No available COVID-19 test kits in Phl yet — FDA

Maris Federez   •   March 15, 2020   •   1514

MANILA, Philippines — The Food and Drug Administration (FDA) has reiterated that there are no registered COVID-19 diagnostic test kits that are now available to the public yet.

In a statement issued on Sunday (March 15), the FDA said this is so “because no company has complied with the minimum set of requirements.”

The FDA added that they are only asking for a License to Operate (LTO) as a distributor and a Certificate of Product Registration (CPR) from a reliable and mature national regulatory agency (NRA) such as FDA counterparts in the United States, Japan, Singapore, South Korea, Europe, among others, from those who want to import test kits.

In the absence of such, a Certificate of Prequalification or Emergency Use Listing from the World Health Organization (WHO) is also admissible.

As of Sunday, the FDA said, no company has submitted these.

The agency also denied that there is a delay in the approval of the test kits, adding that as soon as proper documents are submitted to the FDA, the certification will be immediately released.

The FDA stressed that the submission of proper documents relative to the test kits will safeguard the public interest and ensure that the available test kits for use are safe and will give useful results.

“Many companies have been marketing test kits since the start of the COVID outbreak, however, the source and reliability of these devices are yet to be verified,” the statement reads.

Director-General Eric Domingo explained, “We cannot vouch for its safety and efficacy by merely accepting the stated claims of a testing kit without the proper regulatory certification from the country of origin and a reliable NRA. These kits may give false positive and false negative results which may affect the response to this pandemic. They may also be counterfeit products that will not test for the novel coronavirus at all.”

The FDA added that the only COVID-19 diagnostic test kits used now are PCR based lab kits at the Research Institute of Tropical Medicine (RITM) which were donated by the WHO, and the University of the Philippines National Institutes of Health (UP NIH) and Department of Science and Technology (DOST) developed test kit which is scheduled to start field testing on Monday, 16 March 2020.

The FDA ensures that it is committed to staying true to its mandate of safeguarding public health.

“During these difficult times, we strongly request everybody to cooperate and to be vigilant. This is not the time to take advantage of the scarcity of resources by allowing unregulated items into the system. Let us continue to look after each other’s safety.” DG Domingo concluded. — /mbmf

Pagbabantay sa PH borders, mas hihigpitan vs COVID-19 Delta variant — DOH

Robie de Guzman   •   June 21, 2021

MANILA, Philippines — Mas hihigpitan pa ang gagawing pagbabantay sa lahat ng border sa bansa, mula sa mga paliparan, pantalan hanggang sa mga boundary ng bawat lugar sa Pilipinas, ayon sa Department of Health (DOH).

Ayon kay Health Undersecretary Maria Rosario Vergeire, naabisuhan na ang lahat ng lokal na pamahalaan para sa paghihigpit sa kani-kanilang mga border upang mapigilan ang pagkalat ng Delta variant, isang uri ng COVID-19 na mas nakakakahawa kumpara sa ibang variant.

“Nasa heightened alert po lahat. Lahat ng local governments were informed, lahat po ng mga regional offices were informed na kailangan bantayan maigi ang Delta Variant across our borders,” ani Vergeire.

Ayon sa opisyal, mas paiigtingin pa ng pamahalaan ang pagpapatupad ng COVID-19 testing at quarantine protocols, at contact tracing pati na ang pagpapalawig sa entry ban sa mga magmumula sa bansang India, United Arab Emirates, Oman, Pakistan, Bangladesh, Sri Lanka, at Nepal hanggang June 30.

“We are going to uphold the directive of the IATF as well as the Office of the President. This is because we want to prevent further entry of this Delta Variant,” ani Vergeire.

“We cannot have non-uniformity in the implementation of our border control. So iyan po napag-usapan, napagkasunduan, nakausap na rin po ang mga officials, regional directors ng iba’t ibang ahensya last Saturday,” dagdag pa niya.

Ang mas mahigpit na border control sa Pilipinas ay kasunod ng pahayag ng World Health Organization na ang Delta variant na ang dominant variant ng COVID-19 matapos itong mapaulat sa mahigit 80 bansa.

Ang Delta variant ay unang natuklasan sa bansang India.

Sa Pilipinas, 17 na ang kabuuang kaso ng Delta COVID-19 variant matapos itong madagdagan nang magpositibo sa naturang variant ang apat na returning overseas Filipino mula sa South Korea at Saudi Arabia.

