GlaxoSmithKline's new shingles vaccine Shingrix quickly captured the market after winning FDA approval and a preferential recommendation from CDC vaccine advisers, but now strong uptake is leading to supply restrictions. In response, GSK is putting TV advertising on hold, a spokesperson said.
In a note on the CDC's website, the agency says that due to "high levels of demand," GSK has introduced order limits. Meanwhile, providers are experiencing shipping delays. CDC predicts the limits and delays will continue through this year.
GSK has boosted its U.S. supply through the end of this year, and the company intends to "release doses to all customer types on a consistent and predictable schedule for the rest of 2018," according to the CDC. The agency says the supply will be more than enough to support the same number of patients who sought shingles vaccination last year.
But Glaxo's Shingrix is seen as a better vaccine than Merck's older Zostavax, a factor that could be driving uptake and creating the supply constraint. According to GSK spokesman Sean Clements, healthcare providers are vaccinating against shingles "at a rate many times that of prior years."
Shingrix has seen "unprecedented" demand during its launch, Clements told FiercePharma via email. As of last month, more than 1.5 million people have received the vaccine.
"We’ve informed the CDC that we are focused on a fair and equitable allocation plan across all customer segments, to help ensure your patients complete the two-dose series," he added.
Until the company can fully restore its inventory levels, GSK has decided to delay "broad consumer education activities" such as TV ads, Clements said.
A CVS spokesperson said that due to high demand, "it has become challenging to keep an ample supply across all of our more than 9,800 stores due to supply restrictions from the manufacturer." She added that the stores are getting shipments "intermittently."
After its October approval, Shingrix quickly captured the market. In a first-quarter conference call, GSK CEO Emma Walmsley said due to strong demand, "low inventory levels" are likely going forward.
She said GSK is "very focused on minimizing this and are prioritizing all the actions to supply the vaccine." The company will focus on the U.S. launch first, with other rollouts to follow, she said.
Commercially, the shingles vaccine is exceeding expectations. The company reported $150 million in first-quarter sales, and executives said the vaccine should continue at the same sales pace through 2018, implying first-year revenues of $600 million for the vaccine.
Another complication of the launch is administration errors. In a Notes from the Field report last month, the CDC reported 13 administration errors during the first four months of the rollout, likely due to the switch from Merck's Zostavax. Shingrix is administered intramuscularly in two doses, while Merck's vaccine is given subcutaneously in one dose. Responding to the errors, the company boosted its physician education efforts.
Last year, CDC advisers recommended the vaccine for people 50 and older, creating a "target universe of over 100 million patients in the U.S. alone," a Glaxo exec previously told analysts.