COVID-19 updates: Bharat Biotech to submit Covaxin Phase 3 trial data in July; Jharkhand, Nagaland extend lockdowns

India registered 92,596 new coronavirus cases on Wednesday, pushing the tally of infections to 2,90,89,069. With 2,219 deaths, the toll climbed to 3,53,528

FP Staff June 09, 2021 22:29:07 IST
COVID-19 updates: Bharat Biotech to submit Covaxin Phase 3 trial data in July; Jharkhand, Nagaland extend lockdowns

Representational image. AP

After facing flak over lack of clinical trials data, Hyderabad-based Bharat Biotech which manufactures the indigenously developed COVID-19 vaccine COVAXIN said on Wednesday the company will submit the Phase 3 clinical trial data of the vaccine in July.

The data will be first submitted to the Central Drugs Standard Control Organisation, followed by peer-reviewed journals with a timeline of three months for publication. The Hyderabad-based company told ANI that once the final analysis of the Phase III data is available, it would apply for full licensure for COVAXIN.

The indigenously developed vaccine was granted an emergency use authorisation in January – despite there being no Phase 3 trial data. The company had then said it would submit efficacy results by March.

In March, the vaccine maker said COVAXIN demonstrated 81 percent interim efficacy in preventing COVID-19 in those without prior infection after the second dose. The vaccine manufacturer claims that COVAXIN has overall efficacy of 78 percent while efficacy against hospitalisation is 100 percent, the news agency quoted the company as saying.

Meanwhile, after a gap of two weeks, Delhi finally received stock of both COVID-19 vaccines (Covishield and COVAXIN) for the 18-44 age group, the ruling AAP government said on Wednesday.

AAP MLA Atishi said the National Capital has received 1.25 lakh doses of Covishield and 20,000 Covaxin doses on Tuesday evening from the Centre.

She also added that the COVAXIN's supply would be used to administer people who have to take the second dose whereas Covishield would be used for both the first and second doses, reported Mint.

This, as India on Wednesday, registered 92,596 new coronavirus cases, pushing the tally of infections to 2,90,89,069. The new cases were seven percent higher than Tuesday’s count, reports Scroll.in, but remained below one lakh cases for the second day in a row. With 2,219 deaths, the toll climbed to 3,53,528.

In view of the COVID-19 situation in the country, Telangana became the latest state to cancel Class 12 examinations this year. In the Union Territory of Jammu and Kashmir, Lieutenant Governor Manoj Sinha announced that all pending board examinations for Classes 11 and 12 in the UT have been cancelled in the wake of the COVID-19 pandemic.

Centre issues guidelines for COVID management in children; Remdesivir not recommended

The government has come out with comprehensive guidelines for the management of COVID-19 among children in which Remdesivir has not been recommended and rational use of HRCT imaging has been suggested.

The guidelines issued by the Directorate General of Health Services (DGHS) under the health ministry also said that steroids are harmful in asymptomatic and mild cases of infection.

The DGHS recommended steroids only in hospitalised (moderately severe and critically ill) COVID-19 cases under strict supervision. "Steroids should be used at the right time, in the right dose and for the right duration."

The guidelines also said Remdesivir (an emergency use authorization drug) is not recommended in children.

"There is lack of sufficient safety and efficacy data with respect to Remdesivir in children below 18 years of age," the guidelines said.

The guidelines suggested rational use of High-resolution CT (HRCT) for seeing the extent and nature of lung involvement in patients with COVID-19 .

For asymptomatic infection among children, the guidelines recommended no specific medication and promoted COVID-appropriate behaviour (mask, strict hand hygiene, physical distancing) and suggested giving a nutritious diet.

The guidelines said that for mild infection paracetamol (10-15mg/kg/dose) may be given every 4-6 hours for fever and throat soothing agents and warm saline gargles in older children and adolescents have been recommended for cough.

Bombay HC asks Centre for status report on vaccination without IDs

The Bombay High Court asked the Centre and the state government on steps to publicise standard operating procedures for vaccinating beneficiaries without the seven identity cards prescribed for the purpose.

“What has the state and the Union [government] done to inform the public that the seven prescribed identity cards are not mandatory for vaccination?” it asked.

A bench of Chief Justice Dipankar Datta and Justice GS Kulkarni also asked the Central Government to inform the court of the steps taken to cover under its vaccination drive the people who were mentally ill and without a legal guardian and hence, not in a position to give informed consent for receiving the vaccine.

The bench was hearing a bunch of PILs on ensuring greater access of the anti- COVID-19 vaccines to citizens, improved functioning of the CoWIN portal and other issues.

The petitioners informed the bench that the government had prescribed a list of seven recognised identity cards, including the Aadhaar and the PAN cards, for citizens to register for vaccination on the CoWIN portal.

"What has the state and the Union (government) done to inform the public that the seven prescribed identity cards are not mandatory for vaccination?" it asked.

The HC directed the state's counsel, Gita Shastri, and ASG Singh to inform the court of the steps taken by 17 June, the next date of hearing.

Jharkhand, Nagaland extend lockdowns

The Jharkhand government on Wednesday extended COVID-related lockdown-like restrictions till 16 June with some relaxations.

This is the fifth time that the curbs, first imposed in the state on 22 April for a week, were extended. The ongoing measures were scheduled to end on 10 June. The decision was made at a meeting of the state disaster management authority chaired by Chief Minister Hemant Soren.

"The Health Safety Week now stands extended till 16 June. Some relaxations have been given, including the opening of shops in 23 districts from 6 am to 4 pm," the official said.

Even Nagaland on Wednesday announced an extension of the ongoing Covid-related lockdown till 18 June with easing of some restrictions.

The decision was taken by the state's High Powered Committee on COVID-19 at a meeting chaired by Chief Minister Neiphiu Rio two days before the current lockdown was to end, state minister Neiba Kronu said.

This will be the third extension of the lockdown in the state.

Earlier, a seven-day lockdown was imposed in the northeastern state from 14 May to contain the spread of coronavirus . Subsequently, it was extended till 31 May and then up to 11 June.

With inputs from PTI

Updated Date:

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