Category: Immunization News

Flu Vaccine Delays and the 2019-20 Flu Season Supply

While we now think that flu vaccines are delayed if we don’t start seeing them in August, it is important to remember that it wasn’t that long ago that experts recommended that the optimal time to get a flu vaccination was in October and November.

It wasn’t until the 2006-07 flu season that we started to get updated guidelines for earlier flu vaccinations, starting with recommendations to offer flu shots in September for high risk groups “to avoid missed opportunities for vaccination.”

The next year the recommendation for the timing of flu vaccination became “health-care providers should begin offering vaccination soon after vaccine becomes available and if possible by October. To avoid missed opportunities for vaccination, providers should offer vaccination during routine health-care visits or during hospitalizations whenever vaccine is available.”

And with over 150 million doses of flu vaccine produced each year, it has been some time since we have seen a true flu vaccine shortage. The fact that more and more companies are making flu vaccines also helps ensure that shortages don’t happen.

Still, most flu vaccine manufacturers use older egg-based technology to grow flu virus strains for vaccine, which is not as reliable or flexible as many would wish it to be. This is what often leads to flu vaccine delays and shortages – the fact that in some years, the flu virus is simply hard to grow.

Flu Vaccine Delays and Shortages

How common are flu vaccine delays or shortages?

A flu vaccine delay and shortage in 2000 caused a supply of only 26.6 million doses of flu vaccine by October (vs about 76 million the previous year) and about 8 million fewer doses by the end of the season. The delay and shortage was caused by manufacturers having difficulty growing the H3N3 strain of flu and one fewer flu vaccine manufacturer.

In 2004, Chiron Corporation had its license suspended in the United Kingdom because of ‘concerns of possible microbial contamination of product.’ Chiron was to produce between 46-48 million doses of influenza vaccine for the United States and so overnight, we had our flu vaccine supply cut in half, leading to true shortages. An allocation plan that year helped to make sure that flu vaccine got to high-priority providers and people who needed them though.

In 2006, there was a delay in getting flu shots for younger children until November, as Sanofi Pasteur had difficulty producing their flu shots because of poor growth of one of the strains of influenza in the flu shot.

The emergence of H1N1 pandemic strain of influenza led to shortages in 2009. The problem that year was one of timing. The H1N1 flu virus was discovered just as seasonal flu vaccine was starting to be made, which led to a shift in priorities for flu vaccine production. The biggest problem, in addition to a slow growing H1N1 virus for the vaccine, was an early start to the flu season though. When H1N1 vaccine became available in October, it was too late for most people – flu season had already peaked.

After the 2009 H1N1 pandemic, we had several years of a more than ample supply of flu vaccine and on time delivery of our flu vaccine, which likely got most of us spoiled. It also was why we were all surprised by the production problems that led both GSK and Sanofi to have delays in shipping their flu vaccine in 2014.

We also had some flu vaccine delays in 2015. That year, MedImmune, the manufacturers of FluMist were supplying over 16 million doses of flu vaccine, but stated that “We expect customers will begin receiving product in early September and we will continue delivering vaccine throughout the season.”

Sanofi Pasteur also reported problems in 2015, stating that “Multidose vial orders are anticipated to be filled by the end of September; single use syringes will be supplied at a steady pace through November.”

2019-20 Flu Season Supply

Unfortunately, there will be some delays this flu season too, likely caused by a late update to the H3N2 strain because of drifting.

“Two strain changes coupled with the late decision for the H3N2 strain from VRBPAC, due to the drift that was being seen in surveillance was the issue. At least right now, capacity is all right with injectable vaccine.”

L.J Tan, MS, PhD Chief Strategy Officer, Immunization Action Coalition

Remember, the WHO and FDA, via the Vaccines and Related Biological Products Advisory Committee (VRBPAC), made late decisions on which H3N2 strain to include in the 2019-20 flu vaccines.

We will be getting plenty of flu shots this year, just not as early as we have been getting used to...
We will be getting plenty of flu shots this year, just not as early as we have been getting used to…

So it shouldn’t be a surprise that pediatricians are getting notices that they will only receive a small part of their order of FluMist from AstraZeneca this year.

Or that Sanofi Pasteur, which will produce 40% of this year’s projected supply, is reporting a 4 to 6 week delay.

Even if word is just now trickling down to pediatricians, others have known about these delays for months…

Luckily, unlike delays in some other years, this doesn’t mean any shortages of flu vaccine. It is just that some doctors and clinics won’t be getting their first shipments as early as they would have liked. And not everyone will be able to get FluMist, if that is their preference.

Still, there will be a lot of flu vaccine and plenty of time to get everyone vaccinated and protected well before flu season hits!

