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Namrata Shirodkar lauds drive-in vaccination centres in Mumbai, Bhopal

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Namrata Shirodkar lauds drive-in vaccination centres in Mumbai, Bhopal

Actress Namrata Shirodkar on Wednesday lauded the drive-in vaccination centres in Bhopal and Mumbai, saying it is a super cool initiative that will help senior citizens and the differently-abled to get their vaccines.

Namrata posted two pictures on Instagram, featuring drive-in vaccination facilities in the cities.

“Drive-in vaccination centers in Bhopal and Mumbai.. a super cool initiative helping senior citizens and the differently abled get their shot in a car. Requesting all the other state governments to have this implemented. Vaccination is the only way out of this crisis! #GetVaccinated,” wrote Namrata as caption, with three folded hand emojis.

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Pfizer in talks with India over expedited approval for COVID-19 vaccine

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Pfizer in talks with India over expedited approval for COVID-19 vaccine

Global pharma major Pfizer is discussing with the Indian government an expedited approval pathway to make Pfizer-BioNTech vaccine available for use in the country, the company’s Chairman and CEO Albert Bourla said on Monday. CEO also announced a donation of medicines worth more than $70 million.

Earlier in April, Pfizer said that it had offered a not-for-profit price for its vaccine for the government immunisation programme in India and it remains committed to continuing engagement with the government to make the vaccine available in India.

“Pfizer is aware that access to vaccines is critical to ending this pandemic. Unfortunately, our vaccine is not registered in India although our application was submitted months ago. We are currently discussing with the Indian government an expedited approval pathway to make our Pfizer-BioNTech vaccine available for use in the country,” Bourla said in a mail sent to Pfizer India employees that he has shared on his LinkedIn post.

Pfizer has earlier said that, during the pandemic phase, it will supply the Pfizer-BioNTech COVID-19 mRNA vaccine only through government contracts.

The Indian government last month allowed emergency use approval of the imported vaccines in India which have been granted emergency approval for restricted use by the United States Food and Drug Administration (USFDA), European Medicines Agency (EMA), UK Medicines and Healthcare products Regulatory Agency (UK MHRA), Pharmaceuticals and Medical Device Agency (PMDA) Japan or which are listed in WHO (emergency use listing).

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55 lakh people to get Covid vaccine in Telangana from March 1

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55 lakh people to get Covid vaccine in Telangana from March 1

Health authorities in Telangana are making arrangements to administer Covid-19 vaccine to 55 lakh people under the third phase of vaccination from March 1.

With the Centre giving green signal for Covid vaccine for people above 60 years of age and those above 45 with comorbidities, the health department started making arrangements for administering the shot to beneficiaries in these two groups.

The health officials estimate that there are around 45 lakh people who are above 60 years old and about 10 lakh people in 45-60 age group with co-morbidities in the state.

The department has decided to set up 1,500 centres across the state to cover both the target groups.

The authorities had initially worked out plans to vaccinate about 75 lakh people including 3.5 lakh healthcare employees, 2.5 lakh employees of various frontline departments, 65 lakh people who are above 50 years and four lakh in 18-50 age group with comorbidities.

However, with the Centre making some changes like vaccinating people above 65 years of age and those in 45-60 age group with comorbidities, the overall number of beneficiaries came down by 14 lakh.

Telangana currently has six lakh doses of the vaccine and the health department expects to receive another 10 lakh in next couple of days.

Officials said the vaccine will be administered at all government hospitals and 230 private hospitals linked with Arogyasri Trust. In addition, 1,000 primary health centres in rural and urban areas and Basti Dawakhanas will also serve vaccination centres.

The beneficiaries can register themselves on COWIN app by uploading Aadhaar card as proof of age and voter card of any of 11 other identity cards.

Those with comorbidities have to submit certificate from the doctors treating them. The beneficiaries can also choose the vaccination centre where they want to take the jab. However, they will not be given the option to choose the brand of vaccine. “Beneficiaries will have to take whichever brand is available,” an official said.

Those with successful registration will receive a password on their mobile phones. They will also be sent SMS, informing them about the date and time for taking the vaccine.

They will have to report to their respective vaccination centres and show their original identity cards and certificates in case of comorbidities to the officers concerned. They will also have to share the password.

Those who can’t register themselves online can directly go to the vaccination centres and show their relevant documents to the staff, who will register them on the app.

