Dengvaxia ban likely to extend for more than a year – DOH

Marje Pelayo   •   December 11, 2018   •   3468

FILE PHOTO: The controversial dengue vaccine, Dengvaxia

MANILA, Philippines – The Food and Drug Administration (FDA) is likely to extend the ban on marketing and sales of Dengvaxia, according to the Department of Health (DOH).

December 29 this year marks the first year since the license of French pharmaceutical giant Sanofi Pasteur was suspended; banning its sale of Dengvaxia in the country.

The DOH believes that since the controversy on the anti-dengue vaccine is not yet closed, the ban on sale of Dengvaxia still remains.

“Iyong one-year suspension ng Dengvaxia CPR is not yet lifted and I do not see it being lifted anytime soon. We still have a lot of pending issues with the vaccine and at this time we do not see it being registered and allowed for marketing in the Philippines…regulatory issues and cases in Court,” said DOH Spokesperson Usec. Eric Domingo.

It will be recalled that the FDA suspended Sanofi for not submitting its post-marketing authorization requirements which were supposed to prove that the products manufactured by the pharmaceutical company are safe to use.

Sanofi also couldn’t assure the safety of Dengvaxia, according to DOH.

The DOH noted that in November 29, 2017, Sanofi released a statement that Dengvaxia is not advisable to be administered to seronegative recipients —children or adults—who never had dengue infection prior to injection for the reason that their cases are likely to develop into severe dengue.

“It cannot be used without testing for children if they had dengue before. And there are no available testing kits commercially to do that. We don’t see naman any use for the vaccine at this time,” Domingo said.

The DOH also argued that the even regulatory agencies in the world that were granted with licenses to use Dengvaxia such as in Brazil, have set restrictions on the use of Dengvaxia on children who never had dengue infection prior to injection.

Hindi na rin sila magbibigay without screening,” Domingo said.

Based on the latest findings of the DOH, about 24 to 25 cases of dengue infection led to death due to severe dengue.

“We’ve seen talagang meron tayong patients who have, na ang mortality nila was due to severe dengue and I think probably from talagang seronegative patients iyon,” the health official said.

Meanwhile, the DOH is still waiting for the approval of Congress regarding the supplemental budget for vaccinees from the refund that Sanofi gave which reached P1.16-B.

Domingo said before the end of the year, the Office of the Solicitor General is likely to file a case against Sanofi Pasteur in line with the Dengvaxia controversy. – Marje Pelayo (with reports from Aiko Miguel)

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)

DOH agrees with FDA decision to ban Dengvaxia in Phl

Maris Federez   •   August 22, 2019

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

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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