine induces neutralizing antibody responses against the new subvariants BA.2.86, EG.5.1 FL.1.5.1 and XBB.1.16.6, as well as cellular responses ( polyfunctional CD4+ T cells against EG.5.1 and XBB.1.16.6. These data indicate that Novavax's vaccine can stimulate both arms of the immune system and induce a broad response against circulating variants. 1.2
In clinical trials, the most common adverse reactions associated with the prototype Novavax COVID-19 vaccine (NVX-CoV2373) were: headache, nausea or vomiting, muscle pain, joint pain, injection site tenderness , pain at the injection site, fatigue and discomfort.
Novavax's vaccine is authorized in the United States and is currently under review in other markets.
NOVAVAX COVID-19 VACCINE, WITH ADJUVANT (FORMULATION 2023-2024) AUTHORIZED USES
Novavax COVID-19 Vaccine with Adjuvant (Formulation 2023-2024) has not been approved or licensed by the FDA, but has been authorized for use in emergency by the FDA under an EUA to prevent coronavirus disease 2019 (COVID-19) in individuals aged 12 and older. View the full fact sheet to learn more about the Novavax COVID-19 Vaccine with Adjuvant.
Emergency use of this product is authorized only for the duration of the declaration that circumstances exist justifying the authorization of such emergency use of a medical product under section 564( (b)(1) of the FD&C Act, unless the declaration is terminated or the authorization is revoked earlier.
IMPORTANT SAFETY INFORMATION
What should you tell your vaccine provider before you or your child receives Novavax COVID-19 Vaccine with Adjuvant?
Tell your vaccine provider about all of your or your child's health problems, including if you or your child:
- have allergies
- have had myocarditis (inflammation of the heart muscle) or pericarditis (inflammation of the outer lining of the heart)
- have a fever
- have a bleeding disorder or are taking a blood thinner
- are immunocompromised or taking a medication that affects your immune system
- are pregnant or planning to be
- breastfeed
- have received another COVID-19 vaccine
- you have ever passed out from an injection
Who should not receive the Novavax COVID-19 vaccine with adjuvant?
A person should not receive the Novavax COVID-19 vaccine with adjuvant if they have had:
- a severe allergic reaction after a previous dose of Novavax COVID-19 vaccine with adjuvant
- a severe allergic reaction to any of the ingredients in these vaccines
What are the risks associated with the Novavax COVID-19 vaccine with adjuvant?
There is a small risk that the vaccine will cause a severe allergic reaction. A severe allergic reaction usually occurs within minutes to an hour after a dose is administered. For this reason, the vaccinator 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 may include:
- Difficulty breathing
- Swelling of the face and throat
- A fast heartbeat
- A rash all over your body
- Dizziness and weakness
Myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the outer lining of the heart) have been seen in some people who received the vaccine. In most of these people, symptoms appeared within 10 days of vaccination. The risk of this happening is very low. You should seek medical attention immediately if you or your child experience any of the following symptoms after receiving the vaccine:
- Chest pain
- Shortness of breath
- Feeling of rapid pounding, palpitations, or pounding heartbeat
Side effects that have been reported in clinical trials with the adjuvanted Novavax COVID-19 vaccine include:
- Myocarditis (inflammation of the heart muscle)
- Pericarditis (inflammation of the outer lining of the heart)
- Injection site reactions: pain/tenderness, swelling, redness and itching
- General side effects: fatigue or general feeling unwell, muscle pain, headache, joint pain, nausea, vomiting, fever, chills
- Allergic reactions such as hives and facial swelling
- Swollen lymph nodes
Side effects that have been reported during post-authorization use of the adjuvanted Novavax COVID-19 vaccine include:
- Severe allergic reactions
- Myocarditis (inflammation of the heart muscle)
- Pericarditis (inflammation of the outer lining of the heart)
- Paresthesia (unusual sensation in the skin, such as tingling or tingling sensation)
- Hypoesthesia (decreased sensation or sensitivity, especially in the skin)
These side effects may not all be possible. Serious and unexpected side effects may occur. Possible side effects are still being studied.
What should I do if I experience side effects?
If you or your child has a severe allergic reaction, call 9-1-1 or go to the nearest hospital.
