Dengue Vaccine is Now FDA Approved, Coming Soon in Bangladesh

Dr Taniya Sultana a young female doctor who was a postgraduate FCPS trainee in the largest Medical College in Bangladesh named by Dhaka Medical College Hospital died a few days ago due to Dengue. She died in the ICU of my working place, Anwer Khan Modern Medical College Hospital. She sacrificed herself on service, Treating dengue patients. All the caregivers including doctors, nurses and other staffs of Hospital are at risk of getting dengue infection. She is the third doctor to die from Dengue this month. Others are Dr Nigar Nahid Dipu, junior consultant of the radiology and imaging and Dr Mohammad Shahadat Hossain, Civil Surgeon of Habiganj. I could not find the news of Dr Taniya in any mainstream news agency. Such a sad negligency. Also, two university students are reported dead till now. The death toll will rise, no doubt in that. Still various political leader and Mayor of Dhaka City neglecting the severity of the condition. They have utterly failed to control the situation still playing nothing but blame game. The authority should be taken under crucification for their unfortunate failure that leads to sufferings and death of the many valuable lives. Dhaka city is now under major threat due to Dengue. There are not enough govt hospital to treat such a huge number of patients. The rich are people are also affected. The private hospitals are full of dengue patients and no seat is vacant for new patients. I have never seen such conditions that private hospitals are refusing patients. With limited resources, it is quite impossible to manage dengue patients. Dengue patients require close monitoring and supervision. The Govt has issued a National Guideline for Dengue Treatment, 4th Edition 2018 in last year.  There was no news about Dengue Vaccine. But recently FDA has approved Dengue Vaccine with restrictions. The announcement came on 1st May 2019. It is not available in Bangladesh till now. With some controversy, Dengue Vaccine is still under close monitoring.

Dengue first emerged in our country back in 2001. The doctors were not familiar with the pattern of sign symptoms. Legendary Professor Dr ABM Abdullah sir introduced dengue treatment. There is a chance of spreading dengue to the whole country on a massive scale due to upcoming Eid-ul-Adha vacation. Millions of people will leave Dhaka, carrying the dengue virus to the remote part of the country.

Dengue fever pattern is changing day by day. Previously it was believed that Aedes mosquitos bite only during daytime but now Doctors are advising to use mosquito nets all the time. Aedes mosquito lays its eggs on clean water. So must change any contained water every third day. Sign symptoms are also different from the previous year. Fluid management is a crucial part of the treatment.

First Dengue Vaccine Dengvaxia

Dengvaxia is the first-ever vaccine for 4 known serotypes of Dengue. It contains all four serotypes of dengue virus.

Proper Name: Dengue Tetravalent Vaccine, Live
Tradename: DENGVAXIA
Manufacturer: Sanofi Pasteur Inc.

Who can Use Dengue Vaccine?

Dengvaxia is indicated for the patients who

1. Are 9 to 16 years of age.
2. Had the previous laboratory-confirmed dengue infection by any serotype.
3. Living in a Endemic area.

Download Full Dengvaxia Product Information

When will Dengue Vaccine Be Available?

I have contacted with the Sanofi Bangladesh. Sanofi correspondent has assured me that

Dengvaxia will be available in Bangladesh by the Last quarter of the year.

Dengue vaccine can not be used for persons who were never infected previously. FDA approved for the patient’s age within 9 to 16 year. But the EU has approved for the ages of 9 to 45 years. “This is because, in people who have not been infected with dengue virus, Dengvaxia appears to act as a first dengue infection — without actually infecting the person with wild-type dengue virus — such that a subsequent infection can result in severe dengue disease,” the agency said in a May 1 statement.

The vaccine was shown to be approximately 76 per cent effective in preventing symptomatic, laboratory-confirmed dengue disease in individuals 9 through 16 years of age who previously had laboratory-confirmed dengue disease. [Source]

If you are not previously infected then the dengue vaccine will act as the first infection. The previous infection can be detected by AntiDengue IgG, which becomes positive after the first infection. I had Dengue in 2017.

Dengue vaccine contains Live lyophilized vaccine antigen (Dengue) 0.5ml in each vial. Three doses are given, stat and then 6 monthly intervals 2 doses. That means now 1 dose then 6 months later and last one in another 6 months or 1 year from the current dose.

The dengue vaccine is administered subcutaneously and stored at 2ºC to 8ºC (36ºF to 46ºF). It can not be given as an IM injection.

There is Increased Risk of Severe Dengue Disease Following DENGVAXIA in Persons not Previously Infected with Dengue Virus. There is no FDA cleared test available to determine a previous dengue infection. Available non-FDA cleared tests may yield false-positive results (e.g., due to cross-reactivity with other flaviviruses). Sanofi has said they would bring the test available in late 2020.

DENGVAXIA initiates dengue-specific immune responses against the four dengue virus serotypes. The exact mechanism of protection has not been determined.

The efficacy of DENGVAXIA was evaluated in two randomized, observer-blind, placebo-controlled, multi-centre studies. The study was conducted in Latin American countries and Puerto Rico, Asia-Pacific countries.

Side Effects: The most commonly reported side effects by those who received Dengvaxia were a headache, muscle pain, joint pain, fatigue, injection site pain and low-grade fever.

The FDA granted this application Priority Review and a Tropical Disease Priority Review Voucher under a program intended to encourage the development of new drugs and biologics for the prevention and treatment of certain tropical diseases. The approval was granted to Sanofi Pasteur.

Dengue Vaccine Price:

The price is still unknown. But it costs 87USD in Thailand. That’s around 8000 takas per dose. If that’s the case, then surely it will be very costly for the poor people in Bangladesh.

Philippines Dengue controversy

The 2017 dengue vaccine controversy in the Philippines involved a vaccination program run by the Philippines Department of Health. It vaccinated school children with Sanofi Pasteur’s Dengvaxia dengue vaccine. Some of the children who received the vaccine had never been infected by the dengue virus before. The program was stopped when Sanofi Pasteur advised the government that the vaccine could put previously uninfected people at a somewhat higher risk of a severe case of dengue fever. A political controversy erupted over whether the program was run with sufficient care and who should be held responsible for the alleged harm to the vaccinated children.

IAMAT guideline for Dengue: For the travellers to visit Bangladesh, here is the guideline by the International Association for Medical Assistance to Travellers.

Dengue vaccine Medscape Review

Questions and Answers on Dengue Vaccines – WHO

How to remove mosquito from your garden?

Thanks, everyone, stay safe.