“You may choose to look the other way, but you can never say again that you did not know.”

— William Wilberforce

Front Page » Business » Pharma » Should We Be Concerned About Vaccines Made in China?
Text size:

Should We Be Concerned About Vaccines Made in China?

vaccines made in china

It is unclear what percentage of the vaccines currently used in the United States are made by Chinese pharmaceutical companies in China or by Western companies with manufacturing facilities in China.

The past few weeks, there have been a series of news reports coming out of China revealing that thousands of doses of improperly stored and expired vaccines for children and adults were illegally sold for millions of dollars on the black market by more than 100 people associated with Chinese companies and vaccination centers. The international scandal has raised a lot of questions about vaccines made in China, just as China has been trying to enter the global vaccine market while simultaneously dealing with setbacks related to vaccine quality control issues.

Most Americans do not understand that many pharmaceutical products, including vaccines, are not made in the United States and foreign pharmaceutical companies are not subject to U.S. Food and Drug Administration (FDA) quality control regulations.  With no civil liability for vaccine injuries and deaths that occur in the U.S. for FDA licensed vaccines, Americans have a right to be concerned about vaccines made in China.

It was back in November 2011 that the Associated Press (AP) ran a story announcing the entry of China into the world vaccines market.1 The news was picked up by major newspapers and published as articles with titles such as “China Prepares for Big Entry into Vaccine Market”2 3 4 and “Could Your Vaccines Soon Be ‘Made in China?'”5 and “China to Enter World Vaccine Market Soon.”6

The AP report cited the announcement by the World Health Organization (WHO) in March 2011 that China had met “international standards for vaccine regulation” as a milestone in the process to that country’s entry into the market.”2

It opened the doors for Chinese vaccines to be submitted for WHO approval so they can be bought by U.N. agencies and the GAVI Alliance.2

The AP quoted  Nina Schwalbe, who was then head of policy at the Global Alliance for Vaccines and Immunization (GAVI)—a public-private partnership organization that buys vaccines for more than 50 million children annually—as describing China’s entry as a “game changer.”2 Ms. Schwalbe, now principal adviser on health at UNICEF,7 added, “We are really enthusiastic about the potential entry of Chinese vaccine manufacturers.”2

On Oct. 9, 2013, the WHO gave its stamp of approval to a Chinese-produced vaccine against Japanese encephalitis (JE). It was the first Chinese vaccine to be prequalified by the WHO for procurement and use by United Nations (UN) agencies.8 The move marked the official entry of China into the global vaccines market. The Chinese vaccine manufacturer was Chengdu Institute of Biological Products Co., Ltd. (CDIBP),9 10 a subsidiary of China National Biotec Goup Co., Ltd. (CNBG).10

Following approval of CDIBP’s JE vaccine, it looked as if many more Chinese vaccines would soon be entering the global market. However, this did not happen. In December 2013, 17 children were reported to have died after receiving a hepatitis B vaccine manufactured by Shenzhen Kangtai Biological Products Co., Ltd. (SKTB).11 12 13

Over a period of two months, eight infants in China died within hours, and in some cases minutes, of receiving hepatitis B vaccines. In all, 17 deaths among Chinese children aged 5 and younger have been reported following hepatitis B vaccines administered in late 2013.12

Chinese authorities said that nine of the deaths were unrelated to the vaccine, and that the other eight deaths were not believed to be linked to the vaccine.11 12 13 Nonetheless, the incident raised concerns about vaccine production safety standards in China.

