Review of Zika Virus Vaccine Market Place

The zika virus (ZIKV) is an enveloped, positive-sense single-stranded RNA virus first found in the Zika forest in Uganda in 1947. Before 2007 ZIKV was considered to be a mild illness with rash, headache and cold like symptoms with few infections reported globally. The first outbreak occurred in 2007 in Micronesia, followed by an outbreak in 2013 in French Polynesia and then in 2015 in South America.

This series of and magnitude of the outbreaks, coupled with a sudden on-set rise of congenital defects of microcephaly and Guillian-Barre syndrome caused the WHO to declare ZIKV, and its suspected link to birth defects, a Public Health Emergency of International Concern in February of 2016.

While the emergency was brief and declared over by the WHO in November 2016 this declaration spurred the research, development, and pursuit of vaccines targeted for the prevention of ZIKV and antiviral remedy.

To adequately combat the risk of fetus and infants the creation of a childhood vaccine to prevent pregnancy complications from ZKV later in life would be the goal. The creation of a life-long immunity from one shot would require a live attenuated virus. While this would suit the immunization of children it does little for the current issue, of protecting women of child bearing age. Live-virus vaccines have side effects that can harm the fetus. Prior to the outbreak in 2015 research and development for prevention and treatment of ZIKV was limited.

Since 2015 research has increased significantly and worked through the testing and regulation process for development of affective vaccines and treatment. However, none of the current developments are market ready and available. In addition, it may prove to be difficult to achieve phase III trial success because of the current declining rates of ZIKV. It is of concern that another outbreak similar to the 2015 outbreak could occur and without a vaccine in place for prevention it would again be difficult to manage the containment of the neonatal ramifications.

The design of a vaccine against ZIKV would be beneficial for those with high exposure to ZIKV. The virus is spread through mosquitos or as a sexually transmitted virus. This would indicate that both males and females need to be vaccinated in order to prevent congenital effects of their offspring. The implication of the childhood vaccine would be best prescribed by a doctor routinely seeing the child and administering all other childhood routine vaccines. However, if the vaccine development is limited to short-term protection the vaccine administration would look more similar to the United States flu vaccine, administered seasonally, typically in both doctor's offices and certified pharmacies.

Current practices by insurance providers indicates that they would cover the cost of the immunization of preventive care in the United States. Globally insurance provision differs. However, it is assumed that because of the nature of the epidemic the widespread of the vaccine would be advantageous for the country of ZIKV infection and would therefore be willing to consider unique subsidy and payment method for the use of the vaccine on a majority of those willing to be vaccinated.

The impact of ZIKV is significant in the global regions where it is prevalent. ZIKV has a significant impact to fetus for pregnant women. ZIKV creates an annoyance for those not pregnant or not planning on becoming pregnant. The disease is life altering for infants and young children. ZIKV is able to be sexually transmitted. ZIKV has been found in Africa, Asia, The Caribbean, Central America, North America, The Pacific Islands, and South America. ZIKV has higher impact is specific regionals of the above listed areas, but has been identified wide spread throughout.

With such a global reach, vaccination would be necessary for those interested in traveling to the impacted areas. The Center for Disease Control was quoted as to the regional location of ZKV "Zika virus infection remains a significant threat to pregnant women and their developing fetuses, and we can expect to see periodic outbreaks and cases in areas whereAedes aegyptimosquitoes thrive." Depending on the development of the vaccine it would be recommended that the vaccine be incorporated into routine vaccine regimen (i.e. rubella) or annually for short term protection (i.e. flu shot).

Many of the vaccines being researched and developed are inactivated-virus vaccines or DNA or RNA based. These vaccines require more than one dose and/or boosters to prolong coverage to the appropriate time for seasonal safety of ZKC. While the current market place does not have the 100% best answer it does provide relief for emergencies.

Based on a review of the stakeholders, scale of the need and current market landscape I believe that the first to market will have the best opportunities to meet the market opportunity. The value of the vaccine is to prevent non-hereditary neonatal effect, that can be prevented. With the current timeline to the market place it is foreseeable that few players will get to the marketplace and at that time, the technology will be owned and patented by the current inventor and therefore rare and hard to imitate. There are two options for the vaccine: complete ZKV prevention or treatment during pregnancy of the woman with ZKV, however the first – prevention is more likely and heavily pursued, this reduces the substitution possibility of new vaccines.

The opportunity is exploitable and the market is ready. The impact of the last outbreak was detrimental to regions of the world and have given them a desire to prevent further outbreaks. It is my recommendation to continue pursuit of vaccine with intention to be first to market. The product would be marketed to both the patient and the clinician with the historic assumption with vaccines that insurance purveyors would consider this a coverable item.

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