Fix rules to ensure smooth Covid-19 bivalent vaccine rollout --Concepcion

Go Negosyo founder Joey Concepcion on Saturday, Dec. 10 warned that the “same mistakes” might happen again in the further implementation of the country’s Covid-19 vaccination efforts, particularly with the new bivalent vaccines, if flaws in local healthcare regulation are not fixed.

Go Negosyo Founder Joey Concepcion (Photo courtesy of Go Negosyo)

The former presidential economic adviser raised concerns on the lack of urgency and unclear delineation of the roles of different agencies on the acquisition of bivalent vaccines after he consulted with several medical and policy experts comprising the Advisory Council of Experts, a group he organized to provide guidance to the private sector on matters of public health and the economy.

The group is composed of the country’s foremost authorities on medicine, public health, economics, and research and data analytics.

“We can’t afford to make the same mistakes twice with our bivalent vaccines,” Concepcion said in a statement, noting how delays in decision-making contributed to billions of pesos worth of Covid vaccines being wasted due to expiration.

Bivalent vaccines provide a broad protection against the original Covid-19 virus and a component of the Omicron variant.

In the early days of the pandemic, Concepcion led private sector efforts to procure Covid-19 vaccines through a tripartite agreement that overcame regulatory roadblocks for the vaccines.

The Department of Health (DOH) has announced that it has already reached out to vaccine manufacturers to secure bivalent vaccines against Covid, but they are now waiting for the emergency use authorization from the Food and Drug Administration (FDA).

“This time around, we should know what went wrong, what went right, how to move forward so we can execute well,” public health advocate Dr. Tony Leachon said.

Concepcion is not alone in his concerns since medical experts admitted that the foremost cause of the delays during the Covid response was due to the lack of clarity on the roles of the Vaccine Expert Panel (VEP) and the Health Technology Assessment Council (HTAC).

The experts said there is a duplication of roles and overreach of mandates among the committees that comprise the government’s vaccine bodies.

The VEP, NITAG, HTAC, Food and Drug Administration (FDA), and Formulary Executive Committee (FEC) are just some of these government bodies that handle the procurement, approval, and administration of vaccines.

But while the VEP is under the Department of Science and Technology (DOST), the rest are under the supervision of the DOH.

The primary role of the HTAC is to examine the cost-benefit and effectiveness studies before the government proceeds with procurement while the VEP gives its recommendations regarding age indication and priority populations.

Former DOH Secretary and now Iloilo 2nd district Rep. Janette Garin, said that this process should be followed.

“Unfortunately, it’s not happening that way. HTAC rules. Even if the expert panel or specialty society say otherwise, fear prevails if HTAC does not give the go signal,” she explained.

“Clearly, the functions overlap across the committees. Time to delineate each and maybe collapse one or two,” Dr. Maricar Limpin, immediate past president of the Philippine College of Physicians (PCP), added.

She raised the possibility and practicality of eventually removing the FEC from the equation because its functions overlaps with the FDA.

Limpin said it might be better for tasks such as the assessment of factors for government procurement like cost effectiveness, distribution, and storage, to be relegated to the HTAC, which can then be included in the drug formulary.

“The FEC, tasked to look at drugs to be included in the drug formulary for government procurement and justifies PhilHealth reimbursement, appears to overlap with that of HTAC. Maybe it will be better to collapse the FEC? Or if not, there should be clear delineation of roles to avoid redundancy and speed up the process,” she asked.

The medical experts are also concerned about the “lack of urgency” in decision-making since, as Garin noted, HTAC members do not work full-time at the HTAC while FEC usually conducts its meetings outside the National Capital Region (NCR), which results to more delays.

They also observed that government agencies adhered to their usual roles even when the situation calls for a different response.

“When the private sector was allowed to buy , the least that the government can do is support the inoculation as long as it’s not harmful,” said Garin.

“Separate guidelines for privately procured should have been released but they didn’t want ,” she recalled.

And while the medical experts appreciate the efforts of HTAC, Dr. Benjamin Co, chief medical officer of Metro Pacific Hospital Holdings and OCTA Research fellow, called it “another red tape layer".