Biodefense Headlines – 24 August 2021

 In Threats

News highlights on health security threats and countermeasures curated by Global Biodefense

This week’s selections include the debate on COVID-19 booster shots; funding health security investments; and the WHO’s new Scientific Advisory Group for the Origins of Novel Pathogens.

POLICY + INITIATIVES

Calling for a New Multilateral Financing Mechanism for Global Health Security and Pandemic Preparedness

At the 2021 United Nations General Assembly, world leaders should launch a 100-day action plan to establish and resource a new financing mechanism, or Fund, that can mobilize at least US$10 billion annually over the next five years to bolster global health security and pandemic preparedness. History has shown time and again that if action is not taken during a crisis, then political will dissipates once the crisis. Pandemic Action Network

WHO: $7.7 Billion Needed for COVID Variant Detection, Oxygen

As many parts of the world battle the more transmissible Delta (B1617.2) variant, the World Health Organization today said $7.7 billion is needed to track new variants and boost the supply of oxygen.  Low testing levels, especially in low- and middle-income countries, is leaving the world blind to how the virus is evolving, leaving it vulnerable to new variants. CIDRAP

Science and Technology Review Under the BTWC: Constructive Ambiguity

Preparing for possible agreement on an S&T review mechanism at the 9th Biological and Toxin Weapons Convention (BTWC) Review Conference will not follow the CWC Ad Hoc Group experience and should not be influenced by it. Any proposal on the table would not seek to create a subsidiary body in some future organization. Also, there exists absolutely no political consensus on the necessity of such an international body for the BTWC. Today, views on the purpose, functions and organization of a review mechanism appear to converge but political consensus on its necessity is not a given. States parties will therefore need to strike a first-stage external compromise that includes other expectations for future BTWC governance before they can turn to second-stage internal compromises that will settle the S&T review mechanism’s final format and procedures. The Trench

Here We Go Again: U.S. Policy and Health Security

The perennial claim that a harmony of interests exists between low-income and high-income countries on health security was threadbare before COVID-19. The behavior of the United States and other high-income countries during the pandemic has thoroughly shredded that proposition. In a common health security crisis, “no one is safe until everyone is safe” has not been a principle identifiable in the responses of high-income countries, especially concerning vaccine access. Think Global Health

U.S. Government Pays Damages to Rick Bright in Whistleblower Settlement

Bright was removed in April 2020 as Director of the Biomedical Advanced Research and Development Agency (BARDA), after he pressed for rigorous vetting of hydroxychloroquine, an anti-malaria drug embraced by Trump as a coronavirus treatment and raised specific concerns that the administration had put “politics and cronyism ahead of science” with regard to the federal medical countermeasures portfolio. Bright will be compensated to the fullest extent allowed by law, including back pay, as well as damages to cover the costs of private security and temporary housing that he required after receiving threats. He will also receive compensation, said his attorney, for distress “associated with the disparaging comments and threats” made by administration officials including Mr. Trump, who had blasted Dr. Bright on Twitter as a “creep” and a “disgruntled employee.” Endpoints News, New York Times

Biodefence Research Two Decades On: Worth the Investment?

In response to the terror attacks of 2001 in the USA, extensive research funding was awarded to investigate bioterror-related pathogens.  The legacy of modern biodefence funding includes advancements in biosecurity, biosurveillence, diagnostics, medical countermeasures, and vaccines. Have the past 20 years of investment into biodefence research and preparedness been worth it? The Lancet Infectious Diseases

Private Contractors Cost Millions While Demonstrating Few Clear Results and Papering Over Weaknesses Public Health System

The American vaccination drive came to rely on global behemoths such as McKinsey and Boston Consulting Group (BCG), with downsized state and local health departments and even federal health agencies relying on the private sector to make vaccines available to their citizens. But critics question whether such contracts improve government performance, arguing the arrangements are costly and difficult to oversee. Taxpayers have no way to know what precisely they are getting under no-bid contracts worth millions of dollars because the internal documents of private consultancies are not subject to public records laws. Complicating matters, some contractors contributed to the political campaigns and projects of elected officials who then became clients. Washington Post

Biden Poised to Repeat Mistakes that Led to COVID Pandemic, Biosecurity Experts Say

