Tag: Samoa

The Tragedy in Samoa Was Not Caused by the MMR Vaccine

Remember the two young children who died in Samoa in early July 2018, shortly after getting an MMR vaccine?

In addition to the tragic deaths of those two children, it led to the suspension of all vaccinations in the country.

The Tragedy in Samoa Was Not Caused by the MMR Vaccine

Fortunately, that suspension was eventually reversed, but they did continue to hold MMR vaccinations.

How long did they suspend MMR vaccinations?

They actually don’t restart until April 15.

And while the trial for the two nurses involved in the tragedy is delayed until June, the Director General of Health, Leausa Take Naseri, has said that their deaths were a mistake caused by human error.

And that the MMR vaccine is safe.

With measles outbreaks in many nearby countries, health experts and parents are eager to get vaccinations restarted and to get kids caught up.

Local officials say that Taylor Winterstein, the face of the VAXXED tour in Australia, is taking advantage of what happened at the Safotu District Hospital

Hopefully, they get vaccinated before anti-vaccine folks head to Samoa to try and scare folks away from getting vaccinated.

More on The Vaccine Tragedy in Samoa

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

Update on the Samoa Vaccine Tragedy

Breaking News – MMR vaccination on Samoa will resume on April 15 (see below).

Many people remember that two young children died in Samoa in early July, shortly after getting an MMR vaccine.

Two toddlers died after being vaccinated at Safotu Hospital in Samoa.
Two toddlers died after being vaccinated at Safotu Hospital in Samoa.

Both incidents happened on the same day in the same hospital on the island of Savai’i.

“Until the investigations have been completed and reported on we cannot say what did happen.

However, given the batch of vaccine involved had been in use in that country since August last year, and given the same batch of vaccine has been used in South American countries and the Caribbean island nations without incident, it seems unlikely that there was anything wrong with the vaccine.

The reports from the parents of the children affected on Friday indicate the reactions occurred within minutes after vaccination. This would preclude a response to the vaccine viruses as this takes at least a week. While anaphylaxis occurs within minutes and can be fatal when not treated the odds of seeing this twice in a day at the same place, given a chance of 1 in a million doses, is literally astronomical.”

Dr. Helen Petousis Harrison on What happened in Samoa?

And while many people have speculated on what had happened, we didn’t get much new information until the Attorney General Lemalu Herman Retzlaff issued a press statement:

It can be confirmed that one of the nurses involved with the vaccination injections of the two babies who passed away 6th July 2018, was charged by police on Saturday 4th August 2018. She is set to appear in Court 14th August 2018, where the charges will be confirmed publicly.

According to AG Lemalu, “the file was referred to this office for advice last week, after swift and hard-working investigations by the CID section of the Ministry of Police both in Apia and Savaii, which is to be commended.”

“And the decision to charge was thereafter supported by advice; and it is also confirmed by Police, that investigations are still active and on-going.”

Both nurses have now been charged and both have entered not guilty pleas to charges of manslaughter, negligence and conspiracy to defeat the course of justice.

A trial is set for January 21 June 2019.

Apparently though, an ongoing investigation into the deaths of the two toddlers that had been adjourned until September 12, 2018 as they were still waiting on the the post mortem reports from the pathologist in Australia, has been suspended even further.

“The inquiry into the deaths of two babies in Samoa has been suspended until further information is available from post mortem results”

Delays in Samoa deaths inquiry

So, we still don’t know what happened.

Were the vaccines contaminated somehow?

Was an error made?

Why were the nurses charged with manslaughter? Many think the main issue is that the nurses continued to use the MMR vaccine even after the first baby died.

“This particular vaccine batch lot arrived to Samoa in August 2017 and has been in use since then. The same vaccine batch lot used in Samoa is also in use in a number of South American and Caribbean countries (Belize, Ecuador, St. Vincent, Trinidad Tobago, Chile, Aruba, Dutch Antilles, St. Kitts & Nevis and Cuba) with no reports of adverse events from those countries.”

Government of Samoa – Ministry of Health Press Statement

Whatever happened, it is important to remember that these kinds of tragedies are very rare and that vaccines are safe.