What You Need to Know about Flu Vaccine Delays and Shortages

Other things to know about flu vaccine delays and shortages include that:

  • Pharmacies often seem to get their shipment of flu vaccine before pediatricians do, especially when there is any kind of delay.
  • Since even in a typical year, flu vaccine for the Vaccine for Children’s program gets to pediatricians a few weeks after other flu vaccine, this stock will likely also be delayed this year.
  • While they can certainly be frustrating, a flu vaccine delay shouldn’t mean that your family can’t get a flu vaccine.
  • Tamiflu can be an alternative to the flu shot for some high risk children who haven’t been vaccinated yet.

If there is a flu vaccine delay or shortage and your child is in a high risk group for complications from the flu, get a flu vaccine as soon as you can, wherever you can, and be sure you pediatrician puts you on a high priority list to get any vaccine that becomes available.

More on Flu Vaccine Delays and Shortages

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

Who Should Write Your Child’s Medical Exemption for Vaccines?

Why would anyone go visit a new doctor just to get their child a medical exemption for vaccines?

A medical exemption should be for kids who can't be vaccinated, not just because you don't want your child to be vaccinated.
A medical exemption should be for kids who can’t be vaccinated, not just because you don’t want your child to be vaccinated.

Shouldn’t they just get the medical exemption from their regular pediatrician?

Who Should Write Your Child’s Medical Exemption for Vaccines?

As lawmakers in California debate passage of a new vaccine bill, SB276, which would put help stop doctors from writing fraudulent medical exemptions, we are learning more and more about what are thought to be fake MEs and the doctors who write them.

“The exemption practices of three doctors in the records have already come under investigation by California authorities, and many are on lists of “vaccine-flexible” pediatricians circulated online by anti-vaccine parents. Three exemptions were signed by a doctor in New Jersey, and a fourth by one in Florida.”

California’s vaccine battle: Here are the doctors behind Bay Area students’ medical exemptions

One of these doctors practices at an anti-aging clinic, so it doesn’t seem like they are the regular primary-care physicians for these kids getting exemptions.

“SB277 did not substantially change the granting of medical exemptions by physicians, which expected and anticipated that each child would be evaluated by a physician who regularly cared for that child and receiving the exemption applying the standard of care.

Instead, after passage of SB277, we witnessed physicians who advertised exemptions for cash on social media and the internet. Some parents posted that their child’s physician refused to grant their child a medical exemption, so they bought one from a distant physician.”

Richard Pan SB 276 Assembly Health Committee Testimony

And that’s why a state without non-medical exemptions continues to have schools with fewer than 50% of the kids vaccinated.

Doctors who think that they are “vaccine experts” are granting kids medical exemptions because they think that everything is a vaccine injury. Or that a family history of something that they think is a vaccine injury qualifies a child for a medical exemption.

“I’ll tell you what I do personally is I charge the same amount of money for a patient who I see for a medical exemption as I do for new patients coming in to me for a check up or a consultation. I don’t charge any more. In fact, my medical exemption appointments are actually two appointments. I don’t make any more money from medical exemption appointments as anything else.”

Bob Sears SB 276 Assembly Health Committee Testimony

Most of us don’t make any money from medical exemption appointments…

“And just to follow up – is there some other… back to the idea of a specialist in this. Could there be some other standard in which a specialist could do more of these?”

Chad Mayes SB 276 Assembly Health Committee Testimony

There are certainly situations in which a specialist will be the one writing the medical exemption.

Is your child getting chemotherapy for ALL? Then his oncologist might be the one to write the exemption.

Did your infant get immunoglobulin to treat Kawasaki disease? Then her cardiologist might write a temporary medical exemption for live vaccines.

Does your child have infantile spasms? Then his neurologist might write a temporary medical exemption for DTaP.

Why Are Medical Exemption Visits a Thing?

In most situations though, it would be your pediatrician who would write the exemption.

“When we passed SB 277, again as we mentioned, we didn’t really touch the medical exemption, but what our expectation was is that it’s going to be your child’s regular doctor who knows the child granting them… And what we’re seeing is that actually we have physicians… who are not really the primary care doctor.

I mean I find this idea of having medical exemption visits kind of intriguing because you shouldn’t really have medical exemption visits. Either you’re the doctor or you’re not. If you’re the doctor you should take care of them. You have that relationship and if they have an issue with vaccines, you write them the exemption.

That’s it. That’s what’s supposed to normally happen. People shouldn’t be going out finding other doctors for exemptions. If you happen to see a specialist, and they think you can’t get vaccinated safely, then they either submit the exemption or they tell your primary care doctor, by the way, that child should not get vaccinated, we should get an exemption. That’s how it should normally work.”

Richard Pan SB 276 Assembly Health Committee Testimony

Of course, medical exemptions to get vaccines are not very common though. If your pediatrician refuses to give your child a medical exemption, it is likely because they don’t need one.

