Tag: adults

Did the FDA Approve a New HPV Vaccine for Adults?

What do you know about the HPV vaccine?

Hopefully you know that it can prevent cervical cancer and that lots of folks spread misinformation that is intended to confuse and scare you away from getting vaccinated and protected with it and other vaccines.

Did the FDA Approve a New HPV Vaccine for Adults?

News that the approved ages for Gardasil have been expanded will likely add to that confusion for a little while.

The FDA simply approved the expanded use of the existing Gardasil 9 vaccine – not a new vaccine.
The FDA simply approved the expanded use of the existing Gardasil 9 vaccine – not a new vaccine.

The first thing to understand is that the FDA did not approve a new Gardasil vaccine for older adults.

They very simply expanded the age recommendations for who should get the existing Gardasil 9 vaccine, which was approved back in 2014, replacing the original Gardasil vaccine, which was approved in 2006.

“The U.S. Food and Drug Administration today approved a supplemental application for Gardasil 9 (Human Papillomavirus (HPV) 9-valent Vaccine, Recombinant) expanding the approved use of the vaccine to include women and men aged 27 through 45 years.”

Why the new age indication?

“In a study in approximately 3,200 women 27 through 45 years of age, followed for an average of 3.5 years, Gardasil was 88 percent effective in the prevention of a combined endpoint of persistent infection, genital warts, vulvar and vaginal precancerous lesions, cervical precancerous lesions, and cervical cancer related to HPV types covered by the vaccine.”

But isn’t the whole point of giving the HPV vaccine to preteens that you want to get them vaccinated and protected before they are sexually active and exposed to and infected by HPV?

Sure, but if you didn’t, and unless you are sure that you have been exposed to and have been infected by all 9 types of HPV strains that Gardasil 9 protects you against, then the vaccine is still a good idea when you are older.

Except FDA approval doesn’t automatically mean that your insurance company will pay for it.

That usually comes once a vaccine is formally added to the immunization schedule by the ACIP.

“In a 2005 study, 92% of insurance plans reported following Advisory Committee on Immunization Practices recommendations to determine covered vaccines; of those, 60% could extend coverage within 3 months after issuance of recommendations and 13% in 1 month.”

Lindley et al on Financing the Delivery of Vaccines to Children and Adolescents: Challenges to the Current System

And Obamacare still requires insurance plans to provide ACIP-recommended vaccines at no charge.

Will Gardasil 9 be added to the immunization schedule for adults?

The extended age indication for Gardasil 9 will be discussed at the next ACIP meeting.
The extended age indication for Gardasil 9 will be discussed at the next ACIP meeting.

We should know sooner, rather than later. It is on the agenda for the next ACIP meeting on October 25…

More on Gardasil for Older Adults

Catch-Up Immunization Plans for Adults

It isn’t hard to figure out how to catch-up kids when they fall behind on their vaccines.

After all, the CDC publishes catch-up immunizations schedules for both younger kids and teens.

Catch-Up Immunization Plans for Adults

What happens when an unvaccinated adult needs to get caught up?

Adults need vaccines too, especially if they have never been vaccinated before.
Adults need vaccines too, especially if they have never been vaccinated before.

They essentially follow the catch-up immunization plan for teens, with a few exceptions:

Are you an adult that needs to get caught up because you have never been vaccinated, your parents skipped or delayed some vaccines, or you lost your immunization records?

Get caught up! It’s likely easier than you think.

More on Catch-Up Immunization Plans for Adults

Avoiding the Most Common Vaccine Errors

Although it would be great if mistakes never ever happened, the best we can do is to understand that mistakes do sometimes happen and take steps to avoid them.

How can we avoid mistakes and errors about vaccines?

