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Vaccine candidate Janssen Covid-19 received the green light from the Food and Drug Administration (FDA) to conduct an independent trial in the country before the first week of January, CEO Eric Domingo said Tuesday. This, even as revelations that certain government officials and close security aides to President Duterte had already received an unnamed vaccine without FDA sanctions continued to generate controversy.
On Tuesday, Customs Office officials said they were investigating the circumstances under which certain vaccines had entered the country from abroad, in apparent violation of customary procedures.
Meanwhile, Sunday from the FDA also said the Department of Science and Technology (DOST) will look for the site where Janssen’s clinical trials will take place. Recruitment of subjects for said trial will also begin.
“We received three requests for clinical trials here and yesterday [December 28]We approved one, ”Domingo said, referring to Janssen, in a DOH online forum.
Regarding possible vaccine smuggling, Assistant Customs Commissioner and Spokesperson Atty. Vincent Philip C. Maronilla told BusinessMirror that Customs Commissioner Rey Leonardo B. Guerrero gave instructions to investigate the problem during Monday’s executive committee meeting.
While Maronilla has not yet disclosed the initial findings of the investigation, she said the instruction was to terminate the investigation “immediately.”
In a separate radio interview on Tuesday, Maronilla said it is still too early to jump to conclusions that vaccines used in certain people were smuggled or did not clear customs, but said they are already coordinating with the FDA and the Department of Health. (DOH).
Maronilla said they are also reviewing their own records.
“What our president said about some soldiers who received injections, we still have to find out in what context the vaccines were administered,” he said in Filipino, adding that “certain processes or, for example, trial runs may have been done. ” While he emphasized that he was not prejudging the issue, he strove to indicate that there may be some justification for the entry of vaccines, “but again we will have to investigate.”
He also said that they are investigating their own processes in the bureau to come up with clearer and more specific procedures, as he said that these vaccines may have been wrongly declared or there was a misunderstanding in the representation of their use, especially since concessions were granted. . under the Bayanihan to Recovery as One Act for the government to ensure the prompt release of medical supplies and equipment in response to the Covid-19 pandemic.
However, if the vaccines are shown to have entered the country without proper approvals, Maronilla said those responsible could face charges for violating the Customs and Modernization Law for smuggling.
They can also face civil, criminal and administrative charges for violating special laws on the entry of illicit drugs.
Domingo, director of the FDA, previously said that those who received the vaccine did not commit any violations. What is prohibited, Domingo said, is importing, distributing and dispensing unregistered drugs. The FDA said that the commission of such prohibited acts can lead to potential liabilities provided by law.
Duterte revealed in his public speech last Saturday that some soldiers were inoculated with the vaccine from Chinese pharmaceutical company Sinopharm.
The Secretary of Defense, Delfin Lorenzana, has also clarified that only members of the Presidential Security Group (PSG) received the vaccine.
This was confirmed by the PSG commander, Jesús Durante, who said that those vaccinated were a close security for the president.
During said they were aware of the possible risk of using new vaccines.
China Vaccine Candidates
According to Domingo, applications for Sinovac Biotech and Clover Biopharmaceuticals, two candidate vaccines developed by China, are still pending.
Clover waits while the agency awaits certain documents “from the proponent in order to complete the requirements, while Sinovac has requested some changes in the design of its protocol,” Domingo said.
When asked about possible “gains” after Janssen decided to conduct clinical trials in the country, Domingo replied: “The good thing about this is, of course number one, that we will be contributing to the global knowledge on the development of a vaccine”. . “
He added, as profit: “The potential use of a vaccine. The added bonus for us is that if this turns out to be a good vaccine, then at least we know that a few thousand Filipinos have been tested, seen [the] effects and possible side effects “.
“That would make it easier for us to make a decision, in regards to the authorization and perhaps the actual use of that potential vaccine,” he said.
Pfizer seeks USA
Meanwhile, Domingo said that only the US pharmaceutical company Pfizer has submitted a request for an emergency use authorization (USA) of its Covid vaccine in the country.
Domingo said they will complete the preliminary investigation of Pfizer’s application “within two weeks” to review their evaluation “from both the regulatory and clinical sides” to determine the efficacy and safety of the vaccine before making a decision.
