Beneath a Covid Vaccine Debacle, 30 Years of Government Culpability

Washington has rejected plans to revamp vaccine preparedness for decades and repeatedly paid a price. The Biden administration is at a similar crossroads.

#anthrax, #astrazeneca-plc, #biden-joseph-r-jr, #biological-and-chemical-warfare, #biomedical-advanced-research-and-development-authority, #botulism, #coronavirus-2019-ncov, #defense-department, #drugs-pharmaceuticals, #el-hibri-fuad, #emergent-biosolutions-inc, #epidemics, #food-and-drug-administration, #gaithersburg-md, #government-contracts-and-procurement, #johnsonjohnson, #moderna-inc, #politics-and-government, #public-private-sector-cooperation, #smallpox, #stockpiling, #united-states, #vaccination-and-immunization

Dr. Sherif R. Zaki, Acclaimed Disease Detective, Dies at 65

He helped identify numerous viruses, including Covid-19, as well as the bioterrorism attack that spread anthrax in 2001.

#anthrax, #centers-for-disease-control-and-prevention, #coronavirus-2019-ncov, #deaths-obituaries, #ebola-virus, #sars-severe-acute-respiratory-syndrome, #zaki-sherif-r

Federal Government Cuts Ties With Troubled Vaccine Maker

Emergent BioSolutions ruined millions of doses of Covid-19 vaccines. Now its $600 million deal is canceled.

#anthrax, #astrazeneca-plc, #coronavirus-2019-ncov, #emergent-biosolutions-inc, #food-and-drug-administration, #government-contracts-and-procurement, #health-and-human-services-department, #johnsonjohnson, #kramer-robert-g, #vaccination-and-immunization

Soviets Once Denied a Deadly Anthrax Lab Leak. U.S. Scientists Backed the Story.

The accident and a subsequent cover-up have renewed relevance as scientists search for the origins of Covid-19.

#anthrax, #coronavirus-2019-ncov, #russia, #wuhan-institute-of-virology-china, #yekaterinburg-russia

Contractor that ruined 15M doses of J&J vaccine hiked price of another by 800%

The Emergent BioSolutions plant, a manufacturing partner for Johnson & Johnson's COVID-19 vaccine, in Baltimore, Maryland, on April 9, 2021.

Enlarge / The Emergent BioSolutions plant, a manufacturing partner for Johnson & Johnson’s COVID-19 vaccine, in Baltimore, Maryland, on April 9, 2021. (credit: Getty | Saul Loeb)

Things are not looking good for Emergent BioSolutions, the contract manufacturer that ruined 15 million doses of Johnson & Johnson’s one-shot COVID-19 vaccine and millions more doses of AstraZeneca’s COVID-19 vaccine at its production facility in Baltimore.

The Food and Drug Administration on Wednesday released a searing inspection report of the facility, finding a slew of significant violations and failings.

Meanwhile, federal lawmakers have opened a multi-pronged investigation into whether Emergent used ties to the Trump administration to get billions of dollars in federal contracts despite a history of failing to complete contracts, inadequately training staff, persistent quality-control issues, and an “unjustified” 800% price increase for an anthrax vaccine.

Read 15 remaining paragraphs | Comments

#anthrax, #clyburn, #covid-19, #cross-contamination, #emergent-biosolutions, #fda, #infectious-disease, #johnson-johnson, #maloney, #public-health, #science, #vaccines

How Emergent BioSolutions Put an ‘Extraordinary Burden’ on the U.S.’s Troubled Stockpile

The shortage of lifesaving medical equipment last year was a searing example of the government’s failed coronavirus response. As health workers resorted to wearing trash bags, one Maryland company profited by selling anthrax vaccines to the country’s emergency reserve.

#anthrax, #atlanta-ga, #bernard-kenneth, #biological-and-chemical-warfare, #biomedical-advanced-research-and-development-authority, #bright-rick-a, #coronavirus-2019-ncov, #coronavirus-risks-and-safety-concerns, #drugs-pharmaceuticals, #emergent-biosolutions-inc, #frieden-thomas-r, #hatchett-richard-j, #hoekstra-peter, #kadlec-robert-p, #obama-barack, #stockpiling, #terrorism, #trump-donald-j, #united-states-politics-and-government

U.S. House approves remote voting, though the tech is unclear

Congress will allow remote voting for the first time in its history, after the U.S. House approved Resolution 965 late Friday in response to the coronavirus pandemic.

