FDA to investigate vaccine mystery. Inquirer Newsletter. December 30, 2020

No images? Click here   GUARDED MOMENTS   The mask requirement exempts no one—not even the Marine honor guard at the Rizal Monument in Manila. The nation marks the 124th anniversary of the national hero’s martyrdom today, a nonworking holiday. —LYN RILLON     News Janssen candidate vaccine first to be OKd for PH trials Janssen Pharmaceutica, a subsidiary of Johnson & Johnson, will be the first to hold clinical trials of candidate vaccines against the new coronavirus disease (COVID-19) in the Philippines. The Food and Drug Administration has approved the application of the Belgian company to conduct a clinical trial and is still reviewing those of Clover Biopharmaceuticals and Sinovac. —STORY BY PATRICIA DENISE M. CHIU Read more: newsinfo.inquirer.net   Regions 2 more Boracay tourists held for fake test results   Two more Boracay-bound tourists were arrested on Monday for submitting falsified COVID-19 test results so they could enter the resort island. They will face criminal complaints for falsifying documents and violating a public health law. Earlier this month, six other Boracay tourists were arrested after five of them presented forged test results that were based on a genuine document.  —STORY BY NESTOR P. BURGOS JR. Read more: newsinfo.inquirer.net/regions   Newsletter / Join us Has this been forwarded by a friend? Subscribe now to the Philippine Daily Inquirer Newsletters and get your latest news and important updates straight to your device. Subscribe     Get here   Banner story FDA to investigate vaccine mystery By the Inquirer Staff The Food and Drug Administration (FDA) will investigate the inoculation against COVID-19 of government officials, presidential guards and soldiers with a vaccine from China that has not been approved for use in the Philippines. The Bureau of Customs  will also investigate to see how supplies of the vaccine developed by the Chinese pharmaceutical company Sinopharm got past inspectors at the border. Interior Secretary Eduardo Año and Lt. Gen. Cirilito Sobejana, the Army chief, confirmed the vaccinations on Monday after President Duterte disclosed them during a meeting with health experts in Malacañang last Saturday. Brig. Gen. Jesus Durante, commander of the Presidential Security Group (PSG), also confirmed that troops from the presidential guard had been vaccinated to avoid becoming a health threat to the President. Vaccine donated The three officials did not say what vaccine was used and where it came from, but presidential spokesperson Harry Roque, who also confirmed the inoculation of troops from the PSG, identified it as the Sinopharm vaccine and said it was a donation but he did not know who the donor was and what the circumstances behind the donation were. On Tuesday, FDA Director General Eric Domingo told an online press briefing that he had directed his agency’s regulatory enforcement unit to investigate the vaccinations and how they happened. Domingo said part of the investigation was determining what vaccine exactly was used. The Sinopharm vaccine is called New Crown COVID-19, which, at $149 for the two-dose regimen, is the most expensive of the candidate vaccines for the new coronavirus disease. Sinopharm has not applied for emergency use authorization for its vaccine in the Philippines. Domingo said he was surprised by the news of the vaccinations because the FDA had not approved any of the candidate vaccines for local use. He said the preliminary investigation would take days and that it may take a while before he got the results because of the holidays. Illegal Domingo refused to say what penalties awaited the people behind the unauthorized use of the Sinopharm vaccine, but reminded the public that the “manufacture, importation, exportation, sale, offering for sale, distribution, transfer, nonconsumer use, promotion, advertising, or sponsorship of any health product” not registered with the FDA is illegal. The FDA chief said he doubted that the order to inoculate PSG troops had come from President Duterte. Health Undersecretary Maria Rosario Vergeire, who was also at the news briefing, likewise expressed doubt that Mr. Duterte would order the inoculation without FDA approval. Domingo reiterated that at present, there is no approved COVID-19 vaccine in the Philippines. At the customs bureau, Assistant Customs Commissioner Vincent Philip Maronilla said the agency had received no communication about the arrival of supplies of any COVID-19 vaccine. Maronilla, who is also the spokesperson for the customs bureau, said exemptions and shorter processes were provided under the coronavirus response law for the importation of certain goods, but vaccines were not among those goods. He said no COVID-19 vaccine should have been allowed to enter the country, as the FDA had made it clear that it had not cleared any COVID-19 vaccine for importation. “But if the statement of Undersecretary Domingo is that they had not approved any vaccine for general use, then that’s different from provisional use. That’s something that we will have to clarify,” Maronilla said. If proven that the vaccine had been brought in without permit from the government, he said, then those responsible may be charged with smuggling. But it’s too early to say, he said, whether the vaccine had been smuggled into the country. ‘Token’ Malacañang said the PSG’s use of the donated vaccine was not a violation of the graft law, as the vaccine could be considered a “token” that had little value. “Tokens