All News
WHO, US press Russia for more info about lab worker’s death
News briefToday at 4:23 p.m.
Stephanie Soucheray, MA
Topics
Plague
The World Health Organization (WHO) and the United States Department of State both formally requested more information from Russia about last week’s death of a lab worker at the Irkutsk Research Anti-Plague Institute in Siberia.
“The State Department’s Level 4 Travel Advisory (Do Not Travel) for Russia remains in place and states U.S. citizens currently in Russia should depart immediately,” the State Department said yesterday.
The WHO and the State Department made their requests as various Russian media outlets reported a second death today. That death has not been verified or recognized by the Kremlin.
Russia says no emergency occurred
While media outlets around the world have reported the woman fell ill with severe pneumonic after a lab incident involving plague samples, the Kremlin said today those reports were lies.WHO Director-General Tedros Adhanom Ghebreyesus, PhD, said in a statement yesterday, “Timely, complete and transparent information sharing under the International Health Regulations is essential to clarify conflicting reports and enable an accurate assessment of potential public health risks.”
Kremlin officials said they have already shared all that is known about the initial case, and Rospotrebnadzor, Russia's public health agency, said it saw “no epidemic risk” in the woman’s death. Today Rospotrebnadzor also said the woman had been vaccinated against all the pathogens she worked with, and no “emergency situations” had occurred at the lab last week.
“The media are reporting a great deal right now, and the overwhelming majority of what the media are reporting around this situation is false information," Kremlin spokesman Dmitry Peskov said.
Vaxcyte’s 31-strain pneumococcal conjugate vaccine passes phase 3 test
News briefToday at 3:10 p.m.
Chris Dall, MA
Topics
Pneumonia
Adult (non-flu) Vaccines
Vaccine maker Vaxcyte this week announced positive topline results from a phase 3 trial of its investigational 31-valent (31-strain) pneumococcal conjugate vaccine (PCV) candidate, VAX-31.
VAX-31 was designed to prevent serious and sometimes fatal infections caused by Streptococcus pneumoniae, including invasive pneumococcal disease IPD and pneumococcal pneumonia. The 31 serotypes covered by the vaccine account for approximately 95% of IPD and 88% of pneumococcal pneumonia cases circulating in adults age 50 and older.
PCVs are recommended by the Centers for Disease Control and Prevention for adults aged 50 and older who have not previously received one, children under 5 years, and older children and adults with certain risk conditions. The four PCVs approved in the United States are PCV15, PCV20, PCV21, and the pneumococcal polysaccharide vaccine (PPSV23).
The OPUS-1 trial evaluated the safety, tolerability, and immunogenicity of a high dose of VAX-31 in 3,572 adults aged 50 and older and a lower dose in 475 adults aged 18 to 49 years. Participants aged 50 and older were randomized 1:1:1 to receive VAX-31 or PCV20 or PCV21, while younger participants were randomized 3:1 to receive a single dose of VAX-31 or PCV20.
Comparable immune response, safety profile
Vaxcyte said VAX-31 was well tolerated and demonstrated a similar safety profile to PCV20 and PCV21 in all age-groups, with generally mild-to-moderate local and systemic reactions and no serious adverse events.In adults 50 and older, VAX-31 showed a comparable immune response across all 28 serotypes shared with PCV20 and PCV21 and met prespecified noninferiority criteria for immunogenicity; the three serotypes unique to VAX-31 met the superiority criterion. In adults aged 18 to 49, VAX-31 elicited an immune response similar to older adults.
“These OPUS-1 results strengthen our confidence in VAX-31’s potential to provide broader protection against invasive pneumococcal disease and pneumococcal pneumonia,” James Wassil, MS, MBA, Vaxcyte’s chief scientific officer and chief operating officer, said in a company press release.
Vacxyte said the results will be the “cornerstone” of a biologics license application to the US Food and Drug Administration, along with results from two other trials, OPUS-2 and OPUS-3, which are expected next year.
ALL BRIEFS