Two new MERS cases reported in Saudi Arabia

Today Saudi Arabia's Ministry of Health (MOH) reported two new MERS-CoV cases, both in Wadi Al Dawasir, a town in south-central Saudi Arabia.

In an update to its epidemiologic week 5 report, the MOH said the patients were a 44-year-old man and a 62-year-old women, both hospitalized for their MERS-CoV (Middle East respiratory syndrome coronavirus) infections.

Their cases were designated as secondary, community acquired. Neither patient had camel contact.

In the World Health Organization's most recent MERS-CoV update, it said that, as of Dec 31, it had received reports of 2,279 MERS-CoV cases since 2012, at least 806 of them fatal. The Saudi MOH has reported 14 MERS cases this month.

Jan 31 MOH report

Study notes 90% flu vaccine protection against hospitalization in HK kids

An early-season estimate of flu vaccine effectiveness (VE) against hospitalization for influenza in children in Hong Kong has found 90% VE, according to a report today in Eurosurveillance.

Researchers enrolled 2,016 children 6 months to 17 years old from three public hospitals from Sep 2, 2018, through Jan 11, 2019, 180 of whom (8.9%) had been immunized. The investigators used a test-negative design for the study.

Of the children studied, 344 (17.1%) tested positive for influenza A or B. Among those, 85% (292/344) were positive for 2009 H1N1 and 13% (45/344) for the H3N2 strain. Among the 180 vaccinated children, 160 (89%) received the quadrivalent (four-strain) flu vaccine.

Ten of 344 children (2.9%) who tested positive for influenza had been vaccinated, compared with 170 of 1,672 (10.2%) who had not received the vaccine. That amounts to a flu VE of 90% (95% confidence interval, 80% to 95%).

The authors conclude, "Our findings were consistent with previous estimates against influenza A(H1N1)pdm09 in children in Hong Kong from 2012/13 to 2016/17."

Jan 31 Eurosurveill study

Merck gets FDA breakthrough tag for 15-valent pneumococcal vaccine

Merck yesterday announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for V114, its investigational 15-valent (15-strain) pneumococcal conjugate vaccine.

The step helps speed the development and review of drugs for serious or life-threatening conditions for products that have been shown in early clinical trials to provide substantial improvement over currently available therapies.

In a press release, Merck said the designation applies to the prevention of invasive pneumococcal disease in children ages 6 weeks to 18 years. It added that the vaccine is also being developed for preventing the disease in adults and that both indications are currently under evaluation in phase 3 clinical trials.

The FDA based its breakthrough therapy decision partly on immunogenicity data from two studies, one a phase 1 / 2 study to evaluate safety, tolerability, and immunogenicity of four different lots of a new formulation of V114 in healthy adults and infants and another to confirm the first study in a larger population of infants. For both, the vaccine prompted an immune response in infants for two disease serotypes (22F and 33F) not included in the current 13-valent vaccines and showed a similar protection against the serotypes contained in the current vaccine.

Jan 30 Merck press release

Positive phase 1 Lyme vaccine data noted, including booster-dose benefits

Valneva, a biotechnology company based in France, today reported promising early findings for a booster dose regimen and final phase 1 data for its experimental Lyme disease vaccine, VLA15, the only one of its kind in clinical development.

In 2018 the company amended its phase 1 study protocol to add a booster dose to a subgroup, and during the same time it completed follow-up of all people who received all doses, providing the final phase 1 data.

In a press release, Valneva, based in France, said the trial confirmed the safety and tolerability it saw in the interim results for VLA15, a multivalent protein subunit vaccine that targets the outer surface protein A (OspA) of the Lyme disease bacterium, Borrelia burgdorferi. Final findings showed the alum-adjuvanted formulation elicited higher immune responses. As expected, antibody titers dropped after day 84 in all groups, reaching baseline at about 1 year after initial vaccination.

To gauge the benefit of a booster dose, 64 participants in the two higher-dose groups received a booster dose 12 to 15 months after the first dose, which the company said resulted in a significant immune response with antibody titers 2.7- to 5.8-fold higher than the titers at day 84, which it says is consistent with other Lyme vaccines in development that target OspA.

Last month, Valneva announced that the vaccine had entered a phase 2 trial at study sites in the United States and Europe.

Jan 31 Valneva press release

Dec 18, 2018, CIDRAP News scan on phase 2 announcement