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Expert panel clears Covishield vaccine's emergency use in India

Expert panel clears Covishield vaccine's emergency use in India”

The Subject Expert Committee (SEC) on COVID-19 of the CDSCO, which had earlier sought additional safety and immunogenicity data from SII, deliberated on its application seeking emergency use authorisation (EUA) for the shots on Wednesday, and met again on Friday to review the matter.

The latest figures show NHS England is achieving 250,000 Covid-19 vaccines a week.

"There are important differences between the SII's Indian trial and the foreign trials of the AstraZeneca/Oxford vaccine".

As for Bharat Biotech, after detailed deliberation, the committee had recommended that the firm should present the safety and efficacy data from the ongoing phase 3 clinical trial in the country for further consideration.

The Indian government has approved the coronavirus vaccine developed by Oxford University/AstraZeneca for emergency use.

Ahead of the dry-run for COVID-19 vaccine in the national capital, Union Health Minister Harsh Vardhan on Friday held a review meeting with the Delhi government officials for the preparations of the mock drill, which is scheduled for January 2.

The panel will now forward its recommendation for final approval to the regulator Drugs Controller General of India (DCGI), NDTV reported quoting sources. Pfizer had applied for regulatory approval for its vaccine on December 4.

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"Doctors, medical staff, frontline workers who will be working under this drive are listed up and the list will be uploaded on COVID-19 platform", he said.

"The company should continue with the trial that is going on".

As per a report in CNBCTV18, the recommendation comes with certain conditions but it didn't elaborate on them.

The approval for the mass use of the vaccine now turns the spotlight on the rollout, set to follow a priority list prepared by the Centre. For the two full doses given 28 days apart, there is "no corresponding efficacy analysis" reported for such a dosing regimen in the published data of the United Kingdom and Brazil trials for the AstraZeneca/Oxford vaccine, they say. SII was also asked by the panel to come after approval was granted by UK.

Fiocruz expects to deliver the first 1 million doses between February 8 and February 12, though that will depend on the arrival of the active pharmaceutical ingredient for the vaccine scheduled for January 9, Trindade said.

The EUA has been recommended for Covishield with regulatory provisions including that the vaccine dose is indicative for active immunization in individuals of 18 years or more in preventing the disease.



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