MANILA, Philippines — The government has approved protocols on coronavirus vaccine clinical trials, including the recruitment of vaccine recipients from areas with high number of infections.
The approval of the recommendations of the sub-technical working group for vaccine development is contained in Inter-Agency Task Force for the Management of Emerging Infectious Diseases (IATF) Resolution No. 68 issued on September 3.
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WHO solidarity trial a priority
Under the approved protocols, the World Health Organization (WHO) solidarity trial will be prioritized in the assignment of trial zones. However, independent trials by pharmaceutical firms would not be deprived of trial sites.
Vaccine recipients under the WHO's solidarity trials will be recruited from the "top five to ten barangays reporting high COVID-19 (coronavirus disease 2019) cases" based on the attack rates — the proportion of people infected in an area where a disease previously did not exist — per 1,000 population per barangay.
The data will be provided by the health department's epidemiology bureau. Regional health development offices will monitor the database of all trial participants. The epidemiology bureau, meanwhile, will manage the database, which will include participants' details.
"Trial sites will be at the barangay level and randomization will be by households," the resolution read.
The household census will be obtained from the barangay to identify the residents of the area.
Transient residents will be discouraged from joining the trials unless they can show proof that they will be staying in the trial site for the next two years.
Trial zones
"Independent clinical trials by private vaccine companies will also be assigned trial zones, such that they are equally and rationally distributed to avoid competition in subject recruitment," the resolution read
For outbreak situations, the WHO solidarity trial vaccine teams can move into the affected barangay as long as there is no ongoing independent clinical trial in the area. If there is an existing clinical trial, the WHO team may transfer to the next most adjacent barangay.
To address recruitment shortfalls, the deficit can be taken over by other barangays with faster recruitment to meet the total target sample size.
The interior and science departments may sign memoranda of agreement to authorize the deployment of vaccine clinical trial teams.
"Close coordination with the LGU (local government units) for zoning in barangays will be made. The barangays should be informed to prepare for immunization in case there is an outbreak. There should be a meeting with city health officers to discuss the data needs and considerations for recruitment," the IATD resolution read.
Due to mobility restrictions, alternative modes of follow-up should be adopted like the tapping of barangay health workers or local barangay volunteers and the use of mobile phones for reminders.
The sub-technical working group has also proposed the creation of a separate sub-technical working group on vaccine procurement.
The procurement group should be led by the budget department and should be composed of the health, finance, foreign affairs, interior, and trade departments, the Philippien International Trading Corp., and the National Economic and Development Authority, according to the sub-technical working group's proposal.
"DOH (Department of Health) will decide on which vaccine and number of vaccines doses to be procured, as well as the program of vaccine deployment," the resolution read.