Health Secretary Francisco Duque III on Friday assured the public the Department of Health would provide a detailed roadmap for the procurement of a COVID-19 vaccine.
Duque, during a Senate hearing last month, said the Philippines was in close collaboration and negotiation with several international pharmaceutical companies that are currently frontrunners in the development of COVID-19 vaccines.
The IATF also approved in its Resolution 68 the creation of a separate sub-Technical Working Group on Vaccine Procurement that will be headed by the Department of Budget and Management-Procurement Service. DOH, as a member of the sub-TWG, will determine the appropriate vaccine deployment program including the vaccine to be procured and the required number of doses.
Prior to the rollout, the country will participate in clinical trials of advanced COVID-19 vaccine candidates.
“The FDA, the DOST and the IATF-Sub-Technical Working Group on Vaccine Development are closely monitoring foreign pharmaceutical companies who will conduct local clinical trials here in the country to ensure the vaccine’s quality, safety, and efficacy,” Duque explained.
Aside from independent vaccine trials, the Philippines will also participate in the World Health Organization’s Solidarity Trial for Vaccines, a global effort to rapidly develop and evaluate possible candidate vaccines against the COVID-19.
Once a viable vaccine for procurement is identified, the Department will provide a detailed roadmap for its procurement and rollout.
The details would include its budget, financing scheme, pricing schemes, interim reimbursements of vaccines, clinical trial insurance for side effects, participation fees for volunteers to the testing, and other specific guidelines.
To expedite procurement, DOH, as supported by the Health Technology Assessment Council, Food and Drug Administration, and the Philippine Medical Association, also proposed to waive the required Phase IV clinical trials, specifically for COVID-19 vaccines and medications in the Bayanihan II (Bayanihan to Recover as One Act).
The bill, including the proposed provision, has passed the Congress and is President Rodrigo Duterte’s signature.
“We acknowledge the limitations of the law in meeting the urgent needs to address a pandemic given the severity posed by the SARS-COV-2 virus, particularly in immediate access to much-needed vaccines. Rest assured that DOH, together with the rest of government and its partners, will act swiftly given the evolving study of the virus and the uncertain development of the situation,” Duque said.
Meanwhile, Health Undersecretary Maria Rosario Vergeire said the World Health Organization’s solidarity trial for COVID-19 vaccines might start in the Philippines by the end of October.
Vergeire said health authorities would first coordinate with local government leaders and stakeholders to inform them of the advantages and risks of the vaccine trial.
By the third week of October, the initial roll-out of the WHO solidarity trial for COVID-19 vaccines might start in selected areas.
The Department of Science and Technology said that around eight vaccines would be included in the WHO trial.
While vaccine developers are negotiating separately with the Philippines, the government said it would prioritize the WHO trial, which would allow simultaneous testing of several vaccines in different countries.
Currently, the Philippines is also in talks with vaccine developers from Russia and China.
She said the other vaccines were still under negotiation, including the ones from Chinese companies Sinovac and Sinopharm.
“Their confidentiality agreement we have already transmitted to them,” she said, adding that they cannot reveal more information until they get the response from the Chinese companies.
In a related development, the Philippine clinical trials on anti-flu drug Avigan have yet to start, more than a month after the country received the drug from the Japanese government, the Department of Health said on Friday.
The DOH said requirements for the clinical trials, which seek to test how effective Avigan is against COVID-19, were almost complete.
The DOH earlier said that the Avigan clinical trial would start in August but that was moved to September 1.
However, the clinical trials did still not push through because of pending requirements, specifically the ethics review board approvals of the participating hospitals.
The database is among the requirements needed to assess the results of the clinical trial.
Vergeire said that once the database and agreements are finalized they could already start.
She said the DOH legal office already gave comments on the clinical trial agreement and the team handling the trial is already responding to it, “so we can expedite the clinical trial agreement.”