Citing justifiable grounds, the Food and Drug Administration (FDA) has granted the request for revision of the issued emergency use authorization (EUA) to Pfizer-BioNTech Covid-19 Vaccine to include individuals 12 years of age and older in its indication for active immunization for the prevention of Covid-19.
The FDA said that “foregoing revision is made pursuant to the discretionary power of the FDA under Section 6 of Executive Order [EO] 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 and safety.”
In issuing this EUA, the FDA stressed that the “recognition and reliance” have been accorded to the Emergency Use Listing (EUL) of the World Health Organization (WHO), and EUAs given by mature and established National Regulatory Authorities (NRAs) such as the United States of America, United Kingdom, Canada, European Union and Singapore, respectively.
“Under Section 5 of EO 121, the Director General of the FDA has been granted power to implement reliance and recognition processes, and accept regulatory decisions of recognized and established regulatory authorities.”
The FDA also reiterated that the EUA is “not” a marketing authorization or a Certificate of Product Registration (CPR), “Hence, this EUA cannot be used as an authorization to market the vaccine commercially.”
Meanwhile, Health Undersecretary Maria Rosario Vergeire said that while, the Department of Health (DOH) welcomes more vaccines that are approved for children and adolescents, “due to limited vaccine supply, our vaccination strategy remains the same— prioritize the vulnerable and adhere to our prioritization framework.”
“The general consensus of our vaccine experts is to revisit pediatric and adolescent vaccination once our vaccine supply has stabilized. Vaccine Cluster through Secretary Charlie [Carlito Galvez Jr.] is doing all they can to secure the doses necessary to vaccinate the eligible population for free,” Vergeire stressed.
Additional Covid cases
The DOH logged 4,777 additional cases on Tuesday, bringing the total number of infections in the country to 1,280,773.
There were also 7,122 recoveries and 95 deaths.
Of the total number of cases, 4.4 percent (56,452) are active, 93.9 percent (1,202,257) have recovered, and 1.72 percent (22,064) have died.
Eight duplicates were removed from the total case count. Of these, 6 are recoveries.
Moreover, 40 cases that were previously tagged as recoveries were reclassified as deaths after final validation.
All laboratories were operational on June 6, 2021 but 10 were not able to submit their data to the Covid-19 Document Repository System.
Based on data in the last 14 days, the 10 non-reporting labs contribute, on average, 2.7 percent of samples tested and 2.9 percent of positive individuals.