WASHINGTON, United States (AFP) — The US drug regulator gave full approval to a new Alzheimer’s medicine on Thursday, a move that makes it more widely available to the public through government-run health insurance for the elderly. Leqembi, developed jointly by Japan’s Eisai and Biogen of the United States, was shown in a clinical trial to modestly reduce cognitive decline among patients in the early stages of the disease. But the study also raised concerns […]
Tag: FDA
US panel recommends Covid vaccines for youngest children
by Issam AHMED Agence France Presse WASHINGTON, United States (AFP) — A panel of experts convened by the US Food and Drug Administration unanimously recommended Covid-19 vaccines Wednesday for children under five, the final age group awaiting immunization in most countries. Formal authorizations for Moderna and Pfizer should follow soon, with the first shots in arms expected early next week, just over a year-and-a-half after the first Covid vaccines were greenlighted for the elderly […]
DOH guidelines recommend use of self-administered antigen test kits for individuals with Covid symptoms
(Eagle News) – The Department of Health has issued guidelines on the use of self-administered antigen test kits, recommending these only for those with Covid-19 symptoms to be taken “within seven days from onset of symptoms.” In the Department’s Memorandum No. 2022-0033, the DOH said that “only self-administered antigen test kits approved by the Philippine Food and Drug Administration (FDA) and validated by the Reasearch Institute for Tropical Medicine may be used.” The FDA […]
Hope seen with anti-COVID drugs: FDA gives special permit for Bexovid, cheaper generic version of Pfizer’s Paxlovid
Bexovid and Paxlovid, with the generic name Nirmatelvir, could reduce hospitalization and deaths by around 90 percent, says Palace (Eagle News) – The Philippine Food and Drug Administration has given a compassionate special permit to the anti-Covid-19 drug Bexovid, the first generic version of the Pfizer antiviral treatment drug Paxlovid. This is good news for Filipinos since this would mean treatment for COVID-19 would be more accessible to ordinary Filipinos since this generic drug […]
Pfizer vaccines can now be given to children aged 5 to 11 in the PHL, according to FDA
PHL FDA chief says EUA granted to Pfizer for administration to kids aged 5 to 11; vaccination could start in January next year depending on supplies (Eagle News) – The Philippines’ Food and Drug Administration (FDA) has approved the use of Pfizer vaccines for children aged 5 to 11 years old in the country. FDA Director-General Undersecretary Eric Domingo said that they have already approved the emergency use authority (EUA) for the administration […]
PHL okays shortened interval of 3 months for booster shots
From the previous interval of 6 months, boosters can now be administered 3 months after second primary vaccine dose (Eagle News) — Effective December 22, the interval for the administration of booster doses shall be shortened — from at least six months to at least three months after the full or second dose of the primary vaccine, according to the Department of Health. Health Secretary Francisco Duque III said the shortened interval between the second […]
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 […]
PHL starts giving booster shots to health workers; DOH issues recommended booster dose combinations
(Eagle News) – The Philippine government started on Wednesday, Nov. 17, giving booster shots to the country’s health workers, giving them the choice to pick their preferred COVID-19 vaccine brand. The Food and Drug Administration (FDA) issued an emergency use authorization for four vaccine brands as homologous boosters – Sinovac, AstraZeneca, Pfizer, Moderna. This means these brands can be given as a third dose, for those who have received the same brand as first […]
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 […]
29 FDA employees test positive for COVID-19
(Eagle News) — Twenty-nine Food and Drug Administration personnel have tested positive for COVID-19. As a result, the FDA main office in Muntinlupa City will be closed for disinfection on Friday, Aug. 27. Earlier, the OCTA research group said Metro Manila topped its list of 20 areas with the most new COVID-19 infections on Wednesday, Aug. 25. The Department of Health has said a community transmission of the Delta variant had been observed in Metro […]
FDA gives EUA to Russia’s single-dose vaccine Sputnik Light, bringing to 9 total COVID jabs for emergency use
With this EUA, there are now 2 single-dose Covid vaccines allowed for PHL use: Sputnik Light and Janssen (Eagle News) – The Philippine Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for Russia’s single-dose COVID-19 vaccine, Sputnik Light. Sputnik Light is the ninth COVID-19 vaccine to be given an EUA in the Philippines. Before this, FDA granted EUA to China’s Sinopharm vaccine on June 7. The other vaccines with EUA are […]
