India Is Reportedly Seeking More Data On Oxford-AstraZeneca Vaccine Before Granting Emergency Authorization

[perugu_vada]

Indian regulators refused to immediately grant emergency approval requests for Serum Institute of India’s license-produced Oxford-AstraZeneca Covid-19 vaccine CovidShield and Bharat Biotech’s indigenously developed Covaxin due to inadequate safety and efficacy data, multiple media outlets reported on Wednesday, citing sources.

 

KEY FACTS

The decision was made by the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO), which met to review applications from the Serum Institute of India (SII), Bharat Biotech and Pfizer on Wednesday, NDTV reported.

Approval for two of the proposals was not immediately granted due to the lack of adequate safety and efficacy data and SII and Bharat Biotech have been asked to submit more data, which will be examined in the SEC’s next meeting, the report added.

It is unclear if any decision regarding the Pfizer vaccine —  which has been approved and rolled-out by the U.K. — has been made yet.

[reality]

Ee athi 10g ante mundhu untadu Bodi gadu.... 

[perugu_vada]

2 minutes ago, reality said:

Ee athi 10g ante mundhu untadu Bodi gadu.... 

Actually govt is pushing, it is cdsco asking for more data

The Indian government, however, dismissed early reports that requests have been outright rejected, with the Ministry of Health and Family Welfare tweeting that the reports were “Fake News.”

[reality]

3 minutes ago, perugu_vada said:

Actually govt is pushing, it is cdsco asking for more data

The Indian government, however, dismissed early reports that requests have been outright rejected, with the Ministry of Health and Family Welfare tweeting that the reports were “Fake News.”

Raju thalchukunte debbalaki kodhava? Ayina cdsco comes under health ministry only. 

[Hector8]

Pfizer vaccine india afford cheyaledu ani lite tisukunnaranta nijamena