Set rules to ensure smooth deployment of bivalent Covid-19 vaccine --Concepcion

Set rules to ensure smooth deployment of bivalent Covid-19 vaccine –Concepcion

Go Negosyo founder Joey Concepcion warned on Saturday December 10 that the “same mistakes” could happen again in the continued implementation of the country’s vaccination efforts against Covid-19, especially with the new vaccines. bivalents, if loopholes in local health care regulations are not corrected. .

Joey Concepcion, founder of Go Negosyo (Photo courtesy of Go Negosyo)

The former presidential economic adviser expressed concern about the lack of urgency and unclear delineation of the roles of different agencies on the acquisition of bivalent vaccines after consulting with several medical and policy experts including the Expert Advisory Board, a group he organized to provide advice. to the private sector on public health and economic issues.

The group is made up of the country’s leading authorities on medicine, public health, economics, research and data analysis.

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

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

Early in the pandemic, Concepcion led private sector efforts to procure Covid-19 vaccines through a three-party agreement that overcame regulatory hurdles for vaccines.

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

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

Concepcion is not alone in his concerns as medical experts have admitted that the main 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).

Experts said there was duplication of roles and overreaching of mandates among the committees that make up the government’s immunization bodies.

The VEP, NITAG, HTAC, Food and Drug Administration (FDA), and Formulary Executive Committee (FEC) are just a few of these government agencies that manage the supply, approval, and administration of vaccines. .

But while the VEP falls 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 review cost-effectiveness and effectiveness studies before the government proceeds with procurement, while the VEP makes recommendations regarding age indication and priority populations.

Former DOH Secretary and now Iloilo 2nd District Representative Janette Garin said this process should be followed.

“Unfortunately, it’s not like that. HTAC rules. Even if the group of experts or the specialized company says otherwise, fear prevails if the HTAC does not give the starting signal,” she explained.

“Obviously, the functions overlap between the committees. It’s time to delineate each one and maybe narrow one or two,” added Dr. Maricar Limpin, outgoing president of the Philippine College of Physicians (PCP).

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

Limpin said it might be best if tasks such as evaluating factors for government procurement such as profitability, distribution and storage were relegated to the HTAC, which can then be included in the drug formulary.

“The FEC, responsible for reviewing drugs for inclusion in the public procurement drug formulary and justifying reimbursement from PhilHealth, appears to overlap with that of the HTAC. Perhaps it will be better to collapse the FEC? Or if not, there should be a clear delineation of roles to avoid redundancy and speed up the process,” she asked.

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 the FEC usually holds its meetings at the outside the National Capital Region (NCR), which results in more delays.

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

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

“Separate guidelines for private purchases should have been issued, but they did not want [that]“, she recalls.

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



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