DOH agrees with FDA decision to ban Dengvaxia in Phl

Maris Federez   •   August 22, 2019   •   1088

A Filipino nurse prepares to administer an anti-dengue vaccine during a nationwide vaccination at a school in the flood-prone city of Marikina, east of Manila, Philippines, 04 April 2016. (Photoville International / FILE)

The Department of Health (DOH) has rejected the request of Sanofi Pasteur to overturn the decision of the Food and Drug Administration (FDA) to ban the use of Dengvaxia vaccine in the Philippines.

With this, the DOH approved the ruling of the FDA to permanently revoke the certificate of product registration of Dengvaxia for Sanofi’s failure to submit the necessary post-approval requirements.

“The decision concerns Sanofi’s complete disregard of FDA regulations, which were precisely put in place by law to ensure safety,” DOH Secretary Francisco Duque III said in a statement.

Although Sanofi was able to submit the first two versions of its risk management plans (RMP), the pharmaceutical company failed to submit the third and final version of the plan.

The DOH said, however, that Sanofi may apply for a new certificate of product registration (CPR) for Dengvaxia but this must be in accordance with the FDA regulations.

“Given that Dengvaxia is an innovative drug, the importance of complying with these post-marketing commitments is critical to public safety,” the statement added.

Meanwhile, the department has assured that it continues to address the increasing cases of dengue in the country. /mbmf

FDA recalls locally-made COVID-19 test kits for ‘minor defects’

Marje Pelayo   •   May 21, 2020

MANILA, Philippines — Some ‘minor defects’ have been seen in the test kits made by the University of the Philippines – National Institute of Health (UP-NIH), according to the Food and Drug Administration (FDA).

This prompted the agency to order the recall of all locally-made coronavirus disease (COVID-19) test kits and stop its use in medical facilities until the problem is resolved.

Specifically, FDA Director Eric Domingo said evidence of contamination had been traced in the reagents that were used in the test kits of UP-NIH; hence, they should not be sold or used for now.

The said locally-made test kits were approved for use by the FDA in April.

Nonetheless, Health Spokesperson Undersecretary Maria Rosario Vergeire ascertained that the UP-NIH is soon to complete correcting the deficiencies in their test kits. 

“They are in the final stages of correcting the identified deficiencies of the kits by RITM and hopefully by next week they can be re-validated by RITM and we can already use the UP testing kits,” Vergeire said. 

As regards the rapid antibody test kits, Malacañang maintained that local government units (LGU) may still use the said kits despite claims by medical societies that the use of such would be a waste of resources when they only give false results. 

According to Presidential Spokesperson Secretary Harry to  Roque, the LGUs just need to confirm the results of the rapid antibody test kits through real-time reverse transcription polymerase chain reaction (rRT-PCR) test within the succeeding 14 days. 

Sa ngayon po, dahil po wala pa tayong sapat na kakayahan at dahil tayo po ay nagbi-build up pa lang ng capacity ng PCR testing, siguro naman walang mawawala kung ira-rapid testing natin ang gusting magpa-rapid testing at yung mga positive, ipa-verify natin sa PCR [For now, since we do not have enough capacity yet and we are still building up our PCR testing capacity, there’s no harm if we still proceed with rapid testing to those who request it, and if it yields a positive result, then have it confirmed through PCR],” Roque explained.

 FDA-approved rapid test kits costs around P3,500 and up depending on the source company and the country of origin. MNP (with reports Aiko Miguel)

Philippines eyes 30,000 daily COVID-19 tests by end of May

Robie de Guzman   •   May 12, 2020

MANILA, Philippines – The Department of Health (DOH) is eyeing to achieve 30,000 daily tests for novel coronavirus disease (COVID-19) by the end of the month as it works to ramp up the country’s testing capacity.

The DOH set the target after it finally attained its first target to conduct 8,000 COVID-19 tests in a day.

On Sunday, May 10, the agency reported it has conducted 8,637 tests in one day. This is, however, 10 days past its target date of April 30.

