HONG KONG – In the midst of a COVID-19 crisis, India has waived the need for “well-established” foreign vaccines to undergo local trials. That could open doors for vaccines by Pfizer Inc., Johnson & Johnson and Moderna Inc.
HONG KONG – India’s conditional approval on Jan. 3 of a COVID-19 vaccine developed domestically by Bharat Biotech International Ltd. but still in phase III trials has sparked concerns about its safety. The Drugs Controller General of India (DCGI) gave emergency authorization to the product, Covaxin, along with the Astrazeneca plc and Oxford University vaccine Covishield. The DCGI said the conditional approval granting “restricted use in emergency situation” for Covaxin was done in “clinical trial mode” to account for the fact that the shot is still being tested. But the rush to approve it has created controversy and confusion.
NEW DELHI – India is taking a multipronged approach to developing and distributing vaccines against COVID-19, with at least 10 different products under development, domestically or through collaborations with foreign developers. Vaccinations are likely to begin early next year but, with a population of around 1.2 billion, it is unlikely India will be able to vaccinate everybody it needs to before the end of 2022.
Bharat Biotech International Ltd. has successfully developed India’s first indigenous vaccine candidate for COVID-19 to enter human trials. Named Covaxin, the vaccine has been cleared by the Drug Controller General of India (DCGI) and Ministry of Health & Family Welfare for phase I and II trials after the company submitted positive preclinical study results regarding safety and immune response.