COVID-19 vaccine updates in India: Oxford’s COVID-19 vaccine trials can be over by December, if SII doesn’t go for emergency licence

COVID-19 vaccine updates in India: Oxford’s COVID-19 vaccine trials can be over by December, if SII doesn’t go for emergency licence
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  • Covishield, Oxford’s coronavirus vaccine candidate being tested by Serum Institute of India in the country, could be ready as early as December.
  • Dr Reddy’s Laboratories on October 28 said that phase 3 trials of Russia’s COVID-19 vaccine, Sputnik V, is likely to be finished by the end of March next year.
  • PM Modi has assured that every Indian citizen will be vaccinated and no one will be left behind once a vaccine is available.
Scientists are still looking for a cure for the deadly coronavirus, which has infected millions of people around the world. Two of the front runners in the race of vaccine — Moderna and Pfizer — are expected to launch their COVID-19 antidote by December. Whereas, Oxford-AstraZeneca’s vaccine is triggering an immune response for both young people and adults.

The overall number of global coronavirus cases is nearing the 44 million mark, while the deaths have increased to more than 1,173,270,, according to Johns Hopkins University.

There are over 100 potential vaccine candidates being tested on volunteers globally. In India, three vaccines are in advance trials. In India, 3 vaccines are under advanced stage trials while 4 others are in preclinical stages.
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PM Modi has assured that every Indian citizen will be vaccinated and no one will be left behind once a vaccine is available.

Oxford’s COVID-19 vaccine to be ready by December, SII to seek emergency licence
Covishield, Oxford’s coronavirus vaccine candidate being tested by Serum Institute of India in the country, could be ready as early as December.

"If we don't go for an emergency license, our trials should be over by December and then we can maybe launch in India in January subject to the UK trial, which is on the verge of being completed," Adar Poonawalla told NDTV in an interview.
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However, Poonawalla believes data from UK clinical trials is going to play a key role in determining the further status.

Dr Reddy’s says Phase 3 trials of Sputnik V will be over by March
Dr Reddy’s Laboratories, on October 28, said that phase three trials of Russia’s COVID-19 vaccine, Sputnik V, is likely to be finished by the end of March next year.

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"Phase-3, we should finish somewhere by March, and then of course, it depends on the ability to compile the data, obtain the approvals, etc. It can be as early as the end of March or April /May and beyond. It depends on the results. It's a combination of phase-2, global phase-3 and phase-3 in India," Dr Reddy’s CEO Erez Israeli said.

Dr Reddy’s will test the vaccine on 100 volunteers for phase 2 trials, and is likely to recruit 1,400 volunteers in the phase 3 trials.

Bharat Biotech is looking to raise manufacturing capacity above 500 million doses
Bharat Biotech — one of three companies conducting advanced stage trials in India for its COVID-19 vaccine candidate — says it is producing Covaxin at its own risk.
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According to Bharat Biotech executive director Sai Prasad, the pharma company has a manufacturing capacity of 150 million doses per year. However, it is looking to increase “capacity north of 500 million doses as soon as possible.” Bharat Biotech is looking at developing a new facility in Hyderabad — adjacent to the existing one.

Biological E to begin phase I and phase II human trials of its COVID-19 vaccine in India
Hyderabad-based Biological E got the approval to conduct phase I and phase II human trials of its COVID-19 vaccine in India. The pharma company has partnered with an unidentified firm to conduct the trials, according to ET.

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Third phase human trial of COVID-19 vaccine to commence in Bhubaneswar soon
The third phase of the human trial of the indigenous vaccine against COVID-19, COVAXIN, will commence at a private hospital in Bhubaneswar soon.
Like the previous phases, half of the volunteers would receive placebo and the remaining half would be administered COVAXIN in this phase. Even health care workers would be recruited for the trial. The volunteers would be followed up over a considerable period of time to look at the efficacy of the vaccine in preventing the development of the Corona disease, according to Dr. E Venkata Rao, Principal Investigator in the COVAXIN human trial

Bharat Biotech is looking to raise manufacturing capacity above 500 million doses
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Bharat Biotech — one of three companies conducting advanced stage trials in India for its COVID-19 vaccine candidate — says it is producing Covaxin at its own risk. According to Bharat Biotech executive director Sai Prasad, the pharma company has a manufacturing capacity of 150 million doses per year. However, it is looking to increase “capacity north of 500 million doses as soon as possible.” Bharat Biotech is looking at developing a new facility in Hyderabad — adjacent to the existing one.

SII finishes phase II trials of Oxford’s COVID-19 vaccine candidate in Mumbai
Serum Institute of India (SII) and the Brihanmumbai Municipal Corporation have completed phase II trials of Oxford-AstraZeneca's COVID-19 vaccine candidate in Mumbai. The civic body is soon going to begin the third phase.

“With the approval, we will be able to start the third phase of the trial once the first set of volunteers complete 28 days of the first vaccination. As per ICMR (Indian Council of Medical Research), the third trial can only be conducted on volunteers after a gap of 28 days,” said Suresh Kakani, additional commissioner, BMC.
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Every Indian citizen to get free COVID-19 vaccine, claims Union Minister Pratap Sarangi
Union Minister Pratap Sarangi, on October 26, said that all people of the country would be given a free COVID vaccine. This comes amidst the demand by opposition parties to BJP to not use the vaccine as a poll promise to win Bihar elections.

The BJP announcement of free COVID vaccine for Bihar, where assembly polls begin this week, had kicked up a controversy with the opposition parties tearing into the NDA government, alleging that the ruling party was using the pandemic for political reasons.

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Union Finance Minister Nirmala Sitharaman had said the announcement was in order as it was an election manifesto announcement.