Call the vaccinator or your health care provider 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). The VAERS toll-free number is 1-800-822-7967. You can also file your report online at https://vaers.hhs.gov/reportevent.html . Please indicate “EUA for Novavax COVID-19 Vaccine with Adjuvant (formula 2023-2024)” in the first line of box 18 of the declaration form.
Additionally, you may report side effects to Novavax, Inc., using the following contact information: Website: www.NovavaxMedInfo.com , Fax: 1-888-988-8809, Tel. : 1-844-NOVAVAX (1-844-668-2829).
What about pregnancy or breastfeeding?
If you or your child are pregnant or breastfeeding, discuss options with your health care provider.
There is a Pregnant Exposure Registry that monitors pregnancy outcomes in women exposed to the adjuvanted Novavax COVID-19 vaccine during pregnancy. Women vaccinated with the adjuvanted Novavax COVID-19 vaccine during pregnancy are encouraged to enroll in the registry by visiting https://c-viper.pregistry.com .
Please see the information sheet for recipients and caregivers for more information. Reporting adverse events and vaccine administration errors
Adverse events may 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: 1-888- 988-8809, Tel. : 1-844-NOVAVAX (1-844-668-2829).
About Nuvaxovid
™ to target the Omicron XBB.1.5 sub-variant. It is a protein-based vaccine made by creating copies of the SARS-CoV-2 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 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 stored at 2-8°C, allowing use of existing vaccine supply and cold chain channels.
About Matrix-M™ Adjuvant
When added to vaccines, Novavax's patented saponin-based Matrix-M adjuvant enhances the immune system response, making it more effective and longer lasting. Matrix-M adjuvant facilitates penetration of antigen-bearing cells at the injection site and enhances antigen production in 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 based in Gaithersburg , Maryland , USA, offers a differentiated vaccine platform that combines a recombinant protein approach, innovative nanoparticle technology and Novavax's patented Matrix-M adjuvant to to improve the immune response. Focusing on the most pressing health challenges, Novavax is currently evaluating vaccines for COVID-19, influenza, and combined COVID-19 and influenza. For more information, please visit novavax.com and LinkedIn .
Forward-Looking
Statements Statements regarding the future of Novavax, its operating plans and prospects, the scope, timing and results of future regulatory filings and actions, including the availability of its Novavax COVID-19 vaccine, recombinant, with adjuvant (formula 2023-2024) (NVX-CoV2601), its coordination with certain countries and the delivery and distribution schedule of its vaccine, including the plan to make its vaccine available in Europe in the coming weeks, 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 in such statements. These risks and uncertainties include, but are not limited to, challenges to address, alone or with partners, various safety, efficacy and product characterization requirements, including those related to process qualification and the validation of tests, necessary to satisfy the applicable regulatory authorities; difficulty obtaining scarce raw materials and supplies; resource constraints, including human capital and manufacturing capacity, on Novavax's ability to pursue planned regulatory pathways; challenges or delays in obtaining regulatory approval for its product candidates, including its updated XBB version of its COVID-19 vaccine in time for the fall 2023 vaccination season or future changes COVID-19 variant strain; challenges or delays in clinical trials; Novavax's exclusive dependence on Serum Institute of India Pvt. Ltd. for co-formulation and filling and the impact of any delay or disruption of their operations on the delivery of customer orders; difficulties in meeting contractual requirements under agreements with multiple commercial, governmental and other entities; and other risk factors identified in the “Risk Factors” “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of Novavax’s Annual Report on Form 10-K for the fiscal year ended 31 December 2022 and subsequent quarterly reports on 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 these statements and other risks and uncertainties. The forward-looking statements contained in this press release speak only as of the date hereof, and we undertake no obligation to update or revise them. Our business is subject to considerable risks and uncertainties, including those discussed above. Investors, potential investors and other stakeholders should carefully consider these risks and uncertainties.
Contacts :
Investisseurs
Erika Schultz
240-268-2022
ir@novavax.com
Media
Ali Chartan
240-720-7804
media@novavax.com
References :
Wherry EJ, Barouch DH. T cell immunity to COVID-19 vaccines. Science. 2022;377(6608):821-822. doi: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. doi:10.1038/s41579-023-00878-2.
Source: prnewswire.com
