Tag: Vaxelis

ACIP June 2019 Update

The Advisory Committee on Immunization Practices (ACIP) holds three meetings each year at the Centers for Disease Control and Prevention (CDC) in Atlanta, Georgia to review scientific data and vote on vaccine recommendations.

Topics at the ACIP June 2019 meeting, held on June 26 and 27, included:

  • 9vHPV Immunogenicity and Safety Trial in Mid-Adult Females
  • Overview of Health Economic Models for HPV Vaccination of Mid-Adults
  • HPV Vaccines Evidence to Recommendations (EtR) Framework
  • HPV Vaccines Work Group Considerations and Proposed Policy Options
  • Considerations for PCV13 use among adults 65 years or older and summary of the Evidence to Recommendations (EtR) Framework Proposed policy options
  • Combination Vaccines – Summary and Relevant Evidence to Recommendation Information
  • Update: Safety Monitoring and Surveillance for Recombinant Zoster Vaccine (RZV)
  • Herpes Zoster Work Group Summary
  • Pertussis Vaccines EtR Framework, Work Group Considerations and Proposed Policy Options
  • Rabies Vaccine
  • 2018-19 U.S. Influenza Activity
  • 2018-19 Influenza Vaccine Effectiveness
  • 2018-19 Influenza Vaccine Safety
  • Influenza Vaccine Proposed Recommendations for 2019-20
  • Proposed Recommendations for Use of Hepatitis A
  • Dengue Epidemiology in the U.S.
  • Dengvaxia Phase III Clinical Trials and Long Term Follow Up
  • Dengue Vaccine Work Group Considerations and Next Steps

If you haven’t been watching the meeting, the slides, videos, and minutes will be available later.

ACIP June 2019 Meeting Votes

And ACIP members voted on a number of issues, including:

Passed.
Passed.
This changes the 2014 ACIP recommendation to give PCV13 to all adults 65 years or older.
A series of votes on DTaP, Hib, IPV, and hepB got Vaxelis, the newly FDA approved hexavalent vaccine, added to the VFC program.

Coming up tomorrow will be votes on flu, hepatitis A, and meningococcal B vaccines.

More on the ACIP June 2019 Meeting

Vaccines – Year in Review 2018

Another year has passed and although anti-vaccine folks keep talking about those 300 vaccines in pipeline, there were few new developments in the vaccine world in 2018.

Bob Sears got in trouble with the Medical Board of California over vaccine exemptions.
This happened in 2018.

Well, maybe that’s not entirely true.

Vaccines – Year in Review 2018

So what can we say about 2018 when it comes to vaccines?

Well, we did get some new ones!

  • approved by the FDA in late 2017, a new hepatitis B vaccine for adults, Heplisav-B, the formal recommendation for its use from the ACIP came on February 21, 2018
  • although it was both approved by the FDA and formally recommended by the ACIP in late 2017, Shingrix, the new shingles vaccine, became more widely available in 2018 – well kind of – there have been a lot of shortages due to high demand for the vaccine
  • Vaxelis, a hexavalent vaccine that combines DTaP-IPV-Hib-HepB into one shot was FDA approved on December 21, 2018, but likely won’t be available for a few more years
  • FluMist, the nasal spray flu vaccine, returned

And we lost one… Last year was the first full year that Menomune, an older meningococcal vaccine, was no longer available. It was discontinued because of low demand, as we began to use the newer vaccines, Menactra and Menveo instead.

In other immunization news:

  • a 2017 shortage of yellow fever vaccine continued into 2018
  • a shortage of monovalent pediatric hepatitis B vaccine will continue into 2019 (doesn’t affect combination vaccines with hepatitis B)
  • Gardasil 9 received an expanded recommendation – women and men between the ages of 27 and 45 years can now get vaccinated and protected with this HPV vaccine
  • the hepatitis A vaccine got a lower age recommendation – at least in special situations – “HepA vaccine be administered to infants aged 6–11 months traveling outside the United States when protection against HAV is recommended.”
  • the recommendation to use a third dose of MMR to control outbreaks of mumps was formally approved
  • the WHO updated its recommendations for use of the dengue fever vaccine (Dengvaxia) to makes sure that only dengue-seropositive persons are vaccinated, as they found an increased risk of severe dengue in seronegative people who were vaccinated
  • Of the 163 million to 168 million doses of flu vaccine that will be distributed in the United States for the 2018-2019 season, more than 80% will be thimerosal free.
  • China had an issue with substandard DTaP vaccines made by one company in one part of the country
  • India had an issue with contaminated polio vaccines made by one company in one part of the country – bivalent oral polio vaccines (two strains) still contained all three strains of polio vaccine virus
  • Measles cases and deaths spiked globally because of gaps in vaccination coverage