There certainly doesn’t seem to be a good reason to continue to halt all vaccinations in Samoa!

“This stop order is for the M.M.R. to be put on hold for the time being until the case and the investigation are completed,” said Tagaloa.

“But in relation to other vaccines, the ministry did not have any stop order on this. We advise that the other vaccination still continue, especially the vaccinations relating to newborns.”

He added the stop order in question was issued by the National Health Service (N.H.S.) and it involves all vaccinations from the day of the incident.

“But we have already advised them to continue with the other vaccines except for the M.M.R. vaccinations.”

Order to stop immunisation only for M.M.R.

Vaccinations in Samoa, except for MMR, did resume already thanks to a push by their Nurses Association.

What’s next?

MMR vaccinations are scheduled to restart on April 15.

We will have to wait until June for the trial though…

They have said that human error caused the tragedy. It wasn’t the MMR vaccine itself.

More on Samoa Vaccine Tragedy

Updated on April 10, 2019

Vaccination Tragedies are Rare

Vaccines work to prevent at least 2 to 3 million deaths each year worldwide.

Tragically, either because of errors or contamination, vaccines can sometimes actually cause people to get sick.

This can happen when health workers:

  • use a reconstituted vaccine after six hours – live vaccines can quickly become contaminated if they are kept and used for too long a time
  • mixup diluents – in addition to using the wrong diluent vaccination tragedies can occur when a dangerous medication is used instead of a vaccine’s standard diluent
  • improperly handle vaccines – breaking the cold chain
  • a vaccine is given to someone with a true medical contraindication

Fortunately, these situations are rare.

History of Vaccination Tragedies

With billions of doses of vaccines being given each year, it is likely not surprising that we see some problems. But when many of those vaccines are being given to kids, even one mishap, especially if it leads to life-threatening complications, is too many.

That’s why many safe guards have been put in place in the manufacturer and distribution of modern vaccines, so that we don’t see these types of vaccine tragedies:

  • the Cutter Incident, when, in 1955, at least 56 people developed polio and 5 children died after being vaccinated with inactivated polio vaccine that was poorly manufactured by Cutter Laboratories and still contained live polio virus
  • hepatitis-contaminated yellow fever vaccines – some lots of yellow fever vaccines used in the military in 1942 were unintentionally contaminated with the hepatitis B virus
  • the Lubeck Disaster – 75 children died and others got tuberculosis in 1929 Germany after there was a mixup between the BCG vaccine and the strain of Mycobacterium tuberculosis that causes tuberculosis. The BCG vaccine was supposed to be made with a weakened strain of Mycobacterium bovis bacteria instead.
  • the Bundaberg incident – 12 children died in Australia in 1928 after being given contaminated diphtheria vaccine from a multidose vial without preservative
  • tetanus contaminated smallpox vaccine in the 1890s and early 20th century

Although vaccines are much safer now, some rare incidents still occur.

Fifteen infants died and 75 children got sick in Syria in 2014 after they received a neuromuscular blocking agent, atracurium, instead of the measles vaccine they were supposed to get. How? The measles vaccine that was being used is mixed with a diluent, but instead of using the proper diluent, the health worker unintentionally used a bottle of atracurium instead.

In 2015, at least two kids died and 29 got sick in Chiapas, Mexico, among 52 children who were vaccinated. The children were reportedly given a BCG vaccine, the rotavirus vaccine, and/or a hepatitis B vaccine that day. However, the only vaccine that all of the sick children received in common was the hepatitis B vaccine. Since 130,000 doses from the same batch of vaccines had been given in the area, it was not thought to be a manufacturing problem or widespread issue. It was instead bacterial contamination of hepatitis B vaccine vials at that one clinic.

Fifteen children died in 2017 in a village in South Sudan after a poorly trained team that wasn’t adhering to WHO immunization safety standards used the same syringe to reconstitute measles vaccines over a four day period. They also didn’t keep the vaccine vials refrigerated.

