U.S. FDA Places COVID-19 Vaccine on Clinical Hold

Pennsylvania-based Ocugen, Inc. today announced that the Company was informed by the U.S. Food and Drug Administration (FDA) that the agency placed its Phase 2/3 immuno-bridging and broadening study for Covaxin™ on clinical hold.

As of April 12, 2022, the FDA has not Authorized or Approved Covaxin's use in the U.S.

This action results from the Company's decision to voluntarily implement a temporary pause in dosing participants of the OCU-002 clinical trial while it evaluates statements made by the World Health Organization (WHO) following their inspection of a Bharat Biotech International Limited's (BBIL) manufacturing facility.

On April 2, 2022, the WHO confirmed the suspension of the supply of Covaxin through UN procurement agencies and recommended that countries using the vaccine take action as appropriate.

The suspension is in response to the outcome of a WHO inspection in mid-March 2022 and the need to conduct process and facility upgrades to address recently identified deficiencies in good manufacturing practices.

The WHO's risk assessment to date does not indicate a change in Covaxin's risk-benefit ratio. And the data available to WHO indicate the vaccine is effective, and no safety concerns exist.

Covaxin is an inactivated COVID-19 vaccine that uses adjuvant Alhydroxiquim-II to boost immune response and is available in various countries.

Prune, India-based BBIl created Covaxin (BBV152) in 2020, and the WHO granted emergency use listing on November 3, 2021.

Note: This news article edited the Ocugen press statement for clarity and was manually curated for mobile readers.