The healthcare workers and employees of various frontline departments, who could not take vaccine during the two phases, will get a final chance to receive the shot from Thursday. Health officials made it clear that all those who missed the vaccine will have to take it before March 1.

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Andhra Pradesh begins second phase of Covid vaccination

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Andhra Pradesh begins second phase of Covid vaccination

Andhra Pradesh on Saturday began administering the second dose of coronavirus vaccine to frontline workers. Healthcare and Integrated Child Development Services (ICDS) workers are taking the second vaccine shot at the same place they were inoculated for the first time.

“Frontline workers should get inoculated with the same company’s vaccine as their first jab,” said Health Commissioner Katamneni Bhaskar.

Like most places in India, Andhra Pradesh is using ‘Covishield’ produced by the Pune-based Serum Institute of India (SII) and ‘Covaxin’ made by Hyderabad-based Bharat Biotech.

Following the completion of 28 days, the state government has begun the second phase of vaccination lining up 19,108 workers on Saturday.

Bhaskar directed all healthcare workers and ICDS personnel to finish taking their first vaccine dose before February 25.

“After February 25, health workers would not be inoculated with the first vaccine dose,” said Bhaskar. However, he allowed them to take the first vaccine shot anywhere in the state.

Likewise, he directed employees from all other departments to complete vaccination by March 5, clarifying that there would be no vaccination for them after this date.

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Covid: Andhra manages to vaccinate 61% of 1st day’s target

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Covid: Andhra manages to vaccinate 61% of 1st day’s target

Andhra Pradesh has managed to vaccinate 19,108 frontline workers (61 per cent) by 8.30 p.m. on Saturday for the novel coronavirus against a target of 31,570, officials said.

The highest number of vaccination sessions — 33, was held in East Godavari district. However, the highest number of beneficiaries was recorded at Guntur — 2,274.

“Vaccination will continue till completion of today’s target – 33,200 beneficiaries,” said an official statement. The target, however, could not be achieved by the time the latest numbers arrived, which also showed some inconsistency in the targeted vaccinations.

Likewise, none of the districts managed to achieve all the targeted number of vaccinations on the first day.

In Prakasam district, only 436 of the planned 2,200 vaccinations were done. In percentage terms, Andhra Pradesh managed to vaccinate only 61 per cent of the targeted numbers.

Meanwhile, Andhra Pradesh Governor Biswa Bhusan Harichandan congratulated the Indian scientists and doctors for successfully launching the vaccination programme.

He congratulated them for successfully developing, manufacturing, distributing and launching the countrywide vaccination programme on Saturday.

“The scientists with their untiring efforts have fulfilled the aspirations of the people of the country by making the vaccines available to people in a very short period,” said Harichandan.

He also congratulated other officials involved in the entire exercise.

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4,000 healthcare workers to get Covid vaccine on first day in Telangana

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4,000 healthcare workers to get Covid vaccine on first day in Telangana

The stage is set for Covid-19 vaccination rollout in Telangana where 4,000 healthcare workers in government-run facilities will receive the first dose on Saturday.

Health authorities have made all arrangements to vaccinate the beneficiaries at 139 centres spread across all 33 districts in the state.

Health minister Eatala Rajender and director of medical education Ramesh Reddy will receive the vaccine at Gandhi Hospital in Hyderabad.

Governor Dr Tamilisai Soundararajan will participate in vaccine rollout programme at Nizam’s Institute of Medical Sciences (NIMS).

Ministers, members of Parliament, members of state legislative assembly and council and public representatives down to the level of village sarpanchs will participate in the programme in district and area hospitals and in primary health centres in rural and urban areas.

Director of public health G. Srinivas Rao said Prime Minister Narendra Modi will launch the programme in virtual mode at 10.30 a.m. Arrangements have been made for two-way communication at two vaccinations centres at Gandhi Hospital and a rural health centre at Narsingi.

A maximum of 30 beneficiaries will be vaccinated at each centre. The numbers will be ramped up in phases from Monday and in coming days this will reach the maximum level of 100 per centre.

Majority of beneficiaries during the first few days of the vaccination drive will comprise staff from sanitation and security wings of teaching, hospitals, district hospitals and area hospitals and ASHA, Anganwadi and other workers at primary health centres .

