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While the World Health Organization noted that as of September 22, 2020, there were nine candidate vaccines for Covid-19 already in Phase 3 of its clinical trials, the country’s Food and Drug Administration (FDA) has yet to has not received any application for clinical trials in the Philippines.
FDA Director General Dr. Eric Domingo said that the Vaccine Expert Panel (VEP), which is led by the Department of Science and Technology, is currently reviewing two applications for clinical trials to be conducted in the Philippines. However, they have not been referred to the FDA as the vaccine proponents are still completing the necessary documents.
“So officially, the FDA has not approved any clinical trial applications. The expert panel is currently reviewing documents submitted by the Russian vaccine company for Johnson and Johnson’s Sputnik and Janssen. Their goal is to begin clinical trials at the end of October. There is no mention of a Chinese pharmaceutical app at this time, ”said Dr. Domingo.
Dr. Domingo was one of the panelists for the webinar “Understanding the Leading-edge Vaccine Development Landscape” hosted by the Philippine Pharmacists and Health Association. Philippine Foundation for Vaccination and Philippine Medical Association.
Regulatory perspective
In his presentation, Dr. Domingo explained the regulatory perspective on vaccine development. The FDA oversees two aspects of the drug development process. First is to regulate clinical trials and second is the Product Registration Certificate.
“If you want to conduct a clinical trial in the Philippines, all facilities must obtain a license to operate from the FDA as a clinical sponsor or as a contract research organization. [CRO], “he said.” The application is considered filed upon full submission of the documentary requirements, including payment of fees and charges. “
The request will be evaluated based on the integrity and veracity of the documents presented and compliance with the corresponding standards. Generally, it takes the FDA 60 days to process a regulatory request.
For Covid-19 vaccines, the FDA evaluation process has been shortened to 40 days as all applications will first be submitted to the Vaccine Development Sub-Working Group under the Interagency Task Force on Emerging Infectious Diseases (IATF) and the DOST was created. a VEP that will simultaneously review the protocol.
Registry of clinical trials
If the application is approved by the VEP and the Board of Ethics, the application and completed documents will be sent to FDA. Then the FDA will evaluate and give the final decision. Dr. Domingo reiterated that the FDA does not conduct clinical trials. They regulate clinical trials.
Once the FDA has approved the clinical trial, the sponsor must fulfill the following responsibilities:
Upload information about the clinical trial to the Clinical Trials Registry, which is publicly accessible. This must be done within 30 calendar days of approval.
They have to provide periodic study reports to the FDA. For long-term projects, these reports are annual. For Covid-19, it will be more frequent, possibly monthly. Sponsor is responsible for expediting all reports of potential unexpected serious adverse effects to FDA in accordance with international standards.
When the trial comes to an end, whether it has actually ended or due to unexpected adverse events, the CRO is responsible for completing the study; Y
The FDA can also inspect the clinical trial at any time, especially in areas where Covid is present.
Once the FDA approves the CRO’s application, the clinical trial can continue. Even before reaching the clinical trial stage, the candidate vaccine must undergo a preclinical evaluation that complies with good laboratory practice, production, characterization, and quality assurance guidelines.
“The preclinical evaluation examines the toxicity and the safe tests, the potency of the vaccine, the immunogenicity or the ability to produce an immune response in the body and the presence of adjuvants and additives,” said Dr. Josefina Carlos, a pediatric specialist in diseases and clinical essayist of the Vaccine Study Group.
Phases of the clinical trial
The phases of the vaccine trial are Phase 1, in which 20 to 50 healthy volunteers are selected to investigate the safety and immunogenicity of the vaccine. Phase 2, for its part, defines the optimal dose and schedule and the safety profile of the vaccine. Several hundred high-risk subjects are selected for this study. Phase 3 involves thousands of subjects ranging from 3,000 to 5,000 people who will be studied to determine the safety and efficacy of the vaccine on a large scale.
“Based on the data collected in Phase 3 and if the candidate vaccine is determined to be safe and effective, the manufacturer can now apply for marketing authorization,” said Dr. Carlos.
“After the FDA has evaluated that the candidate vaccine is safe and effective, the manufacturer will obtain its certification and the vaccine will now be available to the public.”
The follow-up, however, does not stop there, as Dr. Carlos explained that the vaccine will still need to undergo post-marketing surveillance or Phase 4, also known as the post-marketing phase. The government has a committee that investigates this and the trial subjects will be the entire population. The main objective of the post-marketing phase is to evaluate the safety of the vaccine.
“The term for classic vaccines is 10 to 15 years. However, since we are in the middle of the Covid-19 pandemic, there is a race to finish the development of the vaccine in 12 to 18 months, ”said Dr. Carlos.
Dr. Domingo clarified that clinical trials do not have to take place in the Philippines. Clinical trials may have already been conducted in other countries, and with adequate support from the World Health Organization or foreign counterparts to the FDA, these candidate vaccines may be submitted for in-country registration applications.
“It is possible that by the end of the year or the beginning of next, we already have the registration requests. Our goal is that once the vaccine manufacturers have applied to us and have been approved elsewhere, we set 45 to 60 days for evaluation and approval here, ”said Dr. Domingo.
