Trial process for Covid 19 vaccine will not hamper vaccine roll out timing: Dr VK Paul

Days after India's drug controller general asked for more data from three pharma giants before giving them Emergency Use Authorisation (EUA) for their Covid vaccine candidates, Dr VK Paul, chairman of national expert group for vaccine administration said on Tuesday that the the clinical procedure will not affect the timing for vaccine roll out process.

New Delhi: In wake of India's drug controller general asked for more data from three pharma giants before giving them Emergency Use Authorisation (EUA) for their Covid vaccine candidates, Dr VK Paul, chairman of national expert group for vaccine administration said on Tuesday that the the clinical procedure will not affect the timing for vaccine roll out process.

"Application are with the DCGI. It's under examination. It will be ensured that the vaccine is safe and at the same time a final decision will be taken based on science," said Dr Paul who is also a Niti Aayog member. He further said that DCGI has given approval to another domestic pharma giant Gennova for phase I and II human clinical trials of its Covid19 vaccine candidate. "Gennova in collaboration with Department of Bio Technology will roll out the third indigenous Covid19 vaccine. Most interestingly, this vaccine candidate has work efficacy like the Pfizer vaccine candidate," said Dr Paul and added "Gennova vaccine can be stored at a normal temperature." Gennova is a mRNA based vaccine manufacturing platform. It may be mentioned here that Serum Institute of India (SII), Bharat Biotech and Pfizer have applied for EUA of their Covid 19 vaccine. Dr Paul said that vaccines in India will be scientifically approved and there should not be any doubt on their accuracy and effectiveness. "We must have faith on our vaccine. The DCGI will take a call on EUA soon," he said.

Asserting that India's Covid19 status is far better than rest of the world, Dr Paul cautioned that the stability should not be taken for granted. "Looking into the character of Covid19, it is noteworthy to mention that situation can be changed at any moment," said Dr Paul. He said that the situation in Delhi might be under control but a few states like Uttarakhand, Nagaland and Himachal Pradesh still depicts a worrisome picture. When asked about the incidents of fungal infections among Covid19 patients being reported from Delhi, Dr Paul said it (Covid19) is a devastating disease. "We must be alert over any kind of infection as the disease affect all around the body system," said Dr Paul.

Dr VK Paul, chairman of national expert group for vaccine administration said on Tuesday that the the clinical procedure will not affect the timing for vaccine roll out process

Union Health Secretary Rajesh Bhushan, however, said that the central government has chalked out an elaborative arrangements for vaccination in phase wise. The Government has also taken steps to counter adverse events following immunisation (AEFI) of Covid19 vaccine across India. Bhushan said that states and UTs have been asked to identify atleast one AEFI management centres in each block. "States and UTs have already been provided with detailed instructions on infection prevention and control practices during vaccination. The AEFI will also manage minor, severe and serious adverse events," Bhushan said. He said that PHCs, CHCs, DH, private health facilities or any other fixed health facility with medical officers and para medical staff as AEFI management centres. Bhushan said that every immunisation session sites will be linked to a designated AEFI management centre.

Bhushan said that as planned, 30 states and UTs have concluded meetings of state steering committee as well as state task force. In all 633 districts across India have concluded meetings of district task force. "23 ministries and departments of central and state government have been identified and assigned with roles for planning, implementation, social mobilisation, awareness generation etc for vaccine rollout," said Bhushan. Apart from imparting training to the concerned people, the Health Ministry has also issued guidelines for management of cold chain points. Bhushan said that 29,000 cold chain points, 240 walk in coolers, 70 walk in freezers, 45,000 ice-lined refrigerators, 41,000 deep freezers and 300 solar refrigerators will be used for the vaccine process. He said that emphasis has been given for vaccination of security personnel who remain deputed along the border areas.

"Vaccine session will be conducted in unit centres also so that the security officials do not need to walk a long way for vaccination, " Bhushan said. However, giving details of India's Covid 19 situation, Bhushan said that 94 lakh people have been recovered till date with active cases remain only 3.4 lakhs. He said that India has conducted more than 15.5t crore tests till date with cumulative positivity rate upto 6.37 percent. India's Covid cases per million population is 7,178 which is amongst the lowest in the world. India has also reported 150 new cases per million population in last 7 days which is also the lowest in the world. India has also recorded lowest deaths (104) per million population, lowest in the world. Bhushan said that Kerala, Maharastra, Rajasthan, West Bengal and Delhi are the top five states registering highest daily new cases.