Tag: EUA

Pfizer’s EUA application for 5 to 11 age group under review by PHL vaccine experts, says FDA

  (Eagle News) – Pfizer-BioNTech has already submitted its application for emergency use authorization (EUA) for the use of its vaccines to children aged 5 to 11 years old, and is now being evaluated by the Philippine vaccine experts’ panel, according to Food and Drug Administration chief Undersecretary Eric Domingo. Pfizer’s application has already been forwarded to the country’s vaccine experts for their evaluation as of late last week. Domingo said that Pfizer claims its […]

Marcoleta says mandamus SC petition to compel gov’t agencies to give EUA for Ivermectin against COVID

  (Eagle News) — House Deputy Speaker Rodante Marcoleta talked about the importance of the writ of mandamus he and other lawmakers are seeking from the Supreme Court so that government agencies would be compelled to allow the use of Ivermectin, an anti-parasitic drug, as a possible treatment and preventive drug against COVID-19. In the interview with NET25’s “Balitalakayan” on Thursday, Sept. 16, Marcoleta said that by filing the petition for a writ of mandamus, […]

WATCH: Interview with FDA director Usec Eric Domingo on EUA amendment for Moderna for 12 to 17 years old

  (Eagle News) — Balitalakayan interviews Food and Drug Administration (FDA) Undersecretary Eric Domingo who explains the amendments to the emergency use authority (EUA) for Moderna so these could be used for adolescents aged 12 to 17 years old. Domingo also explains other issues related to vaccines, including the aim to achieve population protection or even herd immunity by year-end. He also explains the importance of completing vaccination, and getting the full dose, as studies […]

WATCH: Interview with FDA chief Domingo on vaccination of children, other issues – Balitalakayan

https://www.youtube.com/watch?v=dBJtZX_68bE   The Eagle News Service program “Balitalakayan” interviews Food and Drug Administration Director General Undersecretary Eric Domingo on the various issues surrounding vaccines which have already been given emergency use authorization, including the application of Sinovac to extend its EUA so the vaccine could also be administered to children aged 3 to 17 years old. Balitalakayan, anchored by Weng dela Fuente, airs Monday to Friday, from 7 a.m. to 8 a.m. on NET25 and […]

DOH welcomes FDA amended EUA for Pfizer allowing its use for 12-15 years old

But DOH Usec Vergeire says adult priority groups to first be given Pfizer doses   (Eagle News) – The Department of Health (DOH) welcomed the decision of the Food and Drug Administration (FDA) to amend the emergency use authorization given to Pfizer vaccine so it could be given to 12 to 15 years old. Health Undersecretary Maria Rosario Vergeire said that the Pfizer vaccines could be given to adolescents or teenagers once more vaccine supplies […]

Moderna given emergency use authorization by FDA, becomes 7th vaccine to be issued EUA in PH

(Eagle News) – The Food and Drug Administration issued an emergency use authorization (EUA) to Moderna vaccine. In an online press conference, FDA Director General Eric Domingo said that they granted the EUA to Moderna, which is produced in the United States, “after rigorous and thorough review by regulatory and our medical experts using the currently available published and unpublished data.” “FDA is granting an emergency use authorization to Zuellig Pharma Corp. for the…COVID-19 vaccine […]

Moderna applies for EUA with FDA; EUA issued to 6 vaccines so far, the latest is for India’s Covaxin

  (Eagle News) — The COVID-19 vaccine Moderna has already applied for Emergency Use Authorization (EUA) with the Food and Drug Administration (FDA). Zuellig Pharmaceuticals filed the application for EUA, on behalf of Moderna. The application came more than a month before the scheduled arrival of the initial doses of Moderna vaccines. The first batch of Moderna vaccines are expected to arrive on June 15. In an earlier interview, FDA director general Eric Domingo said […]

PHL FDA issues EUA to J&J’s single-dose Janssen COVID-19 vaccine

  (Eagle News) – After careful consideration, the Philippine Food and Drug Administration issued an emergency use authorization (EUA) to the “Janssen COVID-19 Vaccine” of Johnson and Johnson on Monday, April 19. The single dose vaccine can only be used for individuals aged 18 and above. The FDA said that Johnson and Johnson was able to provide all the supporting documents, and these had been reviewed by local experts. The EUA was issued amid a […]

Moderna vaccine doses to start its PHL delivery by June 15, says PHL Ambassador Romualdez

Moderna to file EUA with FDA next week, delivery of 20-M doses to be completed by year-end; Moderna booster shots also to be made available starting September https://youtu.be/Cf4WASYf3Jc     (Eagle News) — Moderna would start delivering its vaccines to the Philippines by June 15 by which time more vaccines coming from the United States, including those from Pfizer, would be also arriving, according to Philippine Ambassador to the United States Jose Manuel “Babe” Romualdez. […]

Russia’s Sputnik V vaccine gets emergency use authorization from FDA

  (Eagle News) – Russia’s anti-COVID-19 vaccine Sputnik V has been given emergency use authorization (EUA) by the Food and Drug Administration (FDA), the agency’s director general said. FDA Director General Undersecretary Eric Domingo said that they issued the EUA to Sputnik V manufactured by Russia’s Gamaleya Research Institute after a “rigorous and thorough review.” Sputnik V even has a higher efficacy rate against COVID-19 at 91.6 percent, which is higher than the 63.09% against […]

FDA chief assures public: Sinovac effective for those aged 18-59; “good option” for those with allergies

  (Eagle News) – The Food and Drug Administration stressed that China’s Sinovac vaccines had an efficacy rate as high as 91.2 percent in the general population in Turkey, and up to 65.3 percent in Indonesia, and were therefore effective for the general population in preventing COVID-19. FDA Director General Undersecretary Eric Domingo also assured the public that Sinovac vaccines, under the trade name Coronavac, had not exhibited any severe adverse effects in the various […]

FDA says emergency use authorization for Pfizer COVID-19 vaccine out in 1 to 2 days

EUA process for AstraZeneca may be completed mid-January (Eagle News) — The Food and Drug Administration said the emergency use authorization for the Pfizer-BioNTech COVID-19 vaccine will be out in one to two days. Food and Drug Administration chief Eric Domingo made the announcement on Monday, January 11, during the Senate inquiry into the country’s roadmap for a COVID-19 vaccination. According to Domingo, the processing of the EUA for AstraZeneca’s COVID-19 vaccine, for its part, […]