New Delhi: Against the backdrop of Serum Institute of India (SII's) vaccine controversy, Union Ministry of Health and Family Welfare (MoHFW) on Tuesday clarified that the issue of the adverse effect of the vaccine will not affect the timeline of trial and rolling out of the vaccine. A volunteer who was administered with the vaccine had alleged that it has caused physical and mental damages.
"Right now this is a Court case, where we would not like to comment. But I would like to reiterate that trial of the vaccine will continue," said Union Health Secretary Rajesh Bhusan in New Delhi. He said that Institutional Ethics Committee (IEC) of the hospital where the volunteer got the vaccination and the Data Safety and Monitoring Board (DSMB) will submit their report on the adverse effects of the vaccine trial to the Drug Controller General of India (DCGI) within a month.
He pointed out that whenever a trial takes place, the volunteer is subjected to sign a consent form which highlights that there could be the possibility of adverse impact and without the sign of the volunteer, he or she cannot undergo vaccine trial."
He said that the vaccine trial is multi-site and multicentric. "The subject get vaccination under proper medical care and it is being monitored by the Institutional Ethics Committee," Bhushan said. He further said that all trial takes place under the clinical trial rule and in case of an adverse effect, the Form 5, need to be submitted to the DCGI by the principal investigator after proper screening of the matter.
"After getting the report from IEC and DSMB, the DCGI takes a final call on such a vaccine trial. The drug regulator also tries to find the direct link between vaccination and the adverse effect, if any," said Bhushan. The findings, however, did not necessitate stoppage of the trial, Bhushan added.
When asked whether Indian Council of Medical Research (ICMR) endorse the Rs 100 crore claim made by SII against the volunteer, Bhusan said that ICMR does not endorse any such claim. On the duration of vaccine roll-out, Bhushan said that normally it takes 8-10 years to roll out a vaccine, but we are trying to cross the time limit and complete the rollout process in 16-18 months.
SII has been conducting phase 2 and 3 human clinical trials. The Bharat Biotech has also been conducting a Phase 3 trial of its vaccine candidate. A similar case of adverse impact took place during Bharat Biotech trial process in August, said Bhushan.
Read: Inspite of controversy SII trial will continue, says IMA Official
ICMR Director-General Dr Balram Bhargava said that adverse effect may take place during the vaccine trial and if the volunteer needs hospitalization then it is a serious event. When asked on the issue of vaccinating all people across India, the Health Secretary reiterated that the Central government has never spoken about vaccinating the entire country.
"It is important that we discuss such scientific issues, based on factual information only," said Bhushan. Echoing the same view, Dr Bhargava said that government's purpose is to break the chain of transmission. "If we take care and break the chain among the high-risk population, we may not go to vaccinate the entire population," said Dr Bhargava.
It may be mentioned here that Health Minister Dr Harsh Vardhan on Monday said that the government is planning to vaccinate 30 crore population after a vaccine gets enrolled. Bhushan said that the National Task Force on Vaccine Administration is examining whether people with antibodies need vaccination or not.
The World Health Organisation (WHO) suggest not to measure antibodies. Bhushan said that all the state governments and Union Territories have been suggested to make a fixed rate for COVID testing and hospital beds for COVID patients.
"We have started producing COVID testing kits which have helped on reducing the proves for testing process. In fact, we are now exporting the testing kits," Bhushan said. Earlier, RT PCR test kits were sold at Rs 1200 and now people get it at Rs 75.
Referring to the situation in the national capital, Bhusna said that whenever required Central Government always extend its help to the Delhi government. He further informed that his Ministry is preparing a guideline on vaccine hesitancy highlighting the issues like the necessity of proper communication, benefits and after-effects of a vaccine "which needs to reach out to the masses."
Meanwhile, Bhushan said that India has conducted 10,55,386 tests on an average on daily basis in November. Similarly, the country was also witnessing 43,152 daily new cases on an average against the recovery number of 47,159 daily on an average.
He said that India has conducted 14.13 crore tests till date with a positivity rate of 6.69 per cent. India also registered 6857 cases per million population which is the lowest in the world. He informed that states like Maharastra, Karnataka, Kerala, Andhra Pradesh and West Bengal have registered a decline in COVID cases during last one month whereas states like Punjab, Himachal Pradesh, Madhya Pradesh, Haryana and Rajasthan have been witnessing rise in COVID cases.
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