According to Health Undersecretary Maria Rosario Vergeire, the tests were done on 158,176 unique individuals.

She explained that one of the causes of the delay was the slow processing of samples after the Research Institute for Tropical Medicine (RITM) had to scale down its operations in April when over 40 of its medical staff contracted COVID-19.

The RITM has since returned to normal operations after most of its personnel recovered from the disease.

So far, the Philippines has 26 accredited laboratories capable of detecting the strain of coronavirus strain that causes COVID-19.

Vergeire said they are eyeing to open additional testing facilities to reach its target of 30,000 daily tests.

This way, the country will be able to improve efforts on contact tracing, isolation and treatment of COVID-19 patients to effectively curb the spread of the disease.

“Hindi pa po tapos ang laban ng World War C (COVID-19) sa bawa’t bagong impormasyon bawa’t bagong teknolohiyang nadidiskubre upang malabanan ang COVID-19 tayo’y dapat maging manatiling alerto dahil ang bawa’t bagay na nagagawa natin ay mayron buhay na mailigtas,” Vergeire said.

To date, the Philippines has recorded 11,086 confirmed coronavirus infections, with 726 deaths and 1,999 recovered patients. – RRD (with details from Correspondent Aiko Miguel)

WHO hopes to have vaccine for COVID-19 ready in 18 months

Marje Pelayo   •   February 12, 2020

GENEVA, Switzerland — The World Health Organization (WHO) announced on Tuesday (February 11) that it takes time to develop a vaccine against the novel coronavirus now named COVID-19.

However, the international health body hopes to have an effective vaccine within 18 months.

 “The development of vaccines and therapeutics is one important part of the research agenda. But it’s not only one part. They will take time to develop — but in the meantime, we are not defenseless,” said WHO Chief Dr. Tedros Adhanom Ghebreyesus during a press conference at the agency’s headquarters.

 “The first vaccine could be ready in 18 months, so we have to do everything today using the available weapons to fight this virus, while preparing for the long-term,” he added.

He noted, however, that even though WHO already named the new virus as COVID-19, there are still many unknown factors that are preventing scientists from finding an exact cure.

“It’s hard to believe that just two months ago, this virus – which has come to captivate the attention of media, financial markets and political leaders – was completely unknown to us,” Tedros said.

“To defeat this outbreak, we need answers to all those questions and more,” he added.

READ: New virus named ‘COVID-19’ to avoid public stigma — WHO

During briefing, the official labeled the disease as “public enemy number one” that poses a global threat, despite most of the cases being confined in mainland China.

“With 99 percent of cases in China, this remains very much an emergency for that country, but one that holds a very grave threat for the rest of the world,” the official noted.

So far, Dr. Tedros said, WHO is working with countries to strengthen laboratory capacity around the world, ensuring enough supplies of testing kits and protective equipment for health workers and training them to help prevent further spread of COVID-19.

What’s important for now, he added, is for every individual to become part of the preventive strategy.

At least, he explained, individuals should be sensitive not only of his or her own health but also of the people around.

“And we’re keeping the public informed about what everyone can do to protect their own health and that of others,” he said.

“That’s why reaching out to the public directly and telling them the precautions they should take,” he added.

Dr. Tedros reiterated the basic preventive measures that people should religiously practice while there remains no cure for the coronavirus disease.

“Clean your hands regularly, either with alcohol-based rub or soap and water. Keep your distance from someone who is coughing or sneezing. And when you cough or sneeze, cover your mouth and nose with a tissue or your elbow,” he concluded.

REACH US

The Philippine Broadcast Hub

UNTV, 915 Barangay Philam,

EDSA, Quezon City M.M. 1104

(+632) 8396-8688 (Tel)

info@untv-newsandrescue.com (General inquiries)

ABOUT UNTV

UNTV is a major TV broadcast network with 24-hour programming. An Ultra High Frequency station with strong brand content that appeal to everyone, UNTV is one of the most trusted and successful Philippine networks that guarantees wholesome and quality viewing experience.