On Rohith Vemula's death anniversary, his mother vows to fight communal forces

New Delhi, Jul 6: The Indian Academy of Sciences, a Bengaluru-based body of scientists, has said the Indian Council for Medical Research's (ICMR) target to launch a coronavirus vaccine by August 15 is "unfeasible" and "unrealistic".

The IASc said while there is an unquestioned urgent need, vaccine development for use in humans requires scientifically executed clinical trials in a phased manner.

While administrative approvals can be expedited, the "scientific processes of experimentation and data collection have a natural time span that cannot be hastened without compromising standards of scientific rigour", the IASc said in a statement.

In its statement, the IASc referred to the ICMR's letter which states that "it is envisaged to launch the vaccine for public health use latest by 15th August 2020 after completion of all clinical trials".

The ICMR and Bharat Biotech India Limited, a private pharmaceutical company, are jointly developing the vaccine against the novel coronavirus -- SARS-CoV-2.

The IASc welcomes the exciting development of a candidate vaccine and wishes that the vaccine is quickly made available for public use, the statement said.

"However, as a body of scientists including many who are engaged in vaccine development IASc strongly believes that the announced timeline is unfeasible. This timeline has raised unrealistic hope and expectations in the minds of our citizens," it said.

Aiming to launch an indigenous COVID-19 vaccine by August 15, the ICMR had written to select medical institutions and hospitals to fast-track clinical trial approvals for the vaccine candidate, COVAXIN.

Experts have also cautioned against rushing the process for developing a COVID-19 vaccine and stressed that it is not in accordance with the globally accepted norms to fast-track vaccine development for diseases of pandemic potential.

The IASc said trials for a vaccine involve evaluation of safety (Phase 1 trial), efficacy and side effects at different dose levels (Phase 2 trial), and confirmation of safety and efficacy in thousands of healthy people (Phase 3 trial) before its release for public use.

Clinical trials for a candidate vaccine require participation of healthy human volunteers. Therefore, many ethical and regulatory approvals need to be obtained prior to the initiation of the trials, it added.

The IASc said the immune responses usually take several weeks to develop and relevant data should not be collected earlier.

"Moreover, data collected in one phase must be adequately analysed before the next phase can be initiated. If the data of any phase are unacceptable then the clinical trial is required to be immediately aborted," it said.

For example, if the data collected from Phase 1 of the clinical trial show that the vaccine is not adequately safe, then Phase 2 cannot be initiated and the candidate vaccine must be discarded.

For these reasons, the Indian Academy of Sciences believes that the announced timeline is "unreasonable and without precedent", the statement said.

"The Academy strongly believes that any hasty solution that may compromise rigorous scientific processes and standards will likely have long-term adverse impacts of unforeseen magnitude on citizens of India," it said.

Lucknow, Feb 14: Uttar Pradesh doctor Kafeel Khan was on Friday booked under the National Security Act (NSA) over his alleged anti-CAA speech at Aligarh Muslim University on December 12, 2019.

The Uttar Pradesh slapped NSA on Kafeel Khan on Friday even as the doctor waited to be released from jail despite being granted bail on Monday in connection with his alleged inflammatory speech.

SP Crime Dr Arvind said that there were sufficient grounds to book the doctor under NSA.

The suspended pediatrician, Kafeel Khan, was arrested for allegedly delivering a controversial speech during Anti-CAA protests on December 12 at the Aligarh Muslim University or AMU. While he was granted bail on Monday, his family members claimed on Thursday that he was yet to be released.

Dr Kafeel Khan's brother Adeel Ahmed Khan had issued a statement saying that despite being granted bail Mathura jail authorities had not honoured the court's order.

Dr Kafeel Khan was arrested by the UP Special Task Force from Mumbai on January 29 for participating anti-CAA protest at AMU. A case was registered against him at the Civil Lines police station here for promoting enmity between different religions.

After his arrest in Mumbai, Dr Khan was brought to Aligarh, from where he was shifted to the district jail in neighbouring Mathura.

According to police, this was done as a precautionary measure in view of the anti-CAA protests on the AMU campus and at the Eidgah grounds in the old city. Police had said that the Dr Khan's presence in the Aligarh jail could have aggravated the law and order situation in the city.

The doctor was earlier arrested for his alleged role in the death of over 60 children in one week at the BRD Medical College in Gorakhpur in August 2017. Short supply of oxygen at the children's ward was blamed at that time for the deaths.

About two years later, a state government probe cleared Khan of all major charges, prompting him to seek an apology from the Yogi Adityanath government.

New Delhi, Jun 25: After the Drug Controller General of India (DCGI) given its approval to manufacture and market the generic version of COVID-19 drug Remdesivir, COVIFOR, Hyderabad-based drugmaker Hetero Limited has delivered the first set of 20,000 vials in two equal lots of 10,000 each across 5 states.

The first batch, which is being marketed under the brand name of COVIFOR, was delivered to Maharashtra, Delhi, Gujarat Tamil Nadu and Hyderabad. Hetero has set a target to produce one lakh vials of the drug in two-three weeks.

The other lot would be supplied to Kolkata, Indore, Bhopal, Lucknow, Patna, Bhubaneshwar, Ranchi, Vijayawada, Cochin, Trivandrum and Goa within a week to meet the emergency requirements.

Managing director of Hetero Healthcare M Srinivasa Reddy said “the launch of Covifor in the country is a milestone in addressing public health emergencies. Through Covifor, we hope to reduce the treatment time of a patient in a hospital thereby reducing the increasing pressure on the medical infrastructure overburdened ue to accelerating COVID-19 infection rates," he said as reported by news agency.

"We are closely working with the government and the medical community to make Covifor quickly accessible to both public and private healthcare settings across the country”, Reddy said.

Covifor is a generic brand of Remdesivir which is used for the treatment of COVID-19 in adults and children hospitalised with strong symptoms of the disease. The Health Ministry had, on June 13, recommended the use of anti-viral drug Remdesivir in moderate stage of COVID-19.

Dr Reddys Laboratories and Hetero are among others which have separately entered into non-exclusive licensing agreements with the original drug-maker Gilead Sciences Inc to register, make and sell the investigational drug Remdesivir in India and other countries.

Remdesivir would be made in the company's formulation facility in Hyderabad, which has been approved by global regulatory authorities such as US Food and Drug Administration (USFDA) and EU, among others, Hetero had earlier said.

The treatment first showed improvement in trials on coronavirus patients and was approved for emergency use in severely ill patients in the United States and South Korea.