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Bharat Biotech Gets Emergency Use Authorization For Intranasal Vaccine Against Covid-19
Bharat Biotech International Ltd (BBIL) on Tuesday got emergency use authorisation from the Drugs Controller General of India (DCGI) for its intranasal COVID-19 vaccine, announced Union Health Minister Mansukh Mandaviya. With this, Bharat Biotech's intranasal COVID-19 vaccine will be India's first nasal vaccine for the deadly virus in India. The approval came after the Bharat Biotech completed the third and final trial of the drug, used for… read-more
Tags: Intranasal vaccine, Bharat biotech, Union government, DCGI, EUA
Courtesy: The Free Press Journal
Photo: The New Indian
Bharat Biotech Concluded Phase III Clinical Development
Bharat Biotech International said that controlled clinical studies on participants showed that BBV154 (the intranasal vaccination) was safe, well-tolerated, and immunogenic on August 15. A pre-fusion stabilized spike protein is present in the recombinant replication-deficient adenovirus vector vaccine known as BBV154. Phase I and II clinical studies conducted previously on this vaccine candidate had positive outcomes. BBV154 has been created… read-more
Tags: Bharat biotech, phase iii, clinical development, covid booster dose, Covid-19
Courtesy: ANI
Photo: Twitter
Bharat Biotech Slow Downs Covaxin Production, Releases Statement
Hyderabad-based Bharat Biotech, manufactures of India-made Covaxin, announced to slow down production temporarily. On April 1, the pharma company said, "For the coming period, the company will focus on pending facility maintenance, process, and facility optimisation activities". The decision came after recent WHO post Emergency Use Listing inspection, which emphasized on need of optimization activities. The companies also ensured to be… read-more
Tags: Bharat biotech, Covaxin, Production, WHO, Hyderabad
Courtesy: The Free Press Journal
Photo: Bharat Biotech Website
DCGI Approves Bharat Biotech's Intranasal COVID-19 Vaccine For Phase III Trials
The Drugs Controller General of India on January 28, approved clinical trials of Intranasal vaccine against COVID-19. Manufactured by Bharat Biotech, the phase III trials will be conducted on 5,000 subjects, who are vaccinated with Covishield or Covaxin, in nine Indian states. If successful after evaluation, the Intranasal vaccine will also be used as booster dose, especially when the nation is fighting COVID-19's new variant Omicron and the… read-more
Tags: Bharat biotech, Intranasal vaccine, Drugs Controller General of India, Hyderabad, Booster shot
Courtesy: Money Control
Photo: Hindustan Times
India-Made COVID-19 Vaccines Likely To Get Market Approval With Capped Prices
The two COVID-19 vaccines, Covishield and Covaxin will soon get the regular market approval with capped prices. According to the Drug Controller General of India, the SII and Bharat Biotech urged the DGCI to grant regular market approval for adult population with certain conditions. If approved, vaccines will be available at Rs 275 plus Rs 150 additional charges. Notably, Covaxin and Covishield are available at Rs 1,200 and 780, respectively… read-more
Tags: Covaxin, Covishield vaccine, Bharat biotech, Serum Institute of India, DRUG CONTROLLER GENERAL OF INDIA
Courtesy: Zee News
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No Paracetamol Needed For Children After COVAXIN Dose: Bharat Biotech
The Hyderabad-based Bharat Biotech advised not to give any pain killers, paracetamol or any other drug to children, who took COVID-19 vaccine doses. "No paracetamol or pain killers are recommended after being vaccinated by COVAXIN," said Bharat Biotech in a tweet. Reportedly, mild symptoms, which usually last for 1-2 days, can be resolved without any medication. However, the company also recommended consulting with a physician for medication… read-more
Tags: Covid-19, Paracetamol Tablet, children, Covaxin, Bharat biotech
Courtesy: The Print
Photo: Bharat Biotech Website
DCGI Approves Phase III Trial Of Bharat Biotech's Intranasal COVID-19 Vaccine
The Director Control General of India (DCGI) approved phase III trial of Intranasal COVID-19 vaccine, manufactured by Bharat Biotech. On January 4, the Subject Expert Committee (SEC) of the DCGI, approved the report, following which phase III trail will begin on 5,000 subject, 50% Covishield vaccinated people and 50% COVAXIN vaccinated people. If successful, the Intranasal vaccine will be used as booster shot, especially when nation is facing… read-more
Tags: Bharat biotech, DCGI, Intranasal vaccine, Covid-19, omicron
Courtesy: One India
Photo: Business Standard
DCGI Gives Nod To Bharat Biotech For Administering Covaxin To Kids
Hyderabad-based Bharat Biotech was granted emergency approval to administer the COVID-19 vaccine to kids between the age of 12 to 18 years by the Drug Controller General of India (DCGI), on December 25. Reportedly, the company has further started the regulatory process to make it available on CoWin platform. Biotech's vaccine has become the second vaccine to receive approval after Zydus Cadila's three-dose needle-free vaccine ZyCoV-D in India… read-more
Tags: Covaxin, Bharat biotech, DCGI, approval, kids
Courtesy: Money Control
Photo: The Economic Times
Hyderabad's Bharat Biotech Seeks Phase 3 Trial Of Intranasal Vaccine Booster Shot
Hyderabad based Bharat Biotech, on December 20, sough approval for phase 3 trial of its COVID-19 booster shot. The company urged the DCGI to approve trials for intranasal vaccine against COVID-19, especially amid Omicron scare. "The application has been filed and the company is awaiting approval from the drug regulator," reported PTI. Notably, the company already conducted phase I and phase II trials and submitted a detailed report… read-more
Tags: Intranasal vaccine, Covid-19, Bharat biotech, DCGI, Omicron Strain
Courtesy: The Indian Express
Photo: Hindustan Times
Covaxin Maker Seeks Approval In US For Children Under 18 Years
Bharat Biotech's partner Ocugen on November 6, asked the US Food and Drug Administration (FDA) for the emergency use authorisation of Covaxin for children under 18 years. Earlier the vaccine was granted approval by the World Health Organisation (WHO) for its Emergency Use Listing (EUL). "We are pleased to announce our EUA filing to the US-FDA through our partners-Ocugen,"… read-more
Tags: covid 19, Coronavirus, Covaxin, Bharat biotech, FDA
Courtesy: ANI
