ZyCoV-D to start adaptive phase I/II clinical trials

Total of 20,783 people cured in the last 24 hours: Health Ministry.

July 16, 2020 08:24 pm | Updated 08:27 pm IST - NEW DELHI:

Image for representation.

Image for representation.

The Department of Biotechnology (DBT) supported coronavirus ( COVID-19 ) vaccine, ZyCoV-D, designed and developed by Zyuds Cadila, will begin adaptive phase I/II clinical trials to assess its safety , tolerability and immunogenicity, the Union Health Ministry said on Thursday. It also noted that a total of 20,783 people were cured of COVID-19 in the last 24 hours,

Union Health Minister Dr. Harsh Vardhan said in a tweet: “this is an important milestone for Atmanirbhar Bharat . I hope that the vaccine continues to show positive outcomes as it has done so far in the pre-clinical phase where it was found to be safe, immunogenic and well-tolerated.’’

Renu Swarup, Secretary, DBT, said the tie-up with Zydus was to address rapid development of an indigenous vaccine for COVID-19 under the National Biopharma Mission.

“We hope that the vaccine continues to show positive outcomes as it has done so far in the pre-clinical phase, where it was found to be safe, immunogenic and well tolerated. This will be a big leap forward for Indian scientific research”, he stated

Commercial vaccine will take at least 12 months, say officials

“In pre-clinical phase, ZyCoV-D was found to elicit a strong immune response in multiple animal species like mice, rats, guinea pigs and rabbits. The antibodies produced by the vaccine were able to neutralize the wild type virus in virus neutralization assay, indicating the protective potential of the vaccine candidate. No safety concerns were observed for the vaccine candidate in repeat dose toxicology studies by both intramuscular and intradermal routes of administration. In rabbits, up to three times, the intended human dose was found to be safe, well tolerated and immunogenic,’’the DBT said.

Chairman of Zydus Cadila, Pankaj R. Patel, stated that this was a very important step in the fight against the pandemic and one that would help the nation combat this healthcare challenge.

Recovery rate

The Health Ministry, highlighting a growing recovery rate, said that from mid-June 2020, after crossing the 50% mark, there had been a steady increase in the number, and a decline in the number of active cases. It pointed out that 63.25% of the patients had recovered so far.

“Less than 2 percent of the affected patients are admitted in ICUs. Gradually we are moving in the direction to win the battle against the pandemic. Our lab network has been strengthened; we have had an exponential growth in the number of labs which have grown from one in Jan 2020 to 1234 currently,’’ Dr. Vardhan said.

The Ministry said targeted measures have contributed to a steady decline in the number of active cases. As on date, the actual caseload in the country was only 3,31,146 and these contributed to a little more than a third (34.18%) of the total cases detected so far.

The actual caseload had remained limited and manageable due to proactive containment measures, including house-to-house survey, perimeter control activities, timely contact tracing and surveillance of containment zones, aggressive testing and timely diagnosis, and effective clinical management of the moderate and severe cases through a well implemented standard of care protocol substantially increasing their chances of recovery, it noted.

“The joint efforts by the Centre and the State/UT governments to increase the testing capacity, ramp up the health infrastructure, prioritise surveillance in the SARI/ILI cases, and ensure mapping of the aged population and people with co-morbidities have led to a continuous improvement in the recovery rates seen across the country,’’ it added.

New OPD block in AIIMS

Dr. Vardhan on Thursday inaugurated the Rajkumari Amrit Kaur OPD Block of All India Institute of Medical Sciences (AIIMS) here. “Built on an area of approximately 6300 sqm, RAK OPD is the largest OPD in India. The block also has smart lab built at a cost of ₹15 crore. This connects the various analyzers and technologies in a single integrated workflow,’’ said a Health Ministry release.

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