Within the document published on Tuesday, the FDA recommends that diverse populations most affected by COVID-19 are included in every phase of clinical development, including racial and ethnic minorities as well as elderly people and people with pre-existing conditions.
There are 17 vaccine candidates now undergoing clinical trials, including three in China.
Since the beginning of the coronavirus pandemic, scientists around the world were trying hard to develop an effective vaccine for SARS-CoV-2 and some of them claimed to be successful.
The permission to initiate Phase I & II Human clinical trials came after the company submitted results generated from preclinical studies, demonstrating safety and immune response. The crucial human trials are scheduled to start across India next month.
Further elaboration also emphasized the import of ensuring clinical trials are large enough to demonstrate the safety and effectiveness of a vaccine.
Bharat Biotech has accelerated its objective in completing comprehensive pre-clinical studies by expediting the national regulatory protocols.
Bharat Biotech Joint Managing Director, Suchitra said, "Our ongoing research and expertise in forecasting epidemic has enabled us to successfully manufacture a vaccine for the H1N1 pandemic". But businesses have several vaccine candidates for COVID-19 in advanced testing, and also, a new report shows that a different drug has obtained approval for usage. However, all of them are in pre-clinical stage as of now.
The ChAdOx1 vaccine technology has been used to produce candidate vaccines against a number of pathogens including flu, chikungunya, Zika and another coronavirus, Middle East Respiratory Syndrome (MERS). Meanwhile, according to the World Health Organization, the vaccine Oxford University is working on is at the forefront of the coronavirus break.
Coronavirus outbreak: Europe's first COVID-19 vaccine trial underway in United Kingdom.
The inactivated vaccine was jointly researched and developed by Beijing-based National Vaccine and Serum Institute of China National Biotec Group (CNBG), a subsidiary of Sinopharm and National Institute for Virus Disease Control and Prevention, the Chinese Center for Disease Control and Prevention.