Tag: cold chain

A Toddler Has Died After Being Vaccinated in Cuba

No one expects to hear stories of kids dying after being vaccinated. Fortunately, these types of tragedies are very, very rare.

Still, even one is too many when it might have been prevented. After all, that’s why we vaccinate our kids in the first place. To protect them from life-threatening vaccine preventable diseases.

A Toddler Has Died After Being Vaccinated in Cuba

The Ministry of Health in Cuba released a statement a few days after her death:

“Between October 7 and 8 of this year, three one-year-old children were diagnosed with an adverse event associated with vaccination with PRS, which protects against Mumps, Rubella and Measles, this is applied according to official scheme to children one and six years old.

All had been vaccinated on October 7 at the “Betancourt Neninger” Polyclinic in the municipality of Habana del Este, province of Havana, and immediately after symptoms appeared, they were admitted and received medical attention by professionals of high scientific level in the Pediatric Hospitals ” Borrás Marfán ”and Centro Habana.

Through the active research carried out on all children vaccinated in that Health Area, two more children were detected with symptoms, which motivated their admission.

Painfully on October 9 at night, the one-year-old girl Paloma Domínguez Caballero dies, admitted to the “Borrás Marfán” Hospital as a result of complications. The remaining four children remain admitted: one with intensive attention, which is stable and the others evolve favorably.

The system of active surveillance of the events associated with vaccination carried out in the country has not identified any other children with symptoms.

The PRS vaccine has been used for years in Cuba, imported from India, is endorsed by the World Health Organization and certified by the Center for State Control of Medicines, Equipment and Medical Devices (CECMED).

A Commission of the Ministry of Public Health investigates the causes that caused this unfortunate event.”

Official Note from the Ministry of Public Health on adverse event associated with vaccination with PRS (computer translation)

So what happened?

Tragically, either because of errors or contamination, vaccines can rarely cause people to get sick, either if:

  • a reconstituted vaccine was used much after six hours – live vaccines can quickly become contaminated if they are kept and used for too long a time
  • vaccine diluents were mixed up – some vaccines need to be mixed before use and vaccination tragedies can occur when a dangerous medication is used instead of a vaccine’s standard diluent
  • vaccines were improperly handled – breaking the cold chain – or allowed to expire
  • a vaccine is given to someone with a true medical contraindication

In Samoa, the recent tragedy in which two toddlers died, we know that the vaccine diluent was mixed up with a powerful anesthetic.

It doesn’t sound like a diluent mixup happened in Cuba though.

“The mother told the news portal CiberCuba that the daughter’s arm began to swell the same day she was vaccinated. Then the vomits arrived. Less than 24 hours later I was already in intensive care, from where I did not come out alive again.”

Vacuna en mal estado suministrada en Cuba podría haber dejado 25 niños en estado de gravedad

With reports that the vaccines were possibly expired and the child getting sick later in the day, with swelling in her arm, it is more likely that there was some contamination, maybe in a vaccine vial itself.

A 10 dose vial of MMR from the Serum Institute of India Pvt. Ltd.
A 10 dose vial of MMR from the Serum Institute of India Pvt. Ltd.

Which vaccine?

The report says that it was the PRS vaccine – Parotiditis, Rubéola, and Sarampion – or MMR, which is usually available in 5 or 10 multi-dose vials when one dose vials aren’t available.

It was imported from India, which makes many of the vaccines that are used throughout the world, but any contamination likely would have occurred well after it was manufactured and shipped to Cuba.

In all of these cases, there is typically nothing inherently wrong with the vaccine itself.

“Cuba, a relatively poor and small country (population 11.2 million), has managed to bring about remarkable achievements in health in the past 30 years despite difficult fiscal restraints and limited resources.”

MacDonald et al on Infectious Disease Management: Lessons from Cuba

Interestingly, Cuba actually makes most of their other immunizations.

So why would they be using expired vaccines?

Was it a mistake?

Did someone use a leftover vial that had become contaminated with bacteria? Were the vaccines not refrigerated properly? Is it an isolated issue or part of a bigger breakdown in their healthcare system?

With four other sick kids, the use of a contaminated leftover vial that was part of an original 10 dose vial becomes one possible scenario.

We might get some answers if the vaccine vials had not been thrown away after they were used, and are still available for testing.

In Chapias, Mexico, after two infants died in 2015 after getting multiple vaccines, a vial was found to be contaminated with the Staphylococcus hominis bacteria.

A few years later, in 2017, 15 children died in South Sudan when unrefrigerated vaccine was mixed with a syringe that was reused over and over for four days and given to kids by untrained workers.

Again, these are very rare and isolated cases. Remember that billions of doses of vaccines are given each year without problems, saving millions of lives.

Hopefully we will soon learn what really happened to these children in Cuba, especially as that will hopefully help to make sure it doesn’t happen again.

Most importantly, don’t let these very rare tragedies scare you away from vaccinating and protecting your kids.

“The Cuban government has confirmed that five children suffered severe reactions and one of them — a 1-year-old girl — died after receiving a vaccine. The serum came from the same company in India that produced vaccines linked to the deaths of three other children following inoculations administered in Cuba in 2002.”

Child dies in Cuba after receiving vaccine made in India. It’s not the first time

We should remember what happened following the tragedy in Samoa. All vaccinations were unnecessarily suspended in the country for a time and MMR vaccinations were suspended for nine months!

What came next?

A measles epidemic that has already seen the death of one toddler!

The death of the girl in Cuba is a terrible tragedy, but folks shouldn’t make it any worse. There is almost certainly nothing wrong with the vaccines from India or any other vaccines in Cuba or anywhere else.

Vaccines are safe, with few risks.

Hopefully we can continue to work to eliminate even the rare risk of these kinds of awful tragedies too.

