THREE more developers of vaccines for COVID-19 have applied for the conduct of clinical trials in the country, the Department of Science and Technology (DOST) said yesterday.
Science Undersecretary Rowena Cristina Guevara said the applications submitted to the government’s task group on vaccine evaluation and selection came from West China Hospital and Sichuan University and Shenzhen Kangtai Biological Products Co. of China and South Korea’s Eubiologics Co. Ltd.
The DOST chairs a vaccines expert panel that evaluates the applications for clinical trials. The applications are also reviewed by an ethics board.
Guevarra said the applications of the Chinese vaccine developers are undergoing evaluation while Eubiologics is completing requirements.
Earlier, the Food and Drug Administration (FDA) approved the applications of Janssen Pharmaceuticals, Clover Biopharmaceuticals and Sinovac Biotech.
The clinical trials of Janssen, a company based in Belgium and owned by Johnson & Johnson, and of China’s Clover Biopharmaceuticals are ongoing. Sinovac, also a Chinese company, has yet to submit a protocol amendment.
Guevarra said the independent clinical trial aims to determine the safety and effectiveness of the vaccines, including those that were already issued emergency use authority (EUA).
She said the trials also aim to find out the length of the effectiveness of the vaccine, if it would need booster shots to enhance effectiveness, and how it can be tweaked to be more effective especially against the new variants.
Data from these trials would be used by the developers when they apply for a certificate of product registration and commercial use.
Guevarra said the country also expects the World Health Organization (WHO) Solidarity Trial to start in the latter part of June or early July, pending submission to the FDA and the ethics board a final protocol and the list of vaccines to be used in the trial.
Guevarra said the DOST and Department of Health (DOH) will also conduct two “mix and match” clinical trials this year using the current available vaccines.
She said the trial will run for 18 months with then initial output to be submitted to the National Task Force on Vaccine. She said a similar trial is ongoing in the United Kingdom and other countries are also preparing to do similar trials.
The government is doing the mix and match trial due to limited supply of vaccines, most of which are given in two doses.
Guevarra said the mix is likely to be the vaccine from Sinovac, CoronaVac, for the first dose and from another brand for the second dosage.
Most of the current supply of vaccines in the country are from Sinovac. Of the 8.27 million doses of vaccines, Sinovac accounts for 5.5 million doses and the country is expected to receive 4.5 million more doses in June. The country bought 25 million doses of vaccines from Sinovac.
The government is expecting 3.5 million doses this month including the 2.2 million doses from Pfizer through the COVAX Facility.
The National Task Force against COVID-19 said that as of May 24, the government has administered 4.3 million doses with 3.318 million receiving the first dose.
MANUFACTURING
Guevarra said two more companies have expressed interest in manufacturing vaccines in the Philippines, bringing the total to eight.
Of the eight companies, five are planning to produce COVID-19 vaccines while two want to try to produce vaccines for other diseases. One of the companies has yet to decide what vaccine to produce.
President Duterte wants the country to start producing vaccines amid the difficulty in getting supplies and in anticipation of other pandemics.
JAB DEPLOYMENT
The Department of Health said 2 in every three doses of vaccines have been allocated to the National Capital Region (NCR) and four other regions with the most burden of cases.
“The NCR plus 8 areas are composed of NCR, Metro Cebu, Metro Davao, Bulacan, Batangas, Cavite, Laguna, Pampanga, and Rizal. Based on the latest data, 67 percent of the vaccine supply is distributed to NCR, Regions 4A, 3, 7, and 11,” said the DOH.
Batangas, Cavite, Laguna, and Rizal belong to Region 4A while Bulacan and Pampanga are under Region 3. Metro Cebu is under Region 7 while Metro Davao is in Region 11.
The DOH said this shows that it supports President Duterte’s directive to prioritize the NCR Plus 8 areas in the COVID-19 vaccination program.
“The government is eyeing the NCR Plus 8 areas, which have been determined to be the most populous and of highest density, thus putting these at the greatest risk for COVID-19 transmission,” the DOH said.
“Such risks have economic and social implications, which are inherently tied to health and nutrition outcomes,” it added.
What the DOH is opposing, it said, is a proposal to allocate 90 percent of the COVID-19 doses to Metro Manila alone.
“This is not only impractical, but is also inappropriate and inequitable,” it said. — With Gerard Naval
