FDA approved Novavax and the Indian Serum Institute for emergency use in Thailand

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This is another good news after the FDA approved the COVID vaccine, Novavax and the Indian Serum Institute. to be able to use in Thailand for emergency

Novavax, Inc. (Nasdaq: NVAX), a biotechnology company that develops and markets next-generation vaccines for severe infectious diseases. and the Serum Institute of India (SII), the world’s largest producer of vaccines by quantity. announced today that The Food and Drug Administration (FDA) has approved Emergency Use (EUA) registration for the COVID-19 vaccine. The protein-based form is now the basis of Novawax. It is used to boost immunity against the coronavirus disease (COVID-19) caused by Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) in people aged 18 years and over. Also known as NVX-CoV2373, SII manufactures and markets this vaccine under the brand name Covovax™.

” Novavax hopes to deliver a vaccine against COVID-19. The first protein-based protein for Thai people,” said Mr. Stanley C. Erck, Novavax President and Chief Executive Officer. “We remain committed to helping fight the epidemic. big all over the world By delivering a new vaccine built on a well-known platform that has been applied to other vaccines for decades.”

The Food and Drug Administration’s resolutions are based on preclinical, clinical, and manufacturing data submitted by the company to the FDA. It was taken into account, which included the results of two major phase 3 trials, PREVENT-19, which involved approximately 30,000 volunteers aged 18 and over in the United States and Mexico. The findings were published in the New England Journal of Medicine (NEJM). The other was a trial that assessed the vaccine among nearly 15,000 volunteers in the UK.

The results were published in the journal NEJM as well. The vaccine appeared to be effective. It is also safe and well tolerated. Serious and severe adverse events were rarely seen. And there was not much difference between the vaccinated group and the placebo group. The most common adverse reactions in clinical trials were: (counts only the frequent level that occurs frequently greater than or equal to 1/10) is headache, nausea or vomiting. Muscle aches, joint pains, pain or tenderness at the injection site, fatigue and fever, will continue to collect and analyze NVX-CoV2373 vaccine data from actual use. This includes safety monitoring and evaluating the mutation of the virus once the vaccine has been distributed.

Covovax is registered for Emergency Use (EUL) by the World Health Organization. It is also registered for Emergency Use (EUA) in India, Indonesia, Philippines and Bangladesh. It is also licensed for use by teenagers aged 12 to 18 in India. Find out more about Covovax at the website below.

Serum Institute of India
Thai FDA (Food and Drug Administration)
Novavax COVID-19 Vaccine Licensing in Thailand
The Food and Drug Administration (FDA) has approved Emergency Use (EUA) registration for Covovax /Recombinant Spike Protein of SARS-CoV-2 Virus 5 mcg to boost immunity against COVID-19. which is caused by the SARS-CoV-2 virus, for those aged 18 years and over.

US Authorization NVX-CoV2373 has not been approved by the US Food and Drug Administration for use in the US.

Important safety information

NVX-CoV2373 is contraindicated in people who are hypersensitive to the active ingredient or to any of the ingredients in this vaccine.
Severe allergic reactions were found after receiving the COVID-19 vaccine. In the event of acute anaphylaxis after vaccination, there should be personnel on site to treat and supervise symptoms. Symptoms should be closely observed for at least 15 minutes. A second dose of NVX-CoV2373 should not be given to a person who has developed a severe allergic reaction after the first dose of NVX-CoV2373.

There is a potential for anxiety reactions, such as fainting (hot flashes), rapid shortness of breath. or stress reaction to needle vaccination Countermeasures should be taken to avoid injury if someone is unconscious.
Postpone vaccination in people with severe acute fever or acute infection. Vaccination should not be postponed if it is a mild infection. and/or a low-grade fever

Administer NVX-CoV2373 with caution in persons receiving anticoagulants. or people with thrombocytopenia or a blood clotting disorder (eg hemophilia), where bleeding or bruising may occur after these people have received the vaccine by intramuscular injection NVX-CoV2373 may have Decreased efficacy in immunocompromised individuals.

NVX-CoV2373 vaccination can be given to pregnant women. If the vaccinations are given to you more than the penalty for both the mother and the fetus. The effects of NVX-CoV2373 vaccine may temporarily affect your ability to drive or operate machinery.

Vaccinators may not be fully protected until 7 days after the second dose of vaccination, NVX-CoV2373 vaccination may not protect everyone vaccinated. This is a condition found in all brands of vaccines. The most common adverse reaction in the trial was headache. Nausea or vomiting Muscle aches, joint pains, pain or tenderness at the injection site, tiredness and fever

About NVX-CoV2373

NVX-CoV2373 is a protein-based COVID-19 vaccine structured using the genetic sequencing of the first SARS-CoV-2 strain that causes COVID-19. The NVX-CoV2373 vaccine is created using hybrid nanoparticle technology. Novawax’s To generate antigens derived from the coronavirus’ spiny protein (S) Powered by Novawax’s patented saponin Matrix-M™. to elevate the immune response NVX-CoV2373 contains purified protein antigens that do not multiply and do not cause COVID-19.

Covid-19 vaccine Novavax’s vaccine is a ready-to-use liquid vaccine in glass vials of 10 doses divided into 2 doses, 0.5 mL each (5 mcg antigen and 50 mcg Matrix-M suppositories) administered intramuscularly 21 times apart. Days can be stored at 2-8°C, making it possible to use existing vaccine supply chain and cold chain channels for vaccine distribution.

Novavax has entered into a collaborative agreement to manufacture, market, and distribute the NVX-CoV2373 vaccine worldwide, with the current accredited registration leveraging the manufacturing partnership between Novavax and NVX-CoV2373. The world’s largest vaccine producer by quantity is the Serum Institute of India (SII), and will be supplemented with input from other sources in Novavax’s global supply chain at a later date.

