Trial zone assignment will be prioritized for the conduct of the World Health Organization (WHO) Solidarity Trials according to one of the recommendations of the Sub-Technical Working Group for Vaccine Development chaired by the Department of Science and Technology (DOST).
Under Resolution no. 68 dated September 3, 2020 by the Inter-Agency Task Force on Emerging Infectious Diseases (IATF-EID), while WHO will be prioritized, independent trials should nonetheless be considered in such a way that these will not be deprived of trial sites.
The IATF-EID approved a total of nine recommendations by the Sub-TWG to address some concerns on COVID-19 vaccine clinical trials. These were mentioned by DOST Secretary Fortunato dela Pena during a Palace press briefing on Monday.
It stated that vaccine recipients under the WHO Solidarity Trials will be recruited from the top five to ten barangays reporting high COVID-19 cases, based on the attack rates per 1,000 population per barangay.
The data will come from the Department of Health - Epidemiology Bureau (EB), DOH CHDs (Regional Offices) will be responsible for monitoring, and DOH EB for managing the database of all trial participants and monitoring data at the regional, provincial, city and barangay levels.
Trial sites will be at the barangay level, and randomization will be by households. The household census will be obtained from the barangays to identify residents to ensure follow up. Transient residents will be discouraged unless they can show proof that they will be staying in the area or the trial site for the next two years.
The resolution also stated that 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.
Meanwhile, for outbreak situations, WHO Solidarity Trial Vaccine teams can move into the affected barangay provided that no independent Clinical Trial is going on or is being conducted at such time. In such a case, the next most adjacent barangay may be considered for the WHO Solidarity Trials vaccine teams.
To address shortfalls in recruitment by specific barangays, the deficit can be taken over by other barangays with faster recruitment to meet the total target sample size.
A Memorandum of Agreement is also proposed between the Department of Interior and Local Government (DILG) and DOST, witnessed by appropriate LGU officials and the Vaccine Teams.
The resolution also stated that a communication plan for the COVID-19 vaccine clinical trials should consider different levels of LGU and the criteria and considerations for recruitment such as, for example, transmission rate cutoffs. Close coordination with the LGU 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.
Considering the restriction in mobility due to enforcement of general community quarantine in some areas, alternative modes of follow-up should be put in place such as the use of Barangay health workers or local barangay volunteers, including utilization of cellphones for reminders.
Lastly, the creation of a separate Sub-Technical Working Group on Vaccine Procurement to be led by the Department of Budget and Management-Procurement Service, with the Department of Health, Department of Finance, Department of Budget and Management, Department of Foreign Affairs, Department of Trade and Industry.