Tag: benefits

Is This Year’s Flu Vaccine Working?

Flu season is just getting started, but I’m sure that you have already heard folks rating how well this year’s flu shots are working.

Are flu vaccines working well?
Are flu vaccines working well?

Of course, if you had a flu shot and have already gotten the flu, then you’re gonna think the flu shot isn’t working very well at all.

And if you are vaccinated and protected and have avoided the flu, then it is working so far, right?

Is This Year’s Flu Vaccine Working?

While we won’t know how well this year’s flu vaccine is working until the CDC releases the preliminary estimates on flu vaccine effectiveness, there are some good signs already.

  1. The majority of the influenza viruses collected from the United States so far have been “characterized antigenically and genetically as being similar to the cell-grown reference viruses representing the 2018–2019 Northern Hemisphere influenza vaccine viruses.”
  2. The most frequently identified influenza virus type reported by public health laboratories was influenza A(H1N1)pdm09 virus.

Remember, to be effective, you want the flu vaccine to match the strains of flu virus that are circulating in the community. A mismatch in flu virus strain or antigenic drifting leads to lower flu vaccine effectiveness (VE).

Remember the 2004-05 flu season? That was the year that because of a drifted A(H3N2) virus, “only 5% of viruses from study participants were well matched to vaccine strains.” And the flu vaccine wasn’t very effective at all.

Still, even when the flu vaccine matches circulating strains, in general, as we have certainly seen, “flu vaccines provide better protection against influenza B or influenza A (H1N1) viruses than against influenza A (H3N2) viruses.”

YearFlu Virus StrainVE
2004-05A(H3N2)10
2005-06A(H3N2)21
2006-07A(H1N1)52
2007-08A(H3N2)37
2008-09A(H1N1)41
2009-10A(H1N1)pdm0956
2010-11A(H3N2)60
2011-12A(H3N2)47
2012-13A(H3N2)49
2013-14A(H1N1)pdm0952
2014-15A(H3N2)19
2015-16A(H1N1)pdm0948
2016-17A(H3N2)40
2017-18A(H3N2)40
2018-19A(H1N1)pdm09?

So if you had to guess, you could probably say that this year’s flu vaccine is going to be at least 50% effective.

So just as good as flipping a coin? Not exactly.

There are a lot of benefits to getting a flu shot besides avoiding the flu, like avoiding severe flu, hospitalization, and death.

And since flu vaccines are safe and flu can be a life-threatening disease, even in those without any medical problems, wouldn’t you take any chance you could to reduce your child’s chances of getting sick?

When will we know how well this year’s flu vaccine is really working?

The CDC typically releases the first preliminary flu vaccine effectiveness report of the season in February.

Not that you should wait! Flu season is well underway and this is a great time to get a flu vaccine and get protected for the rest of flu season.

More on the Effectiveness of This Year’s Flu Vaccine

Flu Season Predictions

No, I can’t see into the future…

I predict that I will continue to get a flu shot each year, at least until they come out with a universal flu vaccine.
I predict that I will continue to get a flu shot each year, at least until they come out with a universal flu vaccine.

But some things are very easy to predict.

Flu Season Predictions

Here are some predictions for this year’s flu season.