Iniulat din ng DOH na 14 na dagdag na kaso ng Alpha variant (United Kingdom), at 21 Beta variant (South Africa) ang naitala sa bansa batay sa ulat ng Philippine Genome Center at ng UP-National Institutes of Health ngayong Lunes.

Ayon sa DOH, lubhang nakababahala kapag lalo pang kumalat sa bansa ang mga variant na ito, lalo na ang Delta variant, dahil mataas ang tiyansang maospital ang isang individwal na kakapitan nito.

“Walang sinabi sa mga ebidensyang nakalap natin, even our experts are saying, walang sinabi na deadly pero sinabi na mas nakakahawa talaga siya,” ani Vergeire.

“Ang delta variant is 60% more transmissible than the Alpha variant. So, ibig sabihin po kung ang alpha variant ay nakapanghahawa ng 4-5 tao per every individual infected, ang Delta Variant po can have 8 individual infected sa isang taong may sakit. So ganoon kabilis ang pagkakahawa kapag Delta Variant ang pinag-uusapan,” dagdag pa niya.

Muli ring paalala ng DOH sa publiko na mag-doble ingat at sundin ang ipinatutupad na health protocols kontra COVID-19. – RRD (mula sa ulat ni Correspondent Aiko Miguel)

Filipinos are allowed to get vaccinated anywhere in PH — DOH

Robie de Guzman   •   June 21, 2021

MANILA, Philippines — Filipinos can get inoculated against novel coronavirus disease (COVID-19) anywhere in the country under the government’s “no wrong door policy” in its vaccination drive, the Department of Health (DOH) said Monday.

 “Meron ho tayong tinatawag na no wrong door policy. Ibig sabihin, kung ikaw ay nagpunta sa Davao at ikaw ay puwede nang bakunahan, puwede ka bakunahan doon kahit hindi ka taga-Davao,” Health Undersecretary Mari Rosario Vergeire said in a press briefing.

“Hindi po natin sinasara ang ating mga pinto sa mga bakunahan dahil hindi ka taga doon na lugar,” she added.

The health official, however, stressed that the vaccination should be done through appointments and that walk-ins should be discouraged as this tends to result in crowding.

The DOH previously said that local government units may open separate walk-in lanes in their COVID-19 vaccination centers as walk-ins may be used as substitutes for those who are scheduled for inoculation but do no show up on a certain date.

The agency, however, said that the number of walk-ins that would be accommodated per day in jab sites should be limited.

The DOH earlier urged the public to pre-register for the vaccination and get inoculated when it’s their turn.

DOH says surge in COVID-19 cases in Visayas, Mindanao due to ‘multitude of factors’

Robie de Guzman   •   June 21, 2021

MANILA, Philippines — The rise in COVID-19 cases in the Visayas and Mindanao areas could be attributed to a “multitude of factors,” the Department of Health (DOH) said Monday.

In an online press briefing, Health Undersecretary Maria Rosario Vergeire said they have noted some factors that have contributed to the spike in infections in the Visayas and Mindanao areas, including the complacency in enforcing and observing health protocols.

The DOH also observed the clustering of infections in workplaces and prisons in the said areas.

“Lagi po nating sinasabi na pag may tumataas po na kaso sa bawat lugar, we need to look at a multitude of factors because we know that there are these different factors which causes the transmission of the virus,” Vergeire said.

“Meron tayong pang-indibidwal at pang-komunidad na pagpapatupad po natin ng minimum health protocols at ‘pag tiningnan natin there are reports already coming to us from our different regional epidemiological and surveillance units na talagang mukhang nagkaroon ng complacency sa pagpapatupad ng health protocols,” she added.

Vergeire said the presence of coronavirus variants in some parts of the Visayas and Mindanao may also have contributed to the surge.

“Totoo po na meron na tayong na-detect na variants sa iba’t ibang lugar dito sa Visayas and Mindanao and these can also be drivers of the infection but let us not just rely or let us not just say that it’s just because of the variants, there are a multitude of factors,” she said.

“Kailangan po kapag tayo ay tumitingin sa response natin, it’s a continuum. So we will need to address, not just the variants, but also the other forms of response that we are having,” she added.

Data from the DOH showed that active COVID-19 cases in the Visayas stood at 13,313, and 14,426 in Mindanao as of June 20.

The DOH reiterated its call to the public to continue adhering to health protocols mandated by the government to help break the chain of COVID-19 transmission.

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