FDA to allow commercial sale of COVID-19 vaccines

MANILA, Philippines — The Food and Drug Administration (FDA) has launched a task force whose primary aim 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.

Zacate said 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.

The FDA previously granted emergency use authorization (EUA) to different COVID-19 vaccines used in the government’s ongoing immunization program.

Zacate said vaccine manufacturers may already apply for certificate of product registration (CPR) which shall be thoroughly assessed and evaluated by Task Force Edward.

Only one COVID-19 vaccine manufacturer has so far submitted an application for the issuance of CPR with the FDA.

Zacate urged the pharmaceutical industry to complete all requirements and submit their respective applications for the issuance of CPR or marketing authorization.

He said COVID-19 vaccines that will be granted CPR can become readily available in FDA-licensed drug establishments.

Zacate stressed that any post-market issues shall be addressed through more rigorous surveillance and pharmacovigilance.

Department of Health officer-in-charge Maria Rosario Vergeire previously reported that Janssen Pharmaceuticals has already applied for commercial distribution of SARS-CoV-2 vaccines in the country.

Vergeire said 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

The plan of the FDA to make COVID-19 vaccines commercially available through CPR will greatly help in the country’s transition out of the pandemic, according to Go Negosyo founder Joey Concepcion.

“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.”

Concepcion, 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, earlier recommended to President Marcos the adoption of several measures as part of the country’s pandemic strategy.

Among the recommendations was the prioritization of the granting of CPRs to make the vaccines commercially available.

COVID vaccines are currently available through EUA while the country is still under a state of public health emergency, which, unless extended by the President, will expire this September.

“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.” – Catherine Talavera