Pfizer Drops India Vaccine Application After Regulator Seeks Local Trial - Reuters - Pfizer (NYSE:PFE), BioNTech (NASDAQ:BNTX)

According to Reuters, Pfizer Inc ((NYSE: PFE) and its German partner BioNTech SE (NASDAQ: BNTX) have reportedly withdrawn their application for the emergency-use nod of its COVID-19 vaccine in India, as the Company failed to meet drug regulator’s (Central Drugs Standard Control Organization) demand for small local trial on the vaccine’s safety and immunogenicity for Indians.
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 in countries such as the U.S. and Germany.
India’s drug regulator also said that its experts did not recommend the vaccine because of side effects reported abroad that were still under investigation.
“Pfizer will continue to engage with the authority and re-submit its approval request with additional information as it becomes available in the near future,” as per Reuters.
Pfizer, which was the first drug maker to apply for emergency use authorization of its COVID-19 vaccine, had applied in late last year. Still, the government in January approved two inexpensive shots - one from Oxford University/AstraZeneca Plc AZN and another developed in India by Bharat Biotech with the Indian Council of Medical Research.
Recently, researchers in the U.K launched a study to investigate the patient’s immune responses to an initial dose of Pfizer vaccine followed by a booster of AstraZeneca’s, as well as vice versa.
In January, Moderna Inc MRNA was reported to be in talks with Indian conglomerate Tata Sons to launch and carry out clinical trials for Moderna’s COVID-19 vaccine candidate in India.
Price Action: PFE shares are trading higher by 0.32% at $35 in the pre-market session on the last check Friday.