It's amazing that they didn't know their child needed a medical exemption until they went to see Dr. Stoller...
It’s amazing that they didn’t know their child needed a medical exemption until they went to see Dr. Stoller

Remember, medical exemptions for vaccines should be for kids who can’t be vaccinated, not just because you’re scared or don’t want your child to be vaccinated.

More on Doctors Writing Medical Exemptions for Vaccines

Update on Vaccine Exemption Rates in California

Vaccination rates in California are dropping.

Wait, what?

Didn’t they recently pass a vaccine law that removed non-medical exemptions? How could vaccination rates be dropping?

Update on Vaccine Exemption Rates in California

While SB 277 did indeed remove all non-medical exemptions to getting vaccinated, some folks found a way around it. Since 2015, when it passed, some doctors are giving kids fake or unnecessary medical exemptions. These extra medical exemptions are likely making up for their previous personal belief vaccine exemptions.

The result?

It isn’t fewer exemptions since 2015.

Explain to me how it is ethical to misrepresent the rates of medical exemptions during a measles outbreak?
Explain to me how it is ethical to misrepresent the rates of medical exemptions during a measles outbreak?

While personal belief exemptions are certainly down, medical exemptions keep going up.

In addition to the 0.9% of medical exemptions, another 1.5% of kids, also up as a percentage, are unvaccinated “for other reasons specified under SB 277.”

There are also about 1.7% of kids in kindergarten who enroll as conditional entrants.

Why is that important? Among those conditional entrants are kids with temporary medical exemptions.

And how many kids aren’t vaccinated simply because they are “receiving IEP services?”

So it is not only wrong, it is unethical to try and say that only 0.9% of kids have vaccine exemptions in California this year.

Update on Vaccine Exemption Rates in California’s Clusters

Still, the big story continues to be what’s going on in the clusters of intentionally unvaccinated kids in California and other parts of the United States.

Are they getting vaccinated and protected under SB 277?

Wait, I thought Dr. Bob said that the vaccine exemption rate was just 0.9%. What happened at this Waldorf school? 30% of the kids have medical exemptions!
Wait, I thought Dr. Bob said that the vaccine exemption rate was just 0.9%. What happened at this Waldorf school? 30% of the kids have medical exemptions!

Some actually are!

The MMR rate at the Waldorf school in San Diego was just 44% back in 2014, as a whopping 56% of kids had a personal belief exemption. As sad as it sounds, even though it is still below herd immunity levels of protection, their current MMR vaccination rate of 68% is a big improvement!

Unfortunately, there are many schools with even lower immunization rates. And of course, that means even more students with “medical exemptions” at those schools.

SchoolPMEs
Marin Waldorf School31%
Yuba River Charter64%
Westside Waldorf School37%
Sebastopol Independent Charter45%
Muse Charter50%
Live Oak Charter41%
Nevada City School of Arts31%
Sunridge Charter47%
Santa Cruz Waldorf School34%
Cedar Springs Waldorf School30%
Journey33%
Waldorf School of Orange County33%
Coastal Grove Charter36%
Mariposa School of Global Ed31%
Waldorf School of the Peninsula36%
Maple Village Waldorf School30%

In addition to these permanent medical exemptions (PMEs), some schools also have high rates of temporary medical exemptions.

Medical Exemptions for Vaccines in California are Unusually High

What’s the usual rate of medical exemptions?

As there are few reasons to skip or delay a child’s vaccines, it is lower than those rates.

A lot lower.

In one recent report, Vaccination Coverage for Selected Vaccines, Exemption Rates, and Provisional Enrollment Among Children in Kindergarten — United States, 2016–17 School Year, the median rate of medical exemptions in the U.S. was just 0.2%, with a range of <0.1 to 1.5%.

Also unusual is that in some cases, many of those exemptions are written by just a few doctors. In fact, families often go to these doctors just to get their kids their medical exemptions!

“…the removal of nonmedical exemptions in California was initially effective in increasing vaccination rates, but the substitution between exemption types may render the repeal partially ineffective in improving immunization coverage and preventing VPDs over time.”

Richwine et al on Do Stricter Immunization Laws Improve Coverage? Evidence from the Repeal of Non-medical Exemptions for School Mandated Vaccines

How do we fix this and get more kids vaccinated and protected?

“Beyond fostering compliance, tightening the requirements around medical waivers will also aid in promoting public policies that protect public health.”

Richwine et al on Do Stricter Immunization Laws Improve Coverage? Evidence from the Repeal of Non-medical Exemptions for School Mandated Vaccines

In addition to closing the loopholes that allow some doctors to abuse medical exemptions, it will be important to help parents be more skeptical and see through the anti-vaccine propaganda that other doctors use to scare parents away from vaccinating and protecting their kids.

Vaccines are safe, with few risks, and are obviously necessary.

More on Vaccine Exemption Rates in California