7 firms sign CDA for vaccine trial candidates

Published September 10, 2020, 3:23 PM

by Dhel Nazario

Seven companies have signed a Confidentiality Data Agreement (CDA) providing complete information about their COVID-19 vaccine candidates to be reviewed by the Vaccine Expert Panel for the possible conduct of clinical trials in the country.

Gamaleya National Research Center for Epidemiology and Microbiology who will be manufacturing the Sputnik 5 vaccine was the first to sign the CDA together with the Russian Direct Investment Fund, who will fund it, according to DoST Secretary Fortunato dela Pena during the ”Laging Handa” press briefing.

The five others were from the United States; Australia; Adimmune Corp. from Taiwan; Sinovac Biotech Ltd. from China; and Sinopharm of China.

Dela Pena said that the Vaccine Expert Panel who is part of the Sub-Technical Working Group for Vaccine Development will study the data provided by the companies and if the results are good. They will forward it to the Food and Drug Administration (FDA) who will analyze it and decide if it will be allowed to conduct clinical trials.

Whether their vaccine has only reached the Phase 1, Phase 2, or Phase 3 of their clinical trials, they will disclose all information under the agreement.

There are two types of vaccine clinical trials, Dela Pena explained. One is the independent trials and the other is the World Health Organization (WHO) Solidarity Trials who will be needing less volunteers since there are about 80 countries who will be participating. In the Philippines, it may need only about 1,000 volunteers. Its trials are expected to last for six months and is expected to start by November.

On the other hand, the independent trials which will just be conducted in the country and nowhere else, will require around 6,000 volunteers. As for the Sputnik V, an independent trial, will be conducted in different countries such as their own, the Philippines, Brazil, Saudi Arabia, and the United Arab Emirates, reducing the number of volunteers.

Dela Pena added that the Inter-Agency Task Force on Emerging Infectious Diseases (IATF-EID) has approved the DoST’s recommendations on zones where trials can be conducted. He said that six will be in Metro Manila. one in Calabarzon, and one in Cebu.

Vaccine recipients under the WHO Solidarity Trials will be recruited from the Top 5 to 10 barangays reporting high COVID-19 cases, based on the attack rates per 1,000 population per barangay.