Health

Ema, which approved the Novavax Covid vaccine, is the fifth in Europe

ADVERTISING


Rome, 21 December – As expected, Ema, the European Medicines Agency, yesterday gave the green light for the marketing authorization of the vaccine Nuvaxovid of Novavax against Covid-19.

“Nuvaxovid is the fifth vaccine recommended in the EU to prevent Covid-19. “It’s a protein-based vaccine and, together with the vaccines already approved, it will support vaccination campaigns in EU Member States during a critical phase of the pandemic.” notify the European regulatory body by note.

After a thorough evaluation, the EMA Commission for Human Medicines (CHMP) concluded that the Novavax vaccine data were reliable and met EU criteria for efficacy, safety and quality. The results of two main clinical trials concluded that Nuvaxovid is effective in preventing Covid-19 in people over 18 years of age.

A total of over 45,000 people participated in the studies. In the first study, about two-thirds of the participants received the vaccine and the others were given a placebo injection. in the other study, participants were evenly distributed among themselves Nuvaxovid and placebo. “The first study, conducted in Mexico and the United States, found a 90.4% reduction in the number of symptomatic cases of Covid-19 from 7 days after the second dose in people taking Nuvaxovid (14 cases out of 17,312 people) compared to with individuals receiving Nuvaxovid. placebo (63 out of 8,140 people)“Emma explains. “This means that the vaccine was 90.4% effective in this study.”

“The second study conducted in the United Kingdom also showed a similar reduction in the number of symptomatic cases of Covid-19 in people taking Nuvaxovid (10 cases in 7,020 people) compared to people taking placebo (96 out of 7,019 people). ” adds the agency. “In this study, the vaccine efficacy was 89.7%.”.

Overall, the results of both studies show a vaccine efficacy of Nuvaxovid of approximately 90%. The original Sars-Cov-2 strain and some annoying variants such as Alpha and Beta were the most common viral strains present when the studies were in progress. “There are currently limited data available on the efficacy of Nuvaxovid against other variants of concern, including Omicron.” the note from the european regulator continues. “The side effects observed with Nuvaxovid in the studies were generally mild to moderate and resolved within two days of vaccination. The most common were tenderness or pain at the injection site, fatigue, body aches, headache, general discomfort, joint pain, and nausea or vomiting.

The safety and efficacy of the vaccine will continue to be monitored as it is used throughout the EU, through the EU pharmacovigilance system and further studies by the company and the European authorities.

Nuvaxovid swill be the first protein-based vaccine available in Europe. Designed based on an innovative technology, it has already been approved in Indonesia and the Philippines, where it will be marketed by the Institute of Mount India (SII) under the brand name Covovax. In Europe, NVX-CoV2373 is the fifth vaccine to be approved by the EMA, following formulations by Pfizer-BioNTech, AstraZeneca, Moderna and Janssen-Johnson & Johnson.

ADVERTISING

The recommendation of the EMA comes after a careful analysis of the criteria of safety, efficacy, tolerability and quality of immune doses. Data were obtained from preclinical and clinical evaluations and trials in humans. Prevent-19, for example, is a Phase 3 study conducted by scientists at the University of Maryland School of Medicine that enrolled nearly 30,000 participants in the United States and Mexico. According to research data, posted on New England Journal of Medicine, the vaccine will achieve an overall effectiveness of 90.4 percent. At the same time, a study conducted in the United Kingdom by scientists from St. George’s University of London, with 14,000 volunteers, described in the same journal, indicates an overall efficiency of 89.7%.

The vaccine is being tested by many regulators around the world. The US company expects to submit its chemicals, production and control data to the US Food and Drug Administration by the end of the year, for approval in the coming months. NVX-CoV2373 is not yet approved for use in the United States.

The product developed by Novavax is a protein-based vaccine made from the genetic sequence of the original SARS-CoV-2 strain. Created with recombinant nanoparticle technology, the vaccine generates the antigen derived from the spike protein and is formulated with Novavax’s patented Matrix-M adjuvant to enhance the immune response and stimulate high-potency antibodies. NVX-CoV2373, injected in liquid form, contains purified protein antigen and cannot reproduce or induce Covid-19.

After vaccination, the immune system recognizes the protein and begins to produce natural defenses, such as antibodies and T cells. If an immunized person is exposed to Sars CoV 2, the body must recognize the virus’s protein and fight the infection.

Antibodies and immune cells work together to prevent the pathogen from entering the body and to destroy the infected cells. The vaccination schedule includes two doses of 0.5 milliliters, which must be administered intramuscularly with a difference of 21 days. The drug is stored at a temperature between 2 and 8 C, which is relevant for countries where establishing an effective refrigeration chain can be problematic.

Novavax has established partnerships for the production, marketing and distribution of NVX-CoV2373 worldwide. The senior director of the vaccine development program, according to a presentation by AGI, is Nita Patel, a scientist of Indian descent, head of a research group exclusively women. “We are very pleased with the positive opinion of the EMA Committee on Medicinal Products for Human Use” claims Stanley C. Erck, President and CEO of Novavax. “The approval by the European Commission is a great success for the vaccine, the first protein-based vaccine approved in Europe. “We believe that the ability to rely on different vaccination platforms is important to stimulate the population to receive immunosuppressive doses, which would increase protection against the virus.”





Source link

ADVERTISING