Tag: RSV

Do My Kids Need the RSV Vaccine?

While I’m sure that many parents would love to get their kids vaccinated and protected against RSV, unfortunately, we don’t yet have an actual RSV vaccine.

We do have Synagis (palivaizumab) though, a monthly injection that can be given to high risk children during RSV season to help prevent them from getting RSV.

Do My Kids Need Synagis?

Synagis is not a vaccine and doesn’t stimulate your body to make antibodies,  but is instead an injection of RSV antibodies made by recombinant DNA technology. That’s why you need to get an injection each month. The antibodies don’t last much longer.

So why doesn’t everyone get Synagis if RSV can be such a deadly disease?

For one thing, there is the high cost of Synagis injections, but there is also the fact that Synagis is only approved to be given to kids who are at high risk for severe RSV infections.

“Palivizumab prophylaxis has limited effect on RSV hospitalizations on a population basis, no measurable effect on mortality, and a minimal effect on subsequent wheezing.”

AAP on Updated Guidance for Palivizumab Prophylaxis Among Infants and Young Children at Increased Risk of Hospitalization for Respiratory Syncytial Virus Infection

And Synagis doesn’t have as a great an effect on preventing RSV infections as we would like. That’s why we need a real RSV vaccine instead.

When to start Synagis is carefully determined by the start of RSV season.
When to start Synagis is carefully determined by the start of RSV season.

So because it likely doesn’t provide that much help to kids who aren’t at very high risk for severe disease, the latest guidelines recommend that Synagis be given to:

  • pre-term infants born before 29 weeks, 0 days’ gestation and who will be younger than 12 months at the start of the RSV season
  • preterm infants with CLD of prematurity, defined as birth at <32 weeks, 0 days’ gestation and a requirement for >21% oxygen for at least 28 days after birth.
  • certain infants with hemodynamically significant heart disease during their first year of life and might include infants with cyanotic heart defects, infants with acyanotic heart disease who are receiving medication to control congestive heart failure and will require cardiac surgical procedures and infants with moderate to severe pulmonary hypertension, infants with heart lesions that were corrected by surgery, but who continue to require medications for congestive heart failure, and children under age two years who have had a cardiac transplant.
  • certain children in their second year of life if they required at least 28 days of supplemental oxygen after birth and who continue to require medical intervention (supplemental oxygen, chronic corticosteroid, or diuretic therapy)
  • certain infants in their first year of life with pulmonary abnormality or neuromuscular disease that impairs the ability to clear secretions from the upper airways
  • certain children in their second year of life if they will be profoundly immunocompromised during RSV season

Those who qualify get up to five monthly doses, beginning in November, to help make sure they are covered through the peak of RSV season – December to May.

Whether or not your high risk child gets Synagis, you can help to reduce their risk of getting RSV by making sure they are not exposed to tobacco smoke, keep them away from crowds of people, wash hands often, and if possible, keep them out of day care.

And get them all of their other vaccines, including a flu shot once they are six months old.

What do you do if your high risk child was denied Synagis by your insurance plan? If your infant has a qualifying condition, your pediatrician should be able to help you write an appeal to your insurance company stating that getting Synagis is a medical necessity.

More on Synagis and RSV Vaccines

Vaccine Fast Tracking

Like a few other vaccines, Gardasil underwent Fast Track approval by the FDA.

“This is the first vaccine licensed specifically to prevent cervical cancer. Its rapid approval underscores FDA’s commitment to help make safe and effective vaccines available as quickly as possible. Not only have vaccines dramatically reduced the toll of diseases in infants and children, like polio and measles, but they are playing an increasing role protecting and improving the lives of adolescents and adults.”

Jesse Goodman, MD, MPH, Director of FDA’s Center for Biologics Evaluation and Research

But that doesn’t mean that any corners were cut in getting it quickly approved or that the vaccine isn’t safe.

Vaccine Fast Tracking

The Fast Track process can help get new drugs and vaccines approved more quickly by the FDA because they have:

  • more frequent meetings with the FDA to discuss the drug’s development plan and to help ensure the collection of appropriate data needed to support drug approval
  • more frequent written communication from the FDA about such things as the design of the proposed clinical trials and the use of biomarkers
  • eligibility for Accelerated Approval and Priority Review, if relevant criteria are met
  • a Rolling Review, which means that a drug company can submit completed sections of its Biologic License Application (BLA) or New Drug Application (NDA) for review by FDA, rather than waiting until every section of the NDA is completed before the entire application can be reviewed. BLA or NDA review usually does not begin until the drug company has submitted the entire application to the FDA.

In very simple terms, it is kind of like having a VIP pass at an amusement park. It gets you a guide and helps you jump to the front of many of the lines, but you still don’t get to operate the rides yourself.

Vaccine fast tracking doesn't mean that a vaccine gets approved too fast.
It is a myth that vaccine fast tracking means that a vaccine gets approved too fast.

Which vaccines have had Fast Track approval?

They include Gardasil, Vaxchora, a cholera vaccine, the MenB vaccines, and FluBlock, the flu vaccine that is made in insect cells.

Others that have Fast Track designation include vaccines for  anthrax (NuThrax anthrax vaccine adsorbed with CPG 7909 adjuvant), chikungunya, Clostridium difficile (Clostridium difficile toxoid vaccine), malaria, RSV, Zika, Ebola, Invasive
Staphylococcus aureus infections in surgical populations, Shigella (Flexyn2a), and Lyme disease. None are approved yet though.

And that all of these vaccines have Fast Track designation is a good reminder that it isn’t a guarantee of approval.

“With Fast Track designation, early and frequent communication between the FDA and the biopharmaceutical company is encouraged throughout the entire drug development and review process to help to quickly resolve any questions or issues that arise, potentially leading to an earlier approval and access by patients.”

Encouraging Vaccine Innovation: Promoting the Development of Vaccines that Minimize the Burden of Infectious Diseases in the 21st Century

It just puts them on a Fast Track to get approved if they meet all of the FDA requirements for safety and efficacy.

The ability to develop and approve new vaccines quickly is also important as we continue to face new emerging disease threats. Faced with a deadly global pandemic, everyone will be glad that we have the ability to Fast Track vaccines and other drugs.

More on Vaccine Fast Tracking