Tag: India

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

Where Is Measles on the Rise?

We have been hearing a lot about ongoing measles outbreaks in the United States this year.

Brooklyn. Rockland County. The Pacific Northwest.

Think 2018 was a big year for measles? It was the second highest number of cases since 1996.

How will 2019 shape up?

Consider that it isn’t even the end of January yet is only May and we have already had more cases, 74 92 273 900+, than we had any years since 1994.

Not surprisingly, this isn’t just happening in the United States.

Where Is Measles on the Rise?

In fact, if you understand that the endemic spread of measles was eliminated in the United States in 2000 and that outbreaks are started by folks with measles who travel in or out of the country, then it makes sense that more measles here likely means that there is more measles somewhere else.

Unfortunately, this year, that somewhere else seems to be just about everywhere.

Japan is off to the fastest start in 10 years, with 486 cases so far this year, surpassing 2009, when they ended up with over 700 cases.
Japan is off to the fastest start in 10 years, with 486 cases so far this year, surpassing 2009, when they ended up with over 700 cases.

Are you planning a trip to Europe anytime soon?

With so many measles cases in Europe, it shouldn’t be a surprise to anyone that there are so many deaths.

You should know that their measles outbreaks aren’t over. There are ongoing outbreaks in France, Lithuania, Poland, Romania, Bulgaria and Germany.

“Between 1 April 2018 and 31 March 2019, 30 EU/EEA Member States reported 11 383 cases of measles, 8 396 (74%) of which were laboratory-confirmed. None of the countries reported no cases. The highest number of cases were reported by Italy (2 107), France (2 028), Romania (1 390), Greece (870), United Kingdom (860), Poland (828), Germany (733) and Slovakia (714)…

Twenty-two deaths attributable to measles were reported to TESSy during the 12-month period in Romania (14), Italy (5), France (2) and Greece (1).”

Monthly measles and rubella monitoring report May 2019

Where else are we seeing measles?

  • at least 4,100 cases in Israel, 2 deaths, and a case of encephalitis since 2018, with the majority of cases in Jerusalem, Beit Shemesh, Safed, and Betar Illit
  • over 31,056 cases and 415 deaths in the Philippines (2019)
  • nearly 2,000 cases in Vietnam (2018) and cases are increasing in Hanoi and Ho Chi Minh City already in 2019
  • in Madagascar, as of 3 of April there were 122,840 registered cases, and 1,233 reported deaths
  • at least 517 confirmed cases in the UK (through the 3rd quarter of 2018)
  • India remains the country with the most cases, with over 65,600 cases in 2018
  • a large outbreak in Thailand, with at least 4,327 cases and 4 deaths
  • an ongoing outbreak in Malaysia with over 1,934 cases and 6 deaths (2018)
  • an outbreak in Myanmar with over 1,300 cases and one death
  • at least 79 cases in the Republic of Korea (2019)
  • Ukraine continues to see a lot of cases, over 24,000, and some deaths
  • over 2,200 cases in Russia
  • Australia – 102 cases (2019)
  • Canada – 45 cases (2019)
  • outbreaks in Yemen, Nigeria, Sudan, and DR Congo
Conflict zones plus vaccine hesitancy contribute to measles outbreaks in the Philippines.
Conflict zones plus vaccine hesitancy contribute to measles outbreaks in the Philippines.

And over 16,000 confirmed measles cases, including 86 deaths, were reported in 12 countries of the Region of the Americas in 2018: Antigua and Barbuda (1 case), Argentina (14 cases), Brazil (9,898 cases, including 13 deaths), Canada (29 cases), Chile (2 cases ), Colombia (171 cases), Ecuador (19 cases), Guatemala (1 case), Mexico (5 cases), Peru (38 cases), the United States of America (350 cases), and the Bolivarian Republic of Venezuela (5,643 cases, including 73 deaths).

So far this year, cases have been reported from Argentina, the Bahamas, Brazil, Canada, Chile, Colombia, Costa Rica, Mexico, the United States of America, and the Bolivarian Republic of Venezuela.

Does it seem like measles is on the rise everywhere?

That’s because it basically is.

Since 2017, there has been a measles resurgence in three regions of the world and measles elimination milestones have not been met.

And as you can see, in almost all of these places where we are seeing more measles, we are seeing more people dying of measles?

That’s why it is important to get vaccinated.

There is even a recommendation to get an early MMR if you will be traveling out of the United States. Get vaccinated. Don’t bring home measles and start an outbreak.

More on the Resurgance of Measles

Updated May 17, 2019

What’s the Real Risk from the Contaminated Vaccines in India?

Most people understand that polio vaccines have helped to control and get us close to eradicating polio.

Many even know that there are two types of polio vaccine – the inactivated Salk vaccine and the live Sabin vaccine.

Some might even know that there are actually three strains of polio virus that we have traditionally gotten vaccinated against, and that one of those strains, type 2, has already been eradicated.

“In April 2016 a switch was implemented from trivalent OPV to bivalent OPV in routine immunization programmes.”

OPV Cessation

That’s why we have switched to using a bivalent OPV which only contains type 1 and 3 serotypes.

Contaminated Vaccines in India

What does all of this have to do with the news of contaminated vaccines in India?

“At least three batches of polio vaccines containing 1.5 lakh vials have been found contaminated with type 2 polio virus, putting at risk India’s “polio free” status as children born after April 2016 — when the type 2 virus was withdrawn worldwide including in India — do not have immunity to this particular virus, sources said.”

Unfortunately, some contaminated vaccines were actually administered to children in the Indian states of Maharashtra, Telengana, and Uttar Pradesh before the contamination was discovered.

Will these kids get polio?

No, as the vaccines weren’t contaminated with wild polio virus.

It seems that Bio-Med Private Limited was still producing and distributing polio vaccine with the type 2 vaccine virus, even though this type of vaccine was discontinued a few years ago.

Why?

We will  hopefully find out, as the managing director of Bio-Med Pvt Ltd has been arrested, but we don’t know yet.

We do know that there is little risk from these vaccines and they won’t put India’s “polio free” status at risk.

Why would there be any risk from kids getting an extra vaccine virus strain?

It’s because the type 2 strain of polio is the most likely to cause cVDPV, or outbreaks of polio that are actually caused by the polio vaccine.

Fortunately, these outbreaks are very rare.

A dose of IPV is the backup plan to make sure a problems with the switch to bOPV doesn't end up in a tragedy.
A dose of IPV is the backup plan to make sure any problems with the switch to bOPV doesn’t end up in a tragedy.

But kids in the area are at even less at risk from these “contaminated” vaccines because as part of the plan to switch from trivalent oral polio vaccine (tOPV) to bivalent oral polio vaccine (bOPV), they likely got a dose of IPV, which includes protection against all three polio virus strains.

Not that this means that it isn’t a problem that a company was making and distributing a vaccine that kids shouldn’t have been getting.

That is terrible!

It just isn’t as big a danger as some folks are making it out to be. It is extremely unlikely that there will be any cases of polio in India, and definitely not a resurgence of polio because of these vaccines, as some have suggested.

The real risk will be that an isolated event will scare folks away from getting vaccinated and protected, even though we know that these events are rare and that vaccines are safe.

More on Contaminated Vaccines in India