“A single reconstitution syringe was used for multiple vaccine vials for the entire four days of the campaign instead of being discarded after single use. The reuse of the reconstitution syringe causes it to become contaminated which in turn contaminates the measles vaccine vials and infects the vaccinated children.”

Statement regarding findings of joint investigation of 15 deaths of children in Nachodokopele village, Kapoeta East County in South Sudan

As you can imagine, the conditions that led to these tragedies aren’t present when most kids get vaccinated.

Even in developing countries, most children get vaccinated by people adhering to WHO immunization safety standards. Why did they happened then? Both Syria and South Sudan have been rocked by war for years, leading to a breakdown in the ability to provide routine health care, even as basic as getting kids vaccinated. And Comunidad La Pimienta, Simojovel, Chiapas is a very poor part of southern Mexico.

These kinds of tragedies aren’t going to happen at your pediatrician’s office, as they don’t even have drugs like atracurium.

What Happened in Samoa?

Two toddlers died after being vaccinated at Safotu Hospital in Samoa.
Two toddlers died after being vaccinated at Safotu Hospital in Samoa.

In Samoa, four years after the deaths of the children in Syria, we are once again hearing about reports of deaths after kids were vaccinated with the MMR vaccine.

Two children in Samoa, both one-year-olds, died within minutes  of being vaccinated on the same day in the same hospital on the island of Savai’i.

Not surprisingly, as health officials investigate the cause, use of the MMR vaccine had been suspended in Samoa.

So what happened?

“Until the investigations have been completed and reported on we cannot say what did happen.

However, given the batch of vaccine involved had been in use in that country since August last year, and given the same batch of vaccine has been used in South American countries and the Caribbean island nations without incident, it seems unlikely that there was anything wrong with the vaccine.

The reports from the parents of the children affected on Friday indicate the reactions occurred within minutes after vaccination. This would preclude a response to the vaccine viruses as this takes at least a week. While anaphylaxis occurs within minutes and can be fatal when not treated the odds of seeing this twice in a day at the same place, given a chance of 1 in a million doses, is literally astronomical.”

Dr. Helen Petousis Harrison on What happened in Samoa?

Since it happened so quickly, it sounds like it could have been a mix-up with the diluent, as happened in Syria. A five dose vial of MMR is used in Samoa, which means that unlike premixed vaccines, it does have to be mixed with a diluent.

What about contamination? It is known that vaccine vials can be contaminated with Staphylococcus bacteria if they are mishandled. Although Staphylococcus bacteria can directly cause infections, they can also release a toxin that can cause toxic shock syndrome (TSS).

Considering how quickly these children got died though (within minutes), it isn’t likely that the vaccines became contaminated with Staphylococcus toxins. There have been reports of TSS following vaccination in the past, usually with vaccines that don’t use preservatives, but symptoms typically develop over four to 24 hours.

“This particular vaccine batch lot arrived to Samoa in August 2017 and has been in use since then. The same vaccine batch lot used in Samoa is also in use in a number of South American and Caribbean countries (Belize, Ecuador, St. Vincent, Trinidad Tobago, Chile, Aruba, Dutch Antilles, St. Kitts & Nevis and Cuba) with no reports of adverse events from those countries.”

Government of Samoa – Ministry of Health Press Statement

Could this be related to what happened to two other children in Samoa who had died after getting their MMR vaccines?

Almost certainly not. Those children, siblings, died years earlier, one in 2015 and the other in 2017. Neither died immediately after being vaccinated and there are reports that they may have had some kind of an immunodeficiency syndrome that contributed to their deaths.

“A number of media outlets are already covering these tragic events, speculating on the cause of death before the investigation is completed, and the stories have been picked up by the anti-vaccination movement.”

Government of Samoa – Ministry of Health Press Statement

That some folks would use these rare tragedies to scare parents from vaccinating and protecting their kids is shameful. But that’s the modern anti-vaccine movement

What to Know About Vaccination Tragedies

Kids shouldn’t get sick or die after getting vaccinated. Fortunately, they rarely do, except in extreme circumstances that can make it more likely for errors to occur.

More on Vaccination Tragedies