The FDA cleared the importation of Covaxin COVID-19 vaccine to the Philippines.
The Food and Drug Administration (FDA) on Friday said that it had cleared the importation of Bharat Biotech’s Covaxin COVID-19 vaccine to the Philippines.
FDA Director-General Eric Domingo said that Bharat BioTech’s Covaxin COVID-19 vaccine can be imported to the Philippines.
During the “Laging Handa” briefing, Domingo said this developed after the Food and Drug Administration revised the emergency use authorization (EUA) issued to Covaxin since its importer, IP Biotech Inc, already submitted Risk Management Plan, Good Manufacturing Practice (GMP) Certificate, and updated Chemistry, Manufacturing, and Controls (CMC).
A June 21 FDA letter to IP Biotech Inc on the amended emergency use authorization (EUA) for Covaxin COVID-19 vaccine also stated:
“Finding the compliance to be substantial, the FDA hereby revises the EUA to remove the above stated conditions prior to the commercial importation of the Bharat Biotech COVID-19 Vaccine. The foregoing revision is made pursuant to the discretionary power of the FDA under Section 6 of Executive Order (EO) No. 121, entitled “Granting Authority to the Director General of the Food and Drug Administration to Issue Emergency Use Authorization for COVID-19 Drugs and Vaccines, Prescribing Conditions Therefor, and for Other Purposes,” to revisit any issued EUA as may be appropriate to protect the general public health.“
Earlier, Indian Ambassador to the Philippines Shambhu Kumaran said that an EUA was issued to Covaxin last April.
Based on the FDA evaluation, Covaxin was given in two COVID-19 vaccine doses to those aged 18 years old and above, with the second dose given 28 days after the first dose.
GMA News Online reported that Covaxin COVID-19 vaccine’s storage requirement was 2 to 8 degrees Celsius and should be used within six hours once opened.