The state health authorities have identified 3.15 lakh healthcare workers in government and private institutions and registered them in Cowin application, especially developed for Covid vaccination.

The number of centres for vaccination will also be increased gradually from Monday and in next few days the programme will be conducted at all 1,213 centres depending on the availability of the vaccine doses.

Srinivas Rao said Covid vaccine will be given between 9 a.m. and 4 p.m. every Monday, Tuesday, Thursday and Friday while routine vaccination programme for children and women will continue every Wednesday and Saturday. There will be no vaccination on Sundays and public holidays.

The state has so far received 3.74 lakh doses from union ministry of health and family welfare and they were stored in 2-8-degree temperature. The authorities have already transported over 50, 000 doses to the districts.

The authorities reassured beneficiaries that both Covishield and Covaxin approved for emergency use by Drug Controller General of India (DCGI) were safe and that there is no need for any apprehensions.

When his attention was drawn to reports that some doctors were not ready to take Covaxin as its third phase trials were not completed, director of public health said there should be no discrimination between vaccines.

He said as per Government of India guidelines consent will be taken from those who will be receiving Covaxin shot. Their health status will be examined and scrutinised before giving the vaccine and after vaccination they will be monitored for seven days for any adverse events. Similar process will be followed after the second dose which will be given after four weeks.

“We should be proud that Covaxin has been developed indigenously and that too on the soil of Telangana. Nobody should have any worried. If necessary, I will take Covaxin in coming days,” he said.

The officials said they were strictly following the protocols prescribed by the union ministry and the directions of Chief Minister K. Chandrasekhar Rao to deal with any case of reaction following Covid vaccination.

An observation room has been set up at each centre where every beneficiary will be monitored for 30 minutes after vaccination. The department has arranged vehicles to shift anybody who may develop some reaction after taking the vaccine. Intensive care units with 5-10 beds have been set up at 57 hospitals across the state to tackle such cases. This arrangement will be in place for entire period of vaccination which may last eight to nine months.

“We vaccinate lakhs of people every year under routine immunisation programme. Reactions like pain and developing fever are not uncommon after taking vaccines. One in lakhs may have adverse reaction after vaccination and we are fully geared up to deal with this,” said Ramesh Reddy.

He hopes that Covid vaccination will weaken intensity of the disease as happened in the case of Swine Flu.

“After taking vaccination antibodies will be developed to face the infection. T cells get activated and antibodies kill that particular virus. If this happens we will break the cycle and if we break cycle, the disease will die natural death. Even if it comes back, it will not be intense,” he said.

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Covid vaccines to be administered at 1,213 centres in Telangana

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Covid vaccines to be administered at 1,213 centres in Telangana

Covid-19 vaccines will be administered at 1,213 centres across Telangana from January 16.

Chief Minister K. Chandrasekhar Rao on Monday directed officials to make all preparations for the Covid vaccination. He said arrangements should also be made to treat people who may develop side effects after the jab.

He reviewed the arrangements for vaccination programme during a meeting with the ministers and district collectors. Later, the Chief Minister participated in the video conference with Prime Minister Narendra Modi.

A doctor and a room will be made available at each vaccination centre for those who may suffer side effects after the vaccination. An ambulance will also be kept as stand by. A statewide call centre will also be put in place. The Chief Minister asked officials to strictly follow Covid protocols while administering the vaccine.

“The government of India has identified Serum Institute’s Covishield and Bharat Biotech’s Covaxin as the effective vaccines. We have decided to administer these vaccines in Telangana. Initially, ASHA workers, Anganwadi staff, medical and health employees will be given the vaccine. Later, police, security personnel, sanitary workers and other frontline workers will be covered. Subsequently, the vaccine will be administered to those above 50 years and people with co-morbidities,” the Chief Minister said.

Rao said gram sarpanches and panchayat secretaries should take the responsibility to get the people on priority basis to the vaccination centres. Police Station House Officers and Sub Inspectors should take the responsibility of getting the vaccine for the police and other security personnel.

The government has already made the necessary arrangements to give vaccine in all the primary health centres. In all, 866 cold chain points have been created to transport the vaccine, and volunteers are ready at all the stages.

A committee headed by the Chief Secretary will monitor the vaccination programme.

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Covid vax dry run underway at 46 centres in Telugu states

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Covid vax dry run underway at 46 centres in Telugu states

A dry run of Covid-19 vaccination was underway Saturday at 46 centres in Andhra Pradesh and Telangana as part of nationwide assessment of preparedness of health authorities to implement the programme when the vaccine is made available.

