Drug launches come with an array of challenges, and GlaxoSmithKline is experiencing that firsthand with its U.S. shingles vaccine rollout. While Shingrix sales are churning ahead of expectations—executives are calling for $600 million in sales this year—officials have tracked some administration and storage errors for the new vaccine.
In a recent Notes from the Field report detailing incidents from the first four months of the vaccine's launch through February 20, the CDC noted that there had been 13 administration errors. Some incidents detailed multiple errors. On 9 occasions, healthcare practitioners gave the vaccine through the subcutaneous route versus the intramuscular route.
GlaxoSmithKline took note of the errors, a spokesperson said, and boosted physician education efforts to include campaigns with the Immunization Action Coalition, the National Foundation for Infectious Diseases and the American College of Physicians.
Glaxo's new vaccine boasts stronger efficacy figures than Merck's older Zostavax and is administered intramuscularly in two doses. Merck's shot is a subcutaneous vaccine given in one dose. Importantly, Glaxo's vaccine is refrigerated, while Zostavax is frozen for storage.
In one case, a 39-year-old received the vaccine that's approved for people of age 50 and older, according to the CDC. Another 48-year-old received the vaccine. In two instances, recipients received the wrong vaccine information statement and weren't instructed to return for a second dose. Other reports included a recipient receiving the wrong vaccine, and more.
Nine errors were in a pharmacy, while two were in a health care provider's office; locations for the other two cases were unknown.
The CDC noted that "administration errors are reported most frequently shortly after vaccine licensure and publication of recommendations, likely because of lack of vaccine provider familiarity with the new vaccine."
A GSK spokesperson told FiercePharma the company "anticipated there would be some initial confusion regarding the administration and storage for Shingrix due to the differences between Shingrix and the other licensed shingles vaccine that health care providers had been using for more than 10 years."
The company rolled out a website, shingrixhcp.com, to help healthcare providers learn about the product. After seeing early reports of errors, GSK increased its efforts to include campaigns with the Immunization Action Coalition, the National Foundation for Infectious Diseases and the American College of Physicians, he added.
GSK won approval for Shingrix in October and picked up a preferential recommendation over Zostavax from CDC advisers days later. So far, the vaccine has excelled commercially, with sales climbing to $150 million in its first full quarter on the market. For the full year, Glaxo executives said they expect Shingrix revenues to remain steady, implying expectations of $600 million.
But the vaccine's strong sales performance has come at the expense of Merck's older shingles vaccine, Zostavax. After Shingrix's launch last year, Merck's Zostavax sales slipped 45% in the fourth quarter. Sales for the Merck vaccine were down 58% in the first quarter.