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Pfizer Drops India Vaccine Application After Regulator Seeks Local Trial - Reuters

· 02/05/2021 05:34
  • According to Reuters, Pfizer Inc ((NYSE: PFE) and its German partner BioNTech SE (NASDAQ: BNTX) have reportedly withdrawn their application for the emergency-use nod of its COVID-19 vaccine in India, as the Company failed to meet drug regulator’s (Central Drugs Standard Control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 (NASDAQ: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 (NASDAQ: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.