Coronavirus | Serum Institute seeks emergency permission for Covishield in India

On Sunday, the Indian Serum Institute (SII) was the first to apply to the Indian Drug Controller General (DCGI) for an emergency permit for the Oxford COVID-19 vaccine in the country because of unmet medical needs due to a pandemic. It became an indigenous company. According to official sources, for the benefit of the general public.

One day ago, Indian Arm, a major US pharmaceutical company Pfizer became the first company to seek similar approval After securing such approvals in the UK and Bahrain, from India’s own COVID-19 vaccine drug regulator.

In addition to clinical trials, the Oxford COVID-19 vaccine Covishield is undergoing Phase 3 clinical trials in various parts of the country by the Pune-based SII co-sponsored by the Indian Medical Research Council (ICMR). .. A study conducted by Oxford-AstraZeneca in the United Kingdom and Brazil.

Based on the results of Phase 2 and Phase 3 clinical trials, SII will seek early availability of vaccines for India with the help of ICMR, the National Institute of Health Research said last month.

According to ICMR, SII has already produced 40 million doses of vaccine under a risky manufacturing and stockpiling license obtained from DCGI.

Read again: COVISHIELD completes registration for Phase 3 clinical trials in partnership with ICMR and SII

According to official sources citing the SII application, the company has data from four clinical studies (two in the UK and one in Brazil and India), with Covishield being symptomatic and most importantly severe COVID-19. It states that it shows that it is very effective against infection.

The results are consistent with other anti-coronavirus vaccines, and the burden of the disease is high, so Covishield is predicted to reduce the substantial mortality and morbidity of COVID-19, the company said.

“From a safety standpoint, Covishield was well tolerated for the requested adverse events and was not associated with increased SAE and mortality. Most of the requested reactions were mild in severity. , Solved without sequelae.

Read again: Vaccination is “painless,” according to Covishield trial volunteers

“Therefore, Covishield is safe, well tolerated and can be effectively used to prevent COVID-19 in the target population. Therefore, the ratio of benefit to risk strongly supports the widespread use of Covishield.” Said the source, citing the application.

To introduce a vaccine against COVID-19, which is in urgent need in India, SII, the world’s largest vaccine maker, is working with Oxford University and AstraZeneca to produce the vaccine.

The SII also submitted 12 batches of vaccine to the Central Pharmaceutical Research Institute (CDL) in Kasauli for testing, sources said.

“In line with our philosophy, for the COVID-19 vaccine, we also made our country” aatmanirbhar “(independent), the Prime Minister’s” local voice “and” India for the world. ” The application, signed by Prakash Kumar Singh, SII’s additional director of government and regulatory issues, states.

Given all these facts and the unmet medical needs for the benefit of the general public to save millions of people in the country and around the world, early availability of a vaccine against COVID-19 is needed. Said.

“Therefore, for the national interest, based on our application, and in view of the urgent need for a safe, effective, programmatically appropriate and affordable vaccine for our country, an emergency permit for Covishield. I ask you to give me, “read the application.

According to sources, the vaccine can be stored at 2-8 degrees Celsius, the ideal temperature for refrigerated domestic storage, making it logistically feasible for distribution in both urban and rural areas.

In response to rapid regulation, DCGI agreed with SII on August 2 to conduct a human clinical trial combining Phase 2 and Phase 3 of the Oxford COVID-19 vaccine in Japan.