On June 4, 2014, the Director General of the WHO, Margaret Chan, MD of China, issued a positive assessment of the China Food and Drug Administration’s (CFDA) regulatory system for vaccines. She said:

The results of the WHO assessment are good news for China, but also for the rest of the world. The demand for vaccines is increasing at a time when the number of countries producing vaccines is declining. China has the largest vaccine manufacturing capacity in the world.14

Dr. Chan added:

The door is now open for CFDA to prequalify, with WHO support, many more vaccines made in China.14

On June 12, 2015, the WHO approved  a Chinese-produced seasonal influenza vaccine.15 The vaccine, made by Hualan Biological Bacterin Corp., a subsidiary of Hualan Biological Engineering Inc., was the second Chinese vaccine to be prequalified by the WHO.16 According to the organization, prequalification “assures that vaccines procured by UNICEF and GAVI are safe and effective.”15

Despite WHO’s “prequalification” standards, China’s entry into the global vaccine market hit another snag last month, as news sources around the world reported the growing scandal involving more than 20,000 expired and improperly stored vaccines in China that were sold on the black market for approximately $90 million since 2010. Some 25 different vaccines for both children and adults are believed to have been sold, including vaccines for polio, rabies, hepatitis B, and influenza.17

The Chinese government has detained 130 individuals from 29 companies and 16 vaccination centers. A state-run company called Hebei Weifang Biological Products Supply Center linked to the provincial Hebei Center for Disease Control and Prevention (CDC) has reportedly been found to be a part of the illegal distribution network.18

It is unclear what percentage of the vaccines currently used in the United States are made by Chinese pharmaceutical companies in China or by Western companies with manufacturing facilities in China. We do know that major U.S. and European vaccine makers such as Merck & Co., GlaxoSmithKline plc, and Sanofi Pasteur SA maintain vaccine manufacturing operations in China, that this activity is on the rise, and that Western vaccine makers are also establishing joint venture partnerships with Chinese vaccine companies.

Consequently, it is increasingly difficult to distinguish which vaccines are manufactured by American and European firms and which are produced by the Chinese. A 2012 article in USA Today, however, did report that the FDA estimates that 80% of the ingredients in pharmaceuticals produced by U.S. companies and 40% of the “finished medications” Americans take come from outside the U.S. and, increasingly they come from China and India.19

The article cited a U.S. Government Accountability Office (GAO) report that found the FDA inspects drug manufacturing facilities in China and India only once every 14 years, and that FDA inspectors are not permitted to enter those facilities unannounced.19 USA Today noted that, according to the GAO report, “Up to two-thirds of foreign pharmaceutical sites have never undergone an FDA inspection.”19

These last two points go to the heart of the issue with regard to foreign-made pharmaceuticals, because they indicate that these products—be they prescription drugs or biological drugs such as vaccines—made in China and used in the U.S. are, for all practical purposes, not being inspected by the main U.S. regulatory agency charged with protecting the health of the American consumer.


1 Associated PressChina gears up for big entry into vaccine market. AP (published on YouTube.com on July 30, 2015) Nov. 29, 2011.
2 Wong G. China prepares for big entry into vaccine market. Daily Herald (AP release) Nov. 30, 2011.
3 Wong G. China prepares for big entry into vaccine market. Jakarta Post (AP release) Nov. 30, 2011.
4 Wong G. China prepares for big entry into vaccine market. The Washington Times (AP release) Nov. 29, 2011.
5 Klimas L. Could Your Vaccines Soon be ‘Made in China?’ The Blaze/AP Nov. 29, 2011.
6 China to Enter World Vaccine Market Soon. CBN News Nov. 29, 2011.
7 UNICEF. Nina Schwalbe, Principal Adviser and Acting Chief of Health, Programme Division. UNICEF Press Centre Oct. 2, 2015.
8 World Health Organization.  Newly accessible Japanese encephalitis vaccine will make saving children easier in developing countries. WHO Media Centre Oct. 9, 2013.
9 WHO green light for Japanese encephalitis vaccine. Vaccines Today Nov. 9, 2013.
10 Chengdu Institute of Biological Products Co., Ltd. Officially Submitted Application Documents to WHO for JE Vaccine Prequalification. China National Biotec Group Feb. 1, 2012.
China’s child deaths not linked to hepatitis vaccine: health authorities. Australian Broadcasting Corporation Jan. 3, 2014.
Mercola J. 17 Children Die After Receiving Hepatitis B Vaccine. Mercola.com Jan. 7, 2014.
13 Barboza D. China Investigates Vaccine Maker After Deaths of Infants. The New York Times Dec. 25, 2013.
14 Chan M. WHO assessment of China’s national drug regulatory authority for vaccines. WHO.int July 4, 2014.
15 WHO Western Pacific Region. WHO prequalifies Chinese influenza vaccine. WPR.WHO.int June 12, 2015.
16 WHO approves China flu vaccine, lauds growing industry. Fox News June 12, 2015.
17 More Than 130 Held In China Vaccine Scandal: Reports. NDTV (Agence France-Presse release) Mar. 25, 2016.
Yan T. Chinese official linked to companies in two vaccine scandals: report. South China Morning Post Mar. 25, 2016.
19 Marsteller D. As drug making goes global, oversight found lacking. USA Today Oct. 21, 2012.

