- The Sinopharm anti-COVID-19 vaccine was neither granted an emergency use application (EUA) by the Philippine Government, nor given approval by health or regulatory authorities for any special use; it is, therefore, illegal, illicit, prohibited, unauthorized, unlicensed, unregistered, and unregulated, especially so during the time it was injected, as admitted by Ramon Tulfo, on him and the persons he said were vaccinated with him;
- Ramon Tulfo admits in his column he got his Sinopharm jabs together with “Cabinet-level officials” and the Presidential Security Group three weeks earlier before he wrote his column referred in here;
- Tulfo admits in his column to have arranged a phone call meeting between President Duterte and the Sinopharm vaccine country representative in the President’s office;
- Tulfo admits in his column he applied for distributorship of the Sinopharm vaccine in the country;
- Tulfo admits in his column, it was his friend who smuggled the vaccines in.
EUA (US Food and Drug Administration)
The Emergency Use Authorization (EUA) authority allows FDA to help strengthen the nation’s public health protections against CBRN* threats by facilitating the availability and use of MCMs** needed during public health emergencies.
*Chemical, biological, radiological, and nuclear defense are protective measures taken in situations in which chemical, biological, radiological, or nuclear warfare hazards may be present. CBRN defense consists of CBRN passive protection, contamination avoidance, and CBRN mitigation.
**MCMs are medical countermeasures, such as vaccines, antiviral drugs, antibiotics, antitoxins, and chemical antidotes, used to effectively prevent, mitigate, or treat adverse health effects of an intentional, accidental, or naturally occurring public health emergency.
Medical countermeasures, or MCMs, are FDA-regulated products (biologics, drugs, devices) that may be used in the event of a potential public health emergency stemming from a terrorist attack with a biological, chemical, or radiological/nuclear material, or a naturally occurring emerging disease.
EUA (Department of Health, FAQs)
What is an Emergency Use Authorization?
Risk-based procedure for assessing unlicensed (under development) vaccines, therapeutics
During public health emergencies of international concern
Aim of expediting availability to people affected by a public health emergency
Based on an essential set of available quality, safety, and efficacy performance data
MANILA — Special Envoy for Public Diplomacy to China Ramon Tulfo admits he got his Sinopharm jabs along with other government officials last year. Unauthorized, unregistered, and unregulated, these prohibited doses were smuggled into the country but Tulfo insisted there is “nothing improper with the chief executive asking samples of the unregistered vaccine.”
He disclosed during an interview in “The Chiefs” on One News Tuesday others who also got their jabs with the smuggled vaccines were Department secretaries and a senator, whose names he did not mention, and some members of the Presidential Security Group.
When asked if he and other Government officials knowingly received the smuggled items, he says, “I don’t feel guilty about it.”
With neither authorization for emergency use in the Philippines, nor approval from health and regulatory authorities, Tulfo says he applied to be a distributor of the China-manufactured Sinopharm vaccine in the country.
The Food and Drug Administration (FDA) has recently issued a “compassionate use license” for the president’s security detail to take 10,000 Sinopharm shots. The issuance took place months after the unauthorized inoculation, which left health authorities surprised and the public enraged.
Medical front liners are at the top of the government’s priority list for COVID-19 vaccination. They are followed by senior citizens, indigent population and uniformed personnel are also among the priority groups.
“I don’t find any irregularity there”
It’s what Tulfo wrote in a Manila Times column: Vaccine arrival delayed—why?:
During my private meeting with the President in the presence of Senator Go, I handed him my phone and had him talk to the Sinopharm representative in the country. Digong repeated his request for samples of the vaccine for him and his family. After the meeting, Palace protocol officer Roberto Borje and Malacañan’s appointments secretary Lisette Marquez met with me in another room.
“I don’t find any irregularity there,” Tulfo says, referring to that account in his column.
“We’re now given a choice. Which comes first: the lives of millions of Filipinos or propriety?” he added.
Tulfo also claims vaccine czar Carlito Galvez Jr is “always unavailable” when reached out to talk to about the facilitation of the delivery of those vaccines. He said the former military general appears to be against Sinopharm “for reasons only he knows.”
Public or private persona, does it matter?
In his column, Tulfo admits he has applied for distributorship of the Sinopharm vaccine in the Philippines. He wrote, “That’s another confession: I have applied to be one of the distributors of the Sinopharm vaccine in the country, that’s why I risked my life to have myself inoculated ahead of the public.”
He said he has applied for distributorship with a company named Apollo, which has supposedly secured a contract with a Singapore subsidiary of Sinopharm but denies using his position to secure a deal and get vaccine doses for himself, his drivers, and his bodyguards.
“I got hold of the vaccine from a friend who smuggled it into the country,” Tulfo discloses. “I don’t see any conflict of interest here because I’m a private citizen,” Tulfo says. He is “technically not a government official” because his position as a special envoy is only “honorific.”
Formal investigations are being conducted separately
The FDA and DOH are separately conducting their respective investigations of the inoculation of special envoy to China Ramon Tulfo with smuggled COVID-19 Sinopharm jabs.
Tulfo first confessed that he received smuggled Sinopharm shots last year in a column, then in an interview with One News Tuesday. He says he wanted to test the vaccine on himself because he was applying to be a local Sinopharm distributor.
The vaccine the Chinese state-owned biotech firm developed has no authorization for emergency use in the Philippines. It has not submitted an application for such approval.
FDA Director-General Eric Domingo says the unauthorized vaccination activity has been referred to the agency’s regulatory enforcement unit for investigation.
“We are investigating this because it is not good that we learn that there are individuals who get vaccinated without going through the right process,” Domingo said in a Laging Handa briefing Wednesday.
DOH Undersecretary Maria Rosario Vergeire says in a separate briefing, the ongoing probe into illegal vaccination activities will also include Tulfo.
The FDA is yet to receive a response from President Rodrigo Duterte’s security detail about their queries.
The use of unregistered vaccines violates the Food and Drug Administration Act of 2009, which prohibits the distribution and administering of vaccines not yet approved by regulatory authorities.
Both the DOH and the FDA say that the use of unregistered products poses harm to a person’s health and safety.
Vergeire says individuals who are supplying illegally procured COVID-19 shots will be investigated. “If there will be violations, there will be sanctions.”
An unprecedented revelation
Last year, in December, Duterte revealed that PSG members already got vaccinated against COVID-19 even if the FDA has yet to issue an EUA at the time. Brig. Gen. Jesus Durante, PSG commander, confirmed the president’s disclosure, leaving health authorities surprised and the public enraged.
Meanwhile, the FDA has issued a “compassionate use license” for the president’s security detail to take 10,000 Sinopharm shots on 11 February.
The efficacy divide
Sinovac is not at the level of efficacy as the first two other vaccines approved.
FDA chief Eric Domingo, says when EUA was granted, that Sinovac “is not the most ideal vaccine” for medical personnel because they are constantly exposed to the risk of virus transmission.”
Based on trials in Brazil that involved health workers who had interaction with COVID-19 patients, the shots yielded only 50.5 percent efficacy. Such rating is only a bit higher than the threshold the World Health Organization seeks for deciding on vaccine use.
Health authorities do not recommend the Sinovac vaccine for use by health workers and the elderly, who are at the top of the Government’s priority list.
At the moment, not one of the vaccines has been delivered yet, placing the Government under criticism over delayed rollout while the economy stands in wait. (BG/Headline PH)