This trial is currently enrolling participants in Spain and the UK; enrolment will commence shortly in the US, the Netherlands and Canada, with Brazil and Argentina to follow
Johnson & Johnson has begun vaccinating adolescent participants in the ongoing Phase 2a clinical trial for its covid-19 vaccine candidate, developed by the Janssen Pharmaceutical Companies of Johnson & Johnson.
This trial is currently enrolling participants in Spain and the United Kingdom; enrolment will commence shortly in the United States, the Netherlands and Canada, with Brazil and Argentina to follow. The vaccine candidate will initially be tested in a small number of adolescents aged 16-17 years. Following the review of initial data in this Phase 2a trial, the study will be expanded to a larger group of younger adolescents in a stepwise approach.
“In addition to expanding this ongoing study to include adolescents, we are in discussions with health authorities and are hard at work to initiate studies in pregnant women and children in the near future," said Mathai Mammen, Global Head, Janssen Research & Development, Johnson & Johnson. The randomized, double-blind, placebo-controlled Phase 2a study has been ongoing since September 2020, and was initially designed to evaluate the safety, reactogenicity (expected reactions to vaccination, such as swelling or soreness) and immunogenicity (ability to induce an immune response) of single-dose and two-dose regimens of the Johnson & Johnson covid-19 vaccine candidate in healthy adults aged 18 to 55 years, as well as adults aged 65 years and older. The study is now including adolescents 12 to 17 years of age.
Among the study’s goals are to evaluate reactogenicity and immunogenicity of two dose levels of the vaccine candidate, and to evaluate potential vaccination schedules at one, two and three-month intervals in two-dose vaccine regimens.
The Indian department of biotechnology (DBT) has also scientists and vaccine developers to apply for complementary clinical trials on infants, children, pregnant women and immunocompromised people, with the aim of expanding the country’s covid-19 vaccination strategy to more population groups.
The trials will be funded by the Coalition for Epidemic Preparedness Innovations (CEPI), a global alliance financing and coordinating the development of vaccines against infectious diseases. The DBT is supporting the implementation of the Ind-CEPI Mission, India Centric Epidemic Preparedness through Rapid Vaccine Development. CEPI will offer up to $140 million in funding to vaccine developers and other research institutions globally for rapid complementary clinical data on covid-19 vaccines. The clinical trials are sought to advance current covid-19 immunization efforts by providing data on demographics and age groups such as pregnant and lactating women, infants and children, and those who have low immunity levels, who may at present not be eligible to receive vaccines.
“DBT is supporting pharmaceutical companies in clinical trials on covid-19 vaccines under various schemes. Some of the companies receiving DBT support are Cadila Healthcare Ltd (Zydus Cadila), Biological E for vaccine with MIT USA, Gennova, Bharat Biotech International Ltd for two trials, Seagull BioSolutions Pvt Ltd and Aurobindo Pharma Ltd," said Renu Swarup, Secretary, Department of Biotechnology.
Biological E is in a pact with Johnson and Johnson to manufacture the drug product for the single-dose vaccine developed by the US-based firm. The importance of the vaccine is such that the US government had last month announced that it will invest an undisclosed amount in to the Hyderabad-based firm in lieu of the company manufacturing 1 billion doses of covid-19 vaccines by the end of 2022, including the single-dose vaccine developed by Johnson & Johnson.
However, the two companies as of now do not have plans to supply the vaccine to India, nor have the applied for clinical trials in the country. Instead, the company is currently conducting phase 1 and 2 clinical trials for a vaccine originally developed by US-based Baylor College of Medicine. The company is soon expected to seek the drug regulator's approval to move into phase 3 trials for the protein subunit vaccine.
Biological E in August last year had bought Akorn India, which had sterile injectables plant. The acquisition will help the company scale up its manufacturing capacity to up to 1 billion doses a year, making it the second largest vaccine maker in India after Serum Institute of India.
Johnson & Johnson's vaccine had received the US FDA emergency use authorisation on 27 February and the following month, the World Health Organization's emergency use listing. The approval was based on a trial in the US, South Africa and Mexico. It had an efficacy of 66.3% overall and 74.4% in the US.
Union health ministry recently had said that clinical trials are underway for children for covid-19 vaccines. “Pfizer, Janssen and Moderna are currently doing studies in children 12 and older in the US and will go lower. Astra Zeneca is evaluating the vaccine in children 6-17 years in the UK. Novavax is planning its studies in younger children. Covaxin has to submit the interim efficacy data from adults to get permission for the study in children, but I believe they had a few children over 12 years in their phase 2 study," said Dr Gagandeep Kang, the vice chair, Coalition for Epidemic Preparedness Innovations (CEPI), a global non-profit aiding vaccine development platform for the covid-19 pandemic, and professor at the Christian Medical College (CMC), Vellore, Tamil Nadu.