A vaccine said to be manufactured in China, with Chinese characters on the packaging, is reportedly being sold here by unscrupulous businessmen to overeager and gullible victims made to believe it’s safe and effective.

We knew there would always be enterprising businessmen who’d capitalize on the new coronavirus disease (COVID-19) phobia, by smuggling into the country batches of these vaccines still under trial, and selling them at a premium. We warned readers about it, but we didn’t realize it would happen this soon.

Former Health Secretary Esperanza Cabral has already informed Food and Drug Administration (FDA) Director General Rolando Enrique Domingo, and we’re sure he’ll issue a public advisory about it.

Those who already had themselves vaccinated should also inform the FDA so they could be observed for any untoward reactions in the short and long term, based on the study protocol for that vaccine.

The vaccine being sold may not necessarily be fake, but one thing for sure is that our local FDA has not approved it yet for commercial use, since all clinical trials are still ongoing for the vaccines in the pipeline.

Some doctors in the Philippines could be taking part in the clinical trial for this vaccine, but the subjects should sign an informed consent that they’ve volunteered to be in a clinical trial to determine if the vaccine is really safe and effective. It should not be sold to the subjects, unlike what the supplier of this made-in-China vaccine is doing.

Clinical trials

The clinical trial for the vaccine itself should be approved by the FDA.

Last month, Presidential spokesperson Harry Roque announced that the government has entered into an agreement with Beijing-based Sinovac Biotech for its vaccine and antiviral trials.

Aside from Sinovac, other government partners in vaccine trials are Adimmune Corp., Academia Sinica, Chinese Academy of Science-Guangzhou Institute of Biomedicine and Health, and SinoPharma–Wuhan Institute of Biological Products.

We hope the vaccine being sold here is not from the stocks intended for clinical trials.

While a vaccine is the silver bullet against the pandemic, it could have adverse effects in the long term but which are not initially apparent. That’s why it must undergo extensive clinical testing with long-term observation.

There’s also no guarantee that one shot of the vaccine would be effective for lifetime immunity. It may be like the flu vaccine that has to be given yearly or the pneumonia vaccine given every five years, although there’s a newer preparation that requires only two vaccinations one year apart, and it’s supposed to give lifetime immunity.

We have our doubts about this, as we’ll explain in a while.

Treatment worse than disease

It’s still a blur for the COVID-19 vaccine. I will support and endorse a thoroughly studied/clinically tried vaccine for COVID-19, not one where corners are cut just to expedite its mass use.

Like we keep saying, sometimes the treatment is worse than the disease itself. It’s easy to come up with an effective antibody-producing vaccine, but if it causes serious side effects, that’s not what you signed up for.

At the rate the COVID-19 vaccine race is being run, I’m afraid some safety corners have been cut just to expedite their release. Our advice to everyone, especially our loved ones, is, should a vaccine become available soon, before year’s end, wait at least nine months before getting one. Let all the issues of the vaccine get resolved before we commit ourselves to it and its long-term effects.

You could be exposing yourself to potential vaccine side effects—unnecessary dangers that could be more serious than COVID-19 risks. Even if the risk of a serious, long-term side effect from any of the vaccines is very small, say, just 0.1 percent, or one in a thousand, if we vaccinate the entire Philippine population, that means that around 105,000 Filipinos will have to endure a serious, disabling, possibly permanent side effect of the vaccine.

Compare that to the benefit of avoiding COVID-19 risks, the most serious of which is death. Even if we peg the risk at 5,000 deaths, the balance still tilts heavily to the 105,000 who might have serious side effects.

Potential complications

If one is able-bodied and has a normal immune system, he or she is better off without the vaccine and should rather take a chance of getting COVID-19 and likely surviving it.

Preclinical trials to determine the safety and efficacy of the vaccines should include a sufficient number of subjects, ideally in the thousands. At the rate the global race on COVID-19 vaccines is being run, the number and duration of trials have apparently been reduced to fast-track approval.

Actually, some experts have concerns that, ironic as it may sound, some vaccines could potentially worsen the complications of COVID-19 instead of giving protection.

We’ve heard of this paradoxical reaction to vaccination with the now infamous dengue vaccine. If we recall, the dengue vaccine, which was supposed to protect children from dengue fever, was noted to increase hospitalization risk and other complications in certain subsets of children.

If given to the wrong set of patients, a vaccine could cause a phenomenon called antibody-dependent enhancement (ADE). This complication has also been observed in previous clinical trials on coronavirus vaccines.

Fueling the concern is the research observation that antibodies typical of ADE are seen in the blood of some COVID-19 patients. So, there’s prima facie evidence to be really wary of COVID-19 vaccines.

There should be full transparency with all data, including preclinical trials, on the safety and efficacy of all candidate vaccines, which should be subjected to stringent peer review.

Questionable efficacy

Some experts contend that some COVID-19 vaccines have questionable efficacy.

One or two vaccines have been allowed to undergo human clinical trials, although in preclinical animal studies, they have not been shown to be effective in protecting monkeys from infection of the nose and throat passageways, which are the primary route of infection in humans. This was identified as the cause of failure of vaccines being developed for other previous coronavirus infections like severe adult respiratory syndrome and Middle East respiratory syndrome.

To be fair, all candidate vaccines have been shown to favorably modulate immune system responses. This is good, but one can argue that even without a vaccine, one can boost one’s immune system with a healthy lifestyle that includes exercise, dietary antioxidants, sunlight and adequate sleep, and some natural supplements like melatonin, zinc, and vitamins A, C and D.

Another concern about vaccines is that, in general, older people are not so responsive to the favorable effects, and could be more susceptible to the unfavorable side effects. Resistance or inadequate favorable response to vaccination has been observed early, starting at age 30, and becomes progressively more significant with aging. In infections like COVID-19, where the ones at greatest risk are the elderly, the rationale for vaccination is weak.

For some vaccines, this relative resistance in the elderly is overcome by giving repeated doses and by enhancing the potency of the vaccine by coadministering it with powerful adjuvants like melatonin.

But again, the concern is that as we potentiate the vaccine, the risk grows, with unfavorable side effects. So, it could be a double-edged sword.

As we weigh the pros and cons of getting any FDA-approved vaccine, there’s the cardinal rule—“First, we must do no harm,” and it‘s better to err on the side of caution than to rush on the side of folly. INQ