Tag: China

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

Vaccines Are Made in China!

It shouldn’t be a secret that vaccines are made in China.

There are over 1.3 billion people in China, and no, they don’t import all of their vaccines from the United States.

Neither does India, for all of their 1.2 billion people.

For example, the Serum Institute of India Pvt. Ltd. makes many vaccines, including:

  • GeneVac-B – hepatitis B
  • Quadrovax – DTP-Hib combo
  • Pentavac – DTP-HepB-Hib combo
  • Tresivac – MMR
  • Poliovac – polio
  • Triple Antigen – DTP
  • MenAfriVac – meningococcal group A
At least 34 manufacturers make vaccines for use in China, like this Hib vaccine.
At least 34 manufacturers make vaccines for use in China, like this Hib vaccine.

And there are over 34 vaccine manufacturers in China, including:

  • Chengdu Institute of Biological Products Co., Ltd
  • Hualan Biolgical Bacterin Co., Ltd
  • Jilin Brother Biotech Co., Ltd
  • Wuhan Institute of Biological Products
  • Lanzhouz Institute of Biological Products

These vaccine manufacturers in China, a mix of state run, private, and international joint ventures, help produce the vaccines used in China’s immunization program.

Some US vaccine companies even have vaccine manufacturing plants in China and other countries, but they make vaccines that are used in nearby parts of the world.

For example, Merck recently opened a new vaccine plant in Hangzhou, China to make vaccines to be used in the Asia Pacific region.

Should We Be Concerned About Vaccines Made in China?

If you are getting vaccinated in China, then you likely want to know more about where and how your vaccines are made, especially as there have been some recent vaccine scandals in China. Everyone else should probably be wondering why anti-vaccine folks make such a fuss about this.

In addition to implying that vaccines are made under unsafe conditions, much of this anti-vaccine propaganda includes racist themes.

Parents who are concerned should understand that the United States doesn’t get any vaccines from China or India, or from Brazil, Cuba, Indonesia, or Russia for that matter.

The concern, of course, would be that it might be hard to test and verify these vaccines if they were.

“Following approval, FDA also carefully monitors the quality of vaccines—all manufactured lots must pass tests before they can be used. And as with all manufacturers of medical products, vaccine manufacturers must follow strict manufacturing standards. In addition, FDA conducts routine inspections of manufacturing sites.”

FDA on How does FDA assess the safety of vaccines?

Instead, vaccines that are used in the United States are made by:

  • Emergent Biosolutions – USA – Anthrax vaccine
  • ID Biomedical Corp – Canada – Fluvaval
  • GSK Vaccines – based in Belgium, but vaccines are made in Belgium (Boostrix, Cervarix, Energix-B, Havrix, Hiberix, Infanrix, MenHibrix, Kinrix, Pediarix, Rotarix), Germany (Boostrix, Fluarix, Infanrix, Kinrix, Pediarix, Rabavert), and Italy (Bexsero, Menveo)
  • MedImmune – USA – FluMist
  • Merck – USA – BCG, Gardasil9, MMRII, PedvaxHIB, PneumoVax23, ProQuad, RecombivaxHB, RotaTeq, Vaqta, Varivax, Zostavax are made at Merck’s vaccine manufacturing plants in West Point, Pennsylvania, Elkton, Virginia, and Durham, North Carolina
  • PaxVax – USA – their Vivotif typhoid vaccine is made in Thörishaus, Switzerland
  • Pfizer – USA – (Prevnar, Trumenba)
  • Protein Sciences Corporation – USA – Flublok
  • Sanofi Pasteur – Canada (Adacel, Daptacel, Pentacel), France (IPOL, Pentacel), USA (Menactra, YF-Vax, ),
  • Seqirus – USA – Afluria, Flucelvax, Fluvirin
  • Valneva (Intercell USA) -their  Japanese encephalitis vaccine (IXIARO) is made in Livingston, Scotland, UK
  • Valneva Sweden AB – their Dukoral cholera vaccine is made in Solna, Sweden

A little competition in the vaccine industry wouldn’t be a horrible thing though.

Vaccines are expensive

They are safe, but expensive. Necessary too.

What to Know About Vaccines Made in China

Although plenty of vaccines are made in China, the vaccines that are used in the United States are not, although anti-vaccine folks use this as a talking point to scare parents away from vaccinating and protecting their kids.

For More Information on Vaccine Manufacturer Sites:

Updated August 20, 2018

About Those Measles Outbreaks in China

The MMR vaccine is one of the most effective vaccines ever made. Two doses are at least 99% effective at preventing measles infections. Even one dose is about 95% effective against measles.

We have measles outbreaks in the United States not because the MMR vaccine is not effective, but rather because there are still so many unvaccinated people around. Often, these unvaccinated people travel out of the country, get sick with measles, and start the outbreaks.

About Those Measles Outbreaks in China

A study in PLOS did not find massive outbreaks of measles in China despite high vaccination rates.
A study in PLOS did not find massive outbreaks of measles in China despite high vaccination rates.

But if the MMR vaccine is so effective, then why, as many anti-vaccine folks claim, is China having measles outbreaks when 99% are vaccinated?

The simple answer is that this claim is false – China is not having these big measles outbreaks among highly vaccinated people.

The source of the claim is from a real article in PLoS One, “Difficulties in Eliminating Measles and Controlling Rubella and Mumps: A Cross-Sectional Study of a First Measles and Rubella Vaccination and a Second Measles, Mumps, and Rubella Vaccination,” which found that in 2011, in Zhejiang province, there were:

  • 9 patients with measles, including 3 infants who were too young to be vaccinated and 6 young adults who were unsure if they had ever been vaccinated
  • 1122 patients with mumps
  • 186 patients with rubella

So no big measles outbreaks, but why the large number of cases of mumps and rubella?

History of Measles Vaccination in China

It becomes easy to understand when you look at their immunization schedule.

In the United States, the first live measles vaccine was introduced in 1963, the MMR was introduced in 1971, and a booster dose of MMR was added to the childhood immunization schedule in 1990. That helped to stop the endemic spread of measles in 2000 and rubella in 2004.

In contrast, the measles vaccine timeline has moved much slower in China:

  • a measles vaccine was introduced in 1966
  • continued use of a one-dose, single-antigen measles vaccine through the 1970s and mid-1980s
  • the addition of a single-antigen measles vaccine booster dose in 1985 to children who were 7-years-old
  • in 2007, the switch to a measles-rubella vaccine for 8 months old, with a MMR booster at 18-24 months
  • the addition of a measles-rubella vaccine booster for secondary school students in 2008
  • a campaign to get children between the ages of 8 months and 4 years vaccinated with a measles-mumps vaccine in 2010

So many of the children and young adults who had mumps and rubella would not have had a chance to get a mumps or rubella vaccine. They were too old when they started giving those vaccines and there was no catch-up for older children and adults.

The study authors conclude that a timely two-dose MMR vaccination schedule is recommended, with the first dose at 8 months and the second dose at 18–24 months. An MR vaccination speed-up campaign may be necessary for elder adolescents and young adults, particularly young females.

What To Know About Those Measles Outbreaks in China

Even considering the varied vaccine schedule, the study also clearly states that even for the measles vaccine, there is less than 95% coverage in almost all age groups and that measles cases are at an historic low.

It should be clear that anti-vaccine websites are putting out false information when they say that China is having measles outbreaks when 99% of the population is vaccinated.

More About Those Measles Outbreaks in China