Recently, some people started to blame the government for creating vaccine shortages by quoting the example of Pfizer withdrawing its India vaccine application in February 2021. However, what they stated was just half the story.
The fact remains that Pfizer withdrew its application for emergency-use authorisation for its COVID-19 vaccine in India, after failing to meet the drug regulator’s demand for a local safety and immunogenicity study.
As reported in Reuters:
“Unlike other companies conducting small studies in India for foreign-developed vaccines, Pfizer had sought an exception citing approvals it had received elsewhere based on trials done in countries such as the United States and Germany.”
Even with the Sputnik vaccine, there is much disinformation. Fact remains that the Indian production partner, Dr. Reddy’s Laboratories, was asked by the Subject Expert Committee of the Central Drugs Standard Control Organisation (CDSCO) to furnish complete information related to the vaccine’s safety and immunogenicity from its bridging trials here on February 19. However, an Indian Express story has reported, quoting sources from the CDSCO, that Dr. Reddy’s is yet to provide more information about safety and immunogenicity.
Moreover, there have been fresh concerns about the safety of Sputnik V. It has now emerged that the European Medical Agency got access to leaked Russian government authorities’ files that show deaths occurring after the administration of the Sputnik V vaccine.
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