Categories: Health

Clinical trials begin for Bharat Biotech's Covid-19 vaccine

<p class="p1">Hyderabad-based Bharat Biotech yesterday announced that the Phase-I clinical trials of India's first indigenous Covid-19 vaccine Covaxin began across the country on July 15.</p>
<p class="p1">"This is a randomized, double-blind, placebo-controlled clinical trial on 375 volunteers in India," the company said in a brief statement.</p>
<p class="p1">The leading vaccine maker had announced on June 29 that it successfully developed Covaxin in collaboration with the Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV).</p>
<p class="p1">The SARS-CoV-2 strain was isolated in NIV, Pune, and transferred to Bharat Biotech. The indigenous, inactivated vaccine was developed and manufactured in Bharat Biotech's BSL-3A (Bio-Safety Level 3) High Containment facility located in Genome Valley, Hyderabad.</p>
<p class="p1">The Drug Controller General of India – Central Drugs Standard Control Organisation (CDSCO), Ministry of Health & Family Welfare granted permission to initiate Phase-I and II human clinical trials after the company submitted results generated from pre-clinical studies, demonstrating safety and immune response. The Nizam's Institute of Medical Science (NIMS), Hyderabad is one of the 12 centers selected by the ICMR for the clinical trials.</p>
<p class="p1">The subject enrolment for Phase-I clinical trials at the NIMS began on July 7. There was no clarity on the number of subjects selected at this centre.</p>
<p class="p1">The officials had earlier said that for two days after administering the vaccine, the subjects would be monitored in the ICCU at the NIMS by a team of doctors, after which they would be sent home and monitored through video conference or phone.</p>
<p class="p1">The Phase-I clinical trial would go on for 28 days, after which the ICMR and Drug Controller General of India would accord permission for Phase-II, which will include more subjects.</p>
<p class="p1">Phase-1 would have around 375 subjects across the country and Phase-II, 875.</p>
<p class="p1">In a letter to the selected centers early this month, ICMR Director General Balram Bhargava asked them to fast-track all approvals related to the initiation of the clinical trial.</p>
<p class="p1">"It is envisaged to launch the vaccine for public health use latest by 15th August 2020 after completion of all clinical trials. BBIL is working expeditiously to meet the target, however, the final outcome will depend on the cooperation of all clinical trial sites involved in this project," reads the letter dated July 2.</p>
<p class="p1">While experts raised doubts on the August 15 target, the ICMR defended it, saying its process is in accordance with the globally accepted norms to fast-track vaccine development for diseases of pandemic potential.</p>
<p class="p1">The research body said Bhargava's letter was intended to cut red-tape, without bypassing any necessary process, and speed up recruitment of participants for human trials so that these phases can be completed at the earliest.</p>
<p class="p1">Bharat Biotech had refused to comment on the ICMR's August 15 deadline.</p>.

IANS

Recent Posts

“Prime Minister Narendra Modi is Boss Sahab,” says Fijian PM Sitiveni Ligamamada Rabuka

Prime Minister of the Republic of Fiji, Sitiveni Ligamamada Rabuka, has termed Prime Minister Narendra…

5 minutes ago

La Perouse 25: Indian Navy joins sea phase of multinational exercise to strengthen maritime security in Indo-Pacific

The Indian Navy took part in the sea phase of exercise La Perouse 25 from…

1 hour ago

India welcomes Neutral expert’s decision on Indus waters treaty dispute

India has welcomed the decision of the Neutral Expert on the Indus Waters Treaty, which…

2 hours ago

“People powered initiative”: PM Modi on 10 years of ‘Beti Bachao, Beti Padhao’ movement

Prime Minister Narendra Modi on Wednesday expressed gratitude on the occasion of 10 years of…

3 hours ago

Smriti Irani highlights philanthropy’s role in women-led development at WEF 2025

Union Minister Smriti Irani engaged in discussions with LIM Seok Hui, CEO of Philanthropy Asia…

3 hours ago

US: President Trump reaffirms support for H-1B visas, calls for skilled immigrants to boost economy

US President Donald Trump reaffirmed his stance to support the H-1B visa program, which allows…

4 hours ago