The measure — sponsored by Massachusetts Representative Jim McGovern — authorizes proxy voting by members for renewable periods of 45 days and allows for remote participation in committee hearings.

H.R. 965 could also permanently alter the way Congress operates through a provision that establishes a bi-partisan process to explore digital voting away from Capitol Hill.

Per the directive, “The chair of the Committee on House Administration, in consultation with the ranking minority member, shall study the feasibility of using technology to conduct remote voting in the House, and shall provide certification…that operable and secure technology exists.”

Previous House rules required in person voting only. The Senate still makes decisions by recording verbal “Yeas” and “Nays” on a tally sheet.

Friday’s congressional action is another example of how COVID-19 is forcing every organization in the U.S. to overhaul longstanding ways of doing things, usually through a mix of digital tools.

We still don’t have clear details on what tech the U.S. House will use to implement both the short and longer term provisions of H.R. 965.

The proxy voting arrangement will allow members to vote remotely through designated representatives on Capitol Hill — effectively a form of pinch-hitting for Congress. For remote participation in hearings, there are a range of options that could be selected — from Google Meet to Microsoft Teams. Last week, Dr. Anthony Fauci testified before the U.S. Senate using Zoom.

On determining long-term means for remote voting, that’s now up to the Chairperson of the Committee on House Administration —  representative Zoe Lofgren (D-CA) —  and the ranking minority member Rodney Davis (R-IL), who voted against H.R. 965.

Lofgren offered a preview of how it could shape up in a statement supporting H.R. 965 late Friday: “For voting on the floor, we will rely on a secure email system, coupled with member-driven, remotely-directed authorizations.  This system would use secure email for proxy votes: a solid, well known, resilient technology with very low bandwidth requirements that we understand very well from a cybersecurity standpoint.”

Of course, she and Republican Congressman Davis will have to find agreement on this during a time when both parties rarely agree on anything. The vote on H.R. 965 was split along party lines, with 217 Dems voting in favor and not a single Republican member supporting the measure.

In the past, Congress has resisted calls to allow for remote voting. There was discussion of the need for such provisions after the September 11 attacks and 2001 Anthrax attacks. These was overridden by a long time expectation that those elected to represent constituencies be physically present to vote.

Over the last two months, it appeared the House might become a last holdout in the U.S. for in person only workplaces, as much of the country has shifted to tech-enabled measures for remote operations.

Shortly after the coronavirus outbreak hit the U.S. in March, Congressman Eric Swalwell (D-CA) pressed a resolution with Arkansas Representative Rick Crawford (R-AR) that would allow members to participate virtually in hearings and vote remotely, under special circumstances.

US capitol building at night

Image Credits: Bill Dickinson/Getty Images

That was nixed by House Speaker Nancy Pelosi  who, at the time, wanted Congress to remain in session and present to pass the first coronavirus stimulus bill.

Two months and nearly one hundred thousand American deaths later, it appears COVID-19 could force one of the more significant procedural changes in the House’s 231 year history.

In person voting could soon be replaced with some form of two-factor authentication, digital voting. This could alter longstanding patterns for how lawmakers travel, interact with constituencies, and divide their time between the Beltway and districts back home.

#anthrax, #arkansas, #chair, #congress, #democracy, #elections, #electronic-voting, #google, #government, #il, #massachusetts, #microsoft, #nancy-pelosi, #politics, #senate, #tc, #u-s-senate, #united-states, #voting

Why Congress isn’t working remotely due to COVID-19

As COVID-19 forces much of America to work from home, the United States Congress — whose 535 members have an average age of 60 — is still operating from Capitol Hill.

Why this population (deemed high-risk to the coronavirus) isn’t yet doing legislative business remotely comes down to process, tech and political will.

“The House rules and the Senate rules require voting in person. And it would require a change in those rules to do that,” California Congressman Eric Swalwell told TechCrunch on a call from his Washington, D.C., office.

Swalwell has a plan for Congress to work away from the Hill. He recently reintroduced a resolution with Arizona Representative Rick Crawford (R-AZ) that would allow members to participate virtually in hearings and vote remotely, under special circumstances.

House Speaker Nancy Pelosi appears to have nixed that option, at least for the near-term, reportedly telling her caucus last week, “We are the captains of the ship. We are last to leave.”

