India’s drugs regulator on Friday approved advanced clinical trials for Bharat Biotech’s intranasal Covid-19 vaccine candidate (BBV154), including as a booster dose for those who have been earlier jabbed with either Covaxin or Covishield, according to people familiar with the development.
The trials for the adenovirus vectored vaccine, to be used as a spray to the nose, will be conducted at nine sites across the country with almost 900 participants in all.
The trial sites identified are All India Institute of Medical Sciences, Delhi and Patna (Bihar), Aatman Hopsital, Ahmedabad (Gujarat), Oyster and Pearl Hospitals, Pune, and Acharya Vinobha Bhave Rural Hospital, Wardha (Maharashtra), PGIMS, Rohtak (Haryana), and Prakhar Hospital, Kanpur, and Rana Hospital, Gorakhpur (Uttar Pradesh), and Jeevan Rekha Hospital, Belagavi (Karnataka).
The approval letter, issued to the Hyderabad-based company by the Drugs Controller General of India (DCGI, VG Somani, laid down certain conditions for conducting the trials in the country. HT has seen the approval letter.
The phase 3 trials will be conducted as randomised open label multi-center study to compare immunogenicity and safety of BBV154 with Covaxin.
“Firm should submit the safety data of sufficient duration post second dose. Firm is required to constitute a data safety and monitoring board to review the safety data. The formulation intended to be used in clinical trials shall be manufactured using validated procedures under good manufacturing practices conditions and shall have ongoing stability programme…,” reads the approval letter.
{{/usCountry}}“Firm should submit the safety data of sufficient duration post second dose. Firm is required to constitute a data safety and monitoring board to review the safety data. The formulation intended to be used in clinical trials shall be manufactured using validated procedures under good manufacturing practices conditions and shall have ongoing stability programme…,” reads the approval letter.
{{/usCountry}}Another condition for approval is that the company will be using only Kasauli (Himachal Pradesh) based central drugs laboratory certified batches in the clinical trials.
The company in a statement confirmed the development.
“BBV154 (Nasal covid vaccine) has received approval for phase 3 clinical trials. The trials will evaluate BBV154 nasal vaccine for both the 2 dose primary schedule and booster dose schedule. Intra nasal vaccines are easier to administer in mass immunization campaigns and help reduce / stop transmission,” read the statement.
Suchitra Ella, joint managing director, Bharat Biotech, tweeted, “Covid vaccines are headed for a booster dose( 3rd dose). BBV 154 will be administered as nasal drops instead of a JAB, pain free!!”
Scientists around the world are racing to develop a viable and effective nasal vaccine, which could offer superior protection by creating immunity in the nasal passageway, where the Sars-CoV-2 first takes hold during an infection. Known as mucosal immunity, experts have likened such a protection to “placing guards outside the gates to stop the coronavirus”, as Yale professor Akiko Iwasaki explained while speaking at the Hindustan Times Leadership Summit in December.
Bharat Biotech in a statement added that such vaccines are helpful because they are non-invasive (needle-free), easy to administer and do not require trained health care workers; and are scalable as far as manufacturing is concerned.
In September, 2020, Bharat Biotech had inked a licensing agreement with Washington University School of Medicine in St. Louis for a novel chimp- adenovirus, single dose intranasal vaccine for Covid-19.
In January, last year, the company applied to the central drugs regulator to allow it to start clinical trials in humans.