Swissmedic authorizes Novavax Covid-19 vaccine, Nuvaxovid.

Novavax, Inc. is a biotechnology company. It announced that Swissmedic, which is the Swiss Agency for Therapeutic Products, has recently granted Novavax the conditional marketing authorization (CMA) for its Nuvaxovid Covid-19 Vaccine (recombinant, adjuvanted) for the active immunization to prevent the Covid-19 infection caused by SARS-CoV-2 in individuals that are 18 years of age and older. The vaccine is also known as NVX-CoV2373. It is the first such protein-based vaccine to get authorized for use in Switzerland.

“We are proud that Switzerland is part of the growing list of countries to authorize Nuvaxovid and that people in Switzerland will have a protein-based Covid-19 vaccine option,” stated Stanley C. Erck. “As we continue to fight Covid-19, we think it is incredibly important that people have a choice in vaccine options. Nuvaxovid offers something different from the current portfolio of vaccines by using a more tried and tested technology platform while still providing a strong efficacy and safety profile.” He is the president and chief executive officer of Novavax.

The Swissmedic’s decision was based on the totality of all the preclinical, manufacturing, and clinical trial data submitted for review. That includes two pivotal phases and three clinical trials.

The first such trial was PREVENT-19. It was a major that enrolled approximately 30,000 participants of ages 18 years and older in the United States and Mexico. The findings were published in the New England Journal of Medicine (NEJM). There was also a trial with almost 15,000 adult participants in the United Kingdom, which was also published in the New England Journal of Medicine (NEJM). The new vaccine has demonstrated efficacy and reassuring safety and tolerability profile in both these trials. Any severe and severe adverse events were low in number and were balanced between vaccine and placebo groups. The most common adverse reactions observed during clinical studies, those with a frequency category of very common =1/10,  included headache, nausea or vomiting, arthralgia, myalgia, injection site tenderness/pain, fatigue, and malaise. Novavax is going to continue to collect and analyze more real-world data, including the further monitoring of safety and the evaluation of various variants as the vaccine is distributed.

Novavax has previously announced an agreement with the national government of Switzerland for supplying up to six million doses of Novavax’s Covid-19 vaccine.

Nuvaxovid is a protein-based vaccine engineered using the genetic sequence of the first strain of SARS-CoV-2, the virus that causes Covid-19 disease. It was created using Novavax’s recombinant nanoparticle technology for generating antigens derived from the coronavirus spike (S) protein. It is formulated with saponin-based Matrix-M adjuvant patented by Novavax to enhance people’s immune response and stimulate high levels of neutralizing antibodies. It also contains purified protein antigen and can neither replicate nor can it cause Covid-19.

Novavax’s Covid-19 vaccine is to be packaged as a ready-to-use liquid formulation in a vial which will contain ten doses. The vaccination regimen has called for two 0.5 ml doses, five mcg antigen, and 50 mcg Matrix-M adjuvants, which are given intramuscularly 21 days apart. The vaccine is to be stored at 2°- 8° Celsius, enabling the use of the existing vaccine supply and cold chain channels. The use of the new vaccine should be in accordance with official recommendations only.