Tag: vaccine recalls

The Latest Vaccine Scandal in China

There is a vaccine scandal in China.

What does that mean for you and your kids?

Not much unless they were vaccinated in China. Remember, none of the vaccines used in the United States are made in China.

And our vaccines are tested for safe, pure, and potent before they are released for distribution.

The Latest Vaccine Scandal in China

Changchun Changsheng Life Sciences Ltd. is no longer making vaccines
Changchun Changsheng Life Sciences Ltd. is no longer making vaccines.

Even if your child had been vaccinated in China, there is likely nothing to be concerned about at this point.

The vaccines were not contaminated.

There is a concern that they were “substandard,” or that they might not work as well as they should.

That’s not good either though.

Getting a substandard vaccine might mean that you could get a disease that you thought you were vaccinated and protected against.

Still, since the scandal seems limited to a few companies (well, really just one company) and a few vaccines (just rabies and DTaP), it is very unlikely that many people in other countries have been affected.

“WHO assessed the national regulatory authorities in 2010 and 2014, and found that they met WHO criteria as a functional regulator for vaccines with a clear commitment to continual improvement. WHO welcomes the fact that China’s NDA continues to work with WHO’s Regulatory Systems Strengthening program, as it has been doing for nearly 20 years. While the current incident is clearly regrettable, the detection of this event by an unannounced inspection shows that the regulatory authority’s system of checks and balances to protect population health is working.”

WHO Statement on Rabies Incident in China

It is also important to realize that:

  • affected vaccines include 650,000 doses of DTaP vaccine, which were only sent to Chongqing and the provinces, of Shandong and Hebei. And while they initially passed testing for safety and efficacy before being released for distribution, later, routine testing found low titer testing in vaccines from two companies, Changchun Changsheng Life Sciences Ltd. and Wuhan Institute of Biological Products, who’s vaccines were recalled. Batch numbers have been published, so parents should be able to figure out if they got one of these vaccines.
  • problems with rabies vaccines from Changchun Changsheng Life Sciences Ltd. were discovered on a routine inspection and before the vaccine had been released for distribution. Unfortunately, the problem is that they made up production and inspection records, which is why at least 15 people from the company have been arrested. This is the scandal.

While some folks are concerned of more widespread problems, it is important to keep in mind that vaccines have been working in China. Despite these recent problems, China is polio-free and has “significantly reduced vaccine-preventable diseases such as measles, mumps, rubella, and hepatitis A and B among children.”

If there were a big problem with the effectiveness of their vaccines, they should be seeing more disease. And they aren’t.

And in places that are seeing more disease, like Europe, with their measles outbreaks and deaths, it is clearly unvaccinated folks that are getting sick.

“If you are unsure as to whether or not your child was vaccinated, the doctor can have their blood tested for antibodies to determine their immunity to certain diseases. However, these tests may not always be accurate, so the doctor may not be sure your child is truly protected. In some cases, doctors may prefer to revaccinate your child anyway for best protection. It is safe for your child to be revaccinated, even if your child received that vaccine in their birth country.”

CDC on Adoption and Vaccines

If you are still concerned about vaccines that your child may have gotten in China, either because you were living in China when your child was vaccinated or your child was adopted from China, remember that you can always have those vaccines repeated.

Titer testing is another option for most vaccines.

Until and if we get further guidance on this issue from the WHO, CDC, or AAP, neither seems to be necessary for what seems to be an isolated problem right now.

Update on the Vaccine Scandal in China

There have been a few updates since the initial news of the vaccine scandal in China, including that:

  • at least 10 officials with the State Food and Drug Administration and the State Drug Administration have been fired and 35 non-centrally-administered officials will be held accountable
  • an additional 247,200 DTaP vaccines from Changchun Changsheng Life Sciences Ltd. have been found to be substandard

And there are reports of some parents going to Hong Kong to get their kids vaccinated.

Vaccine Scandals in China

Tragically, these aren’t the first vaccine scandals in China.

