The Zika virus attracted many headlines this winter, but a recent admission by the chief medical officer at a leading vaccine manufacturer -- that the world is ill-prepared to deal with pandemic outbreaks -- underscores a fundamental problem. To ensure safety and efficacy, the federal government's regulatory approval process for new vaccines may extend development timelines for years.
So when The New York Times reports that "eighteen organizations are working on developing a vaccine for the Zika virus," it is likely that those companies will labor for a very long time.
Vaccinations rightly require strict federal approval processes to ensure the safety and the efficacy of a new vaccination. But when pandemic viruses like Zika spread quickly and unexpectedly, the world realizes there is little that can practically and immediately be done other than to implement strict infection control measures up to and including quarantines. This has been true for prior pandemics such as the swine flu, avian flu, SARS and Ebola.
That reality speaks to the need for a new approach to pandemic viruses, including influenza.
The good news with Zika is that it is a fairly stable virus, unlike other frequently mutating viruses such as the influenza virus. During the Zika epidemic in Brazil, reported microcephaly cases rocketed to 2,700 in 2015 and at least 40 babies died. By comparison, there were only 147 reported microcephaly cases in Brazil altogether in 2014. In 60 to 80 percent of cases, Zika is asymptomatic and when symptoms do appear, they tend to be mild, such as joint pain, rash, and/or fever. All of this helps to explain why it hasn't been studied much even though it was first identified nearly 70 years ago. Based on our current knowledge, outside of a lengthy approval process we don't expect a major scientific challenge in developing a Zika vaccine.
Indeed, thanks to herd immunity, acute infections caused by relatively stable viruses often quickly disappear. By the time there's a vaccine for Zika, the U.S. population may well be largely immune to Zika.
But what can be done to improve the hurry-up-and-wait reality of vaccination approval when it comes to more dangerous pandemics? For example, the flu kills up to 500,000 people each year, making it exponentially more damaging than Zika.
For starters, more education is needed about the ineffectiveness of seasonal flu vaccinations. Last year's vaccine effectiveness was only 23 percent and as low as 9 percent in people over 65 years old. Flu vaccines are largely inadequate because the flu virus is constantly mutating, resulting in a flawed attempt to guess which vaccine will work best in any given flu season. While this current "estimation" approach is the best presently available, there is clearly much room to improve.
The situation is even more complex for pandemic flu outbreaks as we never know when, where, and what pandemic flu strain will hit. All we know is that it happens every few years, involving a flu strain new to mankind and therefore potentially much more dangerous than the seasonal flu strains. In addition, approved flu and pandemic vaccine manufacturing processes are more than 70 years old. These processes require four to six months of lead time, primarily because they are produced in poultry eggs. Modernization of the production cycle clearly can help.
More support and resources should be dedicated to potential vaccines that target all flu strains -- seasonal, pandemic and future. Is this a fantasy? Scientists across the world, including those at my company, are hard at work on game-changing 'universal' flu vaccines, including those that act against a denominator common to every influenza strain.
It is clear that the existing "educated guess" approach to flu vaccinations is inefficient and largely ineffective against viruses that frequently and unpredictably mutate. Some next generation universal flu vaccines, currently under development, aim to encourage the body to use its own immune system against conserved elements of seasonal or pandemic flu viruses, leading to broad and long-lasting protection. On a societal level, with enough people taking such universal flu vaccines, ultimately we can even hope to eradicate the flu.
Ron Babecoff is the CEO of BiondVax (www.biondvax.com), a publicly traded biopharma (NASDAQ: BVXV). BiondVax is one of several life science companies researching new therapies to provide a 'universal' vaccine with the potential to protect against pandemic and seasonal flu.