About the NVX-CoV2373 Phase 3 Vaccine Trial

NVX-CoV2373 is currently undergoing two major phase 3 trials.

The PREVENT-19 program in the United States and Mexico enrolled nearly 30,000 volunteers aged 18 years and over, showing a total efficacy of 90.4% in a randomized, 2:1 placebo-controlled trial. and the subject did not know what drug they were receiving. To assess the efficacy, safety, and immune response of NVX-CoV2373 vaccine, the primary outcome of PREVENT-19 was the incidence of symptomatic (mild, moderate, or severe) COVID-19 with confirmed PCR-onset symptoms. At least 7 days after the second dose of vaccination among adult subjects who tested negative for serology (against SARS-CoV-2), the statistical success criteria consisted of 95% CI >30%. is to prevent the spread of COVID-19 Moderate or severe symptoms with confirmed PCR. Both outcomes were assessed at least 7 days after second dose vaccination in subjects not previously infected with SARS-CoV-2. The vaccine was resistant to side effects. It was well tolerated and had a high antibody response in both trials. All trial results are published in the New England Journal of Medicine (NEJM).

The UK trial with 14,039 volunteers aged 18 years and over was a randomized trial. There was a placebo control group. and the subject did not know what drug they were receiving. The results showed a total efficacy of 89.7%. The primary outcome of this study was in the presence of symptomatic (mild, moderate, or severe) COVID-19 cases confirmed by PCR, with onset of symptoms at least 7 days after vaccination. Second dose among adult volunteers who tested negative for serology (against SARS-CoV-2), all results published in the journal NEJM.

About Matrix-M™ suppositories

Novawax’s patented Matrix-M™ saponin-based suppository. Shows potential and tolerability of side effects. by stimulating the entrance of antigen-presenting cells onto the injection site. and elevate the antigen delivery in the lymph nodes to induce an immune response.

About Novavax Novavax, Inc. (Nasdaq: NVAX) is a biotechnology company that promotes better health worldwide. through research, development and distribution of innovative vaccines to prevent serious infections Proprietary Hybrid Technology Platform Combine the power and speed of genetic engineering. to create nanoparticles with high immunity properties Developed to meet the urgent global health needs of NVX-CoV2373, the COVID-19 vaccine. that the company developed It is conditionally approved by many regulatory bodies around the world. Both the European Commission and the World Health Organization, and many regulators around the world are considering the vaccine. In addition to the COVID-19 vaccine, Novavax is currently evaluating a hybrid vaccine to protect against COVID-19. and influenza in a phase 1/2 clinical trial that mixed NVX-CoV2373 vaccine with NanoFlu, the company’s developing four-strain, nanoparticle flu vaccine. These vaccines combine Novavax’s proprietary saponin-based saponin-based additive, Matrix-M™, to enhance the immune response. and inducing high levels of negative antibodies

Find out more at www.novavax.com And follow us on Twitter, Link, Instagram and Facebook.

About Indian Serum Institute The Serum Institute of India (SII) is driven by the philanthropic philosophy of accessible vaccines. It is the world’s largest vaccine manufacturer in terms of dosages produced and sold worldwide (over 1.5 billion doses), providing the world’s lowest priced vaccine and WHO-approved to over 170 countries. The institute was established in 1966 with the aim of producing life-saving immunization drugs, including vaccines, worldwide. With a strong commitment to global health The objective of the institute is therefore broadened by reducing the price of new vaccines such as Diphtheria, Tetanus, Pertussis, Hib, BCG, Hepatitis B, Measles, Mumps and Rubella. SII has been certified for bringing world-class technology to India. Through the most modern multifunctional manufacturing plant in Manjari district, Pune, through cooperation with Zipline and government agencies. to transform the field of emergency medicine and critical care Along with being a leader in vaccine development to prevent the spread of COVID-19

Forward-looking statements

The statements herein relate to the future of Novavax. including plans and prospects for implementation, collaboration, time frame to know clinical trial results. Progress on the NVX-CoV2373 vaccine, including advances in the development of a hybrid vaccine that protects against both COVID-19. and seasonal flu to the scope, time frame, and outcomes for filing documents and taking future regulatory actions. including Novawax’s plans To supplement the certification request with input from other manufacturing sources in Novavax’s global supply chain later. Potential of Novawax and NVX-CoV2373 Vaccine to Solve Vaccine Access Problems control the epidemic and protect the people as well as the intended efficacy, safety and utility of NVX-CoV2373 and the expected delivery of NVX-CoV2373 vaccine. These are forward-looking statements.

Novavax cautions that These forward-looking statements are subject to a number of risks and uncertainties. This could cause actual results to differ materially from those stated in the forward-looking statements. whether express or implied These risks and uncertainties include but not limited to Challenges in meeting safety, performance and product characteristics Either by the company itself or with partners.

This includes requirements related to process validation and analytical assessment testing necessary to meet regulatory requirements; problems in the supply of raw materials and materials that are in short supply; Resource constraints including human capital and production capacity that affect Novavax’s ability to follow the planned regulatory path. Challenges in meeting contractual obligations with private, government and other entities, and other risk factors listed in the “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections. ” in Novavax’s annual report on Form 10-K for the year ended December 31, 2021, as filed with the Securities and Exchange Commission (SEC). This press release is too much. We invite investors to read our SEC filings at www.sec.gov and www.novavax.com. to study these messages and other risks and uncertainties. Forward-looking statements in this press release reflect information as of the date of this publication. We are under no obligation to update or revise these statements. There are many risks and uncertainties in our business. including those referenced above, investors, those interested in investing and others should carefully assess these risks and uncertainties.

FDA approved Novavax and the Indian Serum Institute  to enable emergency use in Thailand | News by Thaiger

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