Codagenix Inc and India's Serum Institute said on Monday they have received regulatory approval in the United Kingdom to begin an early-stage trial of their single-dose, intranasal COVID-19 vaccine.
The companies said 48 volunteers will be enrolled at three dose levels and expect to begin dosing the trial participants in the first week of January.
UK's Medicines and Healthcare Products Regulatory Agency (MHRA) approved the trial for the vaccine, COVI-VAC, after positive safety data in animal studies.
The vaccine candidate uses Codagenix's Synthetic Attenuated Virus Engineering (SAVE) platform, which works by re-coding genes of viruses into safe and stable vaccines.
COVI-VAC will not need a needle and syringe or ultra-cold storage, the companies said, potentially addressing logistical issues likely faced by other vaccine-makers.
Serum Institute of India, the world's largest vaccine producer by volume, has also partnered with British drugmaker AstraZeneca to conduct trials of its vaccine in India and produce the vaccine candidate if it secures approval.
(Reporting by Vishwadha Chander in Bengaluru; Editing by Krishna Chandra Eluri)
