Northlines Correspondent
New Delhi, Jan 01 : A day ahead of the nationwide Covid-19 vaccination dry run, the Indian drug regulator’s expert panel on Friday cleared the decks for emergency use authorisation for the vaccine developed by AstraZeneca and Oxford University. The vaccine, which is being produced locally under the name of Covishield by Serum Institute of India, will now be given the final go-ahead by DGCI.
An expert panel on COVID-19 of the Central Drugs Standard Control Organisation (CDSCO) is set to recommend granting emergency use authorisation for the Oxford COVID-19 vaccine Covishield, being manufactured by Serum Institute of India, sources said on Friday.
The Pune-based Serum Institute of India (SII), the world’s largest vaccine man
ufacturer, has tied up with AstraZeneca to manufacture Covishield.
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Wednesday had approved the COVID-19 vaccine developed by scientists at Oxford University and produced by AstraZeneca for human use.
The Subject Expert Committee (SEC) on COVID-19 of the CDSCO, which had earlier sought additional safety and immunogenicity data from SII, deliberated on its application seeking emergency use authorisation (EUA) for the shots on Wednesday, and met again on Friday to review the matter.
After SII’s application, the SEC has started reviewing the EUA application by Bharat Biotech for its COVID-19 vaccine Covaxin but is yet to take a final decision on the matter, sources said.
“In terms of safety, Covishield was well tolerated with respect to solicited adverse events…majority of solicited reactions were mild in severity and resolved without any sequelae.
“Therefore, Covishield is safe and can be used effectively for prevention of COVID-19 in the targeted population. Thus, the benefit to risk ratio strongly supports the widespread use of Covishield,” the EUA application signed by Prakash Kumar Singh, Additional Director, Government and Regulatory Affairs at Serum Institute of India (SII), had stated.
SII had applied to the Drugs Controller General of India (DCGI) for EUA for Oxford COVID-19 vaccine on December 6, while the Hyderabad-based Bharat Biotech had sought the nod for its indigenously developed Covaxin on December 7.
Pfizer had applied for regulatory approval for its vaccine on December 4.
- Vaccination to start soon across J&K
Jammu Tawi, Jan 01
The Jammu and Kashmir government said on Friday that the vaccination drive will soon start in the Union Territory and during the first phase around 2.8 million identified people will be vaccinated.
The details in this regard were shared in a meeting of Union Territory Level Adverse Events Following Immunization (AEFI) regarding COVID-19 vaccination programme chaired by Financial Commissioner, Health and Medical Education, Atal Dulloo on Friday.
The meeting, he said, was also attended by the representatives of J&K Police, National Health Mission, J&K, Health Officers of Jammu Municipal Corporation and Srinagar Municipal Corporation besides other concerned officers.
According to the official spokesperson, State Immunization Officer, Dr Qazi Haroon, gave a detailed presentation about the development and the current stage of COVID-19 vaccine in the country.
“He informed the meeting that a vaccine is expected to be introduced shortly for which two doses would be administered and the second dose to be administered after 28 days of first dose,” he said.
Regarding vaccination of the population and target groups, Haroon, as per official spokesperson said that a phase-wise strategy will be incorporated wherein health care workers have been identified followed by frontline workers of seven lakh population, adding that it would be followed by high risk population consisting greater than 50 years of age and less than 50 years of age associated with comorbid conditions.
“He said in Phase-I, a total of around 28 lakh (2.8 million) population have been identified for the COVID-19 vaccination across Jammu and Kashmir,” he said, adding “He added that detailed instructions on infection prevention and control practices during vaccination and management of minor, severe, serious AEFI would be issued. He also informed the meeting that a detailed strategy has been chalked out and a requisition for deep freezers and other equipment has already been sent to the Government of India.
Dulloo, as per the official spokesperson asked tertiary care hospitals viz SKIMS, Soura and eight GMCs of J&K to make a provision for a dedicated ward in their hospitals during vaccination session so that if any AEFI surfaces it would be resolved with timely intervention.
“He also asked them to follow all the AEFI Standard Operating Protocols so that no shortcoming would remain during the process. He asked them to ensure streamlining of the system in their respective domains with respect to drugs, equipment and other requirements,” he said.
