Department of Science and Technology Secretary Fortunato dela Peña
(TOTO LOZANO / Presidential Photo / MANILA BULLETIN FILE PHOTO)
DOST Secretary Fortunato dela Peña said the Indian biotechnology company has yet to submit the requirements for clinical trials amid its recent signing of a Confidentiality Disclosure Agreement (CDA) with the Task Group on Vaccine Evaluation and Selection.
“A CDA with Bharat Biotech for their clinical trial in the Philippines was recently signed. Submission of their requirements for clinical trial is being awaited which will be evaluated by the Vaccine Expert Panel and Ethics Board before it is given to FDA for approval,” he told the Manila Bulletin.
India has clocked more than 100 cases of the UK variant.Work on vaccines will have to continue on parallel tracks, say experts as they map the future course of the infection
The Straits Times
Covaxin or Covishield? A dilemma for India s healthcare workers
A sanitation worker waits to receive a dose of Bharat Biotech s Covaxin at a hospital in New Delhi, on Jan 16, 2021.PHOTO: REUTERS
https://str.sg/JKBE
They can read the article in full after signing up for a free account.
Share link:
Or share via:
Sign up or log in to read this article in full
Sign up
All done! This article is now fully available for you
Read now
Get unlimited access to all stories at $0.99/month for the first 3 months.
Get unlimited access to all stories at $0.99/month for the first 3 months.
Covax firms urge DCGI to change fact sheet on blood thinners: ICMR chief ANI | Updated: Jan 28, 2021 23:39 IST
New Delhi [India], January 28 (ANI): India s drug regulatory body has received requests from both Pune based Serum Institute of India and Hyderabad-based Bharat Biotech to make necessary changes in the vaccine fact sheet to allow people using blood thinners to get inoculated against Covid-19, Indian Council of Medical Research (ICMR) said on Thursday.
The Drugs Controller General of India (DCGI) has given restricted emergency use approval to SII s vaccine Covishield and Bharat Biotech s Covaxin. There is no contraindication in administering COVID-19 vaccines to those who on blood thinners such as Aspirin and Clopidogrel. Both the pharma companies have written to the DCGI regarding changing this point and that will happen very soon, Dr Balram Bhargava, Director General of Indian Council of Medical Research (ICMR) said.
Bharat Biotech Covaxin Can Neutralise UK Variants Of COVID-19: Study Jan 27, 2021, 17:23 IST
Covaxin - vaccine developed by Hyderabad-based Bharat Biotech is said to be effective against UK variants of COVID-19, according to a study titled Neutralization of UK-variant VUI-202012/01 with COVAXIN vaccinated human serum , after research conducted on 26 participants, shared by the company on Wednesday.
The findings published in an article - Neutralization of UK-variant VUI-202012/01 with Covaxin vaccinated human serum - on the website of bioRxiv, which said these are preliminary reports that have not been peer-reviewed. A comparable neutralization activity of sera of the vaccinated individuals showed against UK-variant and the heterologous strain with similar efficiency, dispel the uncertainty of possible neutralization escape, the article said.