  1. We will have a flu season epidemic in the United States this year. Surprised by that prediction? Don’t be. Flu activity reaches epidemic levels each and every year. What we don’t always have are flu pandemics, during which flu activity is very high in multiple parts of the world. By definition, flu season is an epidemic.
  2. Almost all states will eventually report having widespread influenza activity as flu season peaks. Again, this is not a bold prediction. It happens every year. How severe is flu season going to be? No one can really predict that, but we can look at the proportion of people seeing their health care provider for influenza-like illness (ILI) and laboratory-confirmed influenza-associated hospitalization rates as flu season moves along to get some idea. Remember, measures of the geographic spread of the flu don’t really tell you anything about the severity of flu activity.
  3. Dozens of kids will die with the flu – most of them unvaccinated. Remember, 37 kids died in the mildest flu season we had.
  4. A little under half of adults will get a flu vaccine, even though the current recommendation is that everyone who is at least six months old without a true contraindication get vaccinated each year.
  5. A little over half of parents will get their kids a flu vaccine.
  6. Some people who get a flu vaccine will still get the flu. You know the flu vaccine isn’t the most effective, but it still has plenty of other benefits, so even if you did still get the flu, hopefully you got a milder case, weren’t hospitalized, and didn’t die.
  7. Some people who get a flu vaccine and get the flu will blame their flu shot, even though it is well known that the flu shot can’t give you the flu.
  8. Many people who aren’t high risk will be prescribed Tamiflu. Or Xofluza, because it is new.
  9. Tens of thousands of adults will die with the flu. Even in a mild flu season, the flu is very deadly.
  10. Some folks will continue to push the idea that there is a vaginal spermicide in flu shots, even though that anti-vaccine talking point has been refuted a thousand times already.

What else can you predict about flu season?

Some folks will think it is too late to get a flu shot.

It isn’t.

Get your flu shot if you haven’t and get protected for the rest of flu season.

Another bold prediction? Elderberry syrup and Oscillococcinum are not going to help prevent or treat your flu symptoms.

More Flu Season Predictions

The Latest Anti-Vaccine Bombshell on Infanrix Hexa is Just Another Dud

There are a lot of things about the latest anti-vaccine bombshell that won’t surprise you

For one thing, the “bombshell” isn’t recent. Anti-vaccine folks are just re-posting it now because a new hexavalent vaccine just got FDA approval.

The Latest Anti-Vaccine Bombshell on Infanrix Hexa is Just Another Dud

What about the 1,271 page confidential GSK document that was leaked to the press?

It was actually a document that was submitted as part of an Italian court case.

What about the idea of “missing deaths” and under-reporting of vaccine deaths?

“Before specifically addressing your analysis, it’s important to note that the issue of whether there is an increased risk of Sudden Infant Death following vaccination generally and following vaccination with DTP-containing vaccines more specifically is one that has been considered and thoroughly evaluated not only by GSK but also by a number of world-renowned regulatory agencies and public health authorities, including the European Medicines Agency, the US Centers for Disease Control and Prevention and the World Health Organization. The clear consensus amongst such agencies and authorities is that one cannot reasonably conclude, based on available data and information, that there is a causal relationship between vaccination generally or vaccination with Infanrix hexa and Sudden Infant Death.”

Dr. Norman Begg, Chief Medical Officer, GSK Vaccines on Infanrix hexa and sudden death: a review of the periodic safety update reports submitted to the European Medicines Agency

It’s no bombshell that this is all propaganda and these issues have been thoroughly investigated. Or that someone got a “study” that manipulated and misinterpreted data published in a predatory journal.

The idea that the hexavalent vaccines could be causing unexplained cases of sudden infant death shortly after vaccination began after a few case reports from Germany in 2003. Further studies, including a large study in Italy, found no risk.

What about the idea of “missing deaths” in safety reports from the manufacturer?

If there are so many "missing deaths," then why is the cumulative number of deaths higher in the latest report?
If there are so many “missing deaths,” then why is the cumulative number of deaths higher in the latest report?

Of course, there are no missing deaths.

I found the “missing deaths” that Puliyel talks about in his Infanrix hexa paper – in the GSK report he used to write his “study.”

The GSK report explains that twelve deaths were excluded from analysis, apparently eight from the first year (101 cumulative) and three from the second year (five cumulative), which is why the cumulative deaths dropped from eight to five.

Why?

“A cumulative review of Sudden Death (SD) since launch has been performed. Follow-up information received for older cases was taken into account. Design of the below observed to expected analysis was revisited in view of comments EMA expressed in the assessment report of PSUR 15-16 (dated 26 April 2012).”

