News Scan for Apr 16, 2019

Needle-free flu vaccine boost
Promise for chikungunya vaccine
Global flu mostly dropping

Ensesi and BARDA partner on needle-free flu vaccines

Enesi Pharma, a biotechnology company based in the United Kingdom, announced yesterday that it has partnered with the US Department of Health and Human Services Biomedical Advanced Research and Development Authority (BARDA) to develop new flu vaccines using its ImplaVax technology.

ImplaVax is a novel formulation and needle-free device that allows solid-dose vaccine to be delivered quickly under the skin. The goal is for health providers or even patients to administer vaccine disease using the simple reusable needle-free device. The company said the system has the potential to boost immune responses to vaccination and cut storage and distribution costs.

The project is part of BARDA's DRIVe (Division of Research, Innovation) initiative, which seeks and funds bold innovative solutions to transform health security, with an eye toward improving vaccine update, coverage, compliance, and preparedness. It will involve evaluating solid-dose formulations of marketed flu vaccines, along with in vitro tests to confirm titer generation, mechanical strength, and surety of implantation.

In vivo tests will compare efficacy and dosing regimens, including a comparison of solid-dose implants with placebo and vaccine administered by syringe.
Apr 15 Enesi Pharma press release


Phase 2 results promising for VLP chikungunya vaccine

Emergent BioSolutions today announced promising initial results for a phase 2 clinical study of its experimental chikungunya vaccine, a virus-like particle (VLP) product called CHIKV-VLP.

For the study, researchers evaluated safety and immunogenicity across a range of dosing regimens, the company said in a press release. Results suggest that, after a single dose, 98% of study participants had an antibody response by day 7. Also, the immune response persisted through study participants' 6-month visit, including those who got the one-dose regimen.

The dose-finding part of the study included 415 healthy adults at three US study sites. Subjects got a one- or two-dose series with or without an adjuvant over a 4-week period. Seroconversion occurred in 74% to 98% of subjects within 7 days of one dose and in all of them 28 days after the last dose. No significant safety problems were identified, suggesting that the vaccine was well tolerated.

Emergent said studies have shown VLP vaccines typically prompt higher neutralizing antibody titers needed to protect against chikungunya virus, which spreads to people from mosquitoes and causes symptoms such as joint pain, headache, muscle pain, joint swelling, and rash. Emergent licensed the vaccine from the National Institute of Allergy and Infectious Diseases at the National Institutes of Health. The Food and Drug Administration granted it fast-track designation in May 2018.

Abbey Jenkins, the company's senior vice president and head of its anti-infectives business unit, said, "Chikungunya virus infection represents a significant unmet medical need—having no vaccine or treatment available—despite its emergence as a global threat because of the highly debilitating nature of the associated disease and unprecedented magnitude of its spread."
Apr 16 Emergent BioSolutions press release


Northern Hemisphere flu drops, but a 2nd wave for some Asian locations

Flu activity continues to decline as the Northern Hemisphere pushes late into its flu season, though activity is still elevated in some countries, with a second wave of flu reported in some eastern Asia locations, the World Health Organization (WHO) said yesterday in its latest global flu update. The report includes data reported to Mar 31.

In Europe where both influenza A strains circulating with H3N2 a little more common, Bosnia, Herzegovina, Luxembourg, and Slovakia reported medium intensity activity. Flu levels are still above baseline in Estonia, Norway, and Moldavia.

Flu levels were low in central Asia and North Africa. For most of western Asia and the Middle East, virus activity is declining in most countries, except for Saudi Arabia, which reported a slight increase. Meanwhile, flu activity continues in East Asia but is decreasing, with influenza B as the dominant strain, which is typical for the latter part of the Northern Hemisphere season. Northern China has reported a second wave of flulike illness in recent weeks, as has South Korea.

Globally, of respiratory specimens tested the last half of March, 82% were influenza A and 17.8% were influenza B. Of subtyped influenza A strains, 40.6% were the 2009 H1N1 strain and 59.4% were H3N2.
Apr 15 WHO global flu update

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