Study affirms negative effects of Dengvaxia

Marje Pelayo   •   June 14, 2018   •   17620

The controversial anti-dengue vaccine, Dengvaxia

The New England Journal of Medicine published an article about the negative effects of the controversial anti-dengue vaccine, Dengvaxia to those who have not contracted the disease prior to inoculation.

According to the article entitled “Impact of Dengue Serostatus on Dengue Vaccine Safety and Efficacy,” the vaccine is effective in protecting the patient from a re-occurrence of dengue. However, to those without prior dengue infection, the vaccine is not recommended as it could lead to severe dengue.

The study focused on the analysis of the dengue vaccine manufactured by Sanofi Pasteur which is Dengvaxia. This means the research study is in conformity with the recommendation of the World Health Organization (WHO) in April that Dengvaxia should not be administered to children without prior exposure to dengue.

In November 2017, Sanofi Pasteur issued a warning saying there is very high possibility of contracting severe dengue if Dengvaxia is received by individuals without prior dengue infection.

Dengvaxia has been administered to nearly 800,000 children in the Philippines under the government’s Dengue immunization program. – UNTV News & Rescue

Study suggests wearing of masks generates immunity vs. COVID-19

Marje Pelayo   •   September 16, 2020

MANILA, Philippines — Wearing of masks gives a person immunity against coronavirus disease (COVID-19), according to an article published by the New England Journal of Medicine on September 8, 2020.

The article said there is a high possibility that people are being exposed to small amounts of coronavirus as masks cannot totally filter such viral particles. This allows people to develop immunity or antibodies to eventually fight the virus. This process is called “variolation.”

Infectious disease specialist Dr. Rontgene Solante also noted the level of immunity that wearing of masks gives to an individual and its effect on the community.

“There is evidence that if all of us wear face mask, there’ll be no transmission; there’ll be no infection in the community. So, indirectly the face mask protects the individual and that in itself is defined as immunity against the infection,” he said.

But the Department of Health (DOH) couldn’t confirm the said study. 

“We still have to study further itong sinasabing immunity,” DOH Undersecretary Maria Rosario Vergeire said. 

Baka iyong (Maybe the) preventive measures that can really work are the combined preventive measures of wearing face masks, wearing face shield, doing physical distancing and hand-washing para tayo ay makaagapay habang wala pang bakuna (for us to survive while there’s no vaccine yet) and we can live with the virus,” Vergeire said. 

Dr. Solante, on the other hand, said maintaining a healthy lifestyle is an effective measure against infection.

“You have to keep yourself healthy aside from the health protocols. Exercise, don’t drink. If you have hypertension or diabetes, drink your medication regularly,” Solante said.

“Based on our patients na smokers mataas ang [mortality rate] kasi smokers. Their lungs are already inflamed…doble ang inflammation mas lalong severe (Based on our patients who are smokers, mortality rate is high among smokers because their lungs are already inflamed. The inflammation is double, more severe),” he added. 

The DOH has issued Memorandum 0165 in March requiring all nutrition and dietetics services in hospitals with cases of COVID-19 to provide their patients and staff with healthy and nutritious foods to help boost their immune system. MNP (with details from Aiko Miguel)

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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