Review on EUA of COVID-19 vaccines underway — FDA

Maris Federez   •   October 28, 2021   •   259

MANILA, Philippines — The Food and Drug Administration is now in the process of reviewing the possibility of administrating booster shots or third doses of COVID-19 vaccines, said FDA Director-General Eric Domingo.

This was prompted by the Department of Health’s (DOH) submitted request to the FDA to review the amendments of the emergency use authorization (EUA) of COVID-19 vaccines currently being used in the country.

“Nag-send sila ng letter asking for a review of the EUAs for possible na third shot and we sent the data to our experts to take a look at it para makita nga alin ang maari nating payagan whether a homologous or same vaccine, or heterologous or different vaccine […] So this is now under evaluation,” Domingo said.

“Ang hinihingi nila na i- review iyong recommendation ng HTAC (Health Assessment Technology Council),” he added.

Domingo said that based on the recommendation of the HTAC, possible third dose or booster shots that can be administered to vaccines are the ones that already received approval from the FDA and are currently being used COVID-19 vaccines.

To date, the Philippines is using vaccines from Sinovac, AstraZeneca, Pfizer, Moderna, and Janssen.

Health Undersecretary Maria Rosario Vergeire earlier said that an amendment to the existing EUAs is needed before the government can launch another rollout for booster shots or additional doses.

Vergeire also clarified that boosters are given to vaccinees whose immunity to the highly contagious virus has decreased over time after getting inoculated. A third dose, on the other hand, is for those who did not generate a strong immunity after receiving the jab.

Domingo said it will not take long for the FDA to release its decision on the amendment of the EUAs.

“I’m giving experts naman time to take a look dahil napakarami rin talaga ng studies ano and there are separate studies. Hindi kasi ito katulad ng EUA dati na halimbawa, isang bakuna. Ito, several studies, iba ibang bansa, tapos iba ibang methodology, tapos maliliit ang sample size. You have to take them into consideration and put them all together,” Domingo said. —/mbmf

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.

Labor dept asks employers to provide workers with paid isolation, quarantine leave benefits

Robie de Guzman   •   January 17, 2022

MANILA, Philippines – The Department of Labor and Employment (DOLE) on Monday urged employers in the private sector to provide paid leave benefits to workers who have to undergo isolation or quarantine period due to COVID-19.

In a labor advisory, DOLE said this is to “ensure safe and humane working conditions” amid the rising cases of coronavirus in the country.

The labor department said employers in the private sector are encouraged to adopt and implement appropriate paid isolation and quarantine leave program, on top of the existing leave benefits under the company policy. Leave benefits under the Collective Bargaining Agreement, the Labor Code of the Philippines, and special laws should be separately applied.

“The paid isolation and quarantine leaves shall be without prejudice to other benefits provided by the Social Security System and the Employees Compensation Commission,” it added.

DOLE said its advisory applies to all establishments, employers, and their employees in the private sector.

Under the updated guidelines from the Department of Health, fully vaccinated COVID-19 patients who are asymptomatic or with mild symptoms need to isolate for seven days while those who are unvaccinated or partially vaccinated need to complete the isolation period for 10 days.

The isolation period for moderate cases is 10 days while those with severe and critical symptoms, and immunocompromised would have to isolate for 21 days.

The quarantine period for fully vaccinated asymptomatic close contacts has been shortened to five days.

Isolation is for individuals who have tested positive for COVID-19 while quarantine is for those who have been exposed and can possibly develop an infection.

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