Prime Minister Narendra Modi has announced that all people will be provided free of cost vaccines. An estimated ₹500 will be spent on vaccination of each person, Sarangi told reporters after addressing a campaign meeting for the November 3 assembly by-poll in Balasore.

Intranasal vaccine will be easier to deliver, says Biotech founder Kiran Mazumdar Shaw

In India, the intranasal vaccine will be easier to deliver than intramuscular injection, said Biocon’s Kiran Mazumdar Shaw.

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"Indeed intranasal vaccines will be far easier to deliver than intramuscular injections n Asha workers can be trained to deliver it at mass scale unlike IM injections which will need nurses, doctors n MBBS students which is a challenge," Biocon Executive Chairperson Kiran Mazumdar-Shaw tweeted
Bharat Biotech gets nod to conduct phase 3 trial of its COVID-19 vaccine candidate
Bharat Biotech, on October 22, got the approval from the Drug Controller General of India to conduct phase III trials of its COVID-19 vaccine in the country.

"The firm has presented their data from Phase I and II along with animal challenge data in two species including NHP on the Inactivated Corona Virus Vaccine (BBV152) along with the proposal to conduct event-driven Phase III clinical trial to assess the efficacy of the vaccine," the expert panel of Subject Expert Committee (SEC) said.

Indian government reportedly set aside $7 billion to vaccinate 1.3 billion people
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The Narendra Modi government has reportedly set aside ₹50,000 crore ($7 billion) to vaccinate 1.3 billion Indians against COVID-19, said Bloomberg citing sources. The government is estimating the overall cost of nearly $6-7 per person. Moreover, according to the government’s estimates a shot of a vaccine is likely to cost around $2.

IIT-Indore’s COVID-19 vaccine enters animal trial phase

IIT-Indore’s potential COVID-19 vaccine has entered the animal trials stage at the National Centre for Cell Science in Pune.

“The research team, led by Dr Debasis Nayak, has received funds for development of a vaccine against SARS-CoV2. Nayak is a veterinarian and he is running trials on animals to study the vaccine’s side effects,” Prof Neelesh Kumar Jain said.

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Indian pharma Mankind partners with RDIF to market Sputnik V in India
Russian Direct Investment Fund (RDIF) has inked a pact with Delhi-based Mankind Pharma to market and distribute Russia’s COVID-19 vaccine Sputnik V in India, according to Live Mint.

“It depends on how many doses they will give Mankind. RDIF has pacts with Russian and Korean manufacturers for around 50 million doses so far. Talks with Indian manufacturers are also ongoing. Mankind will get the doses once the approvals are in place and the doses are supplied," Mint reported citing sources.

The pact comes after Dr Reddy’s Lab got the approval to conduct human trials of Sputnik V in India.

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Oxford-AstraZeneca’s COVID-19 vaccine will be ready by December
The Serum Institute of India says Oxford-AstraZeneca’s potential COVID-19 vaccine will be ready by December and available in market by March 2021 after procuring a license.

"India may get COVID-19 vaccine by March 2021 provided the regulators speed up the process as multiple manufacturers are working on it," Jadhav said at the India Vaccine Accessibility e-summit organised by HEAL Foundation in association with ICCIDD.

Meanwhile, Serum Institute has proposed the Drug Controller General of India to broaden the norms of clinical trials by including people with different conditions from all ages.
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Bharat Biotech partners with Washington University for an intranasal vaccine
Union Health Minister Harsh Vardhan, on October 19, informed that Bharat Biotech would develop an intranasal vaccine for Sars-CoV-2.

According to Harsh Vardhan, Bharat Biotech has entered into an agreement with Washington University and St. Louis University for the trials of the nasal vaccine candidate.

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"It (Bharat Biotech) has entered into an agreement with Washington University's School of Medicine under which the company will conduct trials, produce and market an intranasal vaccine for the COVID-19," Vardhan told his social media audience at his weekly webinar, Sunday Samvaad.

The Phase 1 trials of the vaccine candidate will take place in St Louis University's vaccine and treatment evaluation unit, while further stages of the trials will be conducted in India.

Dr Reddy’s receive approval for Sputnik V’s human trial in India
Dr.Reddy’s Laboratories and Russian Direct Investment Fund, Russia’s sovereign wealth fund, on October 17, announced that they have received approval from the Drug Control General of India to conduct an adaptive phase 2/3 human clinical trial for Sputnik V vaccine in India. Dr Reddy’s said that this will be a multi-center and randomised controlled study, which will include safety and immunogenicity study.
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Additionally, Phase 3 clinical trial of the vaccine commenced in the UAE last week
On August 11, 2020, the Sputnik V vaccine developed by the Gamaleya National Research Institute of Epidemiology and Microbiology was registered by the Ministry of Health of Russia and became the world's first registered vaccine against COVID-19 based on the human adenoviral vectors platform. A month later, Dr Reddy’s and RDIF entered into a partnership to conduct clinical trials of Sputnik V vaccine and its distribution in India.

Sputnik V is currently undergoing Phase 3 clinical trials in Russia and the proposed number of subjects is 40,000.

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Apollo Hospitals is ready to administer 1 million COVID-19 vaccines daily
Apollo Hospitals announced on October 15 that it is prepared to administer one million Covid-19 vaccines per day whenever the vaccine is rolled out.

The group said it will leverage its robust pan-India network of 19 medicine supply hubs with cold chain facilities, 70 hospitals, over 400 clinics, 500 corporate health centres and 4000 pharmacies alongside their omni-channel digital platform to ensure massive administration capacity of COVID-19 vaccines.

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Another round of economic stimulus not off the table, according to Sitharaman
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