COVID-19: Bharat Biotech seeks DCGI's permission to conduct Covaxin booster trials in 2-18 age group
The company has already conducted trials in the age group of 2-18 for two doses of Covaxin
Corbevax, Biological E's COVID-19 vaccine, gets DCGI's emergency use authorisation for children aged 5-12
The DCGI has also given restricted emergency use authorisation to Covaxin, manufactured by Hyderabad based pharmaceutical company - Bharat Biotech, for children between 6 and 12 years
Bharat Biotech has been asked to submit safety data alongwith the data on adverse event with due analysis, every 15 days for the first two months and after that monthly data for up to five months
DCGI expert panel holds meet on recommendations to use Corbevax, Covaxin vaccines for 5-12 age group
India is currently administering two COVID-19 vaccines for children above 12
Hyderabad-based Dr Reddy's Laboratories is the Indian partner of the Russian Direct Investment Fund (RDIF), which has sought approval from the Indian drug regulator for use of single-dose Russia's Sputnik Light one shot
Molnupiravir, developed by US-based biotechnology company Ridgeback Biotherapeutics in collaboration with US pharma giant Merck, was approved for emergency use in India on Tuesday
The vaccine uses an older recombinant protein yeast fermentation technology similar to that used for the recombinant hepatitis B vaccine which has been around for 40 years.
Sickle cell anemia is one of a group of disorders known as sickle cell disease. Sickle cell anemia is an inherited red blood cell disorder in which there aren't enough healthy red blood cells to carry oxygen throughout your body.
Arora said, "Very soon, mRNA vaccine is also coming. Based on international data, it is very encouraging that we can use that for children."
Biological E seeks DCGI approval to conduct Phase 3 trials for Corbevax as booster dose for Covishield, Covaxin
Currently, phase 2/3 trials of the RBD protein sub-unit vaccine is underway and the results are likely to be declared this month.
If approved, the two-dose vaccine will be given to children within 20 days apart.
The paediatric Covaxin is similar to the one administered to adults - two doses of the vaccine given 28 days apart.
Indian drug regulator allows Cadila Healthcare to conduct phase III trials for two-dose COVID-19 vaccine
The company has already received the emergency use authorization from the Drug Controller General of India (DCGI) for ZyCoV-D to be administered in three doses
ZyCoV-D was approved by the country’s apex drug regulator, Drug Controller General of India (DCGI), on August 20. The first indigenously-developed vaccine in India is Bharat Biotech’s Covaxin.
ZyCoV-D, a Plasmid DNA vaccine against COVID-19, will help not only adults but also adolescents in the 12 to 18 years age group, Zydus Cadila said
Earlier news agency PTI had reported that the DCGI has granted permission to Cipla to import Moderna's COVID-19 vaccine for restricted emergency use in the country.
The European Union (EU), United Kingdom (UK) and Canada have not included COVAXIN in their approved list of vaccines as it has not been approved by the WHO
The SII plans to seek restricted emergency use permission of the vaccine in India.
The Pune-based firm has collaborated with Gamaleya Research Institute of Epidemiology and Microbiology in Moscow for developing Sputnik V at its licensed Hadapsar facility
These exemptions have been made in light of the huge vaccination requirements in India in the wake of the recent surge of COVID-19 cases and the need for increased availability of imported vaccines to meet national requirements