Two potential vaccines to undergo final evaluation for clinical trial — DOH

Aileen Cerrudo   •   December 11, 2020   •   484

MANILA, Philippines — The Department of Health (DOH) has reported two potential COVID-19 vaccines will undergo the final evaluation of the Food and Drug Administration (FDA).

DOH spokesperson Maria Rosario Vergeire said Janssen Pharmaceuticals, under multinational giant Johnson & Johnson, and Chinese company Clover Biopharmaceuticals already passed the pre-evaluation of the DOH’s vaccine experts panel (VEP) and ethics review board.

“You need both approvals from the vaccine experts panel (VEP) and the ethics review board in order for that specific vaccine to go through the process of the FDA. Janssen and Clover, they will go through the FDA process already and we will wait for the information to be given to us by the FDA,” she said.

Meanwhile, another Chinese company, Sinovac already passed the VEP’s evaluation while British-Swedish pharmaceutical company AstraZeneca was cleared by the ethics review board.

FDA Director-General Dr. Eric Domingo said they will carefully evaluate the results of the clinical trials to assure that the recipients of the vaccines will not experience any side effects.

Magagamit natin ito as batayan sa approval or disapproval, or if approve para makapag-set tayo conditions or warnings (We can use this as bases for approval or disapproval, or if [the vaccine] is already approved, we can set conditions or warnings [for allergic reactions], he said.

Vergeire further said that they will also check the health history of the vaccine recipients to prevent any reaction from the vaccine.

“That’s why if you would notice, if you are going to be given a medicine or a vaccine, doctors would always ask you if you are allergic to something like food or if you have taken drugs before na naging allergic kayo kasi nga (which made you allergic is because) it’s a common side effect of any technology that is given to our body,” she said.

The FDA is positive that the COVID-19 vaccine will roll out by January 2021. —AAC (with reports from Aiko Miguel)

DOJ, DILG crafting guidelines for Duterte order to detain people improperly wearing face masks

Robie de Guzman   •   May 6, 2021

MANILA, Philippines – The Department of Justice (DOJ) and the Department of the Interior and Local Government (DILG) are crafting guidelines for the latest order of President Rodrigo Duterte to detain those who are improperly wearing face masks in public, Justice Secretary Menardo Guevarra said Thursday.

In a message to reporters, Guevarra said the guidelines will include details on the booking and detention processes, as well as the investigation and the filing of charges against those who will be apprehended.

The DOJ chief, however, stressed that Duterte’s order takes effect immediately even if the guidelines are still being formulated.

“The President’s directive takes effect immediately even without the guidelines. Existing laws and ordinances define the prohibited acts and impose the corresponding penalties therefore, and the relevant rules of court govern the procedure,” Guevarra said.

He also advised the public to wear face masks properly and to follow the law to avoid being detained.

“The best way to avoid being arrested while the guidelines are being formulated is to wear a face mask and obey the law,” he said.

On Wednesday, Duterte ordered the Philippine National Police to impose a stricter mask mandate to stem the spread of COVID-19 that mostly affected urban centers.

DOH studying possibility of mixing vaccine brands – FDA

Robie de Guzman   •   May 6, 2021

MANILA, Philippines – The Department of Health (DOH) is currently looking into the possibility of mixing different brands of vaccines against novel coronavirus disease (COVID-19), the Food and Drug Administration (FDA) said Thursday.

FDA director general Eric Domingo said the DOH is already drafting a set of guidelines that will allow a person to receive different brands of COVID-19 vaccines for first and second dose in case of severe allergic reaction and other adverse effects.

Aaralin po ngayon yan ng Department of Health, in fact, meron naman po talagang ongoing meetings ang Department of Health on that dahil meron po talagang instances na for example naturukan ka ng bakuna ng first dose tapos nagka-severe allergy ka so hindi ka na puwede sa second dose nun at kailangang isipin ngayon yung magiging alternative,” Domingo said during the Laging Handa briefing.

“Gumagawa na ng guidelines ngayon ang DOH kung paano ‘yung interchangeability or mixing ng vaccines in case the second dose cannot be given na identical doon sa first dose,” he added.

Domingo said this after President Rodrigo Duterte said he has requested China to recall the 1,000 doses of Sinopharm vaccines it donated following criticisms over his decision to receive a jab that has yet to secure an emergency use authorization from the FDA.

Duterte received his first dose of Sinopharm vaccine on Monday night.

Malacañang earlier said that the vaccine dose used on the president was covered by the compassionate special permit issued by the FDA for the Presidential Security Group.

Clinical trials on ivermectin to start in June – DOST

Marje Pelayo   •   May 6, 2021

MANILA, Philippines – Department of Science and Technology (DOST) Secretary Fortunato dela Peña said that preparations are underway for the anticipated clinical trials on the use of ivermectin as a treatment for COVID-19.

In his report to President Rodrigo Duterte on Wednesday (May 5), the official said the trials will be spearheaded by pulmonary doctor Dr. Aileen Wang of the University of the Philippines – Philippine General Hospital (UP-PGH) and will be implemented for eight months from June 2021 to January 2022.

He said the Department of Health (DOH) has allotted a total of P22 million for the trial of ivermectin.

It will be conducted on 1,200 volunteer adults, 18 years old and above, who are asymptomatic or non-severe COVID patients.

The team is awaiting ethics approval this month before proceeding with the trial.

“Ang ginagawa ay ethics approval para sa kanilang gagawin at recruitment ng staff na mag-a-administer ng clinical trials,” Dela Peña said.

They are currently coordinating with the Philippine Red Cross for the utilization of its facilities.

Other agents also under clinical trial are as follows:

* Randomized control clinical trial on the efficacy and safety of Tawa Tawa for adjunctive treatment of mild to moderate COVID-19 patients (11 months);

* Randomized, placebo-controlled trial on the safety and efficacy of Lagundi in patients with mild COVID and without comorbidities (10 months);

* Clinical trial on the safety and efficacy of virgin coconut oil (VCO) as adjunctive therapy for hospitalized COVID patients (12 months);

* Beneficial effects of VCO among suspect and probable cases of COVID-19 (14 months, extension included);

* Melatonin as adjuvant treatment for COVID-19 in patients requiring hospitalization (9 months) ;

* Convalescent Plasma as adjunctive therapy for hospitalized COVID-19 patients. (12 months).

Dela Peña noted that the duration of clinical trials for ivermectin is almost similar in period as other agents. The progress of each study still depends on the number of patients who want to volunteer for the trial.

“Kapag dumadami ang pasyenteng magbo-volunteer, mas mapapabilis ang pagtatapos ng mga trials,” the official assured.

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