FDA grants 2 more hospitals compassionate permit for ivermectin use vs COVID-19

Robie de Guzman   •   April 27, 2021   •   487

MANILA, Philippines – Two more hospitals have been granted compassionate special permit (CSP) for the use of anti-parasitic drug ivermectin to treat COVID-19 patients, Food and Drug Administration (FDA) director-general Eric Domingo announced Tuesday.

There are now a total of five hospitals that have received a limited permit for the use of ivermectin on COVID-19 patients.

Domingo, however, did not specify the names of these hospitals.

The FDA earlier said that a compassionate special permit only allows limited off-label use of experimental or unregistered drugs and is not an agency’s endorsement of its safety and efficacy.

The agency also reiterated that a compassionate use permit is different from certificate of product registration for the drug, which allows manufacturers to commercially sell the anti-parasitic drug for human use.

Domingo likewise emphasized that only the hospital that has secured a permit for ivermectin’s compassionate use for humans will be allowed to import the drug through a licensed importer.

Doctors who will prescribe the drug to treat COVID-19 patients are required to report to the FDA on a monthly basis. They will also be held liable for possible side effects.

The FDA earlier said that distribution and promotion of ivermectin as a COVID-19 treatment remains prohibited in the country.

Ivermectin is registered in the country for veterinary use to prevent heartworm disease and treat internal and external parasites in certain species.

The agency also stressed that the ivermectin products registered for human use in the country were in topical formulations under prescription use only.

President Rodrigo Duterte earlier ordered concerned government agencies to conduct clinical trials on ivermectin to treat COVID-19.

 

1,749 commuters attempted to ride trains sans proof on first day of ‘no vax, no ride policy – DOTr

Robie de Guzman   •   January 18, 2022

MANILA, Philippines – The Department of Transportation (DOTr) on Tuesday reported that a total of 1,749 commuters attempted to take rail lines without showing proof of their COVID-19 immunization during the first day of the implementation of the “no vaccination, no ride” policy in Metro Manila.

In a statement, the DOTr said the breakdown of commuters who tried to board trains are as follows:

  • Philippine National Railways: 8
  • MRT-3: 1,204
  • LRT-2: 136
  • LRT-1: 401

The DOTr said the first day of the implementation of the policy was “generally peaceful.”

The Land Transportation Office (LTO), the Land Transportation Franchising and Regulatory Board (LTFRB), and the Inter-Agency Council for Traffic (I-ACT) – the agencies primarily responsible for enforcing the policy in the road sector – said the first day of the policy’s implementation saw enforcers comprehensively explaining the guidelines of the DOTr order to commuters.

“According to reports from our men on the ground, most of the passengers were prepared for the policy. They voluntarily handed over their vaccination cards to our enforcers for thorough inspection and verification before boarding public utility vehicles (PUVs),” said Transportation Secretary Arthur Tugade.

“Since this is just the first day of the policy’s implementation, our enforcers were instructed to just issue the violators warnings instead of outrightly apprehending them for non-compliance,” said DOTr Assistant Secretary for Road and Infrastructure Mark Steven Pastor.

“These persons were later properly turned over to their respective local government units (LGUs) for assistance,” added Pastor.

The “no vaccination, no ride” policy was implemented on Monday, January 17, 2022, in a bid to help curb the spread of the virus that causes COVID-19 amid a recent spike in the number of infections in Metro Manila.

Tugade said the department’s “no vaccination, no ride” aims to also protect the unvaccinated from getting severe COVID-19 infections.

The policy will be in effect while a COVID-19 Alert Level 3 level or higher remains hoisted in the NCR as to be determined by the Inter-Agency Task Force for the Management of Emerging Infectious Disease (IATF).

Meanwhile, exempted from the “no vaccination, no ride” policy are the following:

  • Persons with medical conditions that prevent their full COVID-19 vaccination as shown by a duly-signed medical certificate with the name and contact details of their doctor.
  • Persons who will buy essential goods and services, such as but not limited to food, water, medicine, medical devices, public utilities, energy, work, and medical and dental necessities, as shown by a duly issued barangay health pass or other proof to justify travel.

Galvez: Nearly 7 million Filipino minors vaccinated vs COVID-19

Robie de Guzman   •   January 18, 2022

MANILA, Philippines – Nearly 7 million minors in the Philippines have been inoculated against COVID-19 in the ongoing vaccination campaign, vaccine czar Carlito Galvez Jr. said.

