FDA allows use of Sinovac vaccine on senior citizens

Robie de Guzman   •   April 7, 2021   •   235

MANILA, Philippines – The Food and Drug Administration (FDA) on Wednesday announced that it has approved the use of CoronaVac COVID-19 vaccine, developed by China’s Sinovac BioTech, on senior citizens.

The FDA’s announcement comes after the Vaccine Expert Panel (VEP) recommended the administration of Sinovac’s vaccine on the elderly.

“After considering the recommendation of the experts and the current situation of high COVID-19 transmission and limited available vaccines, the FDA is allowing the use of Sinovac on senior citizens,” FDA Director-General Eric Domingo said in a statement.

Domingo, however, emphasized that the vaccination of senior citizens using CoronaVac should strictly be preceded by careful evaluation of the person’s health status and exposure risk.

“Vaccination should be preceded by an evaluation of the person’s health status and exposure risk to assure that benefits of vaccination outweigh risks,” he said.

In a separate statement, the Department of Health (DOH) further stressed that while the current efficacy data for senior citizens from Phase III trials is insufficient, the benefits of using the vaccine for this particular group outweigh its risks, and more scientific data on the use of senior citizens may soon become available.

As the government continues its COVID-19 vaccination drive, the DOH and FDA urged the public especially senior citizens and persons with comorbidities to “register for and participate” in the immunization program “to afford themselves the added layer of protection that it can provide.”

“Registration for free vaccination may be done in their respective LGUs,” the two agencies said.

FDA issues advisory on sale of unregistered drug Lianhua Qingwen Jiaonang

Robie de Guzman   •   April 19, 2021

 

MANILA, Philippines – The Food and Drug Administration (FDA) has advised the public against the sale and distribution of unregistered drug Lianhua Qingwen Jiaonang with Chinese characters.

In its advisory, the FDA said there is still an “incessant sale and distribution” of the product, which were verified as unregistered.

 “As per continuing surveillance, there is still an incessant sale and distribution even through social media platforms, such as Facebook, of Lianhuan Qingwen Jiaonang with Chinese characters, which were verified as unregistered by the FDA,” the agency said.

The FDA added that only the Lianhuan Qingwen Jiaonang with English text and details provided in the advisory was issued with a certificate of product registration and approved to be sold/marketed in the Philippines.

“The agency cannot guarantee the quality and safety of the product with the Chinese text due to these have not undergone evaluation by the FDA and these came from unlicensed sources or establishments. The consumption of such violative product may pose potential danger or injury if administered,” it said.

Lianhuan Qingwen Jiaonang is a traditional Chinese drug that some people believe can cure COVID-19, but health experts said this drug should only be taken with a doctor’s prescription.

“All concerned establishments and/or entities are warned not to distribute the above-identified violative drug product, otherwise regulatory actions and sanctions shall be strictly pursued,” the FDA said.

Under the country’s Food and Drug Administration Act of 2009, the manufacture, importation, sale, offering for sale, distribution, transfer, promotion, advertising, or sponsorship of health products without proper authorization from the FDA is prohibited.

Second hospital given compassionate permit on ivermectin use vs COVID-19 – FDA

Robie de Guzman   •   April 16, 2021

MANILA, Philippines – Another hospital has been granted with compassionate special permit (CSP) to use anti-parasitic drug ivermectin to treat patients with COVID-19, the Food and Drug Administration (FDA) said Friday.

“Two hospitals na actually na nag-apply sa atin ang nabigyan ng CSP,” FDA director-general Eric Domingo said in an interview with ANC.

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

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

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

Domingo likewise reiterated 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 use ivermectin to treat COVID-19 patients are required to report to the FDA on a monthly basis, he said.

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

Ivermectin is registered in the Philippines 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. – RRD (with details from Correspondent Aiko Miguel)

US gives P170M support for Philippines’ COVID-19 vaccine deployment

Robie de Guzman   •   April 15, 2021

MANILA, Philippines – The United States (US) government, through the United States Agency for International Development (USAID), has provided P170 million or $3.5 million funds to support the Philippines in its COVID-19 vaccination rollout, the US Embassy in Manila said Thursday.

U.S. Embassy Chargé d’Affaires John Law announced this during a visit to a vaccination site in Caloocan City with Philippine Secretary of Health Francisco Duque III, Caloocan City Mayor Oscar Malapitan, USAID Philippines Mission Director Lawrence Hardy II, and other U.S. and Philippine officials.

The embassy said the new assistance will support the Philippines in strengthening the vaccine supply chain, monitoring vaccine safety, and delivering effective communication campaigns to address vaccine hesitancy.

It will also support local government units as they plan for, track, and administer vaccines, it added.

“While the pandemic has tested our peoples and our economies, the strong bonds between Americans and Filipinos will help us rise above this challenge,” Law said.

“We will continue to fight this unprecedented global health crisis together,” he added.

The latest assistance fund brings the total U.S. government support for the Philippines’ COVID-19 response to nearly P1.3 billion ($27 million), the embassy said.

Meanwhile, the embassy further reported that the White House recently announced a P194 billion ($4 billion) commitment to support the COVAX facility.

COVAX Facility is a global initiative to support early vaccine access for 92 countries, including the Philippines.

An initial P97.2-billion ($2 billion) contribution, provided through USAID, is supporting the purchase and delivery of safe and effective COVID-19 vaccines, the embassy said.

The Philippines has so far administered over 1.2 million vaccine doses out of the more than 3 million doses that were delivered in the country.

Government data showed that 1,093,651 people received their first shot while 162,065 individuals already got two doses since the vaccination program started on March 1.

 

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