Polling shows a large majority of the public supports a $30 billion pandemic-prevention plan recently floated by President Biden. The plan hits the right notes. It would improve response time to develop therapeutics and vaccines, beef up the national stockpile and tighten regulations on risky lab research. But just because Biden proposed it doesn’t mean Washington politicians are tripping over themselves to implement it. The bipartisan infrastructure package did not include funding for the plan, and it’s not clear the $3.5 trillion spending bill that Democrats hope to pass without Republican support will include that money, either—Democrats are reportedly considering paring down funding to 20 percent of the original proposal. On this omission, Biden has so far been silent. Newsweek

MEDICAL COUNTERMEASURES

What Does Full FDA Approval of Pfizer’s COVID-19 Vaccine Mean?

Under the EUA, the FDA initially required the companies to submit about only two months of safety monitoring data on study participants, the period when side effects are most likely to occur. For full approval, the FDA required six months of follow-up data. FDA inspectors also visited the plants where the vaccines are made and reviewed each step of the production process for extra assurance that the shots are made under safe, sterile conditions. Public health experts hope the change will convince more unvaccinated people to get the shot and spur more employers to require vaccinations. AP

Covid-19: 40% of Patients with Weakened Immune System Mount Lower Response to Vaccines

Overall, 60% of immunocompromised patients had an antibody response equivalent to that of healthy vaccine recipients, but 11% of those with a weakened immune system failed to generate any antibodies. Failure to seroconvert was particularly high in certain groups: 72.4% of patients with ANCA associated vasculitis and 98% of patients with inflammatory arthritis were in this category. Notably, all of the patients with ANCA associated vasculitis had received rituximab, a targeted B cell depletion therapy, and the researchers suspect a possible link between low seroconversion and rituximab because of the importance of B cells in the immune response to covid-19. The BMJ

The Case for Covid-19 Boosters Is as Shaky as Ever

There isn’t much controversy over a recommendation by the CDC that an extra shot is merited for a small number of vaccinated people with weakened immune systems. But scientists are raising serious questions about the wisdom of the push for a third COVID shot for everyone, unveiled on Wednesday by the Biden administration. Washington Post

Should You Get a Booster Shot? Here’s What We Know

“The groups it is clear should be getting additional doses include highly immunocompromised people: recipients of solid organ transplants, those with AIDS, those taking highly immunosuppressive drugs for cancer or autoimmune disease—these people have less of a response to vaccination. Some will respond to an extra dose but not all. Also, people in nursing homes, where we have seen breakthrough infections turn bad and lead to severe disease and death. Unvaccinated caregivers can introduce the virus to nursing homes. It makes sense to give additional doses to nursing home residents, but you would probably have a bigger impact giving them to caregivers. Beyond that, there’s really no clear data to support giving additional doses to the general public in the U.S. at this time.” Scientific American

U.S. Officials’ Decision on Covid-19 Booster Shots Baffles — And Upsets — Some Scientists

To many experts the sequencing of the decisions being made is out of whack. While U.S. health officials announced booster shots could start being offered the week of Sept. 20, the FDA has not even ruled yet on Pfizer’s application for approval of a third shot; it was filed only Monday. Moderna hasn’t yet asked the agency to authorize a third shot at all. ACIP is set to meet this week to look at the data for a third dose. Before Wednesday’s announcement, there was no suggestion a vote might be taken on the issue; the group may need additional sessions to even address the question. “How did you pick the week of September 20?” asked Baylor. “Since this meeting hasn’t occurred and you don’t know what they’re going to say — this is an independent body — suppose they say: ‘We don’t think so.’ Then what are you going to do with that?” STAT

US Authorities Probing Emergent Biosolutions Over COVID-19 Vaccine Issues

Emergent in a filing on July 30 said it has received “preliminary inquiries and subpoenas to produce documents” from lawmakers, the Department of Justice, the Securities and Exchange Commission, the Financial Industry Regulatory Authority, and Maryland and New York Attorneys General. An FDA inspection in April turned up a long list of sanitary problems and bad manufacturing practices at the facility, including failure to train personnel to avoid cross contamination of COVID-19 vaccines from J&J and AstraZeneca. Emergent came under regulatory scrutiny after an error led to millions of vaccine doses being ruined at its manufacturing facility in Baltimore. Reuters

‘Landmark’ Study Finds Artificial Antibodies Can Protect Against Malaria

Although monoclonal antibodies come with high production costs that could put them out of reach of many developing countries, the work could also inform efforts to develop a malaria vaccine better than one now in wide use. Science

BIOSECURITY + BIOPREPAREDNESS

Has COVID Taught Us Anything About Pandemic Preparedness?

