Scientists have criticised India for rushing to approve the new crown vaccine in the absence of effectiveness data

India's drug regulator on January 3 authorized Covaxin, india's Bharat Biotech, to develop the coVID-19 vaccine, without waiting for the results of a Phase III trial to be determined, prompting harsh criticism from some scientists and patient advocacy groups, according to a recent article on the website of the journal Science.
at a news conference on Sunday, VG Somani, head of India's General Administration of Medicines (DCGI), said that while Covaxin's effectiveness studies were still recruiting participants, he had approved the vaccine as a "substantial precautionary measure" in case there was a need to curb the spread of a new strain of the highly contagious coronavirus.
Somani said Covaxin and another vaccine, the Indian version of the vaccine developed by Oxford University and AstraZeneta, had been approved for "controlled use" in an emergency and its manufacturers would continue clinical trials already under way.
Vineeta Bal, an immunologist at India's National Institute of Immunology, said it was "unreasonable" to approve a vaccine without Phase III data.
Gagandeep Kang, a microbiologist at the Welor Christian Medical School in India and a member of the International Alliance for Epidemiological Prevention and Innovation (CEPI), said the approval also appeared to ignore guidelines from india's Central Drug Standards Control Organization (CDSCO), which requires a vaccine manufacturer to prove a minimum protection of 50 percent in Phase III trials to approve the vaccine.
CDSCO is led by Somani, "they provide guidance and then don't follow the guidelines they've developed."
I don't know why they did it.
," the AstraZeneum/Oxford-developed vaccine, produced by the Indian Serum Institute (SII), is supported by Phase III data from studies conducted in Brazil and the United Kingdom.
but the All India Drug Action Network, a patient rights group, said approval of the vaccine was also rushed.
CDSCO guidelines require sII to conduct bridging studies that show that the original AstraZenecom vaccine can trigger a scalable immune response in the Indian population, and the Panel recommends that CDSCO approval of Covishield should depend on the results of the bridging trial.
experts say such trials are necessary because some vaccines, such as those for polio and typhoid, have proven to be less immunogenic in India than in the West.
, the data from the SII study have not been fully analyzed.
India's Ministry of Health and Family Welfare said it planned to vaccinate a quarter of the population by August, starting with medical staff and other front-line workers.
, a member of India's COVID-19 National Task Force, said SII's vaccine is expected to play a key role in the program, which has pledged to provide 100 million doses of vaccine per month by February.
, Covaxin is expected to be a "back-up" vaccine if India faces a surge in cases due to a variant of the virus in the UK.
, critics say it's unclear why regulators are so eager to approve Covaxin.
first applied for regulatory approval in the first week of December 2020, less than a month before it began recruiting Phase III trial participants.
The study's recruitment has been slow, and the company says it has recruited 22,500 of the 25,800 participants so far, of whom 6,000 have received two injections (it's not clear if this includes placebo subjects), meaning the study is not even up to the point where in-period effectiveness analysis can be performed.
a news conference Monday, Krishna Ella, Bharat's chairman and general manager, said it was not uncommon to urgently approve the COVID-19 vaccine before the Phase III data.
he cited Russia's Sputnik V and China's national drug-developed vaccine.
stressed that the safety of all vaccinators would be monitored (as would fully licensed vaccines).
he doesn't care about safety, saying that unlike the mRNA vaccines produced by Pfizer/BioNTech and Moderna, Bharat's inactivated all-virus approach has a long history of safe use.
added that data on the effectiveness of the Rhesus Monkey Challenge study and an immune response from a human Phase II trial suggested that the vaccine could be very effective.
, Kang says that despite proven technology, there are still questions about Covaxin's security.
admixol (the component that enhances the immune response) is a mixture of aluminum hydroxide and a derivative of methasium that has never been used in an approved vaccine.
" I don't think anyone can guarantee that there will be no adverse effects when thousands of people are vaccinated , " she said .
" in addition, the company can not rule out the possibility that the vaccine makes the disease worse rather than protected from it, a rare phenomenon in several other vaccines.
important , scientists have not been able to reliably predict the effectiveness of the vaccine based on the immune response measured in the Phase II trial .
scientists are concerned that CDSCO's hasty approval of the vaccine could undermine public trust.
some argue that India is not in a good enough state to skip the Phase III test.
number of new confirmed cases in the country has fallen for three weeks in a row.
John , an epidemiologist at the Weylor Christian Medical School , said it remains to be seen whether a variant of the virus in the UK will cause a large-scale second wave of epidemics .
, "Is it worth rushing to approve vaccines that are not fully masted?" he asked. "Knowledge-Acorn