WHAT JUST HAPPENED. Cebu City Acting Mayor Michael Rama on Monday, October 18, announced at a press-conference he has stopped the clinical trials of the anti-Covid vaccine from WestVac Biopharma Co. Ltd., saying they can resume in the city once the protocols in the local government are met. He also asked the police to investigate the report that local vaccinees were paid for taking part in the trials.
But did A.M. Rama know that the trials were covered by a Food and Drug Administration (FDA) permit and the project may have already been completed since the permit was only up to September 30?
ALARM FROM TUMULAK. The acting mayor’s response followed the disclosure of Councilor Dave Tumulak (Barug) Wednesday, October 13, about the vaccination of residents from some barangays, among them Basak-San Nicolas, Basak-Pardo, Cogon and Labangon. It was perplexing (“makapahibulong kayo”) since it was done, he said, without the knowledge of the City Government.
Tumulak, in a privileged speech, expressed concern over people’s safety, saying he had never heard of WestVac and learned about it only when some vaccinees asked about their efficacy. Tumulak said he just learned about the vaccine’s Phase 3 clinical trials in Indonesia, Kenya, and the Philippines, involving 40,000 individuals. Phase 1 started in China last June.
On Tumulak’s motion, the Sanggunian decided to ask FDA and the city health department to inquire into, and inform the councilors, about the project at its next session Wednesday, October 20. It also asked Perpetual Succor Hospital, which screens the local vaccinees, whether it has permit from the City Government. Tumulak did not name the hospital but the eight listed project locations in the Philippines include Perpetual Succor.
THEIR CONCERN OR WORRY. Rama and City Health Office chief Jeffrey Ibones made it clear at Monday’s press-con they worry over the health and safety of local residents and for that reason, they request national agencies to coordinate with the local government on any project that involves the LGU or its residents.
But in an earlier news report, Dr. Mary Jean Loreche, DOH-7 chief pathologist, said the project was “properly coordinated with the office of Mayor Edgardo Labella.” It was not specified when that was made, whether it was with Labella himself or his city administrator or his staff, and whether it was made when the mayor was physically present or during one of his medical leaves.
COORDINATION WITHIN CITY HALL. If Loreche was right, the lack of coordination could be within City Hall itself.
That the facts were not ascertained among the city officials — between October 13, when Councilor Tumulak made his speech, and October 18, when Rama announced his stoppage/suspension order — doesn’t speak well of City Hall’s own system. If DOH-7 coordinated with Labella’s office, DOH or the mayor’s office must have left out the City Council.
But then a “perennial” complaint of some councilors is that they are routinely not given the information they seek from the executive department. If they are ignored when they ask, how much more when they don’t?
PERMIT FROM FDA. Had the City Council, then the acting mayor, been informed by Mayor Labella’s office or staff, they would’ve known that the WestVac trials in the city — along with other local governments, including Makati and Manila — are allowed under an FDA permit listed by the Department of Science and Technology-Philippine Council for Health Research and Development. The Phase 3 trial covered 14 months, from July 30, 2020 up to September 30 this year.
Clinical trials of a vaccine, we are told, are “medical studies that involve people,” with its main objective “to evaluate how safe and how effective the vaccine under investigation is for humans before licensed to use.”
The trials in Cebu City and other parts of the country, a SunStar October 13 story said, would “evaluate the efficacy, safety and immunogenicity of recombinant Covid-19 vaccine in adults aged 18 years and older.” The FDA permit was reportedly dated June 28, 2021. Tumulak hadn’t heard about WestVac because the vaccine was not yet approved and was still being tested among his constituents.
But check out the period of coverage again: it was supposed to be finished last September 30 and the City Council led by Councilor Tumulak howled last October 13 and the mayor stopped or suspended it on October 18.
INVESTIGATION? If any investigation is to be done, it may as well include the City Hall system of swapping information. There are supposed to be at City Hall persons who oversee the entire operations and persons who coordinate with other persons on specific activities that require exchange of information.
And they may also look into the specific ordinance or law that requires a holder of an FDA permit on clinical trials to secure also a permit from the office of the mayor and approval of the City Council. And does the requirement also apply to the hospital, in this case, Perpetual Succor Hospital?
Acting Mayor Rama merely cited the general provision of the Local Government Code on the LGU’s control of responses to a public health emergency. But everyone in government bureaucracy knows how much the central government has diminished LGU authority on pandemic matters.
