American pharma giant Johnson & Johnson’s Covid-19 vaccine shots, manufactured in India by Hyderabad-based Biological E, are stuck at the country’s apex vaccine testing laboratory in Himachal Pradesh due to pending data, News18.com has learnt.
The batch of around 35 lakh vaccine doses, which arrived at the Central Drugs Laboratory (CDL) in Kasauli over a month ago, are lying at the facility due to confusion over the pending testing parameters that need to be submitted by Biological E.
“A few tests are done to check the infectivity and potency of S protein. Biological E hasn’t conducted those tests yet because they have to do it according to J&J’s standard operating procedure (SOP) which may require a different set of skills and technology transfer,” said a source privy to the development.
“CDL is waiting for Biological E to submit the test results as the Indian lab will conduct tests based on the given references to verify the parameters claimed by the company. Unless they submit the data, the testing at CDL won’t be completed,” the source added.
News18.com’s emails to Biological E and Johnson & Johnson for official comments didn’t elicit a response at the time of publishing this report. The CDL, too, did not comment on the matter.
While the CDL will run tests according to the procedures designed by India’s drug regulation agency, the Central Drugs and Standard Control Organisation (CDSCO), Biological E is said to be following the SOP given by J&J, the original developer of the single-shot Covid-19 vaccine.
Prime Minister Narendra Modi, during the Quad summit last month, had promised to export 80 lakh doses of the vaccine to the US by October.
However, there is no clarity yet whether the vaccine batches undergoing testing at CDL will be used for the vaccination drive in India or for exports. Chances that the doses will be used in the domestic drive are low as the Indian government hasn’t yet resolved J&J’s demand for indemnity.
News18.com had on September 29 reported that the Modi government is likely to initiate fresh round of talks with Johnson & Johnson to find a middle ground on domestic usage and export of its vaccines manufactured by Biological E in India.
According to a senior government official privy to the development, the Centre and the company have to explore a “middle ground".