Top Infectious Disease News of the Week—January 20, 2019

#5: FDA Approves Fluzone Quadrivalent Vaccine For Children 6-35 Months

The US Food and Drug Administration (FDA) has approved the extended use of the Fluzone quadrivalent vaccine to include children age 6 through 35 months, Sanofi Pasteur has announced.

The approval grants authorization of use of the 0.5mL dose of the vaccine in young children. The dose will be available alongside the 0.25 mL dose for the 2019-2020 season for the young children included in this indication.

The approval was granted based on data from a Phase IV safety and immunogenicity study which demonstrated that 1 or 2 doses of 0.5 mL of the vaccine in children 6-35 months of age had a safety profile that was comparable to 1 or 2 doses of 0.25 mL of vaccine.

Read about the 0.5mL dose of the Fluzone Quadrivalent Vaccine.

#4 Furloughed or Funded—How Are Health Care Agencies Operating During the Government Shutdown?

As the partial government shutdown enters day 32, many questions continue to swirl.

These worries are not restricted to federal employees wondering how to pay their bills or questioning when they’ll be back to work; they extend to all Americans.

Without oversight from federal health care agencies, some may be pondering whether the food they’re eating is free from pathogens. Is it OK to serve a snack to a young child with a life-threatening allergen or is there an undeclared allergen that could lead to anaphylaxis? Is it safe to take my daily medication or is there an impurity or unapproved ingredient?

This shutdown marks the longest in American history and with an unknown end date, Contagion® set out to answer some of these questions and find out the facts about the shutdown’s impact on public health.

Read about the operating status of health agencies during the partial government shutdown.

#3: Wound Botulism Outbreak Linked to Heroin Raises Concern of Opioid Epidemic Effects

An outbreak in California of wound botulism associated with black tar heroin has piqued concern among health officials keen to raise awareness about the risk of infectious diseases related to the nation's opioid epidemic.

A recent Morbidity and Mortality Weekly Report from the US Centers for Disease Control and Prevention (CDC) highlighted 9 cases of wound botulism among San Diego County residents between September 2017 and April 2018, with one death reported.

"One of the key takeaways from the paper is the emphasis that this may be an underrecognized problem because the symptoms of wound botulism can be so similar to other neurologic conditions and also similar to opioid intoxication and overdose," report author Corey M. Peak, ScD, MS, told Contagion^®.

The County of San Diego Public Health Services reported 8 confirmed cases and 1 probable case of wound botulism during the time period, compared with an average of 1 botulism case per year from 2001 to 2016.

Read about the wound botulism outbreak in California.

#2: Infectious Diseases Dominate WHO's List of 2019 Health Threats

While the world is facing many public health threats, the World Health Organization (WHO) has compiled a list of the top 10 threats to global health to focus on in 2019.

The list contains a number of serious issues from climate change to inadequate health care facilities. Unsurprisingly, more than half of the list is made up of infectious disease challenges, both emerging and historic.

Here is a recap, in no particular order:

Read the full recap of the 2019’s list of 2019 health threats.

#1: Investigational RSV Maternal Immunization Could Revolutionize Treatment

The state of maternal immunization is much different now than from when Gregory M. Glenn, MD, first started in health care. It was widely studied and assessed, but still not as practiced in pregnant women.

Now, Glenn, president of Research & Development for Novavax Inc., and his teams of investigators are at the cusp of revolutionary development for maternal vaccines.

The Maryland-based clinical-stage vaccine company intends to share data in the following weeks on its first clinical trial of an investigative respiratory syncytial virus (RSV) vaccine in third-trimester pregnant women. Its findings and eventual successive studies could alter the scope of care for RSV, the most common cause of bronchiolitis and pneumonia in children younger than 1 year in the US.

The trial—which has been ongoing for 4 years and has assessed the potential vaccine in about 3000 treatment-eligible pregnant subjects in that time—has been carried out by teams comprising RSV, vaccination, and maternity-care specialists across 11 countries. “This is an incredible number of people working on a trial,” Glenn told MD Magazine®. “And because they’re on the front line, they are extremely excited at the prospect of having a vaccine for infants.”

Glenn also noted at least 1 other party’s particular interest in the development of an RSV vaccine: the Bill & Melinda Gates Foundation granted $89 million to the outside costs of the trial in 2015.

Global Implications

If the phase 3 results indicate the Novavax vaccine was capable of reaching its primary endpoint—reduced incidence of medically significant RSV lower respiratory tract infection (LRTI) with either hypoxemia or tachypnea in infants through 90 days of life—and key secondary endpoints, it could eventually become the first US Food and Drug Administration (FDA) approved RSV vaccine indicated for infants.

Read about the investigational RSV maternal immunization.