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Bharat Biotech Covid vaccine candidate’s human trials from July

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Hyderabad, June 29 : Leading vaccine maker Bharat Biotech on Monday announced that it has successfully developed Covaxin, India”s first vaccine candidate for Covid-19, in collaboration with the Indian Council of Medical Research (ICMR) and National Institute of Virology (NIV) and will begin its human trials next month.

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-3 (Bio-Safety Level 3) High Containment facility located in Genome Valley, Hyderabad, the company said in a statement.

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 preclinical studies, demonstrating safety and immune response.

Human clinical trials are scheduled to start across India next month.

“We are proud to announce Covaxin, India”s first indigenous vaccine against Covid-19. The collaboration with the ICMR and the NIV was instrumental in the development of this vaccine. The proactive support and guidance from the CDSCO has enabled approvals to this project. Our R&D and Manufacturing teams worked tirelessly to deploy our proprietary technologies towards this platform,” said Dr. Krishna Ella, Chairman and Managing Director, Bharat Biotech.

Expedited through national regulatory protocols, the company accelerated its objective in completing the comprehensive pre-clinical studies. Results from these studies have been promising and show extensive safety and effective immune responses.

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It takes 18 months to develop good vaccine: Ex-ICMR chief

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New Delhi, July 4 : A good vaccine usually takes at least 18 months, before it could be rolled out for production after fast-tracking all the mandatory regulatory approvals, said N.K. Ganguly, former director general of Indian Council of Medical Research (ICMR).

It is expected that India”s first indigenous Covid-19 vaccine, Covaxin may be released on August 15 under a fast-track mechanism. According to the government”s top medical research body, a dozen institutes have been selected for clinical trials of the indigenous COVID-19 vaccine (BBV152 COVID vaccine). Ganguly said the strain of the virus was given to BBIL in May end, and in July, human trials have been scheduled.

Elaborating on the lengthy process involved in vaccine development, he insisted that after spending many months and infusing a lot of funds, the uncertainty continues to linger. “It may be difficult to say whether the vaccine is successful or not”, he added.

The ICMR in a letter said, “It is envisaged to launch the vaccine for public health use latest by August 15, after completion of all clinical trials. BBIL (Bharat Biotech International Limited) 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.”

Before the vaccine is tested on humans, challenge studies are done on mice and monkey, then a toxicology report is prepared, to check if the developed vaccine produces harm to cells, and it takes at least three to four months to finalize this report, said Ganguly. After this phase, the vaccine is tested on two rodents and a large animal and after successful completion of this stage the vaccine is ready for human trials.

“In Phase 1, the age group profiling is done (wherein vaccine study is done on people in different age groups). In Phase 2, nearly 600 to 700 people are vaccinated, and if the vaccine performs successfully in this phase then it progresses into Phase 3, which is called the efficacy study (in this phase, thousands of people are enrolled). Even after fast tracking regulatory approvals, it will take at least 18 months to develop a good vaccine”, said Ganguly.

He insisted that the vaccine being developed by Moderna (RNA vaccine is set to begin Phase 3 trials later this month and targets a vaccine by 2021) and BioNTech-Pfizer (Phase 3 trial is expected to begin in July). Gennova biopharmaceutical is also working on a vaccine and it looks positive, Ganguly added.

(Sumit Saxena can be contacted at [email protected])

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Lightning kills 15 more in Bihar

The meteorological department has issued an alert for thunderstorms in more than a dozen districts, including Patna, Bhojpur, Vaishali and Nalanda in the state.

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Lightning

Patna, July 4 : Fifteen more people lost their lives due to lightning amid heavy rain and thunderstorms in seven districts of Bihar in the last 24 hours.

According to the information received from the districts, 15 persons were killed by lightning during the past 24 hours in the state. Of these, six persons died in Vaishali, two in Lakhisarai, three in Samastipur and one each in Gaya, Banka, Nalanda and Jamui districts.

The meteorological department has issued an alert for thunderstorms in more than a dozen districts, including Patna, Bhojpur, Vaishali and Nalanda in the state.

Chief minister Nitish Kumar has appealed to the people to be vigilant and follow the guidelines issued by the disaster management department for protection against lightning in the inclement weather. He suggested that people stay at home and be safe.

On Thursday, 26 persons died due to lightning striking different districts. These included six in Patna, four in east Champaran, seven in Samastipur, three in Katihar, two each in Shivhar and Madhepura and one each in Purnia and west Champaran districts.

Last Tuesday, 11 persons died as lightning fell in various districts of Bihar while on June 26, 96 persons perished as lightning struck different parts of the state.

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Ex-French PM faces probe into COVID-19 response

Philippe’s future as Prime Minister had been in doubt for several weeks and he will now take up the post of mayor in Le Havre, after winning the local vote on Sunday.

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Edouard Philippe

Paris, July 4 : A French court has launched an inquiry into the government”s handling of the coronavirus pandemic, focusing mainly on three senior figures, including former Prime Minister Edouard Philippe, following complaints from unions and doctors.

On Friday, Philippe resigned amid a cabinet reshuffle, reports the BBC.

Hours after Philippe”s resignation, it was announced that the Law Court of the Republic, which deals with claims of ministerial misconduct, would open an inquiry into the way his government handled the pandemic.

Along with thilippe, those under investigation include Agnes Buzyn, who stepped down as health minister in February, and her successor Olivier Veran, senior public prosecutor Francois Molin said on Friday.

Philippe’s future as Prime Minister had been in doubt for several weeks and he will now take up the post of mayor in Le Havre, after winning the local vote on Sunday.

His successor, Jean Castex, 55, is little known in France, but he is a senior civil servant and has played a key role in the government”s response to the COVID-19 pandemic, said the BBC report.

On Friday evening, Castex warned in a speech that “the health crisis is, unfortunately, not over” and that “the economic and social crisis is already here”.

France has so far reported 202,673 confirmed COVID-19 cases and 29,875 deaths.

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