A priority for Congress is finalizing emergency COVID-19 legislation to provide trillions of dollars in resources to combat the virus and stem the economic havoc it’s wreaking across the U.S.

Without a rule-change and clear plan for members to legislate and vote outside from Capitol Hill, passing that legislation requires lawmakers be present on the building’s floor.

Bill Dickinson/Getty Images

There are mixed messages on who makes the call for Congress to go to a remote-work scenario and what kind of digital contingency would kick in to perform legislative duties at a distance. 

In a subsequent scrum to her “last to leave” comments, Pelosi gave an unequivocal “no” to reporters’ questions on Congress closing due to COVID-19. But she added, the ultimate call was not hers. “That’s a health and security decision up to the Capitol physician [and] Sergeant at Arms,” the Speaker said.

TechCrunch sought input on the matter from the House Office of the Sergeant at Arms. That inquiry referred us to the Chief Administrative Office, which has not yet responded.

Even after the first congressional staffers have tested positive for COVID-19, the majority of Capitol Hill’s high-risk members continue to work on-site and in their office buildings.

Representative Swalwell’s MOBILE (Members Operating to Be Innovative and Link Everyone) resolution proposes to change that.

He’s introduced the measure every year since 2013, but believes it carries extra weight now due to the COVID-19 pandemic. Swalwell reintroduced it again on March 9.

MOBILE would “mandate the development of a secure remote voting system which members could use to vote remotely on suspension bills, generally non-controversial bills that require a two-thirds vote to pass,” according to a statement on the resolution provided by Swalwell’s office.

“It’s bi-partisan, introduced by me and Representative Rick Crawford from Arkansas and we’ve had dozens of members join us in support,” Swalwell told TechCrunch.

“I don’t mean to have this substitute us meeting in person,” the California Democrat said. But Swalwell believes there needs to be tech provisions in Congress, comparable to contingency plans in the private sector, for members to operate virtually outside of Capitol Hill.

Illinois Senator Dick Durbin echoed this on Tuesday, underscoring the need for virtual committee hearings and the ability to vote away from Congress in times of national emergency.

As millions of Americans shift from physical work spaces to platforms such as Zoom, Slack or Google Hangouts during the COVID-19 crisis, detail is lacking on the software, apps and security for Congress to operate under a measure such as MOBILE.

There’s still little in the way of tech in the voting process on Capitol Hill, where the Senate still makes decisions by recording verbal “Yeas” and “Nays” on a tally sheet.

“I’m not offering myself as the technical expert,” Swalwell said on the implementation of his suggested remote voting and convening resolution.

He explained that the House Administration Committee and House Rules Committee would be the subject matter experts to determine how the Congress would secure voting and meetings remotely.

Photo by Brendan Hoffman/Getty Images

“We have smart members on those committees and capable staffers who could give us a tech solution today…and the solution that we ultimately use down the road,” he said.

While the business of Congress still remains a present and in-person affair, the body is taking cautionary measures to protect staff. This week several members, including representative Swalwell and West Virginia Senator Joe Manchin, instructed employees to work from home.

There’s more capability for congressional staff, compared to members, to work remotely, according to Frederick Hill, a Managing Director at FTI Consulting — who spent 17 years as a staffer in the U.S. Senate and House of Representatives.

“The technology is in place to support much of the work that goes on in the background at the staff level,” Hill told TechCrunch.

“They have VPN networks, shared drives for off-site work, devices and smartphones to keep them in contact and help draft legislation.” The September 11 attacks and 2001 Anthrax attacks forced a number of these contingencies for congressional staff members.

Hill explained that when it comes to the most official congressional activity, such as voting on the floor, “there really are no provisions [currently] to use technology.”

Part of that has to do with ensuring those elected to represent constituencies are genuinely present to vote.

But similar to so many previously in-person functions that have shifted to apps paired with security measures, such as multi-factor authentication, decision-making on Capitol Hill could also move to remote and digital options.

An extenuating circumstance, such as the COVID-19 pandemic, could be what finally moves America’s chief legislating body in the direction of being able to vote remotely.

“It certainly has provoked the conversation,” Swalwell said. “I think it is a needed conversation. I wish it were under different circumstances.”

#anthrax, #arizona, #arkansas, #bill, #california, #congress, #coronavirus, #covid-19, #house-of-representatives, #nancy-pelosi, #tc, #u-s-senate, #united-states, #vpn