Merck's rolling with RotaTeq in China while phasing out a discounted Africa supply deal

When supplies are strained, what gives? For Merck & Co., in the midst of global production constraints, it's phasing out shipments of cut-rate RotaTeq doses to Africa while pushing its China launch through a local partner.

Merck inked a deal with the nonprofit group Gavi to supply RotaTeq, a lifesaving rotavirus vaccine, to four low-income countries at a big discount. But now that its Chinese partner is rolling out the vaccine in that market, supplies won't stretch to meet all that demand.

The company can now only ship two-thirds of the promised doses to Burkina Faso, Mali, Cote d’Ivoire and Sao Tome this year and next, Gavi said. It will stop distributing the vaccine to those countries altogether in 2020, according to NPR. More than half a million children could miss out on vaccinations due to the shortfall, according to Gavi.

"Merck’s reduction in rotavirus vaccine supply to Gavi-supported countries means countries affected will now urgently need to find an alternative," Gavi CEO Seth Berkley said in a statement. It's "deeply disappointing news and in the short term will mean that children are likely to miss out on this lifesaving vaccine, leaving them vulnerable to this horrific disease," he added.

The development comes after Merck’s vaccine won approval in China this April. The Big Pharma is selling its vaccines there through partner Chongqing Zhifei Biological Products Co., and that company said it plans (PDF—Chinese) to buy more than $450 million worth of RotaTeq doses through 2021. According to NPR, doses in China carry a significantly higher price than Merck's agreed-upon cost for Gavi.

A Merck representative said vaccine makers have been dealing with increased demand in recent years, and while the company is "increasing our manufacturing capacity, including building new sites, creating that additional capacity is a multi-year process."

She said Merck is "committed to saving and improving lives around the world with our vaccines, and we are working closely with our customers around the world, including UNICEF and GAVI, to meet the unprecedented increase in global demand for vaccines, including for rotavirus."

GlaxoSmithKline, for its part, continues to distribute rotavirus vaccine doses to Gavi. The company supplies 90% of Gavi countries' demands for rotavirus vaccines, but is also dealing with supply constraints, the nonprofit said. GSK can provide its vaccine to countries already running rotavirus vaccination campaigns, but won't be able to support new campaigns this year or next.

Meanwhile, the World Health Organization recently prequalified inexpensive rotavirus vaccines from Bharat Biotech and Serum Institute of India. Those companies—both based in India—have said they can meet demand starting in 2020, but the switch to newer vaccines will result in costs and delays, Gavi said.

While both of those companies' prequalifications mark progress in global efforts to increase access to rotavirus vaccines, an expert with Seattle-based nonprofit PATH told NPR it will take at least two years to make the vaccines available in West Africa. During that delay, millions of babies there will be at risk, Johns Hopkins University professor of pediatrics and pediatric infectious diseases Dr. Mathuram Santosham told the radio network. 

As of the end of 2017, Gavi funded rotavirus vaccinations in 43 countries and for 76 million children, according to the group.  

Merck's RotaTeq brought in $540 million in sales through the first three quarters of 2018, a slight increase over $525 million during the first nine months of 2017.

Merck is also in the process of launching its HPV vaccine Gardasil 9 in China after an approval in April. That launch is also underway through local distributor Chongqing Zhifei Biological Products Co.

Editor's note: This story was modified to clarify a statement from Gavi.

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