Hubris, ineptness, and the vaccine program

By: Solita Callas-Monsod - @inquirerdotnet - Columnist/Philippine Daily Inquirer | February 27,2021 - 08:00 AM

Food and Drug Administration (FDA) Director General Eric Domingo showed a lot of balls when he gave Sinovac’s CoronaVac the green light for emergency use authorization (EUA), but with a recommendation that it not be used for frontline health workers and for the elderly. The way the Senate jumped on him—Tito Sotto, Panfilo Lacson, Francis Pangilinan—together with other members of Congress, you would think that the FDA had not done its homework.

And President Duterte was right to back him up (although he was called to the Palace to explain the FDA’s decision)—science over politicians. On the other hand, this whole brouhaha would not have occurred if our Sinophile President had not been given second-class treatment by the subject of his admiration, China (either that, or some people are going to make a heck of a money from the government’s procurement of a second-class vaccine).

The President has shown his marked preference for the state-owned Sinopharm, whose vaccine has an efficacy rate along the order of 79 percent. In fact, the vaccines given to his Presidential Security Group, some congressmen, some Cabinet members, and of late Ramon Tulfo, are Sinopharm vaccines. But instead the Philippines has ordered 25 million vaccines from Sinovac, whose efficacy rate is a scandalously low 50.4 percent, barely qualifying it for the World Health Organization’s approval (the minimum acceptable rate is 50 percent). And Sinopharm has not even applied for EUA, although the Chinese ambassador said early this month that it would.

Apparently, the data that the FDA studied showed that the Sinovac vaccine had an efficacy rate of 65.3 percent (Indonesia)—91.2 percent (Turkey) for clinically healthy people 18-59 years old, but an efficacy rate of only 50.4 percent for the high-risk groups. It is to be hoped that the FDA bashers understand this point.

And that’s the other thing about Sinovac (and Sinopharm): According to several news reports, they are remarkably untransparent with their data. Shouldn’t that give anyone pause?

And yet, the Department of Health (DOH), per our vaccine czar Carlito Galvez Jr., ordered 1 million doses of Sinovac’s vaccines. If this is true, then the questions arise: Don’t the FDA and the DOH talk to each other? Or was the DOH playing politics? Can it be any wonder that Domingo, whose balls I admired earlier, has softened his position (no pun intended), saying that if the health workers want the CoronaVac, they can get it. What kind of talk is that? If the vaccine is being paid for by the government, shouldn’t government’s advice be heeded? If the health workers pay for the CoronaVac on their own, of course that’s a different story.

By the way, Dr. Antonio Dans, head and spokesperson for the Healthcare Professionals Alliance Against Covid, is reminding everyone concerned that under Section 34 of the Universal Health Care Act (Republic Act No. 11223), investments on any health technology (like a vaccine) by the DOH should have a positive recommendation from the Health Technology Assessment Council (HTAC). The HTAC is having trouble evaluating CoronaVac because of the paucity of data available from Sinovac.

It may interest you to know, Reader, that among the criteria that the HTAC must consider, aside from safety and effectivity, is cost effectiveness—and yet, we still don’t know what the cost of CoronaVac will be to us. The recent statement of Galvez, that the Philippines will be willing to pay a premium so long as it gets the vaccines sooner (or this year), gives us very cold comfort. Aside from being an open sesame to corruption, this statement essentially is an open admission that the country had embarked on this vaccination program after overly long delays that smack of government ineptness.

It is more than a pity that the Filipino people, along with the vaccine reluctance brought about by their Dengvaxia experience, have to contend with another poor vaccine whose efficacy and cost effectiveness are in question, all because of the hubris of their government officials. And it is increasingly clear that the “Philippine National Deployment and Vaccination Plan for COVID-19 Vaccines Interim Plan” needs major surgery, if it is not already stillborn.

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TAGS: China, CoronaVac, Duterte, FDA, Health Care Professionals Alliance Against Covid, Health Technology Assessment Council, second-class treatment, Sinopharm, Sinovac, WHO, World Health Organization

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