If you didn’t hear about any of those things in the news, you may have heard about the death of two young children in Samoa after they received an MMR vaccine. That tragedy almost certainly was caused by an error in administering/mixing the vaccines, and not because there was anything wrong with the vaccines themselves.

Need help getting educated about vaccines? Despite continued outbreaks, 2018 was a good year for vaccine advocates and vaccine education.

Several good books about vaccines were published, including:

And in case you missed it, we found out that:

Of course, for most of us, none of this is really news. We know that vaccines are safe, effective, and necessary.

And sadly, Betty Bumpers died. We can honor her legacy by continuing her work and helping to make sure that every child gets vaccinated and protected.

More on Vaccines Year in Review 2018

What Is a Hexavalent Vaccine?

Most folks know that we have combination vaccines that help reduce the number of injections that kids have to get at one visit.

You might not think of it as a combination vaccine, but one of the first, DPT, simply combines protection against diphtheria, pertussis, and tetanus into one shot.

Of course, we have come a long way since the days when DPT and MMR were considered combination vaccines.

Wait, why aren’t they considered combination vaccines anymore?

It’s not part of any conspiracy. It’s simply because you can’t get their individual components separately anymore. There is no measles or rubella shots anymore. Just the MMR. There is no tetanus shot.

Combination Vaccines

Not surprisingly, it is now becoming routine for kids to get combination vaccines instead of separate shots.

That’s because while the great majority of us want our kids vaccinated and protected, few enjoy shots and needles.

“The use of licensed combination vaccines is preferred over separate injection of their equivalent component vaccines.”

AAP on Combination Vaccines for Childhood Immunization

Does this mean more vaccines at one visit?

Nope.

“So, at a doctor’s visit, your child may only get two or three shots to protect him from five diseases, instead of five individual shots. Fewer shots may mean less pain for your child and less stress for you.”

CDC on Combination Vaccines

It just means fewer injections.

Combination vaccines combine the vaccines that you are already getting into one injection.

What Is a Hexavalent Vaccine?

And they might get even fewer with the latest hexavalent vaccines (six-in-one).

This is the next step up from our current pentavelent vaccines (five-in-one), like Pediarix (combines DTaP, Hep B, and IPV) and Pentacel (combines DTaP, IPV, and Hib).

The hexavalent vaccines combine protection against diphtheria, tetanus, acellular pertussis, Haemophilus influenzae type B, poliovirus and hepatitis B (DTaP-Hib-IPV-HepB) into one injection.

Sounds good, right?

Although not approved in the United States, hexavalent vaccines, including Infanrix Hexa have been used in many other countries since 2000! Another, Hexavac was withdrawn from the market because of issues with waning hepatitis B antibody titers (kids had levels that were still protective, but were on the low side).

When will get a hexavalent vaccine in the United States?

Obviously, the early problems with Hexavac kept us from getting a hexavalent vaccine, at least before the next generation of vaccines was developed.

Hexavalent vaccines are widely available in most parents of the world.
Hexavalent vaccines are widely available in most parents of the world.

Two new hexavalent vaccines, Vaxelis and Hexyon, have recently been licensed in Europe, after many studies showed that they worked and were safe when given with all of the other vaccines on the schedule, including Prevnar, rotavirus, Men C, and MMRV.

And one of these might soon be coming to the United States.

Vaxelis

V419 (Vaxelis), which was developed in collaboration between Merck and Sanofi Pasteur, has been under review by the FDA since 2014 has already received a Complete Response Letter that was “deemed complete and acceptable for review.”

And it was approved by the FDA on December 21, 2018.

Remember, that could mean just two shots at infant well check ups, but continued protection against eight vaccine-preventable diseases, as they get a hexavalent vaccine, Prevnar and the rotavirus vaccine!

It may be at least another year before Vaxelis makes it way to your pediatrician’s office though.

More on the Hexavalent Vaccine