China’s National Medical Products Administration has announced that two Chinese pharmaceutical companies, Walvax Biotechnology and Innovax, have been approved to start selling their own version of drugs previously available only through global pharmaceutical giants Pfizer, Merck and GlaxoSmithKline.1
Cecolin, developed by Innovax, will compete in the Human Papilloma Virus (HPV) arena against Merck’s Gardasil and GlaxoSmithKline’s Cervarix, while Walvax’s pneumococcal 13-valent conjugate vaccine will go head-to-head in competition with Pfizer’s Prevnar 13, previously the only 13-valent pneumococcal vaccine available worldwide. The huge Chinese market has been a major factor in the burgeoning global sales figures for both Merck’s Gardasil and Pfizer’s Prevnar 13 vaccines.
Pfizer Sees Sales of Prevnar Vaccine in China Boost Profits
Prevnar, approved for use in China in 2016 and introduced there the following year as Prevanar, had seen its U.S. sales fall by four percent but overall sales rise by an estimated nine percent, representing $1.77 billion. Pfizer attributes the gain primarily to the product’s launch in China.2
Walvax’s 13-valent pneumococcal vaccine competitor is targeted for use in children between six weeks and five years. More than 15 million babies were born in China in 2018, and the market for vaccines against pneumococcal disease has been strong.3
China Market Gives Merck 37 Percent Sales Growth for Gardasil
The story for Merck’s Gardasil is a similar one. Sales of Gardasil/Gardasil 9 overall reached $3.2 billion in 2018, a growth of 37 percent compared with 2017.4 In the first three quarters of 2019, sales of Gardasil outside of the U.S. rose by 64 percent to $1.46 billion, again attributed to “higher demand in the Asia Pacific region, particularly in China.”5
The overseas market demand for Gardasil is so high that Merck has borrowed from the CDC’s Pediatric Vaccine Stockpile of Gardasil 9 in order to fulfill orders coming in from outside the U.S.6 Merck has announced that it is currently building and/or expanding several large facilities to ramp up production of Gardasil to keep up with the demand, but those facilities are not expected to be in use until 2013.7 8
Persistent Reports of Serious Side Effects for Gardasil Vaccine
Support for the Gardasil promotional campaign has not been as successful in the U.S. or other countries. In Japan, HPV vaccine was removed from the government’s recommended list of vaccines in June 2013 after persistent complaints of serious side effects, including memory loss, muscle weakness, severe headaches, debilitating fatigue, psychiatric symptoms and other brain and immune dysfunction, as well as death.9 10 11 12
1 Liu R, Goh B. China Approves Home-Grown Vaccines, Offering Alternative To Global Drugmakers’ Products. Reuters Dec. 31, 2019.
2 Liu A. Homegrown Rivals To Pfizer, Merck Cash Cow Vaccines Win Nods In China. Fierce Pharma Jan. 2, 2020.
3 See Footnote 1.
4 Merck & Co. Plans $1-Billion Mfg Investment to Expand HPV Vaccine Operations. DCAT Value Chains Insight May 8, 2019.
5 See Footnote 2.
6 Palmer E. Merck Siphons Off Gardasil CDC Supplies Again As Global Sales Surge. Oct. 30, 2019.
7 See Footnote 4.
8 Palmer E. Merck to build Gardasil 9 plant and add 425 jobs, but will cut 150 elsewhere. Fierce Pharma July 29, 2016.
9 Tomljenovic L, Colafrancesco S. et al. Postural Orthostatic Tachycardia With Chronic Fatigue After HPV Vaccination as Part of the “Autoimmune/Auto-inflammatory Syndrome Induced by Adjuvants” Case Report and Literature Review. J Investig Med High Impact Case Rep. 2014 Jan-Mar; 2(1): 2324709614527812.
10 Matsudaira T, Takahashi Y et al. Cognitive dysfunction and regional cerebral blood flow changes in Japanese females after human papillomavirus vaccination. Neurol Clin Neuroscience 2016; 4(6): 220-227.
11 National Vaccine Information Center. Can HPV Vaccine Cause Injury and Death?
12 Normile D. Japanese court rules against journalist in HPV vaccine defamation case. Science Magazine Mar. 27, 2019.