Motto of the famed Special Air Service (SAS), the highly secretive special forces unit of the British Army succinctly states: “Who Dares, Wins.”
Now, those many daring souls out there, mebbeso you want to be also counted as one of the frontliners, but a frontliner, indeed, of another breed?
Because you believe you have that compassion, kindness and goodwill towards your co-Filipino. And strength, bravery as well. The true altruist, shall we say.
Well, here’s your chance to be a frontliner of another breed: volunteer as a trial patient, or as guinea pig, to say it straight, for an unproven vaccine for corona.
As for Ah Kong, your bearded columnist, who has no guts, no glory, no spine, declines to volunteer given that he has no strength and is a coward, as well.
Only remember, those who dares and wins by volunteering, you’ll get paid. How much, Ah Kong doesn’t know and will have insurance but you will also face risks.
You will have to sign a consent and among the conditions set there is that if something medically bad happens to you in the course of the trial, you can’t sue the drug developer.
But if in the end, you come out unscathed, well, you will be remembered as a breed of different frontliner all Filipinos will be grateful. And they will gladly shake your hand for such bravery.
For volunteering, you may be comforted by the public pronouncement of President Rodrigo Duterte that he is willing to volunteer to be inoculated by an untested Russian corona vaccine.
Nonetheless friends, don’t say Ah Kong didn’t warn you.
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To be a trial patient, it’s built on a deceptively simple premise: researchers inject an experimental vaccine into healthy volunteers, exposing them to a microorganism or infectious agent. If the vaccine prevents volunteers from getting ill, the study can then speed development of a promising formula of vaccine.
For now, Russia and China are offering their corona vaccines, but unproven for their efficacy and safety.
President Rodrigo Duterte accepted the Russian offer.
Nobody, but nobody knew what cares and worries ran in the mind of the President when he accepted Russian invitation for its unproven vaccine to serve as trial ground on Philippine soil.
We also know for now that the Philippines continues to suffer the worst corona outbreaks in Southeast Asia with cases increasing along with death, shackled by economic downturn.
In a national address this first week of August, President Duterte said, “I will tell President Putin that I have huge trust in your studies in combatting Covid and I believe that the vaccine that you have produced is really good for humanity.”
At the same time, he offered himself as a trial subject. “When the vaccine arrives, I will inject it publicly. If it works on me, it will work on everyone,” the President added.
Filipinos who heard Duterte’s address on TV wonder, until now, whether this was flippant comment or actual policy.
Duterte said he expects to be injected with the Russian-made vaccine by May and that the Philippines is set to join clinical trials in October.
Russia has named it corona vaccine as “Sputnik V,” the name of the Soviet satellite launched in 1950.
Comes now a big problem: That the Philippines and Filipinos will serve as a trial ground for an unproven and controversial Russian vaccine that even the World Health Organization (WHO) and other world experts, raised reservation about it.
According to Harry Roque, Duterte’s spokesperson, a panel of local health experts will review the results of the production of Sputnik V before large-scale human trials will start in the Philippines.
But only last week, Professor Alexander Chuchalin, Russia’s top respiratory doctor for the Russian Health Ministry abruptly resigned over gross violations of medical ethics regarding the making of Sputnik V.
Dr. Chuchalin objected to the violations committed during the development phase of Sputnik V. He resigned after trying, but failing to block the registration of Sputnik V on safety grounds.
The Russian government ignored his objections, approved the vaccine without large-scale testing. So Dr. Chuchalin quit.
We must remember there are critical stages in the development and testing of vaccines, which Dr. Chuchalin wanted done, the WHO wants done and other world health experts want done.
First, is the exploratory stage, which involves laboratory research. Second, the pre-clinical stage, which studies use of tissue culture or cell-culture systems and animal testing to assess safety of the candidate vaccine.
Then phase 1 vaccine trial which involves usually between 20-80 persons. Phase II vaccine trials involve a larger group, usually a hundred. Phase III vaccine trial involves 10,000 to 60,000 persons.
The most essential in proving a vaccine is safe is Phase III, the phase of human trials and involves tens of thousands of persons.
Without Phase III data, releasing a vaccine can be potentially unsafe and just potentially ineffective.
After Phase III, the developer of the vaccine will submit license application to the Food and Drug Administration (FDA) of the Department of Health.
Along comes China, and also offered its vaccine which was also rushed for production, as noted by world health experts.
The China offer has prompted Senator Francis Tolentino last Tuesday to challenge health secretary Francisco Duque to be the first Filipino to be inoculated with the China-made vaccine.
“Mas mainam pa nga siguro, Secretary, ikaw yong maunang magpaturok, eh kaya napilitan siguro si Presidente na siya, kasi hindi ka nag-volunteer,” Tolentino said crisply to the health secretary in a senate hearing.
“Willing ka mauna? Yung Wuhan vaccine? Willing ka ba magpaturok sa Wuhan?” Tolentino pressed further.
Apparently, Tolentino was referring to Duterte’s pronouncement who said that he would be the first to be inoculated with the Russian vaccine.
Whether he was willing to get the first shot of the China vaccine, Duque refused to give a categorical answer, instead sidestepped Tolentino’s remarks by saying:
“Padaanin po natin yan sa proseso ng ating regulatory FDA, para sigurado po tayo na alinsunod sa kaligtasan, de kalidad at epektibo ng mga bakuna na ito, lalo na kung bago mayroon pong risk na hindi natin alam kung ano ba idudulot nito sa bandang huli.”
In response, senator Tolentino said, “Let me remind you, Mr. Secretary, that your dilly-dallying and semblance of evasion in answering the question is probably reflective of your non-bravery being the field Marshall of this pandemic war.”
Any Filipino who will enroll to become a trial patient or guinea pig will be insured or be given insurance. The problem now is how much will a Filipino trial patient receive if something goes awry after receiving the vaccine, or if the trial patient will succumb to death as a result of receiving the vaccine.
Remember we are dealing here with two vaccines that were rushed for production and didn’t qualify for scientific and other ethical standards set internationally and adhered to by all nations.
While Duque assured during that senate hearing that trial patients will receive insurance, “hindi ko lang sigurado kung anong extent ng health insurance ng kanila pong kinukuha,” he added.
Which prompted Senator Franklin Drilon to tell the senate hearing that no waiver must be issued unless there is a scientific basis that would ensure safety of recipient trial patients.
Drilon wanted to be sure that measures would be in place to ensure the safety of those who will take part in clinical trials for corona vaccines.
In an implied prod at nations rushing to develop vaccines by circumventing safety standards, Christian Lindmejier, Public Information Officer of WHO said, “Sometimes individual researchers claim they have found something, which is course, as such, great news.”
“But between finding or having a clue of maybe having a vaccine that works, and having gone through all the stages, is a big difference,” Lindmejier reminded.
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