18 Responses to Should We Be Concerned About Vaccines Made in China?

  1. Erwin Alber Reply

    April 5, 2016 at 9:55 am

    “Should We Be Concerned About Vaccines Made in China?”

    Good question but the answer is of course that we should not only be concerned, but should absolutely avoid vaccines of any kind REGARDLESS of their country of origin!

    Keeping in mind that vaccines are perfectly safe and effective as long as they are not used, it follows that keeping one’s child or children vaccine-free is the only safe and sane option.

    There is an abundance of evidence which shows that vaccines are ineffective and dangerous, so that any parents who decide to vaccinate their children are in my estimation recklessly irresponsible.

  2. Erwin Alber Reply

    April 5, 2016 at 9:57 am

    Check out Dr Russell Blaylock’s opinion about vaccines produced in China in this excellent lecture of his:

  3. Janem1276 Reply

    April 5, 2016 at 10:04 am

    Sure, vaccines made in China might be a concern — for the Chinese. Vaccines given in the US are NOT made in china

    • A Higgins Reply

      April 5, 2016 at 11:46 am

      Yet. Not made in China *yet*. But as the costs of Obamacare continue to rise and there’s impetus to cut prices for pharmaceuticals across the board, those cheap Chinese imports will start to look pretty good to the bean counters.

    • Redpill1 Reply

      April 5, 2016 at 8:49 pm

      Vaccine made anywhere are dangerous. They are not only dangerous they actually spread the illness the are developed to prevent. There is no such thing as a vaccine preventable disease.

  4. Linda Reply

    April 5, 2016 at 10:13 am

    We should not buy anything from China, as their record shows, they don’t make the best of things, as per babies and dogs being poisoned. Please do not use them. I do not buy items, if I can help it, made in China, especially if they are pharmaceuticals.

  5. Shawn Siegel Reply

    April 5, 2016 at 10:19 am

    Oh gosh yes!, we should be concerned. I much prefer my neurotoxins be made in the U.S., where the quality control is superior.

    • Irena Reply

      April 5, 2016 at 2:10 pm

      Shawn Siegel, I love you!
      Have you ever thought of hosting a late night TV show?
      I would be watching it :-)
      I mean Erwin Alber, I agree with you of course.
      Check Bolen Report too. He thinks imported vaccines are not substantially different from the content of any open sewer in Bangladesh…

    • Ali Becker Reply

      April 7, 2016 at 8:57 am

      So right Shawn. Love those neurotoxins. That way I can get my chronic illness even faster.

  6. Mark Reply

    April 5, 2016 at 11:15 am

    What? Concerned about vaccines made in China? Come on. Seriously? Having lived in China for a brief period we should be concerned about everything made in China. The standards, excuse me, the LACK of standards in China when compared to that of the US are such that we shouldn’t even buy dog food from China. The question should be rhetorical as any sane person would know. Until China STOPS the massive air, water and food pollution that threatens everyone on this planet we must boycott goods produced in China. Tt doesn’t matter where vaccines are produced anyway. All vaccines should be refused – period.

