DOH agrees with FDA decision to ban Dengvaxia in Phl

Maris Federez   •   August 22, 2019   •   951

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

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.

FDA must tighten regulations on processed meat – DA

Marje Pelayo   •   September 17, 2019

MANILA, Philippines – Regulations on processed meat such as well-loved Filipino delicacies tocino and longganisa should be tightened by the Food and Drug Administration (FDA), according to the Department of Agriculture (DA).

According to Agriculture Undersecretary for Consumer Affairs Ernesto Gonzales, consumers cannot be complacent on buying these processed products especially if they are not sure of the source or origin of the raw meat.

Gonzales added that it is difficult to determine if the pork meat is contaminated with African Swine Fever (ASF) once it is processed.

He added that even ‘botcha’ or double-dead pork meat can be made into meat delicacies without the consumer noticing it because of colorings and extenders used in the process.

The official said the best way to determine if the pork meat is safe for consumption is to know the source of the raw meat, and if it is certified by the National Meat Inspection Service (NMIS).

Kapag na-issue-han na ang karne from slaughterhouse ng meat inspection certificate (once meat from the slaughterhouse is issued with meat inspection certificate), definitely that meat is safe to eat,” Gonzales said.

However, the DA admitted that the government is lacking when it comes to regulations on processed meat so the coordination of the local government units (LGUs) is of utmost importance.

Iyang problema natin yung mga maliliit na food processors na gumagawa ng mga longanisa, tocino, ang regulation hindi ganoon ka-strict ( The problem with small-time food processors or makers of longanisa and tocino is that the regulation is not that strict), ” Gonzales noted.

If ever the processed meat is infected with ASF, Gonzales said, it is still safe to eat, provided that it went through the proper cooking procedure of 30 minutes under 70’C temperature. – MNP (with details from Rey Pelayo)

Sanofi Pasteur optimistic Dengvaxia will be restored in PH market

Aileen Cerrudo   •   August 15, 2019

French Pharmaceutical firm, Sanofi Pasteur expressed optimism that the Dengvaxia vaccine will be restored in the Philippine market.

In a statement, Sanofi Pasteur Philippines General Manager Jean Antoine Zinsou said they are open for a discussion with the Food and Drug Administration (FDA) and the Department of Health (DOH).

He also clarified that Dengvaxia is safe and effective to use.

According to Zinsou, the said vaccine was only banned in the Philippines because of incomplete documents or due to “administrative consideration.”

“We definitely need to settle this issue. One way to do it is to discuss with FDA and see what is needed to have this revocation lifted,” he said.

Zinsou also said Dengvaxia is registered in 20 countries across the globe and is acknowledged by the United States Food Drug Administration and the World Health Organization (WHO).

Meanwhile, Sanofi agrees with the DOH that Dengvaxia is not a solution to the Dengue epidemic in the country.

READ: Dengvaxia won’t bring dengue cases down – DOH

“The vaccines that we are mentioning is not a solution or a silver bullet for the ongoing outbreak. We are open to any discussion with the health authorities to see what is needed, what do they need for the future,” Zinsou said.

In February this year, the FDA revoked the certificate of product registration of Dengvaxia.

Sanofi already filed an appeal two weeks ago and the DOH will release their decision on the issue on August 19.—AAC (with reports from Aiko Miguel)

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