GlaxoSmithKline Biological clinical safety and pharmacovigilance’s confidential report to the EMA: PSUR 19, page 440

Keep in mind that these are cumulative deaths since they began using the vaccine in 2000, and which are below the expected background rates of SIDS.

Vaccines are safe.

Hexavalent vaccines are safe.

Do your research before buying into the next anti-vaccine bombshell that try to throw at you to scare you away from vaccinating and protecting your kids.

More on the Latest Anti-Vaccine Bombshell

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

Are the Risks Greater Than the Benefits for Any Vaccines?

The only reason some folks question the risk-benefit ratio of vaccines is because most of them have never had or even known anyone with a vaccine-preventable disease.

As more people are vaccinated and diseases disappear, they forget how bad those diseases are, skip or delay getting their vaccines, and trigger outbreaks.
As more people are vaccinated and diseases disappear, they forget how bad those diseases are, skip or delay getting their vaccines, and trigger outbreaks. Photo by WHO

Of course, that’s simply because most people are vaccinated and protected. But if enough folks decide to skip or delay their vaccines, then we will have outbreaks and a higher risk of getting sick.

We shouldn’t have to wait for outbreaks for anyone to understand that the benefits of vaccines far outweigh their risks though.

Are the Risks Greater Than the Benefits for Any Vaccines?

Vaccines are safe, effective, and necessary.

Unless you have a true contraindication to getting vaccinated, until a disease is eradicated, the benefits of a vaccine will typically be far greater than its risks.

The switch from the live, oral polio vaccine to the inactivated vaccine is a good example of when this wasn’t the case though. Since OPV could rarely cause vaccine-associated paralytic polio (VAPP), once polio was well controlled in the United States, the risk of this side effect became greater than the benefit of continuing to use the vaccine, but only because we had an alternative polio vaccine that didn’t cause VAPP.

Similarly, the original rotavirus vaccine was withdrawn because the extra risk of intussusception, even though it was small, was thought to be greater than the benefits of the vaccine.

In the great majority of cases though, to think that getting vaccinated is a bigger risk than getting a vaccine preventable disease, you have to buy into the anti-vaccine hype:

Of course, none of that is true. These, and other anti-vaccine talking points have been refuted time after time.

Don’t put your kids at risk.

Don’t put others at risk from your unvaccinated child.

Get them vaccinated and protected.

More on Risks and Benefits of Vaccines

Does the Chicken Pox Vaccine Protect You from Shingles?

The chicken pox vaccine protects you from getting chicken pox.

A billboard in Minnesota educates parents about the benefits of the chicken pox vaccine.
A billboard in Minnesota educates parents about the benefits of the chicken pox vaccine.

Shingles is a reactivation of chicken pox, which can occur even after you have gotten the chicken pox vaccine, since it is a live virus vaccine.

Does the Chicken Pox Vaccine Protect You from Shingles?

We have long expected that the risk of shingles after vaccination with the chicken pox vaccine would be lower than a natural infection.

“In the early post-varicella vaccination period, incidence rates of medically attended herpes zoster did not increase for the overall population and decreased moderately for children 9 years and younger, the age group targeted for varicella vaccination.

Tanuseputro et al on Population-based incidence of herpes zoster after introduction of a publicly funded varicella vaccination program

And now we have even more evidence!

A recent study, The Epidemiology of Herpes Zoster in the United States During the Era of Varicella and Herpes Zoster Vaccines: Changing Patterns Among Children, has found that the incidence of shingles “declined in a step-wise pattern since the varicella vaccination program was introduced.”

“We found that HZ incidence declined dramatically among children since 1998 as the varicella vaccination program was being introduced and was maturing…”

Harpez et al on The Epidemiology of Herpes Zoster in the United States During the Era of Varicella and Herpes Zoster Vaccines: Changing Patterns Among Children

Did you need another reason to get your kids vaccinated and protected with the chicken pox vaccine?

More on Protection Against Shingles with the Chicken Pox Vaccine

How Do You Provide Informed Consent to Vaccination?

