A locally produced coronavirus vaccine named COVAXIN, which is supposed to be a replacement to the AstraZeneca/Oxford injection was recommended for emergency use by India’s drug regulator on Saturday.
Bharat Biotech, a company based in Hyderabad, with funding from the state-run Indian Council of Medical Research, has developed COVAXIN (ICMR).
Not much is known about COVAXIN’s protection and efficacy. The company claims to have sent all the details to the drug regulator. At a news conference on Sunday, when its formal approval is likely to be announced, the head of India’s drugs regulator is expected to share information about it.
Here are several big COVAXIN-related developments:
- June 30, 2020– COVAXIN has been approved for human trials by the Drugs Controller General of India (DGCI), making it the first domestic vaccine candidate in the country.
- July 3: In a leaked letter, an official at ICMR, India’s top clinical research agency, says it envisages launching a coronavirus vaccine by 15 August, India’s independence day, leading to concerns about the short timeline from some health experts. Bharat Biotech shares its goal of manufacturing up to 300 million doses of the vaccine on the same day if its trials are successful.
- July 4: ICMR states that its decision to create a possible coronavirus vaccine rapidly is in line with international standards.
- Oct 23: Bharat Biotech says it has shown an interest in its vaccine candidate in talks with more than 10 countries. It says the vaccine was discovered to be effective in phase 1 and 2 trials.
- Nov 1: Bharat Biotech says that in the second quarter of 2021 it is preparing to introduce the vaccine.
- Nov 16 – Bharat Biotech says it is starting phase III trials.
- Nov 20 – Bharat Biotech proposes a vaccine to Brazil and a potential collaboration for technology transfer.
- December 5: Haryana Health Minister Anil Vij, who received a trial dose of Bharat Biotech’s COVID-19 vaccine, Covaxin, at a hospital in Ambala on November 20, tested positive for Coronavirus. Vij was admitted to Ambala Civil Hospital. All those who came into close touch were recommended to screen for the virus.
- December 7: Bharat Biotech seeks COVAXIN emergency use approval.
- December 22: Ocugen Inc, a US-based drug developer, says it has partnered with Bharat Biotech to co-develop a candidate for the US market for vaccines.
- 2 January: Indian drug regulator experts approve the vaccine “for restricted use in an emergency situation in the public interest as an abundant precaution, in clinical trial mode, especially in the context of infection by mutant strains.
- January 3: Vaccines from the Serum Institute of India and Bharat Biotech have been given permission by the Drugs Controller General of India for restricted use in an emergency situation. Prime Minister Narendra Modi praised the efforts of the scientific community to improve the lethal corona vaccine.
A decisive turning point to strengthen a spirited fight!
DCGI granting approval to vaccines of @SerumInstIndia and @BharatBiotech accelerates the road to a healthier and COVID-free nation.
Congratulations India.
Congratulations to our hardworking scientists and innovators.
— Narendra Modi (@narendramodi) January 3, 2021
Bharat Biotech says it has recruited 23,000 volunteers for an ongoing Phase 3 COVAXIN trial in India, which began in mid-November, from its target of 26,000. It is the largest Phase III efficacy study performed in India for any vaccine.
