Prolonged delay in GSK vaccine supply may cost ₩30 bil

a ₩30 billion loss may be inevitable for the company

Supply suspended for 9 types of vaccines including Rotarix due to misdocumentation… cross-inoculation is being recommended

May cause a 6-month long gap at maximum… ‘domino effect’ may be caused if demand focuses on alternatives and cause disruption in their supply as well

The discontinuation in the supply of many GSK vaccines is causing greater ripples.

 

With the rising possibility that the situation may be prolonged, concerns continue over the sales gap, and procurement of substitutes is rising.

 

GSK had announced the supply setbacks of 9 of its vaccines to primary clinics and hospitals on the 25th.

 

The vaccines that were discontinued include: ▲Rotarix (rotavirus vaccine), ▲Cervarix (cervical cancer vaccine), ▲Synflorix (Pneumococcal conjugate vaccine), ▲Manveo (meningococcal conjugate vaccine), ▲Havrix (Hepatitis A vaccine), ▲Priorix (MMR vaccine), ▲Boostrix (Tdap vaccine), ▲Infanrix-IPV, IPV/Hib (DTaP vaccine) The supply of the vaccines was suspended due to errors found in the Common Technical Document while reviewing registration logs.

 

Since the errors are documentation-related and unrelated to quality, GSK had said it will resume shipment after submitting supplementary documents.

 

The problem lies in the possibility of the prolonged GSK supply gap.

 

In the field, it is said that the delay may last up to 6 months at most considering the time necessary to prepare the supplementary documents and the MFDS review period.

 

GSK’s revenue gap from the suspended products also seems inevitable.

 

Annual sales of its main product, Rotarix, was ₩11.7 billion.

 

In addition, Havrix sold ₩6.8 billion, Manveo ₩4.6 billion, Synfloris ₩4.1 billion, Cervarix ₩3.3 billion, and the annual sales of all 9 vaccines grossed to approximately ₩30 billion Also, many of the vaccines that were suspended supply belong to the National Immunization Program and may interfere with essential immunizations for infants and young children.

 

To address this concern, the Korea Disease Control and Prevention Agency advised cross-vaccination with vaccines from other manufacturers.

 

In general, cross-inoculation of vaccines that require multiple doses is not recommended, however, due to the delay that may occur for those who already received their first dose with GSK products, the cross-inoculation was approved as an exception.

 

The situation is better for the DTaP vaccine Infanrix-IPV and IPV/Hib, and they can be substituted with Sanofi’s ‘Pnetaxim,’ ‘Tetraxim,’ Boryung’s ‘Boryung DTaP, IPV.’ However, other vaccines have only one option each as a substitute.

 

The pneumococcal conjugate vaccine Synflorix can be substituted with Pfizer’s ‘Prevenar 13,’ cervical cancer vaccine Cervarix with MSD’s ‘Gardasil.’ The rotavirus vaccine Rotarix can be substituted with MSD’s ‘RotaTeq.’ The concern is that since most are imported products, procurement of the substitutes may be difficult.

 

On this, GSK said, “We are unclear on how long the process will take, but the company will make the most effort to close the gap as soon as possible.” Also, MSD, which owns RotaTeq and Garadsil said, “We are closely monitoring the situation, and will do our best to prevent any disruptions arising in the domestic vaccine supply.

 

Also, we will work closely with the government if necessary.”