EIGHTEEN areas have been identified as sites for the conduct of independent phase 3 clinical trials for three candidate vaccines against coronavirus disease 2019 (Covid-19), an official of the Department of Science and Technology (DOST) said.
The vaccines were developed by Johnson & Johnson subsidiary Janssen Pharmaceuticals, Clover Biopharmaceuticals and Sinovac Biotech.
Janssen, which developed candidate vaccine JNJ-78436735, will conduct trials in Makati City, San Pablo and Cabuyao in Laguna, Iloilo City and Bacolod City.
Clover Biopharmaceuticals, Australian subsidiary of Sichuan Clover Biopharmaceuticals of China, will hold clinical trials for its S-Trimer vaccine, or SCB-2019, in the cities of Quezon, Makati, Manila, Taguig, Las Piñas and Muntinlupa, as well as in Calamba, Laguna and Dasmariñas, Cavite.
Sinovac will conduct clinical trials for CoronaVac in the cities of Quezon, Marikina and Pasay, as well as in Alaminos, Laguna.
DOST Undersecretary for Research and Development Rowena Guevarra said the three companies are expected to begin their clinical trials “soon.”
Guevarra also said they were awaiting the guidance of the World Health Organization (WHO) on the conduct of the solidarity trial.
Cristina Torres of the Forum of Ethical Review Committees in Asia and Pacific said the identification of the areas where trials will be held depends on the number of Covid-19 cases and the data provided by the Epidemiology Bureau.
She said an independent clinical trial is hospital-based while the solidarity trial will be community-based.
Beverly Ho of the Department of Health, Health Promotion Bureau said barangays cannot be forced to participate in a clinical trial but they are being encouraged.
A crucial step
Jaime Montoya, executive director of the DOST-Philippine Council for Health and Research and Development, said clinical trials provide basis and scientific evidence that a vaccine or a drug is safe for humans and is effective against a certain disease.
Without a clinical trial, he said the FDA will not approve the use of a medicine or vaccine in the country.
“It is a crucial step before any product for our use is approved by the FDA,” he said.
Clinical trials have three phases after the pre-clinical stage of development, during which vaccines or medicines are administered on animals.
In the first phase of clinical trials, vaccines or drugs are tried on 10 to 100 people to assess its safety. The second phase involves over 100 but less than 1,000 participants. A larger group is needed for the third phase.
Participants should be “completely voluntary.” They will first be screened and will be briefed about the trial and the vaccines and will undergo physical examination and review of health history.
They will be divided into two groups. One group will receive the vaccine while the other will receive the placebo, or fake vaccine.
Torres said the three companies are looking for healthy adult volunteers who are 18 years and above, including senior citizens.
Pregnant women are not allowed to participate in the trials.
Participants should be aware of the necessary protocols of the trial and should be advised to keep a diary card where they will jot down the symptoms and other health observations following the vaccination.
They would be given schedules for follow-up check-up and they will be monitored for a maximum of 18 months.
Montoya said the conduct of the independent clinical trials should still adhere to the protocols of the FDA which includes insurance to the participants for any eventualities.
He said despite undergoing trial vaccination, participants should still follow health protocols to avoid contracting the virus. (SunStar Philippines)