Photo for representation only.
Ambika Sharma
Solan, July 7
Central Drugs Laboratory (CDL) in Kasauli, which is country’s apex drug-testing lab, today cleared the first batch of the oral VXA-CoV2 enteric-coated tablets manufactured by Vaxart, an American biotechnology company.
This will pave way for its phase II clinical trial in the country.
India is part of the company’s global trial, which was launched in the United States in October 2021.
The samples of the oral tablets were received by the lab in February. Since the CDL is a vaccine-testing laboratory, it had initially refused to test this tablet. Higher authorities, however, directed them to test it, as it is an oral tablet-based Covid-19 vaccine. Lab officials said in a bid to test the tablet, they raised with the US-based manufacturer a series of queries regarding testing procedures and providing standing operating procedures.
“Since the information provided in the summary lot protocols adopted in the US varies from the one adopted in India, the information relating to production and testing were procured from the US-based manufacturer. This helped us test the tablet further on various safety parameters,” said Sushil Kumar Sahu, lab director.
“Though the receipt of documents was time-consuming, we had started cell culture testing,” he said.
WHO flags new Omicron sub-variant in India
New Delhi: The WHO has flagged a new sub-variant of Omicron called BA.2.75 in India and some other countries. It said fewer sequences were available, but in preliminary studies the new sub-lineage appeard to have some mutations. World Health Organisation Director-General Tedros Adhanom Ghebreyesus spoke of the sub-variant detection in India yesterday in his weekly press meet. TNS
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