are allowed, especially during Christmas. Tokens are acceptable, meaning those that are of not much value,”  Palace spokersperson Roque told a news briefing. Roque also said no public funds were used for the vaccine because the drug had been donated. And since the vaccine was not paid for by taxpayers, he said, the government could not be considered to have circumvented its priority list of vaccine recipients. “Our priority remains the same—the poor, the elderly, the front-liners, both health and otherwise,” Roque said. Año maintained that the inoculation of PSG troops was not illegal, as the vaccine used had emergency use authorization from its country of origin. In a television interview, Año said the vaccine fell under the category of personal use and so was not in violation of FDA rules. The home affairs chief said on Monday that Cabinet secretaries were also vaccinated, but he walked back his statement on Tuesday, saying only one Cabinet member was inoculated, though he did not identify the official. Brig. Gen. Edgard Arevalo, spokesperson for the military, said in a television interview that only PSG members were vaccinated. “Definitely no other member of the [Armed Forces of the Philippines], not even the chief of staff (Gen. Gilbert Gapay), not even me, not any high-ranking official of the AFP [was vaccinated],” Arevalo said. FDA law He said he spoke with Durante on Tuesday morning and was told by the PSG commander that he himself did not know how the vaccine was procured. Opposition senators urged the government to crack down hard on the “black market” through which the China-made vaccine was “smuggled” into the Philippines. “This was unsafe and illegal. These vaccines were clearly smuggled through a black market and, even worse, seem to be sanctioned by the government,” Sen. Risa Hontiveros said. Senate Minority Leader Franklin Drilon warned that the people involved in the vaccination of officials without FDA authorization could face imprisonment of up to 10 years or a fine of as much as P500,000, or both, under the FDA law. Drilon said the unauthorized vaccinations clearly violated FDA Circular No. 2020-036, or the Guidelines on the Issuance of Emergency Use Authorization for Drugs and Vaccines for COVID-19. In a dispatch from Camp Crame, detained Sen. Leila de Lima demanded complete disclosure of how and why the vaccination was allowed without going through the proper channels. “They should tell us if there are other civilian officials clandestinely given an unauthorized advance  vaccination,” De Lima said. “Who are they? Why were these individuals prioritized? What vaccines were used? Under what deal? Who exactly gave the imprimatur to what is patently a transgression of law and public policy?” Bayan Muna Rep. Ferdinand Gaite said the vaccine used was illegal because it was not approved by the FDA. Gabriela Rep. Arlene Brosas agreed. “It appears that those who are in power are the ones not following the law,” she said. Bayan Muna Rep. Carlos Zarate said the inoculations showed that COVID-19 vaccines were “only for the privileged.” “They say ‘we heal as one,’ but what is happening now is ‘they heal at once’ because the vaccine is only for the privileged,” he said. “They should be ashamed. They were ahead during the testing. They were again ahead in the [vaccination],” Bayan Muna Rep. Eufemia Cullamat said. —REPORTS FROM PATRICIA DENISE M. CHIU, TINA G. SANTOS, LEILA B. SALAVERRIA, JEANNETTE I. ANDRADE, DJ YAP AND NESTOR CORRALES   Read more: newsinfo.inquirer.net     Editorial Rizal, ‘woke’ in his own time The multifaceted life of National Hero José Rizal yields nuggets of wonder for the conscientious student, whether young or not, and continues to impress as the years wear on. We mark today the 124th year of his death in the hands of Spanish colonial authorities at what was then Bagumbayan—a killing that seemed preordained for a man who subverted the ruling order through an unerring purpose: to educate his fellow Filipinos on the constraints of their objective conditions, and thus empower them to ultimately break their chains. There are crucial lessons to be learned from the plentiful accounts of his time on earth, no matter that, at 35 years, it was all too brief. Millennials cynically casing today’s political landscape for role models, and gagging at what they see, can do worse than get a bead on the life and works of the man named by the newspaperman and diplomat Leon Ma. Guerrero as the “First Filipino,” and marvel at his sheer genius. Although famous for his novels and essays that embodied his moral and political philosophy, he employed his other talents and skills to display the length and breadth of an extraordinary intellect. Today’s youth should learn from this man who was 'woke' in his own time. Wrote the late historian Cesar Adib Majul  in 1999: 'As long as there is exploitation and poverty in society, a lack of bravery in the struggle for the recognition of and protection of human rights, selfish support for power-hungry or corrupt officials in order to partake of the crumbs from their tables, and an urgent need to bring about the best of the people’s creative energy, Rizal’s message for the people he so loved and others in a similar historical situation remains true in the next millennium.' Read more: opinion.inquirer.net   Copyright © 2020 PHILIPPINE DAILY INQUIRER, All rights reserved. Our mailing address is: P.O. Box 2353, Makati Central Post Office, 1263 Makati City, Philippines.   Share    Tweet    Share    Forward  Preferences  |  Unsubscribe