FDA to investigate vaccine mystery

The Food and Drug Administration (FDA) will investigate COVID-19 inoculation of government officials, presidential guards and soldiers with a vaccine from China that has not been approved for use in the Philippines.

The Customs Office will also investigate to see how supplies of the vaccine developed by the Chinese pharmaceutical company Sinopharm passed inspectors at the border.

Interior Secretary Eduardo Año and Army Chief Lt. Gen. Cirilito Sobejana confirmed the vaccines on Monday after President Duterte revealed them during a meeting with health experts in Malacañang last Saturday.

Brig. General Jesús Durante, commander of the Presidential Security Group (PSG), also confirmed that troops of the presidential guard had been vaccinated to avoid becoming a threat to the president’s health.

Donated vaccine

The three officials did not say which vaccine was used and where it came from, but presidential spokesman Harry Roque, who also confirmed the inoculation by PSG troops, identified it as the Sinopharm vaccine and said it was a donation but did not know. who was the donor what were the circumstances behind the donation.

On Tuesday, FDA CEO Eric Domingo told an online press conference that he had directed his agency’s regulatory compliance unit to investigate the vaccines and how they happened.

Domingo said part of the investigation was determining exactly which vaccine 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 novel 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 vaccines because the FDA had not approved any of the candidate vaccines for local use.

He said the preliminary investigation would take days and it could be a while before he gets the results due to the holidays.

Illegal

Domingo declined to say what penalties await the people behind the unauthorized use of the Sinopharm vaccine, but reminded the public that “manufacture, import, export, sale, offer for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of any health product ”not registered with the FDA was illegal.

The FDA chief said he doubted that the order to inoculate PSG troops had come from President Duterte.

The Undersecretary of Health, María Rosario Vergeire, who was also at the press conference, also expressed doubts that Mr. Duterte ordered the inoculation without FDA approval.

Domingo reiterated that at present, there is no approved COVID-19 vaccine in the Philippines.

At the customs office, Deputy Customs Commissioner Philip Vincent Maronilla said the agency had not received any communication regarding the arrival of supplies of any COVID-19 vaccine.

Maronilla, who is also a spokesperson for the customs office, said that exemptions and shorter processes were provided under the coronavirus response law for the importation of certain products, but vaccines were not among those products.

He said that no COVID-19 vaccine should have been allowed into the country, as the FDA had made it clear that it had not authorized any COVID-19 vaccine for import.

“But if the statement from Undersecretary Domingo is that they did not approve any vaccine for general use, then that is different from provisional use. That is something that we will have to clarify, ”said Maronilla.

If the vaccine is shown to have been brought in without government permission, he said, those responsible could be charged with smuggling.

But it is too early to tell, he said, whether the vaccine was smuggled into the country.

‘Symbolic’

Malacañang said that the use of the donated vaccine by PSG was not a violation of the graft law, as the vaccine could be considered a “token” of little value.

“Tokens are allowed, especially during Christmas. The tokens are acceptable, that is, those that do not have much value, “said the Palace spokesman, Roque, at a press conference.

Roque also said that no public funds were used for the vaccine because the drug had been donated. And since taxpayers did not pay for the vaccine, he said, the government cannot be considered to have bypassed its priority list of vaccine recipients.

“Our priority remains the same: the poor, the elderly, the front-line, both in health and in other aspects,” said Roque.

Year argued that the inoculation of PSG troops was not illegal, since the vaccine used had an emergency use authorization from its country of origin.

In a television interview, Year said that the vaccine fell into the category of personal use and, therefore, did not violate FDA rules.

The interior affairs chief said Monday that cabinet secretaries were also vaccinated, but backtracked his statement Tuesday, saying only one cabinet member was inoculated, although he did not identify the official.

Brig. General Edgard Arévalo, an army spokesman, 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 (General Gilbert Gapay), not even me, nor any senior AFP official, [was vaccinated]”Said Arevalo.

He said that he spoke with During on Tuesday morning and the PSG commander told him that he himself did not know how the vaccine was obtained.

FDA law

Opposition senators urged the government to crack down on the “black market” through which Chinese-made vaccine was “smuggled” into the Philippines.

“This was dangerous and illegal. These vaccines were clearly smuggled through a black market and worse, they appear to be sanctioned by the government, ”said Senator Risa Hontiveros.

Senate Minority Leader Franklin Drilon warned that people involved in vaccinating officials without FDA authorization could face a prison term of up to 10 years or a fine of up to 500,000 pesetas, or both, depending on FDA law.

Drilon said the unauthorized vaccines clearly violated FDA Circular No. 2020-036, or the Guidelines on the Issuance of Emergency Use Authorization for COVID-19 Drugs and Vaccines.

In a Camp Crame dispatch, the detained senator Leila de Lima demanded a full disclosure of how and why vaccination was allowed without going through the proper channels.

“They should tell us if there are other civil servants who have received an unauthorized early vaccination clandestinely,” De Lima said. “Who are they? Why were these people prioritized? What vaccines were used? Under what treatment? Who exactly gave the go-ahead for what is clearly a violation of law and public policy?

Bayan Muna’s representative, Ferdinand Gaite, said the vaccine used was illegal because it was not approved by the FDA.

Gabriela Rep. Arlene Brosas agreed. “It seems that those in power are those who do not follow the law,” he said.

The representative of Bayan Muna, Carlos Zárate, said that the inoculations showed that the COVID-19 vaccines were “only for the privileged.”

“They say ‘we heal as one’, but what is happening now is ‘they are cured at once’ because the vaccine is only for the privileged,” he said. “They should be ashamed. They were ahead during testing. They were again ahead in the [vaccination]. “—REPORTS FROM PATRICIA DENISE M. CHIU, TINA G. SANTOS, LEILA B. SALAVERRIA, JEANNETTE I. ANDRADE, DEWEY YAP, AND NESTOR CORRALES

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