AFTER a thorough review of their application, the Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) to Pfizer-BioNTech Covid-19 vaccine as its interim data from the ongoing Phase 3 trial showed that the vaccine has an efficacy of “95 percent” in the study population and at least “92 percent” among all racial groups.
In a media forum of the Department of Health (DOH), FDA Director General Enrique Domingo said that after careful consideration, the application of Pfizer satisfies the conditions of an EUA:
1. Based on the totality of evidence available to date, including data from adequate and well- known controlled trials, it is reasonable to believe that the Pfizer-BioNTech Covid-19 Vaccine may be effective to prevent, diagnose, or treat Covid-19;
2. The known and potential benefits of the Pfizer-BioNTech Covid-19 Vaccine, when used to diagnose, prevent, treat Covid-19, outweigh the known and potential risks of said vaccine as of date; and
3. There is currently no adequate, approved and available alternative to the product for diagnosing, preventing or treating Covid-19.
Scope
After the granting of the EUA, Domingo said the vaccine maker must undertake the following:
First, Pfizer Inc. (Philippines) shall supply Pfizer-BioNTech Covid-19 Vaccine only to emergency response stakeholders consistent with the terms and conditions of the EUA, including Department of Health (DOH), or the National Task Force Against Covid-19 (NTF), or their designees authorized to procure Pfizer- BioNTech Covid-19 Vaccine in line with the Covid-19 vaccination program. Designees may include hospitals (public and private), health facilities of other national government agencies, local government units (LGUs) and other members of the private sector.
Second, Pfizer- BioNTech Vaccine shall be administered only by vaccination providers, and used only to prevent Covid-19 in individual ages 16 and older.
Domingo also reminded the firm to comply with Current Good Manufacturing Practice (GMP) requirements. Pfizer Inc. (Philippines) shall also submit to the FDA quarterly manufacturing reports of the Pfizer-BioNTech Covid-19 Vaccine.
Cold chain management
IN the absence of agreement with the DOH or NTF, Pfizer Inc. (Philippines) was required to provide appropriate cold chain requirements for storage, transport and handling until it is delivered to the inoculation sites and ensure that a contingency plan is in place.
Pfizer Philippines was, likewise, bound to ensure it has a system of monitoring to ensure traceability and that the vaccine is consistent with the storage requirements from the manufacture and transport to the inoculation sites.
Meanwhile, the Emergency Response Stakeholders and Vaccination Providers were also given marching orders.
Emergency response stakeholders shall:
1. Identify vaccination sites to receive the Pfizer-BioNTech Covid-19 Vaccine and ensure appropriate storage and cold chain management is maintained;
2. Ensure administration of the Pfizer-BioNTech Covid-19, consistent with the terms of the FDA Letter embodying the EUA, latest updated product information and the Covid-19 Vaccination program; and
3. Ensure that vaccination providers of their procured Pfizer-BioNTech Covid-19 Vaccine are aware of the FDA Letter of Authorization and its terms herein and any subsequent amendments.
Vaccination providers, on the other hand, were mandated to:
1. Administer the Pfizer-BioNTech Covid-19 Vaccine, in accordance with this EUA, and participate and comply with the terms and training required by the DOH for the Covid-19 Vaccination Program;
2. Provide fact sheets to the recipients and caregivers and provide necessary information for receiving their second dose;
3. Obtain written informed consent from the recipient of the Pfizer-BioNTech Covid-19 Vaccine prior to vaccination;
4. Report any adverse events following immunization on the use of Pfizer- BioNTech Covid-19 Vaccine.
Domingo said the EUA shall be valid only “within the duration of the declared public health emergency” due to Covid-19, or upon issuance of a marketing authorization/Certificate of Product Registration.
Evaluation
The FDA official said that the evaluation was based on current available data and that the assessment ensured that the benefits outweigh the known and potential risks of the product.
According to Domingo, the safety and efficacy were reviewed by a panel of clinical experts and the quality data was reviewed by technical experts from FDA Center for Drugs Regulation and Research (CDRR).
Adverse events following immunization shall be closely monitored. Domingo noted that, “The rollout of the vaccine and use in more than 5 million people worldwide has identified severe allergic reaction in a few individuals.”
As such, he added, “The vaccinations must be done by health professionals trained to recognize and manage adverse reactions and they should have resources at hand to adequately respond.”
Reporting of the patient’s response to the vaccine shall be through the pharmacovigilance system, to be activated once the vaccination program is implemented.
Through Executive Order 121, Series of 2020, vaccines under development may be granted an EUA where there is no adequate, approved and available alternative to a vaccine for preventing Covid-19 during this present public health emergency.
The granting of the EUA is not a marketing authorization, or a Certificate of Product Registration, and thus cannot be used to market the vaccine commercially, the FDA pointed out.
Domingo assured the public that FDA is committed to continue its job to ensure that Filipinos can have access to vaccines that hold greater benefits and outweigh the risk and possible adverse effects during this time of pandemic.
“The development of these vaccines is still ongoing. We will keep track of the progress and FDA will provide our public with the correct information on the authorized products for transparency, to aid the decision-making of Filipinos,” Domingo said.