President Trump signs off on PAHPA reauthorization

President Trump yesterday signed bipartisan legislation reauthorizing the Pandemic and All-Hazards Preparedness and Advancing Innovations Act (PAHPA), which plays a crucial role in preparing the country for natural or manmade biological threats such as pandemic flu or a bioterror attack.

Funding for most programs expired in September 2018, and bills reauthorizing the law passed in the Senate on May 16 and in the House of Representatives on Jun 4. The law was first signed in 2006 by President George W. Bush and was reauthorized for the first time in 2013.

The final passage reauthorizes and improves funding for critical programs including the Biomedical Advances Research and Development Authority (BARDA) and the Strategic National Stockpile with $1.2 billion annually over the next 5 years, along with $710 million annually for 10 years for the Project BioShield Special Reserve Fund, Bavarian Nordic, a federal countermeasure partner, said today in a news release. Paul Chaplin, the company's president and chief executive officer, said the 10-year authorization for Project BioShield "is unprecedented and helps to create a more sustainable framework for companies like ours to develop much needed countermeasures."

In a press release yesterday, the Alliance for Biosecurity, a biosecurity industry group, underscored the importance of the bill. Chris Frech, the group's cochair, said, "PAHPA enables long-term public-private partnerships, which are essential in safeguarding public health and building resilience against chemical and biological threats and emerging infectious diseases. Because of PAHPA, the biodefense industry is better positioned to support the United States’ robust national security strategy."
Jun 25 Bavarian Nordic press release
Jun 24 Alliance for Biosecurity press release
Jun 5 CIDRAP News story "Pandemic preparedness renewal sent to Trump's desk"


Poll finds doubts about vaccine safety amid high support for immunization

An online survey of US adults done by The Harris Poll for the American Osteopathic Association (AOA) found that 45% have doubted vaccine safety. In a press release, the AOA said the reported sources of doubt were online articles (16%), past secrets or wrongdoing by the pharmaceutical industry (16%), and information from medical experts (12%).

When asked to choose a statement that reflects their views on vaccine safety and efficacy, however, the vast majority (82%) favored vaccines, with 8% expressing serious doubts. Another 9% said they were unsure.

Members of the AOA said even small margins of people who doubt can cause significant damage if the doubts result in more unvaccinated people. Paul Ehrmann, DO, a family physician, said, "Some diseases, like measles, require as much as 95% of the population to be vaccinated in order to achieve herd immunity."

Rachel Shmuts, DO, a perinatal psychiatrist, said humans are primed to focus on threats or negative information, so people often hold onto fears that vaccines are harmful, especially when they believe their children are in danger. She added that because vaccines have been so effective, many people fear possible vaccine side effects more than the diseases they prevent.

Though social media has fueled misinformation about vaccines, it hasn't been useful for countering the claims. "The number of people who believe vaccines are dangerous and refuse to get them is still relatively small," she said. "However, online support groups seem to solidify their beliefs, making them less susceptible to influence from their neighbors and real-world communities."

The Harris Poll conducted the online survey from May 28 to May 30 among 2,007 adults. It is not based on a probability sample, so sampling errors couldn't be calculated.
Jun 24 AOA press release

Stewardship / Resistance Scan for Jun 25, 2019

News brief

High-level azithromycin-resistant gonorrhea increases in Taiwan

A study yesterday in Antimicrobial Agents and Chemotherapy details the emergence of gonorrhea strains with high-level resistance to azithromycin in Taiwan.

In an evaluation of 598 Neisseria gonorrhoeae isolates obtained from patients in Taiwan from 2001 to 2018, researchers found that 8.7% (52 of 598 isolates) were resistant to azithromycin and 1.7% (10/598) exhibited high-level resistance. All of the isolates with high-level azithromycin resistance had non-mosaic penA alleles and the same molecular resistance determinants, including four mutated 23S rRNA copies with A2059G mutation, -35A deletion in the promoter region of the mtrR gene, and G45D mutation in the mtrR coding region.

An analysis of the genetic relatedness of the 52 isolates found 24 different multilocus sequence typing (MLST) types, with ST1901, ST1583, ST7371, and ST11196 being the most prevalent among the azithromycin-resistant isolates. Among the 10 isolates with high-level azithromycin resistance, nine were identified as MLST12039 and one belonged to MLST10899. The results of genotyping and pulsed-field gel electrophoresis suggest the clonal spread of high-level azithromycin-resistant isolates in Taiwan and the circulation of a certain strain through sexual networks, instead of de novo development.

Among the 10 patients infected with high-level azithromycin-resistant N gonorrhoeae, 9 were diagnosed in 2017-18, and 1 was infected in 2013. Geographical spread was throughout Taiwan, and no sexual contact was reported between any of the patients.

The researchers say these findings suggest that Taiwan should consider following the guidance of the British Association for Sexual Health and HIV and recommend a single dose of ceftriaxone intramuscularly as the first choice for treatment of N gonorrhoeae infections, rather than the widely recommended dual therapy of ceftriaxone and azithromycin.
Jun 24 Antimicrob Agents Chemother abstract


European regulators to review new pneumonia antibiotic

Drug maker Nabriva Therapeutics of Dublin announced yesterday that the European Medicines Agency (EMA) has determined that the marketing authorization application (MAA) for the oral and intravenous (IV) formulations of lefamulin is valid.

The validation means that the EMA Committee for Medicinal Products for Human Use will now begin the formal review process for lefamulin, a semi-synthetic pleuromutilin antibiotic for treating community-acquired pneumonia (CAP) in adults. If approved, the drug would receive marketing authorization in all 28 European Union member states, as well as in Iceland, Norway, and Lichtenstein. An opinion is expected within the next 12 to 15 months.

"We are grateful for the EMA's quick validation of our MAA submission and look forward to working with the EMA during the MAA review process.  We are committed to providing European patients with CAP the potential option of short course treatment with IV or oral lefamulin," Nabriva Chief Medical Officer Jennifer Schranz, MD, said in a company press release.

Two phase 3 clinical trials demonstrated that lefamulin was non-inferior to moxifloxacin for the treatment of adults with CAP, and was well-tolerated, the company said.

Nabriva also has New Drug Applications (NDAs) for oral and IV lefamulin currently under review by the US Food and Drug Administration (FDA). The FDA is expected to complete its fast-tracked review by Aug 19. 
Jun 24 Nabriva Therapeutics press release
Feb 21 CIDRAP News scan on lefamulin NDA approval


UK announces new AMR funding

The British government is awarding £32 million ($40.6 million US) to 10 UK research centers working to combat antimicrobial resistance (AMR), according to a UK Department of Health and Social Care (DHSC) news release.

Among the institutions receiving the funding is Imperial College London, which will receive £4 million ($5.1 million) for the Centre for Antimicrobial Optimisation. The center aims to develop new technologies and innovative approaches to improve the use of antibiotics. Public Health England will receive £5 million ($6.4 million) to develop a model hospital ward to study how hospitals can be designed to improve infection control and reduce transmission of drug-resistant infections.

The funding is part of the British government's 20-year-vision and 5-year national action plan on AMR.

The government also announced that Dame Sally Davies, the UK's outgoing chief medical officer, will become a special UK envoy on AMR.

"The UK should be proud of its world-leading work on AMR," Davies said in the DHSC press release. "We have made tangible progress but it is essential we maintain momentum. I am honoured to have been asked to continue this vital work on behalf of the UK government."
Jun 23 DHSC press release
Jun 24 Imperial College London press release

This week's top reads