Novavax’s COVID-19 Vaccine Covovax Gets Emergency Use Nod For Adolescents Aged 12-17 In India

New Delhi: Novavax, Inc., a biotechnology company on Tuesday (March 22) announced that the Drugs Controller General of India (DCGI) has granted emergency use authorization (EUA) for its protein-based COVID-19 vaccine for adolescents aged 12 to 17 years in India. Novavax’s COVID-19 vaccine is known as NVX-CoV2373 and is manufactured and marketed in India by the Serum Institute of India Pvt. Ltd. (SII) under the brand name Covovax. As per the company, it is the first protein-based vaccine authorised for use in this age group in India.

Also Read: Vaccine Protection Better Maintained Against Severe COVID-19: Lancet Study

In an official statement issued by the company, Stanley C. Erck, President and Chief Executive Officer, Novavax said,

We’re proud of this first approval in adolescents given the efficacy and safety that our data show in this population, and that our COVID-19 vaccine will provide an alternative protein-based vaccine option for individuals 12 years of age and older in India. We hope that this authorization of our COVID-19 vaccine in adolescents is the first of many worldwide so that families have an additional choice built on a well-understood platform used in other vaccines for decades.

Also Read: Covishield Dose Gap Reduced To 8-16 Weeks From 12-16

A Phase 2/3, observer-blinded, randomised, controlled study in a total of 460 Indian adolescents aged 2 to 17 years was conducted to evaluate the safety and immunogenicity of Covovax. The study demonstrated that Covovax was well-tolerated with a reassuring safety profile, the company said in a statement.

Furthermore, the data indicated that Covovax is immunogenic in adolescents aged 12 to 17 years. The authorisation in India also references the ongoing PREVENT-19 pivotal Phase 3 pediatric expansion trial of NVX-CoV2373 in adolescents in the U.S. aged 12 to 17, results of which were shared in February, the statement read.

PREVENT-19 pivotal Phase 3 trial demonstrated 80 per cent efficacy overall at a time when the Delta variant was the predominant circulating strain in the U.S. The study enrolled 2,247 adolescents aged 12 to 17 years across 73 sites in the U.S. to evaluate the safety, effectiveness (immunogenicity), and efficacy. Important to note, NVX-CoV2373 has not yet been authorised for use in the U.S. by the U.S. FDA.

Five Things To Know About NVX-CoV2373 Or Covovax

1.  NVX-CoV2373 is a protein-based vaccine engineered from the genetic sequence of the first strain of SARS-CoV-2, the virus that causes COVID-19 disease.
2. NVX-CoV2373 contains purified protein antigen and can neither replicate, nor can it cause COVID-19.
3. Novavax’s COVID-19 vaccine is packaged as a ready-to-use liquid formulation in a vial containing ten doses. The vaccination regimen calls for two 0.5 ml doses given intramuscularly 21 days apart.
4. The vaccine is stored at 2°- 8° Celsius, enabling the use of existing vaccine supply and cold chain channels.
5. The most common adverse reactions observed during clinical studies were headache, nausea or vomiting, myalgia, arthralgia, injection site tenderness/pain, fatigue, and malaise.

Also Read: Expansion Of Vaccination Drive To Include Minors Does Not Pose Safety Risk To Recipients, Government Tells Supreme Court

In December 2021, DCGI had authorised Novavax’s COVID-19 vaccine for people aged 18 years and above.

Covovax is the fourth COVID-19 vaccine to be authorised for adolescents aged 12 years and older in India after Biological E’s Corbevax, Zydus Cadila’s ZyCoV-D and Bharat Biotech’s Covaxin.

On March 16, India expanded its COVID-19 vaccination coverage by starting vaccination for children aged 12 to 14 years. According to the guidelines released by the Centre, only the Corbevax vaccine would be used for the beneficiaries of this age group. Two doses of Biological E’s intramuscular vaccine Corbevax would be administered to the beneficiaries in the 12-14 years age group at an interval of 28 days, the guidelines said.

Also Read: Vaccine For 12-14 Age Group: Delhi Parents Feel Relieved, Say Apt Move Ahead Of School Reopening

NDTV – Dettol have been working towards a clean and healthy India since 2014 via Banega Swachh India initiative, which is helmed by Campaign Ambassador Amitabh Bachchan. The campaign aims to highlight the inter-dependency of humans and the environment, and of humans on one another with the focus on One Health, One Planet, One Future – Leaving No One Behind. It stresses on the need to take care of, and consider, everyone’s health in India – especially vulnerable communities – the LGBTQ population, indigenous people, India’s different tribes, ethnic and linguistic minorities, people with disabilities, migrants, geographically remote populations, gender and sexual minorities. In wake of the current COVID-19 pandemic, the need for WASH (Water, Sanitation and Hygiene) is reaffirmed as handwashing is one of the ways to prevent Coronavirus infection and other diseases. The campaign will continue to raise awareness on the same along with focussing on the importance of nutrition and healthcare for women and children, fight malnutrition, mental wellbeing, self care, science and health, adolescent health & gender awareness. Along with the health of people, the campaign has realised the need to also take care of the health of the eco-system. Our environment is fragile due to human activity,  that is not only over-exploiting available resources, but also generating immense pollution as a result of using and extracting those resources. The imbalance has also led to immense biodiversity loss that has caused one of the biggest threats to human survival – climate change. It has now been described as a “code red for humanity.” The campaign will continue to cover issues like air pollution, waste management, plastic ban, manual scavenging and sanitation workers and menstrual hygiene. Banega Swasth India will also be taking forward the dream of Swasth Bharat, the campaign feels that only a Swachh or clean India where toilets are used and open defecation free (ODF) status achieved as part of the Swachh Bharat Abhiyan launched by Prime Minister Narendra Modi in 2014, can eradicate diseases like diahorrea and the country can become a Swasth or healthy India.