  • there were reports of kids getting sick in 2016 in Shandong providence after getting vaccines that had not been stored properly
  • there were reports of kids getting sick in 2015 after getting expired vaccines in Henan province
  • in 2013, several infant deaths were blamed on hepatitis B vaccines, but they were later determined to be coincidental

And before that, in 2010, at least four children reportedly died in Shanxi province after getting what were said to be improperly stored vaccines.

While improperly stored vaccines could become contaminated, getting kids sick, it is unlikely that they would get sick from expired vaccines, which might just be less effective than newer vaccines.

What to Know About Vaccine Scandals in China

While it is horrible that anyone put profits before safety when it comes to keeping kids safe from vaccine-preventable disease, it would also be terrible to further use the China vaccine scandals to scare parents away from vaccinating and protecting their kids.

More on the Vaccine Scandals in China

Updated August 18, 2018

Contaminated Vaccines

comvax
Hib and Comvax vaccines were recalled in 2007 over concerns about bacterial contamination.

Tragically, vaccines can sometimes become contaminated with substances that can get kids sick.

In addition to the Cutter Incident, in which live polio virus contaminated the inactivated polio vaccines, problems with contaminated vaccines include:

  • two children in Chiapas, Mexico who died after getting vaccines that were contaminated with bacteria
  • hepatitis-contaminated yellow fever vaccines during WWII
  • tetanus contaminated smallpox vaccine in the 1890s and early 20th century

Other findings of contamination have not led to any problems, such as:

Still, that has not stopped some from scaring many people about the idea of contaminated vaccines – from misinformation about glyphospate in vaccines to conspiracy theories of a polio vaccine cancer cover up and hidden ingredients that contaminate vaccines.

Worries about contamination should certainly not keep you from vaccinating your kids though.

The most recent episode, in Chiapas,  was because of local conditions in a remote village in Mexico. It had nothing to do with how the vaccine was produced.

In 2007, it is reported that “routine testing identified B. cereus in the vaccine manufacturing process equipment, but not in individual vaccine lots.” Although the vaccines were quickly recalled, no one got sick.

Other cases, like when tetanus or hepatitis contaminated some vaccines, while tragic, was long before the latest safeguard from the FDA were put in place.

Vaccines are very safe from contamination.

For More Information on Contaminated Vaccines:

Hot Lots

That there are Hot Lots of vaccines that cause more side effects or vaccine injuries than other vaccine lots is a common vaccine myth.

The Hot Lots Vaccine Myth

Like most other things, vaccines are made in batches or lots.

These lots are then tested “to ensure safety, purity, and potency.”

Vaccine lots aren’t all the same size though. A small lot is going to appear to be a “hot lot,” having more reports of side effects than a much larger vaccine lot.

And a report of a vaccine injury in VAERS, where most reports of hot lots come from, doesn’t mean that the vaccine actually caused the injury or side effect.

“When evaluating data from VAERS, it is important to note that for any reported event, no cause-and-effect relationship has been established. Reports of all possible associations between vaccines and adverse events (possible side effects) are filed in VAERS. Therefore, VAERS collects data on any adverse event following vaccination, be it coincidental or truly caused by a vaccine. The report of an adverse event to VAERS is not documentation that a vaccine caused the event.”

Guide to Interpreting VAERS Data

Interestingly, the first edition of the National Vaccine Information Center’s newsletter published a list of “especially toxic” DPT vaccine lots.

Their DPT vaccine Hot Lot list was compiled by finding lot numbers “which are associated with the highest numbers of deaths, injuries and hospitalizations reported to the government’s Vaccine Adverse Event Reporting System.”

The NVIC’s “Hot Lot” list and news about Heather Whitestone‘s “vaccine injury” were all bogus.

Again, VAERS is a passive reporting system. Since anyone can report a reaction, simply being in VAERS doesn’t mean that that the reaction was caused by a vaccine.

More on the Hot Lots Vaccine Myth