A panel of experts, whose work guides the policy on vaccination in the US, has just voted to recommend the new vaccine for shingles, Shingrix, produced by GlaxoSmithKline (GSK), over the competitor, Zostavax, which is created by Merck. Members of the Advisory Committee on Immunization Practices voted 8 to 7 to recommend the new vaccine by GSK over Zostavax. An earlier vote to recommend the vaccine passed unanimously. The FDA approved the vaccine for use this October.
Shingrix is approved for use in patients age 50 or older who have competent immune systems. Its use in patients with compromised immune systems is still being explored, as the data on its use in this patient group is still being reviewed.
Shingrix Recommended as Good News For Patients
Dr. Leonard Friedland, who acts as vice president for scientific affairs and public health for GSK’s North American vaccines unit said the recommendation was great news for patients. GSK is said to be preparing the vaccine for release in the US by the end of November. It will take time, however, before insurance reimbursements can be fully worked out for the drug.
Impact on Merck’s Sales Seen
The recommendation of Shingrix over Zostavax may have a major impact on Merck. Analysts think Shingrix could see huge sales, leading up to $1 billion a year by 2022. Dosing of the two drugs is different, as Shingrix is prescribed in two doses which total $280. Zostavax is administered in just one dose, at a cost of $223 per patient.
Furthermore, Merck is facing large-scale lawsuits over the side effects of Zostavax. This vaccine contains a live virus and, as a result, has brought on the shingles virus and other singles-related conditions in thousands of recipients. Thus it has unnecessarily brought on the very illness it claims to prevent.
However, the executive director for adult vaccines at Merck, Dr. Eddy Bresnitz, was dismayed by the preferential treatment given to Shingrix, and he laid out an argument against the vote, especially given its closeness. Another issue was the fact that the new drug has only been used in a clinical trial setting. There is also concern about whether GSK can keep up with demand for the new vaccine. Another issue is the fact that the GSK vaccine contains an immune-system boosting element.
Supporting a Stronger Vaccine
Doctors with knowledge of the two vaccines, however, supported the vote, noting that medical professionals are looking to the ACIP for their recommendations on new medications. The vote was based on data that strongly suggested the two vaccines were not equal in their effectiveness.
According to the studies, Shingrix is shown to bring on a stronger impact on the immune system, even among older patients, age 70 or more. This population is at the greatest risk for shingles and its serious side effects.
Shingrix offers protection at 98 percent in the first year of use. After that, protection stayed at 85 percent or more, three years on. Zostavax, by comparison, does offer protection in the first two years, but then its effectiveness lowers significantly. This leaves patients using the vaccine vulnerable to the illness as well as postherpetic neuralgia.
In the coming months, as Shingrix enters the market, its true effectiveness and impact on the market will be seen. The hope is that this new drug will offer long-lasting protection the the vulnerable older population that needs help in warding off this serious and painful illness.
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