The trial run was being conducted at 39 centres in Andhra Pradesh and seven centres in Telangana. Officials said the process was underway in a smooth manner.

In Andhra Pradesh, where the first phase of dry run was conducted at five centres in Krishna district on December 28, the process was conducted at three centres in each of the 13 districts on Saturday.

Dummy beneficiaries lined up at four designated centres in Hyderabad and at three centres in Mahabubnagar district at 9 a.m. to receive the vaccine.

Except the actual vaccine, the health personnel at the centres followed all guidelines under the vaccine protocol.

The dry run is aimed at testing the planned operations and the laid out mechanisms for Covid-19 vaccination in the state. It will provide insights on any gaps or bottlenecks so that those could be addressed before the commencement of the actual vaccination drive, officials said.

In Hyderabad, the dry run was conducted at Urban Primary Health Centre at Tilaknagar, Area Hospital at Nampally, Gandhi Hospital and Yashoda Hospital at Somajiguda.

In Mahbubnagar district, the identified centres are Primary Health Centre at Janampet, Government General Hospital at Mahbubnagar and Neha Sunshine Hospital at Mahbubnagar.

Governor Dr Tamilisai Soundararajan visited Urban Primary Health Centre at Tilaknagar in Hyderabad to see the dry run. She interacted with the health officials deployed at the centre. They explained to her various stages of the process.

Union Ministry of Health and Family Welfare had asked the state to choose the centres in the state capital and a relatively inaccessible terrain in the state to hold the trial run to strengthen the system ahead of the actual rollout.

Identified beneficiaries participated in the dry run at each session site where the process was conducted with all Covid appropriate behaviour measures.

For each centre, 25 test beneficiaries, mostly employees of health department, were identified for the dry run. They were sent dummy SMSes on Friday night informing them about the time and place of Covid vaccination.

Sanitation was done and physical distancing was maintained at all sites. When the intended benificiaries reported at the sites, they were subjected to temperature check and guided to waiting room.

Vaccinating officers checked the names of the beneficiaries in the list and uploaded their details like name, age and Aadhaar number Co-WIN (Covid Vaccine Intelligence Network) application. Another vaccination officer gave the dummy vaccine and uploaded the information in the Co-WIN app.

The beneficiaries were made to wait for 30 minutes following vaccination to observe their condition. Adverse Event Following Immunization (AEFI) treatment facility was also set up at each centre with 10 beds e by appointing a general medicine doctor as the in-charge.

At each centre, AEFI kits with emergency medicines were also arranged to administer medication in case of complications

Telangana’s Director of Public Health G. Srinivasa Rao said it was merely a demonstration to test the preparedness.

The process also assessed the logistics involved in shifting vaccines from storage points to vaccination centres and the health workers were briefed about the temperatures at which the vaccines were to be stored.

Health department officials expect Covid-19 vaccination to begin this month. They said the department was ready to roll out the vaccine within 24-48 hours of the Centre giving the approval and providing the required doses.

Telangana health minister Eatala Rajender stated that 10,000 health workers will be deployed for vaccination. He said the state has the capacity to administer vaccine to about 10 lakh people every day.

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Dry run slated for Covid vax in Krishna dist of Andhra

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Dry run slated for Covid vax in Krishna dist of Andhra

Dry run for Covid-19 vaccination will be conducted in Andhra Pradesh’s Krishna district on Monday and Tuesday, officials said on Saturday.

Andhra Pradesh is among the four states chosen by the Centre to carryout end to end dry run of the Covid immunisation drill.

Primary objective of dry run in Krishna district is to check operational feasibility of using Co-WIN application in field, planning, implementation and reporting mechanism, said an official.

The dry run is to be planned at five types of session sites in the district, Government General Hospital, Vijayawada, Uppuluru primary health centre, Purna Heart institute, Penamaluru primary health centre, Prakash Nagar eUPHC.

The dry run is aimed at testing the planned operations and the laid out mechanisms for Covid-19 vaccination in the state and it will provide insights on any gaps or bottlenecks so that those could be addressed before the commencement of the actual vaccination drive.

It will be used to test preparedness for vaccinating pre-identified beneficiaries from specified groups supported by Co-WIN, an electronic application.