Expecting to avoid another spillover is about as realistic as stopping lightning from sparking a forest fire. Researchers warn that plans to prevent the next global outbreak don’t consider the failures that have fueled our current predicament. Nature

A Natural Pandemic Has Been Terrible. A Synthetic One Would Be Even Worse

The Covid-19 pandemic has revealed the fragility of the U.S.’s public health preparedness infrastructure when faced with a moderately deadly and moderately transmissible respiratory pathogen. We cannot begin to imagine the devastation — possibly even a threat to civilization — if the country had to face a synthetic pandemic from a virus that had been intentionally engineered to spread as effectively as measles and had the virulence of filoviruses such as Ebola or Marburg. STAT

Role of Pharmacists in Disaster Management

Pharmacists can play a pivotal role of clinical to managerial aspects in disaster management, where they get involved in devising the hazard relief strategies as preventive measures in the pre-disaster phase, focus on response plan during the disaster, and provide care for patients not only through timely administration or distribution of medications, but also through regular counseling and ensuring adherence to therapy after the disaster. Extended pharmacy services including triaging, preventive services, assuring SCM, tele-pharmacy health services, and supporting for possible therapeutic options by continuously being involved in researching the repurposing of drugs and alternative medicines during COVID-19 pandemic are already covered in literature. Disaster Medicine and Public Health Preparedness

The Origins of SARS-CoV-2: A Critical Review

We contend that although the animal reservoir for SARS-CoV-2 has not been identified and the key species may not have been tested, in contrast to other scenarios there is substantial body of scientific evidence supporting a zoonotic origin. While the possibility of a laboratory accident cannot be entirely dismissed, and may be near impossible to falsify, this conduit for emergence is highly unlikely relative to the numerous and repeated human-animal contacts that occur routinely in the wildlife trade. Failure to comprehensively investigate the zoonotic origin through collaborative and carefully coordinated studies would leave the world vulnerable to future pandemics arising from the same human activities that have repeatedly put us on a collision course with novel viruses. Cell pre-proof

COVID-19 Pandemic Origins: Bioweapons and the History of Laboratory Leaks

Had there been genetic manipulation supporting the lab-origin theory, it would have been done with a reverse-genetic system used for betacoronaviruses. Study of the genetic data, however, shows that SARS-CoV-2 did not derive from any previously used viral framework. The results effectively eliminated the possibility of a laboratory leak with a genetically manipulated or “enhanced” virus. With an evidence-based approach, the authors described that if this virus came from a laboratory, then it would have signs of human manipulation; however, this virus does not. Southern Medical Journal

Can Science Help Resolve the Controversy on the Origins of the SARS-CoV-2 Pandemic?

Pathway A envisions infection of an intermediate host from a bat source with subsequent transmission and spread among the human population. Pathway B envisions direct acquisition of SARS-CoV-2 from a feral source, probably a bat, with subsequent spread among the human population. Pathway C is identical to pathway B except for intent and purpose in the sense that it occurs in an individual involved in sampling bat sources for laboratory research purposes. Pathway D involves a lab accident after SARS-CoV-2 had been isolated and brought into the laboratory, possibly adapted to growth in cell lines or laboratory animals. Pathways A and B would represent a direct zoonosis while pathways C and D would represent a laboratory-related origin of a virus that is still a zoonosis since it originally came from a feral reservoir. The literature contains precedents for the four origin pathways. mBio

Wuhan Lab Leak Theory: How Fort Detrick Became a Centre for Chinese Conspiracies

A disinformation campaign claiming that the Covid-19 virus originated from an American military base in Maryland has gained popularity in China ahead of the release of a US intelligence report on the virus origins. BBC News

