By Jennifer P. Rendon
Iloilo first district Rep Janette Garin found alarming and unethical the move of President Rodrigo Duterte’s security group to use unapproved COVID-19 vaccines from Sinopharm.
Garin’s main beef with the inoculation of the Presidential Security Group (PSG) is the safety of the Chinese-made vaccine itself.
“Why? Because we have this so-called global allocation for every country wherein a maximum of 20 percent of the population would be vaccinated. It is being shared in all countries,” she said.
The World Health Organization (WHO) earlier said “that everyone, everywhere who could benefit from safe and effective COVID-19 vaccines should have access as quickly as possible, starting with those at highest risk of serious disease or death.”
Garin, a former health secretary, believed that it’s quite disheartening that the allocation wouldn’t be followed because there are others who needed it more like the senior citizens, health workers, and other direct frontliners.
It’s not about them being doctors or health workers that they should be vaccinated “but because if they become infected they can transmit the infection to other patients.”
“That’s the purpose. You vaccinate the people who could intercept the transmission of the virus in areas where it is highly transmitting,” she said citing that the virus could easily be transmitted in hospital setting or inside a home but still came from the hospital or health care facility,” she added.
Garin said this is also an issue of safety.
“First, if it is smuggled it is questionable if it’s indeed a vaccine or a fake one,” she said.
And even if it is not a fake vaccine, “you cannot just smuggle it because vaccines need special storage and handling procedures.”
“That’s why, it should be coursed through to the person who knows about the vaccine handling,” she said,
Garin hopes that such incident will not happen again. She adds that the vaccine could be easily traced because every vaccine has a batch and lot number.
As such, the manufacturer would know to which country or to whom it was released unlike ordinary imported medicines.
“If it’s smuggled, it’s easy to trace who smuggled it,” she said.
When vaccines or medicines are imported in the country, there’s a certificate of product registration (CPR) specifying if it’s for commercial use, for private use, for clinical trial, or for donation.
“It doesn’t mean that if it’s a donation, it won’t go through the process. Ti paano kung may i-donate kag indi safe? Our greatest concern here is the safety because anything that has not gone through the Food and Drug Administration (FDA) is something that is dangerous,” she said.
Garin stressed that PSG members are also Filipinos that should be taken care of.
“It’s not right that in the desire to protect the president, you put their lives in danger. If the desire is to protect the life of the President, the one that should be vaccinated is the president,” she said.
Garin said she heard that Sinopharm has already finished with Stage 3 testing, but the WHO will have to validate the results before issuing Emergency Use Authorization (EUA).
An Emergency Use Authorization (EUA) is a mechanism to facilitate the availability and use of medical countermeasures, including vaccines, during public health emergencies, such as the current COVID-19 pandemic. Under an EUA, the FDA may allow the use of unapproved medical products, or unapproved uses of approved medical products in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions when certain statutory criteria have been met, including that there are no adequate, approved, and available alternatives. Taking into consideration input from the FDA, manufacturers decide whether and when to submit an EUA request to FDA.
Once submitted, FDA will evaluate an EUA request and determine whether the relevant statutory criteria are met, taking into account the totality of the scientific evidence about the vaccine that is available to FDA.
And again, “One big problem is if you start giving vaccines to those who are not priority in the population, then we have a big problem. The vaccine is designed to intercept. You first inoculate those persons who have the highest possibility of spreading the virus and those population who have the highest mortality risk. They should be given first.”
Garin said that the target here is if you get the disease, there would be no, or just mild, symptoms or you lower the morbidity and mortality risks.
Even before it was reported that PSG members were already vaccinated, there were already talks going around that it happened earlier than November.
“I believe that what’s important is to get the names of those who were vaccinated so that they would be thoroughly monitored,” she said.
It is very important to know the source of the vaccines. “If it’s smuggled, it’s highly unusual because it’s a highly regulated product. If it’s donated, you have to be sure that the batch produce is the batch that has gone through various trails. And take note that Sinopharm (vaccine) is a deactivated virus. So, may ara na precautions if you are using a inactivated virus,” she said.
Inactivated vaccines are considered tried and trusted method of vaccination being the technology used in the vaccine against poliovirus and in some types of flu vaccines.
But aside from PSG, there were reports that some members of the Congress may have been vaccinated already.
“There were reports but we have to verify that. Around August and September, there are reports that vaccines are being sold at P7,000 per dose. If that’s true, it has to stop. I believed that this is not the first time,” Garin said, stressing that she had not been inoculated with the Covid-19 vaccine.
That could have been the reason why the DOH has repeatedly issuing a warning against behind vaccinated, for now, she added.
Meanwhile, Garin admitted that she heard of moves that Congress might be investigating the unauthorized vaccination of PSG members.
“Unfortunately, holiday. But I believe when congress resumes by January, it will be tackled,” she said.