Avoiding Vaccine Errors

It can help to:

  • understand the 7 Rights of vaccine administration, including that you give the Right vaccine to the Right patient at the Right time by the Right route at the Right injection site and then follow it with the Right documentation
  • use a 2d barcoding  system with your EMR to help catch vaccine errors before administration
  • use a screening checklist to help avoid giving vaccines that are contraindicated
  • double check vaccines that look alike or have names that sound like, such as DTaP and Tdap
  • double check expiration dates
  • make sure you aren’t giving live vaccines within 28 days of each other, unless they are given at the same time
  • make sure you aren’t giving the wrong dosage amount for the patient’s age, as some vaccines have different formulations depending on the age of the patient, including flu shots, hepatitis A, and hepatitis B vaccines
  • be careful so that you don’t give a combination vaccine, such as Pediarix, Pentacel, Kinrix, Quadracel, or ProQuad, inappropriately

That we are have a 4-day grace period does help avoid the need to revaccinate some kids when vaccines are given a little too early.

“With the exception of rabies vaccine, ACIP allows a grace period of 4 days (i.e., vaccine doses administered up to 4 days before the recommended minimum interval or age can be counted as valid). However, if a dose was administered 5 or more days earlier than the recommended minimum interval between doses, it is not valid and must be repeated. The repeat dose should be spaced after the invalid dose by the recommended minimum interval.”

Ask the Experts About Scheduling Vaccines

In many cases, as long as vaccine doses were administered less than or equal to 4 days before the minimum interval or age, then they can still be counted and are considered valid.

Common Vaccine Errors

It’s easier than you think to prevent vaccine errors.

Especially if there are more than one child in the room getting vaccines, either the tray itself or the vaccines should be labeled with each child's name so that they don't get the wrong vaccines.
Especially if there is more than one child in the room getting vaccines, either the tray itself or the vaccines should be labeled with each child’s name so that they don’t get the wrong vaccines. Photo by Vincent Iannelli, MD

When are you most likely to make a vaccine error?

When you are doing something that isn’t routine, which most commonly happens when folks delay or skip some vaccines and are now playing catch-up.

In addition to the tips above, remember that:

  • the first dose of the rotavirus vaccines must be given by 15 weeks
  • the rotavirus vaccine series must be completed by 8 months (32 weeks)
  • ProQuad, the MMR and chicken pox combination vaccine, is not licensed for kids who are older than 12 years, although if a teen or adult did get ProQuad, it could be considered an off-label dose and could still count.
  • Kinrix and Quadracel, the DTaP and polio combination vaccines are only licensed for the 5th dose of DTaP and 4th dose of polio in children who are 4 to 6 years old, so wouldn’t be appropriate for an 18-month-old, even if he needs both (DTaP and polio) vaccines. Earlier doses can sometimes count as off-label doses though.
  • the combination vaccines Pediarix and Pentacel are only licensed up through age six years, but don’t necessarily need to be repeated if given to older kids.
  • children and adolescent’s get a pediatric dose (0.5ml) of the hepatitis A vaccine, while older teens, who are at least 19-years-old, get an adult (1.0ml) dose. Since most kids get vaccinated when they are younger, many pediatricians may not have the adult version of the hepatitis A or even realize that there is a different version.
  • children and adolescent’s get a pediatric dose (0.5ml) of the hepatitis B vaccine, while older teens, who are at least 20-years-old, get an adult (1.0ml) dose. Since most kids get vaccinated when they are younger, many pediatricians may not have the adult version of the hepatitis B vaccine or even realize that there is a different version.

Most importantly, even when giving vaccines on schedule, be sure to triple check everything. This is especially important if multiple kids in the same room are getting immunizations.

Also remember that vaccine errors should be reported to the ISMP National Vaccine Errors Reporting Program (VERP) or VAERS, with the correct dose repeated if necessary.

What to Know About Common Vaccine Errors

Although none of these vaccine errors are very common (hundreds of millions of doses of vaccines are given in the United States each year), understanding which ones occur the most often can help to make sure that they don’t happen in your office.

More on Common Vaccine Errors

Updated September 16, 2018