Vaccine war : what is reality ?

Newsmantra — Tue, 05 Jan 2021 06:13:47 +0000

AS the Drug controller of India (DGCI) approval received for 3 vaccine a tug of war intensified between pharma companies and political parties creating more confusion amongst common men. meanwhile the chairman of Bharat Biotech – whose coronavirus vaccine Covaxin has been given “restricted use in emergency situation in public interest” – hit out Monday at critics flagging the lack of Phase III trial data and questioning the drug’s efficacy. “We don’t deserve this backlash,” Dr Krishna Ella said.

Addressing a virtual presser, Dr Ella said his company had carried out “200 per cent honest clinical trials”, had an established track record in producing 16 safe and efficacious vaccines, and was transparent with all data.

“Don’t accuse us of inexperience. We are a global company… have manufactured 16 vaccines. It is not correct to say we are not transparent with data. We conduct clinical trials in many countries, including the UK. The point is we are not an Indian company… but a global one,” he stressed. serum institute CEO Adar Poonawala also raised question on Covaxin and said many questions raised on early approval .

Congress leader SHASHI THAROOR also raised query on twitter . he said

Shashi Tharoor

@ShashiTharoor

The Covaxin has not yet had Phase 3 trials. Approval was premature and could be dangerous.

@drharshvardhan

should please clarify. Its use should be avoided till full trials are over. India can start with the AstraZeneca vaccine in the meantime.

Meanwhile, the Serum Institute of India CEO Adar Poonawalla on Sunday revealed the prices of Covishield and disclosed that his company has fixed two different prices for the vaccine.

Poonawalla announced that COVIDSHIELD price for govt will be rs 250 per dose and the vaccine will be available in the private market for Rs 1,000. According to Poonawalla, Serum’s Covishield is cheaper than the vaccine developed by Pfizer-BioNTech and its transportation is also easy as compared to Pfizer’s vaccine. Poonwalla also said that his company, which is based in Pune, is making 50-60 million doses of the Oxford-AstraZeneca vaccine every month.

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Approval of COVID-19 virus vaccine

Newsmantra — Mon, 04 Jan 2021 04:48:29 +0000

The drug controller of india DGCI has approved two covid vaccine for emergency use in india . in a statement DGCI said The Subject Expert Committee of Central Drugs Standard Control Organisation (CDSCO) met on 1st and 2nd January, 2021 and made recommendations in respect of proposal for Restricted Emergency Approval of COVID-19 virus vaccine of M/s Serum Institute of India and M/s Bharat Biotech as well as Phase III clinical trial of M/s Cadila Healthcare Ltd.

The Subject Expert Committee consists of domain knowledge experts from the fields of pulmonology, immunology, microbiology, pharmacology, paediatrics, internal medicine, etc.

M/s Serum Institute of India, Pune has presented a Recombinant Chimpanzee Adenovirus vector vaccine (Covishield) encoding the SARS-CoV-2 Spike (S) glycoprotein with technology transfer from AstraZeneca/Oxford University. The firm submitted safety, immunogenicity and efficacy data generated on 23,745 participants aged ≥ 18 years or older from overseas clinical studies. The overall vaccine efficacy was found to be 70.42%. Further, M/s Serum was granted permission to conduct Phase-II/III clinical trial on 1600 participants within the country. The firm also submitted the interim safety and immunogenicity data generated from this trial and the data was found comparable with the data from the overseas clinical studies. After detailed deliberations Subject Expert Committee has recommended for the grant of permission for restricted use in emergency situation subject to certain regulatory conditions. The clinical trial ongoing within the country by the firm will continue.

M/s Bharat Biotech has developed a Whole Virion Inactivated Corona Virus Vaccine (Covaxin) in collaboration with ICMR and NIV (Pune), from where they received the virus seed strains. This vaccine is developed on Vero cell platform, which has well established track record of safety and efficacy in the country & globally.

The firm has generated safety and immunogenicity data in various animal species such as mice, rats, rabbits, Syrian hamster, and also conducted challenge studies on non-human primates (Rhesus macaques) and hamsters. All these data has been shared by the firm with CDSCO. Phase I and Phase II clinical trials were conducted in approx.800 subjects and the results have demonstrated that the vaccine is safe and provides a robust immune response. The Phase III efficacy trial was initiated in India in 25,800 volunteers and till date, ~22,500 participants have been vaccinated across the country and the vaccine has been found to be safe as per the data available till date.

The Subject Expert Committee (SEC) has reviewed the data on safety and immunogenicity of the vaccine and recommended for grant of permission for restricted use in emergency situation in public interest as an abundant precaution, in clinical trial mode, to have more options for vaccinations, especially in case of infection by mutant strains. The clinical trial ongoing within the country by the firm will continue.

M/s Cadila Healthcare Ltd., has developed a Novel Corona Virus-2019-nCov-Vaccine using DNA platform technology. The firm initiated Phase-I/II clinical trial in India in more than 1000 participants which is ongoing. The interim data suggests that the vaccine is safe and immunogenic with three doses when administered intradermally. Accordingly, firm has sought permission to conduct Phase-III clinical trial in 26000 Indian participants, which has been recommended by the Subject Expert Committee.

M/s Serum and M/s Bharat Biotech vaccines have to be administered in two doses. All the three vaccines have to be stored at 2-8° C.

After adequate examination, CDSCO has decided to accept the recommendations of the Expert Committee and accordingly, vaccines of M/s Serum and M/s Bharat Biotech are being approved for restricted use in emergency situation and permission is being granted to M/s Cadila Healthcare for conduct of the Phase III .

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Vaccine war : what is reality ?

Approval of COVID-19 virus vaccine