Tag: Sanofi

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

Vaccines In Development

Many of us have heard the myth that there are “300 new vaccines in the pipeline.”

It takes a long time to develop a new vaccine.
It takes a long time to develop a new vaccine.

Of course, no one really believes that means scientists are out there developing vaccines against 300 separate diseases or that it will mean that kids will some day get 300 more vaccines.

Vaccines In Development

So what does it mean?

Surprisingly, it doesn’t even mean 300 new vaccines are in the pipeline anymore. The latest, 2016 update of the Medicines in Development for Vaccines report from the Pharmaceutical Research and Manufacturers of America now states that there are “More Than 250 Vaccines in Development Pipeline.”

To understand what that means, you have to take a look at the vaccines being developed, which include:

  • 124 for infectious diseases
  • 105 for cancers
  • thirteen for allergies
  • eight for neurological disorders
  • seven for other conditions

And even of the 124 vaccines in development or testing for infectious diseases:

  • 36 are to prevent or treat HIV
  • 25 are to prevent influenza, including new nasal flu vaccines
  • 8 are for RSV
  • 8 are for Ebola

So when they talk about “300 vaccines in the pipeline,” remember that even when you consider that only 124 of them are for infectious diseases, of those, 77 are for just 4 different infectious diseases.

The other 47 vaccines in various stages of development include vaccines for CMV, tuberculosis, dengue, Zika, GBS, West Nile virus, Staph, herpes, hepatitis C, E. coli, pseudomonas, malaria, C. diff infections, Shigella, norovirus, anthrax, smallpox, and ricin.

Some others are for infections that you have likely never heard of, including viral hemorrhagic fever, Ross River virus infections, and Venezuelan equine encephalitis.

And unfortunately, very few of these infectious disease vaccines are in stage III trials, which means that very, very few are close to seeing the inside of a pediatrician’s office.

Potential New Vaccines

Which vaccines have the greatest potential to be protecting our kids soon?

A few vaccines have been recently approved, including:

  • Dengvaxia – a dengue fever vaccine developed by Sanofi Pasteur which has already been approved in Brazil, Mexico, the Philippines, El Salvador and Costa Rica (endemic areas)
  • Shingrix – a new shingles vaccine (adults only)
  • Vaxelis – a hexavelent vaccine (a combination vaccine, so technically not a new vaccine or at least it doesn’t mean that your child will get an additional shot, in fact, getting Vaxelis means getting fewer shots)

Based on which vaccines have completed phase III trials and have been submitted for registration to the FDA, the one likely candidate seems to be:

  • an Ebola vaccine from Merck (V920 has finished phase III trials as in under review)

Other vaccines in late development phases include:

  • an MMR vaccine from GSK (already available in other countries)
  • a 15-valent pneumococcal vaccine from Merck (V114, in Phase III trials – would compete with Prevnar 13)
  • Men Quad TT – a “second generation” meningococcal vaccine
  • Bexsero MenB vaccine for infants (in Phase III trials)
  • a Clostridium difficile infection vaccine for seniors by Pfizer (in Phase III trials)
  • a 20-valent pneumococcal vaccine from Pfizer, the makers of Prevnar (20vPnC, in Phase III trials)

And we may see the combination, pentavalent MenABCW-135Y meningococcal vaccine by 2021.

So much for 300 new vaccines…

For More Information on New Vaccines:

Updated May 26, 2019