THE GOVERNMENT has prioritized the vaccination of the Presidential Security Group (PSG) of the President and other Cabinet secretaries over medical and healthcare workers who are risking their lives to fight COVID-19. It is an obvious case of the government’s neglect and disregard of the struggles of our frontliners.
The Food and Drug Administration (FDA) and the Department of Health (DOH) are urged to investigate those who are accountable in this unauthorized and illegal inoculation.
All persons have the right to avail themselves of the COVID-19 vaccines. However, it is illegal to use these vaccines without prior approval and compliance of the required technical evaluation from the FDA.
The FDA plays a critical role in protecting the people from threats brought by the pandemic. It was created by law to establish and maintain a drug regulatory system to ensure the purity, safety, efficacy and quality of drugs and vaccines in the country.
It is dedicated to provide guidelines to support medical development and licensure of vaccines. Thus, it has provided FDA Circular No. 2020-036 or the guidelines on the Issuance of Emergency Use Authorization for Drugs and Vaccines for COVID-19.
The FDA is authorized to issue Emergency Use Authorization (EUA) for COVID-19 drugs and vaccines. It requires all pharmaceutical industries and government entities to comply with the process for the application and issuance of the EUA to ensure immediate access to drug products and vaccines for COVID-19.
The EUA shall only be valid when the applicant complies with all the requirements to support its application as well as undergo all the processes like review and recommendations by the Center for Drug Regulation and Research (CDRR) and by an Expert Panel. After which, the Director General shall act on the application either by issuing EUA or a Letter of Disapproval (LOD).
None of these was done by the PSG and other Cabinet secretaries, making the inoculation illegal and unsafe. This is also tantamount to smuggling through black market.
Republic Act No. 3720 or the “Food, Drug, and Cosmetic Act” provides that “adulterated, unregistered or misbranded or any health product, although requiring registration, is not registered with FDA” are all prohibited. Any person violating this can face a penalty of imprisonment and/or a fine.
President Duterte warned Congress to leave PSG alone. He even ordered the latter not to attend the congressional hearing on the controversy.
So what’s next? Will the government condone such illegal act?
We can’t be sure if or when a vaccine will be available. Thus, the guidelines set forth by the FDA provide the key consideration of the entire vaccination process to make sure all vaccines are safe once they are available.
Ignoring the issue on illegal vaccination undermines public health safety and weakens the effort of the government to fight against COVID-19.
As they say, the people’s health is sacrificed for the convenience and privilege of a few.
Despite this, we should still continue using all the tools we already have such as testing, contact tracing, physical distancing, and the use of mask and face shield./PN
