News18.com has learned that US pharmaceutical giant Covid-19 vaccine shots, which are made by Hyderabad-based Biological E in India, are stuck in the country’s main vaccine testing laboratory in Himachal Pradesh due to pending data.

The batch of about 35 lakh vaccine doses, which arrived at the Central Pharmaceutical Laboratory (CDL) in Kasauli over a month ago, is dumped at the facility due to confusion about the pending test parameters to be provided by Biological E.

“A few tests are being done to check the infection and efficacy of the S protein. A source familiar with the development said that Biological E has not yet run these tests because they have to do so under J&J’s Standard Operating Procedures (SOP) which may require a different set of Skills and technology transfer.

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“CDL is waiting for Biological E to submit the test results as the Indian laboratory will conduct tests based on the assigned references to verify the parameters claimed by the company. Unless they provide the data, the testing in CDL will not be completed,” the source added.

News18.com’s emails to Biological E and Johnson & Johnson for official comments did not warrant a response at the time this report was published. CDL, too, has not commented on the matter.

While the CDL will conduct tests according to procedures designed by India’s Medicines Regulatory Agency, the Central Drug Control and Standards Organization (CDSCO), Biological E is said to follow the SOP provided by J&J, the original developer of the single-shot Covid-19 vaccine.

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Prime Minister Narendra Modi, during the Quartet summit last month, promised to export 80 doses of the vaccine to the United States by October.

However, there is still no clarity as to whether the vaccine batches being tested at the CDL will be used for the vaccination campaign in India or for export. Chances of using potions in local driving are low because the Indian government has not yet resolved J&J’s request for compensation.

News18.com reported on September 29 that the Modi government is likely to start a new round of talks with Johnson & Johnson to find a compromise over the domestic use and export of vaccines made by Biological E in India.

According to a senior government official familiar with the development, the center and the company should explore a “middle ground.”

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