The power of local: Can a domestically produced vaccine increase uptake?

September 24, 2018 by Katie Regan

Improving vaccine coverage rates and vaccine acceptability in Serbia are critical issues. Locally made vaccines might be a part of the solution.

Influenza vaccine development technicians at Torlak_Courtesy of Torlak.jpg

The investigators responsible for conducting seasonal influenza vaccine study in Serbia are confident a locally produced vaccine will help increase vaccination coverage rates and foster vaccine acceptability. Photo: Courtesy of Torlak.

National pride abounds in Serbia. Ask anyone, and they’ll give you a list of things that makes the country better than anywhere else: favorite son Nikola Tesla; homemade rakija; tennis star Novak Djokovic; and … locally made vaccines?

Yes, vaccines. While people in other countries may not give a passing thought to the origin of their inoculations, Serbians do—and their pride, and trust, lies with the homegrown variety.

“In Serbia it’s almost traditional to be reserved regarding foreign things,” says Dr. Snezana Ristic, a general practitioner at Belgrade’s Student Health Center and one of the Principal Investigators (PIs) for the Phase 3 clinical study of the Institute of Virology, Vaccines, and Sera "Torlak’s" seasonal inactivated influenza vaccine. “But we put much trust in domestically produced products.”

It is a unique nuance when considering the benefit of locally made vaccines. They aid a country in so many ways—better access, increased affordability—but in Serbia, they may also serve to bolster vaccine acceptability and uptake. Given the extremely low influenza vaccination rate in Serbia (only 2 percent of the population receives an annual influenza vaccine), this added benefit only fuels the argument for domestic production.

Dr. Ristic agrees.

“Now that we have the power to produce an influenza vaccine, it would be a pity not to use it,” she says. “If production were launched (in Serbia) there would certainly be greater coverage.”

“In Serbia it’s almost traditional to be reserved regarding foreign things. But we put much trust in domestically produced products.”
— Dr. Snezana Ristic, Belgrade Student Health Center

Dr. Ristic isn’t just speculating. Her experience working on the Phase 3 clinical study provides plenty of evidence in support of this. The study took place at six different sites in and around Belgrade—including the one she ran, the Student Health Center—with the goal of enrolling 480 volunteers. Despite the number of sites involved, Torlak and its partners worried it would be a challenge to recruit so many volunteers (Serbia has a strong anti-vaccination lobby). As such, Torlak and team designated two additional sites outside of Belgrade to serve as alternates in case the study didn’t make enrollment numbers.

The exact opposite happened. The study received overwhelming interest. The Student Health Center—which only needed to enroll 50 volunteers—had double the interested parties. Dr. Ristic had to turn people away—an experience not isolated to her site.

“We had much skepticism at first, but in the end the study was very popular,” Dr. Ristic says. “We didn’t expect it, particularly at a university. But (the volunteers) began to advertise among themselves, to tell their friends, and before we knew it we were at capacity.”

Much of this is owed to Torlak’s reputation within Serbia.

“I am proud to have been a part of this study. I am proud of what we achieved for Serbia.”
— Dr. Danilo Mitrovic, General Hospital Vrsac

“The citizens of Serbia have so much trust where Torlak is involved,” says Dr. Danilo Mitrovic, an infectious disease specialist at General Hospital Vrsac in Vrsac, Serbia, and a PI for the Phase 3 seasonal influenza trial. “This is no doubt a reason for the level of interest we received. And I believe that will extend long after the study, to when the vaccine is available on the market.”

Torlak itself has data to support this theory.

“We are sure that Torlak’s vaccine will be more accepted than imported vaccine,” says Dr. Svetlana Filipovic-Vignjevic, Assistant Director at Torlak. “We don’t just imagine this but learned it through public opinion poll. Torlak is recognized as a producer with a long tradition and known quality.”

This belief in Torlak is partly what drew Drs. Mitrovic and Ristic to the clinical study in the first place. Neither had participated in a clinical trial in the past (none of the PIs had, in fact) and had to undergo a fair amount of training before they were ready to do so—but it was well worth it, they feel, to have been able to contribute to the country’s health welfare.

“I am proud to have been a part of this study,” says Dr. Mitrovic. “I am proud of what we achieved for Serbia.”

Not to mention the clinical skills they gained. Both doctors praise the experience for the education it provided, and are confident in their ability to oversee vaccine clinical trials in the future should they be called upon to do so.

Now, with Torlak on track to submit its seasonal influenza vaccine for licensure in 2019, they look forward to the day the vaccine becomes available to the general public and Serbians have one more item for their list of Serbian accomplishments. They look forward to the day influenza vaccination rates begin to climb.

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