The dry run will be used to test Covid-19 vaccination process such as planning and preparations including prerequisites for the vaccine introduction as per the operational guidelines, creation of facilities and users on CoWIN application, session site creation and mapping of sites, healthcare worker beneficiary data upload on Co-WIN, receipt of vaccines by the district and vaccine allocation using Co-WIN.

Session planning, vaccinator deployment, deployment of team members, vaccine and logistics mobilization at session site, mock drill of beneficiary vaccination and reporting and review meetings at block, districts and state and provide feedback to guide actions are the other activities planned.

At a meeting presided over by Krishna district collector, five session sites were identified as per the guidelines. Team members for vaccination were identified and their list was uploaded in CO-WIN portal, healthcare workers beneficiaries were also identified and their list uploaded in CO-WIN. Adverse event following immunization (AEFI) committee formed as per new guidelines. It prepared list of AEFI treatment centres.

Training for team members on dry run was conducted on Saturday. Inspection of session sites (dry run) is planned on Sunday to check the logistics planned.

Dry run will be conducted on December 28 with video coverage. Report will be submitted to district task force and state task force committees. State task force will review the feedback to guide further actions. The state will provide feedback to ministry of health and family welfare.

The test link of Co-WIN (www.Uat.co-vin.in) and (www.app.uat.co-vin.in) for vaccinator(ANM) for dry run kept ready. For each of the five session sites, 25 test beneficiaries (healthcare workers) were identified for the dry run. These test beneficiaries will be present at the session sites for session site simulation

Instruction given that this is a dry run and any SMS generated or received is for the purpose of dry run only.

Officials said 25 dummy beneficiaries will visit session site in two-hour time slot. Vaccinating officer VO-1 will match beneficiary names from list. VO-2 will verify beneficiary using Co-WIN application. Dummy vaccination will be done by VO-2, who will also report vaccination in the Co-WIN app. VO-3 and 4 will manage crowd, IPC (Inter process Communication) messaging, support vaccinator. The dummy beneficiaries will wait for 30 minutes following vaccination while VO-2 will report 2-3 dummy AEFIs in Co-WIN application at session site.

Telugu360 is always open for the best and bright journalists. If you are interested in full-time or freelance, email us at Krishna@telugu360.com.

India may get vax nod for emergency use by year-end; SII’s case strong

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India may get vax nod for emergency use by year-end; SII’s case strong

India is likely to have a Covid-19 vaccine approved for emergency use before December ends as Central Drugs Standard Control Organization’s (CDSCO) expert panel is set to to review the applications of Serum Institute of India (SII) and Pfizer for the emergency use authorisation (EUA) of their candidates, multiple sources associated with the development told IANS.

The sources said that the approval may come after the go-ahead from the Subject Expert Committee, which is likely to meet by the end of this week.

They also strongly indicated that the approval may come first for Adar Poonawalla’s SII vaccine c.

The sources said that the Pune-based SII’s vaccine candidate has an edge over Pfizer’s because of its low cost, effective logistics and easy storage.

However, no official confirmation came from the CDSCO.

Pfizer and BioNTech’s mRNA-based coronavirus vaccine requires a minus 70 degrees Celsius temperature for long term storage while SII’s Covishield, developed from the master seed of Astrazeneca/Oxford University’s Covid vaccine — ChAdOx1 nCoV-2019, can be stored in the domestic fridge at temperature not difficult to maintain (2 to 8 degrees Celsius).

IANS had reported on Tuesday that SII has submitted additional data required by the Drug Controller General of India (DCGI) for determining the safety and immunogenicity for Covishield.

If SII receives approval, then India could be the first country to give regulatory approval to AstraZeneca’s vaccine even as the medicine regulator of the UK, Medicines and Healthcare products Regulatory Agency (MHRA), continues to examine data from the trials.

The US pharma giant, Pfizer, whose vaccine has been authorised in the US, the UK and Canada, has written to the DCGI seeking a fresh date to present its case for the EUA of their vaccine candidate BNT162b2, after it failed to present its data before the reviewing committee of CDSCO earlier.

A day ago, the European Commission (EC) granted Pfizer/BioNTech’s Covid-19 vaccine a conditional marketing authorisation (CMA), under the new name Comirnaty.

