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FDA Recalls Dengvaxia Vaccine From The Market

Sale and distribution of the dengue vaccine, known as Dengvaxia have been stopped by the Food and Drug Administration, withdrawing its stocks over the potential risks to the patients.

Sanofi Pasteur, a pharmaceutical firm, has been ordered by the FDA to suspend not only the distribution but also the marketing and sale of the said vaccine. They were also told to recall it from the local market with “pending compliance with the directives of the FDA.” The advisory has been released on Monday.

The FDA said it is working with the Department of Health to monitor potential adverse reactions to the vaccine.

Philippine Food and Drug Administration Recalls Dengvaxia From the Market

Philippine Food and Drug Administration Recalls Dengvaxia From the Market

According to the Department of Health unit, they already had ordered Sanofi to conduct an information campaign in order to raise awareness about Dengvaxia to quell the growing tension and panic about the side-effects of the said vaccine.  The order from FDA came after Sanofi had disclosed the result of a post-clinical trial study of Dengue Tetravalent Vaccine, live and attenuated, had shown an increased risk for hospitalization for dengue and severe dengue patients. The vaccine’s effect will give first-time dengue patients an equivalent of severe dengue even if it’s only their first time. The severe dengue patients have a higher mortality rate than the first.

What is Dengue?

Dengvaxia is Facing Controversy Now Because of its Side Effects

Dengvaxia is Facing Controversy Now Because of its Side Effects

Dengue fever is passed on by a mosquito bite. The mosquito is known to cause dengue is Aedes aegypti mosquito also known as “tiger mosquito.” There is a wide range of symptoms of dengue. These symptoms include pain in the eyes, headache, rash, and muscle and joint pain. There could also be a long-term fatigue experienced by those infected with dengue.

CLASSES OF DENGUE

There are four grades of dengue fever classified by the World Health Organization.

Grade I- this is a type of dengue where a patient is bitten by a mosquito suffers from fever along with other non-specific symptoms. However, the patient gets bruised easily and shows a rapid outflow of blood through a tourniquet test.

Grade II- the second type is characterized by spontaneously bleeding because of the fever and easy bruising. It is usually seen on the skin.

Sanofi is Facing Health Emergency and Controversy With its Dengue Vaccination Program

Sanofi is Facing Health Emergency and Controversy With its Dengue Vaccination Program

Grade III- in this grade, there is a circulatory failure and is characterized by a rapid but weak pulse. The pulse pressure is also narrowed, an indication that the patient is having a hypotension with a cold, clammy skin and restlessness.

Grade IV- is the fever that is accompanied by a great shock where the patient’s blood pressure or pulse cannot be detected.

The Growing Public Fear for Acquiring Severe Dengue After Vaccinated with Dengvaxia

The Department of Health Conducted Dengue Vaccination Program in 2016

The Department of Health Conducted Dengue Vaccination Program in 2016

Sanofi, Department of Health, and the Palace allay the fears of the public about the said vaccine in a press conference held on Monday where the Sanofi clarified that the vaccine does not cause dengue to a vaccinated person. They clarified that the negative effect is when contracting and exposure to dengue virus.

In the advisory, FDA said that they have a close coordination with the Department of Health for the monitoring of the adverse effects and the reactions from the immunization with Dengvaxia. In addition, they will immediately take appropriate measures to protect the public.

On Monday, an order of a probe for a possible criminal liability has been ordered by the Department of Justice. This decision was given after the vaccine scandal over the claims of non-government group Volunteers Against Crime and Corruptions. They claim three deaths due to the vaccine which is yet to be verified.

Presidential Spokesman Harry Roque Quell the Public's Panic Over Dengvaxia

Presidential Spokesman Harry Roque Quell the Public’s Panic Over Dengvaxia

Lyndon Lee Suy, the spokesperson of the Department of Health has clarified on Monday that out of the 700,000 children vaccinated by the Dengvaxia, only 10 percent have the risk of developing severe dengue.

Philippine President Spokesman Harry Roque explained to the public that while he understands the public’s woes about the vaccine (since the public thought they’ll be totally immune to dengue after the vaccination), he reiterated that the severe dengue classification that Sanofi mentioned have symptoms of fever and hemophilia which are not deadly. Furthermore, Roque gave a statement that 9 out of 10 will be protected from getting what could be not just serious but potentially a deadly stage of dengue.

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