Gene Drives Gaining Speed

This review summarizes the phenomenal progress in the field of gene-drive systems, focusing on optimal design features for full-drive elements (drives with linked Cas9 and guide RNA components) that either suppress target mosquito populations or modify them to prevent pathogen transmission, allelic drives for updating genetic elements, mitigating strategies including trans-complementing split-drives and genetic neutralizing elements, and the adaptation of drive technology to other organisms. Nature Reviews Genetics

SELECT AGENTS + CBRNE THREATS

Recombinant Protein Filovirus Vaccines Protect Cynomolgus Macaques From Ebola, Sudan, and Marburg Viruses

Uniform protection against viral challenge was observed in all studies among all animals immunized with three doses of either monovalent or bivalent formulations. With limited filovirus cross-reactive immune response to monovalent MARV GP vaccine, the results suggest the feasibility of formulating a true multivalent filovirus vaccine with recombinant proteins protecting against the three most commonly occurring filoviruses pathogenic to humans. Frontiers in Immunology

The Roles of Antimicrobial Resistance, Phage Diversity, Isolation Source and Selection in Shaping the Genomic Architecture of Bacillus Anthracis

This study reports ten antimicrobial resistance genes and 11 different prophage sequences, resulting in the first large-scale documentation of these genetic anomalies for B. anthracis. The information presented sheds new light on the factors driving genomic structure in this notorious pathogen and may act as a road map for future studies aimed at understanding functional differences in terms of B. anthracis biogeography, virulence and evolution. Microbial Genomics

Source of Ivory Coast Ebola Case Probed

An investigation is under way into the source of an Ebola infection in a traveler from Guinea whose infection was detected in the Ivory Coast’s major urban center of Abidjan, marking the country’s first case since 1994. CIDRAP

Burkina Faso Opens Investigation Into Hemorrhagic Fever Case

Epidemiologists are investigating a suspected case of hemorrhagic fever from Côte d’Ivoire where a case of Ebola fever was recently identified on 14 August. The country’s health ministry says a 22-year-old person is being treated at the Bogodogo University Hospital Center in Ouagadougou. They are isolated and receiving care while awaiting confirmation of any Ebola infection. Africa Times

Guinea Monitoring 172 Contact Cases of Marburg Virus Victim

Guinean health officials are monitoring 172 contact cases of a man who died of Marburg virus. West Africa’s first recorded case of the virus—which belongs to the same filovirus family as Ebola but is somewhat less deadly—was confirmed on August 9. Guinea is also monitoring at least 58 contact cases of an Ebola patient while facing a resurgence in COVID cases that is “severely testing our health services”. Medical Xpress

Efficacy of Delafloxacin against the Biothreat Pathogen Burkholderia pseudomallei

Based on its in vitro and in vivo activity, its safety and tolerability profile, delafloxacin may offer an attractive treatment option as PEP or eradication therapy for B. pseudomallei (based on mouse model). Evaluation in other in vivo infection models for B. pseudomallei should be considered. Antimicrobial Agents and Chemotherapy

Pentagon Shifting Approach to Chem-Bio Defense

Transforming CBRN technology will be limited if the Defense Department doesn’t transition away from its traditional methods of requirements development, R&D investment and acquisition. National Defense

SURVEILLANCE + DETECTION

UK to Begin Offering COVID Antibody Testing to General Public for First Time

On testing positive for COVID-19, participants will be sent two finger-prick tests to complete at home to inform the UK Health Security Agency of the antibody response to different coronavirus variants. The first of these tests should be taken as soon as possible after the patient receives their positive result, and the second should be taken 28 days later. UKHSA, working alongside NHS Test and Trace, will use the results to monitor antibody levels in positive cases. Reuters

Has the WHO Just Advertised the Toughest Job in the World?

The World Health Organization is looking for in its new panel of experts, known as SAGO, or the Scientific Advisory Group for the Origins of Novel Pathogens. The team will be tasked with guiding “WHO on next steps for understanding the SARS-CoV-2 origins” as well as advising on the “technical and scientific considerations regarding the origins of emerging and re-emerging pathogens of epidemic and pandemic potential”. The Telegraph

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