US biotechnology company Novavax on May 3 announced that it has started clinical trials of its proposed coronavirus vaccine on children aged 12-17. According to a press release, the program will evaluate the efficacy, safety and immunogenicity of NVX-CoV2373 in up to 3,000 adolescents across 75 sites in the US. Novavax said that in the trial, participants will randomly receive either the vaccine candidate or placebo in two doses, administered 21 days apart, and they will be monitored for up to two years after their final dose.
Gregory M. Glenn, M.D., President, Research and Development, Novavax, said, “Through the expansion of our PREVENT-19 clinical trial, we hope to build upon the encouraging safety and efficacy data generated to-date in adults for our vaccine candidate and to play a significant global role in offering vaccination to as many people as possible across age groups to end the suffering caused by the pandemic”.
Further, the press note informed that Glenn will share an update regarding the trial during the 21st annual World Vaccine Congress taking place online from May 4-6. It is worth noting that the Novavax vaccine has not yet been authorised in any country, including for adults. However, the company plans to file for emergency authorization in Britain “in the second quarter of 2021,” followed by in the United States.
Back in January, Novavax had announced that clinical trials conducted in Britain involving 15,000 adults showed 89.3 per cent efficacy. The Novavax vaccine is a protein-based vaccine engineered from the genetic sequence of the first strain of the coronavirus. It can be stored at a temperature between 2 and 8 degrees Celsius.
Meanwhile, vaccine authorisation for children is seen as a crucial step towards achieving her immunity. Other vaccine companies including Moderna, Johnson & Johnson and Pfizer/BioNTech are also conducting trials in adolescents. US-based Pfizer has submitted a request to the European drug regulator for emergency approval of its vaccine for use among children aged 12 to 15 years old. Back in March, BioNTech and Pfizer had announced that phase 3 clinical trials of the coronavirus vaccine for children aged 12-15 showed it was 100 per cent effective in warding off the disease.