The Phase-2 trials of the Oxford University vaccine for Coronavirus begin in India on Wednesday. The first doses will be given to six volunteers at Pune’s Bharati Vidyapeeth medical college and hospital. The vaccine, developed in collaboration with AstraZeneca, is believed to be the most promising. It is in phase-3 trials in some countries.
Indian rules require a vaccine to be tested within the country. Pune’s Serum Institute of India, which has an agreement with AstraZeneca to produce and market the vaccine, has initiated human trials. Both phase-2 and phase-3 trials would take place in India. Phase-1, during which the vaccine’s safety is assessed, is not mandatory to be repeated in India.
The phase-2 trials will take place at two more locations, at the KEM Hospital in Mumbai and PGI, Chandigarh. More hospitals would be involved in phase-3 trials, during which the vaccine’s efficacy to protect the volunteers from the disease in reallife situations, is assessed. In phase-3, the vaccine is tried on thousands of volunteers. Since these tests are only being repeated in India, a total of 1,600 volunteers are likely to be administered the vaccine during the phase-2 and phase-3 trials.
Meanwhile India has said talks are on over the possibility of bringing the Russian vaccine, Sputnik-V.
“India and Russia are in communication. Some initial information has been shared,” said Health Secretary Rajesh Bhushan.
Russia has said that India is one of the countries where the vaccine could be manufactured. It is not yet clear if these talks have progressed.
Sputnik-V is the first to be authorized for general use, but experts have expressed doubts because of the speed with which it was developed, without going through phase-3 human trials.
In another releated development, a top US expert on infectious diseases, Anthony Fauci, has spoken against granting emergency use authorisations to the Corona vaccines.
His comments came amid reports that President Trump was ready to granting emergency use authorization to at least one leading vaccine candidate ahead of the November 3 presidential election. The availability of a vaccine could boost Trump’s prospects as he is seeking a re-election.
Meanwhile, the Food and Drug Administration (FDA), the US drug regulator, has rejected Trump’s charge that a “deep state” within the agency was deliberately slowing down the development of vaccines.
Trump had recently claimed that this “deep state” with the FDA was working to sabotage his re-election bid.