Tag: FDA

PHL FDA okays use of Sinovac vaccines for the elderly

FDA gives green light after PHL vaccine expert panel recommendation on Sinovac use for senior citizens, citing its safety and efficacy   (Eagle News) – The Philippines’ Food and Drug Administration approved on Wednesday, April 7, the use of Sinovac vaccines for the elderly. FDA Director-General Undersecretary Eric Domingo said that they approved the Sinovac vaccine with the brand name Coronavac for use in the elderly or those aged 60 and above after the recommendation […]

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 […]

1.4 million more Sinovac doses to arrive this month, says Galvez

(Eagle News) – Some 1.4 million additional doses of Sinovac vaccines are expected to arrive in the country this month, according to vaccine czar Secretary Carlito Galvez Jr. In an interview over government television PTV-4 on Sunday night, Galvez said that 317,359 doses or more than half of the initial 600,000 doses delivered on Feb. 28 of the Sinovac vaccines had already been deployed nationwide to health workers as their first dose. The second dose […]

With vaccine rollout, Fil-Chinese chambers of commerce want MGCQ by end of March

“It’s about time to open up the economy,” says FFCCCII president   (Eagle News) – The head of the Federation of Filipino-Chinese Chambers of Commerce and Industry Inc., (FFCCCII)  said that they prefer a shift to Modified General Community Quarantine (MGCQ) by the end of March at the latest since the vaccine program has already started. FFCCCII president Dr. Henry Lim Bon Liong said that “it’s about time to open up the Philippine economy” noting […]

PGH Director is first to get Sinovac shot; FDA chief also gets Chinese-made jab

PHL rollout begins with medical frontliners, testing czar Dizon also gets Sinovac   (Eagle News)  — The director of the Philippine General Hospital (PGH), Dr. Gerardo “Gap” Legaspi becomes the first person to be given the Sinovac vaccine in the country, as the Philippines begins is vaccination roll-out to defeat COVID-19. Legaspi said that he is also very thankful that vaccines had already arrived in the country.  He said even his family members will get […]

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 […]

PHL to get additional Sputnik V doses after Lancet review showing 91.6 percent efficacy

(Eagle News) – The Philippines said it is looking forward to the acquisition of Russia’s Sputnik V vaccines after the Lancet medical journal review that showed the Gamaleya vaccine was 91.6 percent effective against COVID-19. Vaccine czar Secretary Carlito Galvez Jr. said that they are currently securing additional vaccine doses from Russia’s Gamaleya Institute. “Sa ngayon po, ongoing po ang negotiation natin and we are asking for some doses pero iyon po, sinasabi ko po […]

FDA: PHL clinical trials for 3 COVID-19 vaccines – Janssen, Clover, Sinovac – ready to begin

  (Eagle News) — The Food and Drug Administration (FDA) said that three clinical trials for COVID-19 vaccines which it had earlier approved are about to begin in the country. These are the Phase 3 clinical trials for the vaccines developed by Janssen Pharmaceuticals of Johnson and Johnson, Clover Biopharmaceuticals, and Sinovac. “So wala na po tayong pending ngayon na mga applications for clinical trials with FDA, and all these three clinical trials have been […]

Pres. Duterte says LGUs can procure COVID-19 vaccines as long as these have FDA clearance

  (Eagle News) – President Rodrigo Duterte said that local government units (LGUs) can procure their own vaccines against COVID-19 as long as these had passed the Food and Drug Administration (FDA). Duterte said he sees nothing wrong with LGUs getting their own vaccines, but that they have to follow the requirement, which is clearance from the FDA. “Now, let me be very clear. Doon sa mga local governments, Sakur, wala akong objection kung magbili […]

PHL FDA closely monitoring reported adverse reactions to Pfizer vaccines in other countries

  (Eagle News) — The Food and Drug Administration (FDA) said it is coordinating with Pfizer and BioNTech so that the Philippines can be updated on developments regarding recent response to its vaccines on individuals given this inoculation in other countries. So far, the FDA said that because of reported adverse reactions monitored in other countries in some individuals particularly in very sick elderly patients, and severe allergic reactions in persons with a history of […]

FDA: 2 COVID-19 vaccines, Janssen and Clover Biopharma, approved for PHL clinical trial

  (Eagle News) — Two COVID-19 vaccines have now been cleared for clinical trials in the Philippines, according to the Food and Drug and Drug Administration (FDA). This was after it had approved on Friday, Jan. 8, 2021 the vaccine developed by Clover Biopharmaceuticals AUS Pty Ltd of China, days after it had approved the vaccine made by Janssen Pharmaceutical Companies of Johnson & Johnson. With this development, two vaccines against COVID-19 are now given […]

FDA says WHO listing for emergency use of Pfizer vaccine “very significant” for PHL

  (Eagle News) — The Philippine Food and Drug Administration (FDA) said that the validation of the World Health Organization WHO) of the Pfizer and BioNTech vaccine against COVID-19 for emergency use was “very significant” for a possible grant of emergency use authorization (EUA) in the country. FDA Director General Eric Domingo said that Pfizer submitted its application for EUA on December 23, and so far was the only vaccine maker which had applied for […]