GSK's rotavirus vaccine temporarily runs short, and 'manufacturing challenges' are to blame

Reported pandemic staffing shortfalls within GSK’s manufacturing network have scuttled supplies of a crucial childhood vaccine in four African countries. 

Stocks of the British drugmaker’s rotavirus shot, Rotarix, have run out or are running low in Kenya, Tanzania, Senegal and Cameroon, Reuters reported Wednesday.

“GSK communicated to Gavi earlier this year on manufacturing challenges leading to an unplanned, short-term drop in Rotarix production for 2022, for which priority mitigation plans are fully in place,” a GSK spokesperson said over email.

The company did not elaborate on the nature of its production challenges, though a source close to talks between GSK and Gavi told Reuters the delays were fueled by staff absences during the COVID-19 pandemic.

The shortage covers about 4 million Rotarix doses, portending a total drop in supply to 42 million doses from a planned 46 million, the GSK spokesperson added.

Further, Gavi told Reuters that GSK had already cut deliveries by 10 million doses for the 2022-2028 period.

“Since 2010, GSK has supplied Gavi with more than 945 million vaccine doses and more than 89 million doses in 2021 alone,” the company told Fierce Pharma. GSK estimates Rotarix last year reached some 24 million children across 32 Gavi-eligible countries and four “former Gavi countries.”

Worldwide, rotaviruses are the top cause of severe, dehydrating diarrhea in children under the age of 5, according to the World Health Organization (WHO). The viruses are estimated to cause more than 2 million hospitalizations each year, the WHO said. In 2004, rotavirus infections were estimated to be the culprit behind approximately 527,000 deaths, primarily in developing countries, the organization added.

Aside from GSK’s shot, Gavi has warned of delays with Bharat Biotech’s rotavirus vaccine, Rotavac, thanks to “regulatory procedures,” Reuters wrote. 

Meanwhile, UNICEF, which has been sounding the alarm about a drop in childhood vaccinations, is working with Gavi to switch in rotavirus vaccines from other drugmakers or from countries with doses to spare, Reuters said.

Last month, the U.N. agency unveiled data showing 23 million kids missed out on vaccines in 2020, which was 3.7 million more than in 2019.

“Even before the pandemic, there were worrying signs that we were beginning to lose ground in the fight to immunize children against preventable child illness including with the widespread measles outbreaks two years ago,” UNICEF Executive Director Henrietta Fore said at the time. “The pandemic has made a bad situation worse,” she added.

GSK, like many vaccine makers, knows all too well about the blow the COVID-19 pandemic has dealt to routine immunizations. In fact, GSK recently teamed up with IQVIA to develop a platform to keep tabs on shot uptake in the U.S. after witnessing vaccination rates plunge in the pandemic’s first year.

Dubbed Vaccine Track, the platform has been set up for use by public health officials, industry leaders and medical professionals to “strengthen vaccination data transparency, raise awareness and publicly share vaccination trends to aid improvements in routine adult vaccinations to create healthier communities across the U.S.,” GSK said in a release.

Alongside its rotavirus shot Rotarix, GSK also makes vaccines for hepatitis A and B, influenza, shingles, measles, mumps and rubella, to name a few—plus, it’s working on COVID-19 vaccines.