  7. RL Reply

    April 5, 2016 at 11:23 am

    That should be brought about as a point of debate, especially in the open forums we had here in California when Stephen Pan was lobbying for SB277. That you can not mandate nor enforce a policy that allows for the possibility of harm to the public health. Not that I put my trust in US regulating agencies, but if there are products entering the US unapproved for safety by our agencies that are mandated as public health measures with penalty for refusal, then our representatives have no legal authority to legislate such measures. The People need to be very watchful and educated about our opponent and their strategies. The People are going against corporations and profit motive, gone are the days of companies pursuing altruistic ideas for the good of the people.
    We need to be at the front door of our representatives on measures as important as this. Sit in the streets of Sacramento, litter the halls of the capitol with informed citizens. The equivalent of grabbing your Senator by the shirt collar and letting them know, we wont stand for your blind adherence to corporate campaign donations. You better listen to your “real” constituents or your career on The Hill will be difficult

    • KP Reply

      April 5, 2016 at 3:46 pm

      I completely agree with you RL. I read an article that Senator Pan’s campaign was funded to the tune of one million dollars by the pharmaceuticals. No one ever made a mention about that. It was pay back time for him. This is so heartbreaking to me as I have grandchildren who are going to have to leave school and some what will not be able to start – unless, of course, they are completely vaccinated. My oldest grandson had a very bad reaction to a cocktail and my father died in 2010 from a bad reaction to the Shingles vaccine. This all makes me so sick. I can’t believe parents rights in California have been taken away from them in making intelligent decisions for their children. No one in Sacramento wants to listen. Governor Brown made a terrible in signing the SB277 Bill. But, he has never had any children and has no idea what we all go through.

  8. D. Smith Reply

    April 5, 2016 at 12:06 pm

    Nobody in the medical complex seems interested in checking what’s in the crappy vaccines they make right here in the States, so why would they give a hoot what’s in the ones from China? It’s all garbage and doesn’t belong on the market much less in children’s bloodstreams.

    And if you think they’re not all that concerned with what’s in them, just try finding out what a doctor REALLY thinks about giving vaccines in the first place. They don’t vaccinate their own children, but they’ll put anything in a syringe and give it to another child, even a child who’s only moments old. I can’t believe we live in such a ridiculously stupid world where the “caring profession” doesn’t seem to give a damn.

    • Mark Mel Reply

      June 20, 2016 at 3:16 pm

      What do you mean doctors don’t vaccinate their own children? Where do you get this rubbish? I suspect 95% of doctors with children, at least, vaccinate them. If you have to post outright lies to bolster your position, you don’t have a position, do you?

  9. Carolyn Reply

    April 5, 2016 at 1:42 pm

    Are there any labeling requirements for origin? Like on a package insert or bottle where it has to state a batch number, could that then be used to track if the country of origin isn’t listed?

  10. Sandi Reply

    April 7, 2016 at 9:37 am

    The Who.org is a corrupt organization with the purpose of making vaccines a trillion dollar indusrty for their medical associates and pharmacuetical companies by securing share profits by focusing on middle income families and heads of countries around the world. It’s now about our health its about $$$$
    Vaccines must be made in countries that condone human and animal abuse. Taiwan and Philippines are two other major contributors.
    Quality manufacturing, shipping and storage conditions need to be carefully monitored.
    Major Big Pharma companies are being sued for mounting deaths when these countries are poorly trained and do not understand how to read formulas.
    Bill Gate is loosing in vaccine damage courts around the world for 49 thousand polio sulk vaccines and gardasill deaths and impairments. Merck is a known killer. And they do not care. it’s about the money…..not our health.

  11. Danielita Reply

    April 7, 2016 at 3:05 pm

    Thank you for posting this article that is very important understanding complexity of harm of vaccine. Not only how the ingredients are made and virus/bacteria obtained, but manufacturing. FDA has mostly no access to manufacturing facilities. For those on high horse here–Vaccines don’t belong to our bodies–be concerned–most Vitamin C for example is produced in China!

Leave a Reply

Your email address will not be published. Required fields are marked *


You may use these HTML tags and attributes: <a href="" title=""> <abbr title=""> <acronym title=""> <b> <blockquote cite=""> <cite> <code> <del datetime=""> <em> <i> <q cite=""> <s> <strike> <strong>