Assignment: Chapter 7

WARM-UP ACTIVITY
Where will you find roads without vehicles, forests without trees, and cities without
houses?
Ans: MAP

WRAP-UP ACTIVITY
1. The most vulnerable population is those aged 15-29. Mental health-related
deaths are also the second leading cause of fatalities in this age group. As a
pharmacist, how can you help prevent this problem?

Pharmaceutical care is a responsible provision of drug therapy for the purposes of

achieving definite outcomes and improvement of patient’s quality-of-life. As a
pharmacist I will ensure that all medications are appropriate, effective, and safe for a
particular patient, and be able to identify, solve, prevent various drug-related
problems (DRPs), giving advice, recommendations, counseling about medicines,
following up the patients for drug-related problems, and assessing patients’
adherence on the basis of the skills and knowledge about the medicines.

2. Give a brief history of the dengue vaccine and what caused the dilemma
The U.S. Food and Drug Administration just approved one of the most sought after vaccines
in recent decades. It's the world's first vaccine to prevent dengue fever a disease so painful
that its nickname is "breakbone fever."The vaccine, called Dengvaxia, is aimed at helping
children in Puerto Rico and other U.S. territories where dengue is a problem. But this vaccine
has a dark and deadly history. One that has led to criminal charges in the Philippines,
sparked national panic and fueled a massive measles outbreak that has already killed more
than 355 people. "For individuals who have not been previously infected by dengue virus,
vaccination should not be recommended," the company wrote.
Panic hit the Philippines. In news reports, parents said that the vaccine contributed to the
deaths of 10 children. Protests erupted. The Congress of the Philippines launched
investigations into the vaccine's purchase and the immunization campaign. And Philippine
health officials started performing autopsies on children who died after receiving the vaccine.
"In total, the deaths of about 600 children who received Dengvaxia are under investigation
by the Public Attorney's Office, " the South China Morning Post reported last month.
Investigators have not yet released their results.

Here's the problem with Dengvaxia!

Typically, a vaccine works by triggering the immune system to make antibodies against the
virus. These antibodies then fight off the virus during an infection. But dengue is a tricky
virus. Dengue antibodies don't always protect a person. In fact, these antibodies can make
an infection worse. The dengue virus actually uses the antibodies to help it spread through
the body. So a second infection with dengue when your blood already has antibodies in it
can actually be worse than the first; a person is at a higher risk of severe complications like
plasma leakage syndrome.

In its follow-up study, Sanofi found evidence that Dengvaxia acts like the first infection for a
person who has not been previously infected. The body produces antibodies against the
vaccine, which have a similar potential for harm.

The increased risk seems small. The vaccine raises the risk of hospitalization after a dengue
infection from about 1.1% to 1.6%, the follow-up study from Sanofi found. So out of 1
million kids in the Philippines, the vaccine would cause about 1,000 to be hospitalized over
five years, Sanofi estimated. (On the other hand, the vaccine would prevent about 12,000
hospitalizations for a new dengue infection in children who have had a prior dengue
infection during this same time period.)

But in the world of vaccines, that's not an acceptable risk. A risk needs to be exceedingly
small to be tolerated. For example, with the measles vaccine, the risk of encephalitis is about
1 in 1 million, or 1,000 times less than the risk from a measles infection, WHO says.
WHO eventually changed its recommendation. The agency now says the vaccine is safe only
for children who have had a prior dengue infection.
By the time Sanofi acknowledged this problem with the vaccine, about 800,000 Philippine
children had been vaccinated. The Sanofi study estimated that more than 100,000 of them
had never been infected with dengue and should not have received the shot, according
to WHO's revised recommendation

While Dengvaxia’s use was suspended after Sanofi’s update in November 2017, its long-term
future was still in question until February this year, when the Philippines Food and Drug
Administration permanently withdrew the vaccine’s licence; the regulator’s director general
Nela Charade Puno said the decision had been made because Sanofi failed to comply with its
post-marketing commitments.

Meanwhile, the Dengvaxia scandal had by this time become the subject of two congressional
inquiries and a criminal investigation. In March, the Department of Justice said it had enough
evidence to charge both staff of Sanofi and Philippine health officials, including former
Health Minister Janette Garin. The department argued the named defendants had ignored
“the identified risks and adverse effects of the vaccine” and were responsible for the
subsequent deaths. While a panel of medical specialists are gathering information about the
alleged link, to date no conclusive evidence has been presented that connects the deaths to
Dengvaxia specifically.

Dengvaxia was approved by the US Food and Drug Administration in May, having been
granted a priority review by the agency. Approved under the same restrictions as its licence
in Europe, Dengvaxia is authorised for use in dengue-endemic areas of the US, including
Puerto Rico, Guam and American Samoa.

With dengue cases surging in the first half of 2019 and Dengvaxia the only approved vaccine
option, the Philippine government considered reintroducing the vaccine on the condition
that all participants are pre-screened to confirm that they have had previous exposure to
dengue.

“If Dengvaxia is proven effective to those who already had dengue in the past, then its
application to these individuals will surely cause the decline of the overall number of
cases,” said presidential spokesman Salvador Panelo in August. On 22 August, however, the
Department of Health rejected Sanofi’s appeal to overturn the FDA’s ban on Dengvaxia, with
the department again citing the company’s failure to submit post-marketing data including
risk management plans. A statement by health officials noted that re-approving the vaccine
“is for the FDA to act upon”, leaving the door open to a reversal of the decision if Sanofi can
satisfy the regulator on its post-marketing work.