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Unauthorized COVID-19 vaccinations under probe

THE PHILIPPINE Food and Drug Administration (FDA) on Tuesday said it was investigating the inoculation of some Cabinet officials and military officers against the coronavirus.

The regulator wanted to know how the vaccination occurred and which vaccine was used, FDA Director General Rolando Enrique D. Domingo told an online news briefing. The people who got vaccinated won’t be charged, he added.

He said the investigation would only look at the importation, distribution and administration of the unregistered vaccine.

The law prohibits the manufacture, importation, exportation, sale and distribution of unauthorized health products.

Unregistered products with emergency use authorization from the FDA are exempted, Mr. Domingo said, even as he noted that they had received only one such application from Pfizer, Inc.

He added that China National Pharmaceutical Group (Sinopharm), which made the vaccine used by the officials, had neither applied for emergency use nor clinical trials.

Meanwhile, the FDA would likely finish its evaluation of Pfizer’s emergency use application in the next two weeks, Mr. Domingo said.

The regulator would focus on the quality, efficacy and safety of the vaccine, he added.

The Pfizer application, submitted on Dec. 23, “has been distributed already to our reviewers and regulators and we hope to complete the preliminary evaluation within two weeks,” he said. The FDA expects more applications next month.

Also on Tuesday, Senator Franklin M. Drilon said people who violate the FDA law could face fines of P50,000 to P500,000 or one to 10 years of jail time.

The law also imposes stiffer penalties of five to 10 years in jail and a fine of as much as P5 million on manufacturers, importers and distributors who violate the law.

“What was done completely dismissed the well-entrenched public safety and health protocols,” Mr. Drilon said in a statement.

“It further undermined the regulatory authority of the FDA with regard to the inspection, licensing and monitoring of establishments, and the registration and monitoring of health products,” he added.

Meanwhile, the FDA has approved the application of Janssen Pharmaceutical Companies of Johnson & Johnson to conduct local clinical trials, according to the regulator.

The trial, the only one approved so far out of three applicants, would likely start next month, Mr. Domingo said at the same briefing.

“The next step now would be for the Department of Science and Technology (DoST) expert panel to assign the area where the trial will take place,” he said. The recruitment of patients would follow, he added.

Mr. Domingo said the application of China’s Sinovac Biotech Ltd. was still being reviewed after some minor changes in its research design, while that of Clover Biopharmaceuticals was pending due to some documentary requirements.

Health Undersecretary Maria Rosario S. Vergeire told the same briefing the solidarity trials for coronavirus treatment led by the World Health Organization (WHO) would start later next month.

“They have committed to us that by January, maybe third week of January, we can start,” she said. WHO wanted to keep details of the trial confidential until these are finalized, she added.

Ms. Vergeire said the Health department was preparing the sites for the solidarity trials. — Charmaine A. Tadalan

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