China ‘Conditionally Approves’ Shingles Vaccine Shingrix
China’s National Medical Product Administration (NMPA) announced the ‘conditional approval’ for GSK’s recombinant herpes zoster vaccine, Shingrix.
This announcement is great news for GSK and for the nearly 3 million Chinese adults who are affected by the herpes zoster virus each year.
But, can GSK meet this new consumer demand in China?
Since Shingrix was launched in 2017, it has experienced very strong consumer demand in the USA.
GSK’s Chief Executive Officer Emma Walmsley told wall street analysts on May 1, 2019, “Shingrix has delivered another fantastic performance in the quarter.”
Moreover, the consumer demand for Shingrix has accelerated by very positive research results.
On February 19, 2019, a study reported 2-doses of Shingrix delivered higher cost-effectiveness and herpes zoster protection when compared with the live zoster vaccine Zostavax, or no vaccination.
But, all of this good news has led to US pharmacies to establish extensively long Shingrix vaccine wait-lists.
To address this supply-demand inventory imbalance, GSK announced in April 2019 ‘it would invest $100 million to expand its Montana facility, which will increase adjuvant production, that could help increase the supply for Shingrix in 2020.
Additionally, in the NMPA announcement on May 22, 2019, China’s Food and Drug Administration (FDA) said Shingrix ‘lacks comprehensive domestic epidemiological data, and whether the use of new adjuvants may lead to the risk of potential immune-mediated diseases.’
Shingrix uses DNA recombination technology to express varicella-zoster virus glycoprotein E in Chinese hamster ovary cells. It is prepared by culture, harvesting, purification, and lyophilization.
And the adjuvant used in Shingrix is an extract from the soapbark tree native to Chile, which has been associated with cases of hypersensitive immune system disorders.
On May 17, 2019, GSK received approval from the FDA to add that information to its USA label.
Therefore, China is requiring GSK ‘continue to do a comprehensive post-marketing study, timely conduct drug warnings, update clinical safety and efficacy data at home and abroad, and improve the instructions to fully ensure that patients are safe, effective, and risk-controlled.’
In summary, vaccines are like any medicine, which means they can generate side effects, says the Centers for Disease Control and Prevention (CDC)
According to the CDC, there are an estimated 1 million new cases of shingles each year in the USA. Anyone who has recovered from chickenpox may develop shingles.
While USA consumers and pharmacies wait for GSK to resolve their inventory situation, the CDC prepared several FAQs related to Shingrix.
You are encouraged to report negative side effects of vaccines to the FDA or CDC.