In his report to President Rodrigo Duterte during a Cabinet meeting on Monday, Galvez said 6.88 million or 54 percent of children aged 12 to 17 have been fully vaccinated against coronavirus disease.

“I am happy to report na maganda po ang ating ongoing vaccination for minors at napakataas po ng antas ng public acceptance. Lalo na po noong National Vaccination Day nagdo-dominate po ang mga minors na talagang pumunta po sa mga vaccination site,” he told the president.

“Sa ngayon po ay may 8.49 million or 67 percent na po ang naka-receive ng first dose and 6.88 million or 54 percent na po ang fully vaccinated sa ating aged 12 to 17 years old,” he added.

With the current vaccination output, Galvez expressed optimism that the immunization campaign for the said age group will be completed by March.

“Sa assessment po namin na kung magtuloy-tuloy ang magandang output natin at kaya po nating matapos ang pagbabakuna ng kabataan edad 12 hanggang 17 anyos by end of March at makapagsimula po tayo ng boosters by April pagka po napayagan po tayo ng mga experts,” he said.

Galvez, who is also chief implementer of the National Task Force (NTF) against COVID-19, said the government will continue to pursue the vaccination of children aged 5 to 11 as they expect more supply of vaccines formulated by Pfizer-BioNTech for this age bracket to arrive in the country in the coming weeks.

He also disclosed that Chinese drug firm Sinovac has applied for emergency use of its COVID-19 vaccine shots for kids aged 3 to 17 in the country. He said this brand could be used as a source of alternative supply once approved by the Philippine Food and Drug Administration.

Data presented by Galvez showed that at least 55.1 million people have been fully vaccinated against COVID-19 while more than 4.7 million Filipinos have taken their booster shots.

DepEd eyes expansion of in-person classes by February

Robie de Guzman   •   January 18, 2022

MANILA, Philippines – The Department of Education (DepEd) has recommended the “progressive expansion” of face-to-face classes in areas under COVID-19 Alert Levels 1 and 2 starting next month.

During a pre-taped meeting with President Rodrigo Duterte aired on Monday night, Education Secretary Leonor Briones explained that the expansion of the pilot physical classes will be progressive, which means that only select schools in areas classified as low-risk for COVID-19 will be allowed to resume classes.

“Hindi ‘yung lahat-lahat sabay-sabay. Kung ang isang lugar ay Alert Level 1 and 2, selective, puwedeng mag-expand ng face-to-face,” Briones said.

The DepEd chief said the expansion of face-to-face classes will start in February, with the concurrence of the local government units (LGU) and parents’ consent.

“Iyong framework ng shared responsibility, patuloy. Iyong pag-concur ng LGUs, alam na alam namin ito, conscious kami at saka parents’ consent, requirement pa rin, Mr. President. Hindi kami mag-e-expand ng basta-basta na hindi kami mangangatok sa local governments at saka hindi namin makuha iyong written consent ng mga parents,” Briones said in her report to the president.

“Iyon ang aming proposal, Mr. President. February ang pag-e-expand pero maingat pa rin, taking into consideration the advice of the Department of Health, the LGUs, as well as now the Department of Justice,” she added.

Briones reiterated that only fully vaccinated teachers and non-teaching personnel will be allowed to join the face-to-face classes. Participation of vaccinated students will also be preferred.

“Ang sabi namin, only vaccinated teachers and non-teaching personnel na vaccinated will participate kung tayo ay mag-implement ng faceto-face. At saka ‘yung participation ng vaccinated students, kasi in-announce na ni (vaccine czar) Secretary (Carlito) Galvez na by March, by April, mag-umpisa na tayo sa mga bata, iyon preferred natin ‘yun. So iyon ang aming proposal, Mr. President,” she said.

Briones said 278 schools with about 15,000 students participated in the pilot implementation of face-to-face classes last year.

Around 28 schools from Metro Manila joined the program last December but its resumption was suspended earlier this January due to the increase in COVID-19 cases in the region.

Other regions with high coronavirus infections also suspended limited in-person classes but classes in areas under COVID-19 Alert Level 2 have continued.

The DepEd earlier allowed schools and local education offices to suspend classes for up to two weeks over rising COVID-19 cases.

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