US Pharma giant Johnson & Johnson’s single-shot vaccine against coronavirus has been dispatched for the final round of quality and safety checks at the country’s apex vaccine testing laboratory in Himachal Pradesh, News18.com has learnt. Around 35 lakh doses of the vaccine — which have been manufactured in India by Hyderabad-based vaccine maker, Biological E — have been sent in the first batch, according to an official from the Ministry of Health and Family Welfare privy to the development. “It will take around two to three weeks for testing at CDL (Central Drugs Laboratory),” added the official.
“After completing the testing, the vaccine will be administered to 100 participants first, as mentioned in the rules for foreign vaccines. After analysing those 100 participants for seven days, the regulator will approve the vaccine for national rollout,” the official said.
News18 had on September 9 reported that the vaccine is likely to be ready for a market rollout by next month. On August 7, the vaccine was approved for use in India by the Drug Controller General of India (DCGI), making it the fifth vaccine to get Emergency Use Approval (EUA). In all, six jabs — Covishield, Covaxin, Sputnik V, Moderna, J&J and Zydus Cadila’s ZyCoVD — have been granted EUA in India.
News18 had sent an email to J&J for an official comment in the matter, but there was no response. However, Johnson & Johnson’s India spokesperson had earlier told News18, “Our teams are working round-the-clock to develop and broadly activate our manufacturing capabilities to supply our Covid-19 vaccine.”
“We believe Biological E will be an important part of our global Covid-19 vaccine supply network. While we look forward to meeting our delivery commitments, it is premature for us to speculate on the timing of our vaccine deliveries,” the spokesperson added.
Meanwhile, it is still not clear if J&J would insist on demanding indemnity from the Indian government. If it sticks to its demand, the production by Biological E could be exported instead of being used in India.
Rule for clearance of foreign vaccines
One of the government officials quoted above said that the J&J vaccine — after being checked at CDL, Kasauli — will first be tested on 100 participants for the seven days.
According to the rules, released by the Ministry of Health and Family Welfare on April 13, coronavirus vaccines, which have been developed and are being manufactured in foreign countries — if have been granted emergency approval for restricted use by US-FDA, EMA, UK-MHRA, PMDA-Japan or which are listed in WHO (Emergency Use Listing) — can be granted emergency use approval in India.
The mandatory requirement is of “post-approval parallel bridging clinical trial in place of conduct of local clinical trial as per the provisions prescribed under Second Schedule of the New Drugs & Clinical Trials Rules 2019”.
“Further, the first 100 beneficiaries of such foreign vaccines shall be assessed for seven days for safety outcomes before it is rolled out for further immunisation programmes within the country,” according to a release issued by the central government.