Pfizer was the first to apply for the EUA in India on December 5, followed by Pune-based SII on December 6. Bharat Biotech sought EUA for its Covid vaccine, Covaxin, on December 7.

While Pfizer sought more time from the Subject Expert Committee (SEC) as its experts were busy and could not present their case on December 9, the SEC had asked SII and Bharat Biotech to furnish further safety and efficacy data in order to receive the EUA for their Covid vaccines.

The SEC had asked SII to submit an updated safety data of Phase 2 and 3 clinical trials in the country, immunogenicity (is the ability of a foreign substance, such as an antigen, to provoke an immune response in the body of a human or other animal) data from the clinical trial in the UK and India, along with the outcome of the assessment of the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) for grant of the EUA.

The SEC had asked SII to submit an updated safety data of Phase 2 and 3 clinical trials in the country, immunogenicity data from the clinical trial in the UK and India, along with the outcome of the assessment of the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) for grant of EUA.

Meanwhile, it has recommended Bharat Biotech to present the safety and efficacy data from the ongoing Phase 3 clinical trials in the country for further consideration.

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Hyderabad’s NIMS begins clinical trials of Covid vaccine

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Hyderabad’s NIMS begins clinical trials of Covid vaccine

As part of human trials of Covaxin, India’s first indigenous Covid-19 vaccine, two volunteers were given its first dose at the Nizam’s Institute of Medical Sciences (NIMS) on Monday, doctors said.

The healthy volunteers, who were administered the first dose of the vaccine in the morning, were stable. “Both are stable and we have not found any reaction or side-effects,” said Dr G. Srinivas, a member of the research team conducting the clinical trials.

The volunteers will remain under the observation of a team of doctors till Tuesday. They will be sent home but their condition will be remotely monitored by the doctors for 14 days.

The NIMS is one of the 12 institutes selected by the Indian Council of Medical Research (ICMR) for Phase-I clinical trials of the vaccine.

Hyderabad-based Bharat Biotech had announced on July 17 that the Phase-I clinical trials began across the country on July 15.

“This is a randomised, double-blind, placebo-controlled clinical trial in 375 volunteers in India,” the company had said.

The vaccine maker had announced on June 29 that it successfully developed Covaxin in collaboration with the ICMR and National Institute of Virology (NIV).

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 high containment facility located in Genome Valley, Hyderabad.

NIMS doctors said as many as 60 volunteers had enrolled for the clinical trials. They were screened and the healthy volunteers were selected and their reports were sent to ICMR, which finalised the fit volunteers based on different parameters.

Dr Srinivas said more volunteers would be administered dose as part of the clinical trial. “We will continue the Phase-I trials as per the sample size given by the ICMR and Bharat Biotech,” he told reporters without specifying the numbers.

The Phase-I clinical trials are likely to go on for 28 days, after which the ICMR and the Drug Controller General of India (DGCI) would accord permission for Phase-II trials.

The ICMR said Phase-I would have around 375 subjects across the country and Phase-II, 875.

Doctors say the trials may be completed in five phases including pre-clinical studies which Bharat Biotech has already completed.

Earlier, NIMS Director Dr K. Manohar said subjects would be administered two doses of the vaccine.

Each subject would be given the second dose of the same vaccine after 14 days.

For two days after administering the vaccine, the subjects would be monitored for two days in the ICCU at NIMS by a team of doctors, after which they would be sent home and monitored through video conference or phone.

Telugu360 is always open for the best and bright journalists. If you are interested in full-time or freelance, email us at Krishna@telugu360.com.

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

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

Hyderabad-based Bharat Biotech on Friday announced that the Phase-I clinical trials of India’s first indigenous Covid-19 vaccine Covaxin began across the country on July 15.

“This is a randomised, double-blind, placebo-controlled clinical trial on 375 volunteers in India,” the company said in a brief statement.

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 National Institute of Virology (NIV).

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.

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 centres selected by the ICMR for the clinical trials.

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.

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.

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.

Phase-1 would have around 375 subjects across the country and Phase-II, 875.

In a letter to the selected centres early this month, ICMR Director General Balram Bhargava asked them to fast-track all approvals related to initiation of the clinical trial.

“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.

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.

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.

Bharat Biotech had refused to comment on the ICMR’s August 15 deadline.

Telugu360 is always open for the best and bright journalists. If you are interested in full-time or freelance, email us at Krishna@telugu360.com.

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