When you take your child to their pediatrician, you expect to be given all of the information you need to help you make good decisions about their care.

Whether it is about an antibiotic to treat an ear infection, the need for an MRI if your child is having severe headaches, or weaning off an asthma medication, etc., you deserve to be well informed of the risks and benefits of any and all procedures they have.

How Do You Provide Informed Consent to Vaccination?

Of course, informed consent also applies to vaccinations.

It's not an "informed consent form," but the Vaccine Information Statement can help you get informed consent before getting vaccines.
It’s not an “informed consent form,” but the Vaccine Information Statement can help you get informed consent before getting vaccines.

How do you provide informed consent to vaccination?

  1. Provide the latest edition of the appropriate Vaccine Information Statement (VIS) before a vaccination is given. Although these aren’t actually “informed consent forms,” they are required to be given by federal law and because “cover both benefits and risks associated with vaccinations, they provide enough information that anyone reading them should be adequately informed”
  2. Give parents/guardians the chance to take the VIS home to review later.
  3. Answer any questions about the vaccine that their child is about to get.

Hopefully you always get informed consent before your child is vaccinated.

You should also get informed consent before skipping or delaying any of your child’s vaccines, as it risks their getting a life-threatening vaccine-preventable disease and puts others at risk, all without any extra benefit.

“At trial, the parent and physician both acknowledged that the vaccine was recommended, but the parent stated that the risk of death wasn’t mentioned during the discussion.”

Document ‘informed refusal’ just as you would informed consent

Believe it or not, a pediatrician in California was successfully sued after a parent refused to vaccinate their child with Prevnar and their infant died of pneumococcal sepsis, which the vaccine could have prevented.

Although they realized that their pediatrician had recommended the vaccine and they refused it, they claimed that they didn’t realize that their baby could die without it. He did…

Myths About Informed Consent and Vaccines

Not surprisingly, many folks get the idea of informed consent to vaccination wrong.

For one thing, unless it is required by state law, no one has to sign a consent form before getting vaccinated. Many pediatricians and clinics do have you sign that you received the VIS, although federal law does not require this signature.

And informed consent doesn’t come from reading a vaccine’s package insert, as the parts pushed by anti-vaccine folks are just things included from voluntary reports and have not actually been proven to be caused by the vaccine.

“Now that case one is settled, I can go back to being loud and proud about my belief that every single patient should receive complete informed consent prior to vaccinations. This two-year period of silence has been tough. I will not rest until every single family has been given access to full, complete, objective, and un-doctored information that makes every parent fully aware of the risks they accept if they don’t vaccinate their child, and all the risks they take if they do vaccinate their child. Period. And I will fight against mandatory vaccination laws until they are no more. When every single person on this planet has access to informed consent, and can make a free choice, I will then be able to say my work is done.”

Dr. Bob Sears

When Dr. Bob talks about vaccines, do you think he mentions the parents who skipped the Prevnar vaccine and then successfully sued their pediatrician for not warning them that their baby would die? 

Dr. Bob Sears actually reassured parents that measles wasn't deadly in developed countries, neglecting to mention the dozens of people who have died in outbreaks in Europe - another well-nourished population with lower vaccination rates than the U.S.
Dr. Bob Sears actually reassured parents that measles wasn’t deadly in developed countries, neglecting to mention the dozens of people who have died in outbreaks in Europe – another well-nourished population with lower vaccination rates than the U.S.

Overstating the side effects and risks of getting vaccinated, rarely or ever mentioning the benefits of vaccines, and underestimating the complications and risks of life-threatening vaccine-preventable diseases isn’t informed consent.

It is actually misinformed consent.

It is propaganda.

It is a tool that some folks use to scare you away from making the right decision to vaccinate and protect your kids.

Parents deserve informed consent about vaccines. Unfortunately, that’s not what they are getting from the modern anti-vaccine movement.

More on Providing Informed Consent to Vaccination