MANILA — The Food and Drug Administration (FDA) has established a task force whose primary objective is to make Covid-19 vaccines commercially available in the country.
“Task Force Edward aims to make safe and effective COVID-19 vaccines more accessible to Filipinos,” FDA director general Samuel Zacate said in a statement.
“This initiative will help the current administration to shift its focus from COVID-19 crisis management to a more robust recovery of the national economy,” he said.
According to Zacate, the specialized unit composed of experts will promote the streamlining of the approval and evaluation of SARS-CoV-2 vaccines without compromising their efficacy, quality and safety.
Different Covid-19 vaccines used in the government’s ongoing immunization program were previously granted with emergency use authorization (EUA) by the FDA.
Vaccine manufacturers may already apply for certificate of product registration (CPR) which shall be thoroughly assessed and evaluated by Task Force Edward, Zacate said.
So far, only one Covid-19 vaccine manufacturer has submitted an application for the issuance of CPR with the FDA.
Zacate asked the pharmaceutical industry to complete all requirements and submit their respective applications for the issuance of CPR or marketing authorization.
He stated that Covid-19 vaccines that will be granted CPR will be widely available in FDA-approved drug stores.
Zacate emphasized that any post-market issues will be addressed through more rigorous surveillance and pharmacovigilance.
Earlier, Department of Health officer-in-charge Maria Rosario Vergeire reported that Janssen Pharmaceuticals has already applied for commercial distribution of SARS-CoV-2 vaccines in the country.
According to Vergeire, the CPR application of Janssen is now under thorough evaluation and may possibly be granted by the FDA early next year.
Transition out of pandemic
Go Negosyo founder Joey Concepcion said the FDA’s plan to make Covid-19 vaccines commercially available through CPR will greatly aid the country’s transition out of the pandemic.
“The FDA’s efforts to expedite the granting of CPRs will further promote vaccinations in the Philippines,” Concepcion said in a statement yesterday. “These are in line with what we in the Advisory Council of Experts (ACE) have recommended to the President back in July.”
Along with a group comprising medical doctors, scientists and academics comprising the country’s foremost authorities on public health, molecular biology, disaster resilience, data insight and analysis, and economics, Concepcion earlier recommended to President Marcos the adoption of several measures as part of the country’s pandemic strategy.
Prioritizing the granting of CPRs to make the vaccines commercially available was one of the recommendations.
While the country is still in a state of public health emergency, which will end in September unless extended by the President, COVID vaccines are currently available through EUA.
“We at ACE are happy that one by one our recommendations to the President are being considered,“ Concepcion said. “These recommendations are based on science and data, and take into account the urgency that is needed in taking action so our country can safely transitionto normalcy and continue to keep the economy afloat.”
One Reply to “FDA to permit commercial sale of Covid-19 vaccines”