And no, this is not the MMR vaccine that is used in the United States in case anyone is wondering.

More on Vaccination Tragedies

Vaccine Movies and Videos

All of the attention that Robert De Niro gave the movie Vaxxed has many people realizing that there are anti-vaccine movies out there.

Promoted as documentaries, they mostly include the same anti-vaccine ‘experts’ that scare parents away from vaccinating their kids on the Internet.

These types of movies include:

  • Vaxxed
  • The Greater Good
  • Trace Amounts
  • Who Killed Alex Spourdalakis?
  • Bought
  • Man Made Epidemic
  • Sacrificial Virgins
  • The Truth About Vaccines

Most are propaganda, without even a trace amount of truth in them, and should not be used as a research tool to help you make a decision about vaccines.

Vaccine Movies and Documentaries

What about movies to actually help you get educated about vaccines?

Every Last Child takes a look at the fight to end polio in Pakistan.
Every Last Child takes a look at the fight to end polio in Pakistan.

Watch these movies and documentaries:

Have you seen or heard about any of these movies about vaccines?

Vaccine Videos

Just as bad as so-called vaccine documentaries, many of the vaccine videos that you find on You-Tube are also filled with misinformation and propaganda, including many vaccine scare videos.

Where are you Jon Stewart? Measles is still around...
Where are you Jon Stewart? Measles is still around…

Watch the following vaccines videos instead:

Still have questions?

More on Vaccine Movies and Videos

Updated February 28, 2019

Transporting Vaccines Safely

Need to move your vaccines from one place to another?

In Djibouti, vaccines were once transported using photovoltaic-powered refrigeration systems mounted on camels.
In Djibouti, vaccines were once transported using photovoltaic-powered refrigeration systems mounted on camels.

That might be more difficult than you think.

Transporting Vaccines Safely

Why would you need to move your vaccines?

Lots of reasons, including:

  • a temporary power outage
  • a vaccine clinic at an off-site location or clinic
  • to redistribute vaccines between clinics (should not be done routinely)
  • moving office locations

Why do you need to be careful when transporting your vaccines?

Because vaccines are very temperature sensitive and must be stored at the proper temperature. If your vaccines get too hot or too cold while being transported, then they likely won’t be effective anymore and will have to be replaced.

“The time needed to transport should be less than 8 hours and vaccine should be placed in a stable storage unit as quickly as possible .”

Vaccine Storage & Handling Toolkit

Fortunately, you can safely transport your vaccines if you plan ahead and have:

  • a hard sided coolor or styrofoam vaccine shipping container
  • conditioned frozen water bottles
  • insulating material
  • a temperature monitoring device

Except in emergency situations, you should also contact your VFC program before you transport vaccines to see if they have any specific instructions for you to follow.

What shouldn’t you do?

You should not use dry ice, attempt to transport multi-dose vials that have already been opened, or transport frozen and refrigerated vaccines in the same container.

And once transported, transfer the vaccines quickly to a new storage refrigerator or freezer, as appropriate, continuing to monitor and log temperatures.

What to Know About Transporting Vaccines

Be prepared before transporting your vaccines to another location so that they don’t get too hot or too cold.

More on Transporting Vaccines

Which Vaccines Need to be Refrigerated?

Vaccines have to be stored properly.

Mostly that means that they must be kept at a proper temperature, not getting too hot or too cold, “to protect quality and potency” of the vaccines.

While that can be a challenge in some parts of the world, as they go to great lengths to maintain the cold chain for vaccines, in developed countries, it typically means knowing whether to put the vaccine in the refrigerator or the freezer.

Even in the most industrialized city, a power failure can happen or someone can just unplug the refrigerator by mistake.

Which Vaccines Need to be Refrigerated?

Post a list on your refrigerator so that you don't put vaccines in the fridge that should be frozen.
Post a list on your refrigerator so that you don’t put vaccines in the fridge that should be frozen.

While some vaccines are stored frozen, most must be refrigerated.

Vaccines that are kept refrigerated should be stored in a vaccine refrigerator at a temperature between 36°F and 46°F (2°C and 8°C), with a target of 40°F (5°C).

Of available vaccines, those that must be refrigerated include:

  • Hepatitis A
  • Hepatitis B
  • Hib
  • Gardasil9 (all HPV vaccines)
  • influenza (all flu vaccines)
  • IPV (polio)
  • Menactra, Menveo, Bexsera, Trunembra (Meningococcal)
  • MMR*
  • Prevnar 13, Pneumovax (Pneumococcal)
  • RotaTeq, RotaRix (Rotavirus)
  • Pentacel, Pediarix (all DTaP containing vaccines)
  • Tdap (Adacel and Boostrix)

*The MMR vaccine vaccine can be stored in a freezer or a refrigerator.

Making things a little more confusing, refrigerator stable versions of Varivax and ProQuad, which are usually stored frozen, are also available. They have a shelf life of 24 months when refrigerated, but may also be stored in a freezer.

What do you do if something goes wrong and your refrigerated vaccines have gotten too warm or too cold?

“If you find that a vaccine has been exposed to an inappropriate temperature, determine the reason for the temperature alteration, mark the vaccine “Do Not Use,” and contact the manufacturer or the state or local health department to determine if the vaccine can be used.”

Immunization Action Coalition on Ask the Experts about Vaccine Storage and Handling

Getting educated about proper vaccine storage and handling can avoid many incidents and help you be well prepared if something does go wrong. Once you are all set up and ready to store your vaccines, you just have to know where to put them.

What To Know About Storing Vaccines in a Refrigerator

Vaccines must be kept at a proper temperature, not getting too hot or too cold, “to protect quality and potency” of the vaccines.

More About Storing Vaccines in a Refrigerator