Johnson and Johnson’s (J&J) single-dose COVID-19 vaccine was on Saturday given approval for Emergency Use Authorisation (EUA) in India, making it the 5th COVID vaccine to get the clearance in the country.
The exact road map for making the vaccine available in Indian markets is still under discussion, confirmed Health Ministry officials. Responding to a specific query by The Hindu on the vaccine availability timeline Johnson & Johnson India spokesperson said: "While we look forward to meeting our delivery commitments it is premature for us to speculate on the timing of our vaccine deliveries.”
Union Health Minister Mansukh Mandaviya in a tweet announced that EUA had been granted to the vaccine and that India now had five EUA vaccines.
Drugs Controller General of India (DCGI) had allowed the emergency use of Covishield, Covaxin, Sputnik V and Moderna vaccines.
Earlier this week, NITI Aayog member (Health) Dr. V.K. Paul said the “Indian government is still in talks with Moderna and Pfizer on the indemnity issue to allow their vaccines into India. Moderna’s vaccine had earlier received the EUA, but is still not available in India.’’
J&J India spokesperson declined to speculate on the timing of their vaccine deliveries.
The Health Ministry has maintained that it is continuously working towards ensuring increased supply of COVID-19 vaccines and in a response given in the Lok Sabha during this session maintained that “COVID-19 vaccination protects from severe manifestation of disease and improving herd immunity and is accordingly likely to mitigate the impact COVID-19 may have with any future resurgence. Vaccines currently being utilized for immunization offer substantial protection again COVID-19 besides reducing severity of disease, hospitalization and deaths.’’
Handholding of makers
The Ministry stated that in order to improve vaccine accessibility, the manufacturers were being provided requisite handholding to increase production and newer vaccines were also being planned to be included in the immunisation activities, which will further improve the availability.
It further said the Central Drugs Standard Control Organisation (CDSCO) had granted permission to conduct the phase I clinical trial of intranasal adenoviral vector COVID-19 vaccine (BBV154) (in the age group of 18 and above) to Bharat Biotech International Limited, Hyderabad. Also so far as injectable vaccine for children was concerned, the CDSCO had granted permission to conduct clinical trials of vaccines in children to -- Phase II/ III clinical trial to Bharat Biotech, Hyderabad (in the age group of 2 to 18) for Whole-Virion Inactivated SARS-CoV-2 Vaccine and Phase III clinical trial to Cadila Healthcare Ltd., Ahmedabad (in the age group of 12 yrs and above) for DNA-based vaccine.
“The outcomes of the clinical trials depend on data emerging from the trial for the purpose of its approval for launch in the country. Further, the CDSCO has not granted permission to conduct clinical trial of any imported COVID-19 vaccine on children in the country,’’ the Ministry noted.