The Emergent BiolSolutions fiasco is just another example of Trump administration grifting and failure. Contractor that ruined 15M doses of J&J vaccine hiked price of another by 800% FDA releases damning inspection report as lawmakers question ties to Trump admin. https://arstechnica.com/science/202...-of-jj-vaccine-hiked-price-of-another-by-800/ 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. In a letter sent to Emergent’s top executives Tuesday, Rep. Carolyn Maloney, chairwoman of the House Committee on Oversight and Reform, and Rep. James Clyburn, chairman of the Select Subcommittee on the Coronavirus Crisis, laid out the investigation, writing: Emergent received $628 million in June 2020 to establish the primary US facility for manufacturing vaccines developed by Johnson & Johnson and AstraZeneca. Dr. Robert Kadlec, who served as Assistant Secretary for Preparedness and Response under President Trump and previously worked as a consultant for Emergent, appears to have pushed for this award despite indications that Emergent did not have the ability to reliably fulfill the contract. 800% drain But the investigation stretches back much farther than the start of the pandemic—through years of questionable federal contracts. In 1998, Emergent (then called BioPort) bought the license to an anthrax vaccine. The vaccine, BioThrax, was approved by the FDA in 1970 but remains the only FDA-approved vaccine for anthrax. As such, Emergent is the sole supplier of anthrax vaccine for the federal government’s Strategic National Stockpile (SNS). When Emergent bought the vaccine in 1998, a dose went for about $3.35. By 2010, the price was up to $28 a dose. Now, the price is over $30, and average wholesale prices are even higher, reaching $90 per dose, the lawmakers note. “Emergent has raised the government purchasing price of the anthrax vaccine by 800% since acquiring the drug in 1998,” the lawmakers write in their letter. “As a result, through most of the last decade, nearly half of the SNS’s budget has been spent purchasing Emergent’s anthrax vaccine. These spiraling costs contributed to shortages of critical supplies, including ventilators, reusable respirator masks, and other personal protective equipment, which severely impacted the government’s ability to respond to the coronavirus crisis.” This drain on the SNS budget was particularly apparent during the pandemic—which Robert Kadlec, the former Emergent consultant, himself acknowledged. Kadlec was nominated in 2017 by President Trump to lead the Office of the Assistant Secretary for Preparedness and Response (ASPR). Following his confirmation, Emergent received millions of dollars in federal contracts from ASPR, including contracts for the SNS that were awarded without competitive bidding, the lawmakers note in their letter. In 2020—just before the pandemic hit the US—Kadlec’s office awarded Emergent around $3 billion in long-term contracts for anthrax and other bioterrorism threats. According to the lawmakers, Kadlec later suggested this was a bad move, saying: “If I could spend less on anthrax replenishment, I could buy more N95s. I could buy more ventilators. I could buy more of other things that quite frankly I didn’t have the money to buy.” Failures and an inspection Aside from the skyrocketing prices, the lawmakers suggest Emergent didn’t even deserve the contracts in the first place. In 2012, the Department of Health and Human Services awarded Emergent a $163 million contract to renovate its (currently troubled) Baltimore manufacturing plant. The idea was for the plant to become a manufacturing hub for rapidly producing vaccine in the event of an infectious disease outbreak or bioterror attack. Part of the contract stipulated that Emergent would be required to do a test run, producing 50 million doses of a pandemic influenza vaccine in the span of four months, and obtain manufacturing approval from the FDA by June 2020. Emergent failed to meet those requirements. Reading the FDA’s inspection report of Emergent’s Baltimore facility, it’s clear why. During the nine-day inspection, which ended April 20, FDA inspectors logged a long list of problems at the facility. First on the list is that Emergent failed to thoroughly investigate how the millions of Johnson & Johnson and AstraZeneca doses became contaminated. The agency concluded that, without a thorough review of what happened, it’s possible that other finished batches of vaccine may also be ruined. “There is no assurance that other batches have not been subject to cross contamination,” the inspectors wrote. The FDA inspectors went on to note unsanitary conditions, paint peeling off of the walls and floors, residue on equipment, improperly trained staff, and numerous opportunities for vaccine products to be contaminated. The potential for cross contamination—spread of viral ingredients back and forth between Johnson & Johnson’s vaccine and AstraZeneca’s vaccine—appeared rampant at the facility. Inspectors witnessed Emergent employees dragging unsealed, non-decontaminated bags of medical waste across different manufacturing areas. In some cases, employees tossed bags of medical waste, unsealed, into a service elevator. Emergent did not have proper written procedures for how to decontaminate waste, the inspection report notes. Security footage also caught employees moving from different areas of the facility without following proper procedures for donning and removing protective gowns. At the request of the FDA, vaccine production at the Baltimore facility has been halted since April 16. In a statement Wednesday, Emergent said that the FDA’s findings “provide direction on the necessary steps to improve operations.” The company went on: The FDA’s feedback will help us continue to improve and strengthen the supply chain for Johnson & Johnson’s COVID-19 vaccine. While we are never satisfied to see shortcomings in our manufacturing facilities or process, they are correctable and we will take swift action to remedy them.
who cares dude? this is an untested "vaccine" that was produced in less than a year to protect people from a virus with a 99.9% survival rate oh and once you get the mRNA "vaccine" you dont get to go back to normal, and you can still get and spread the China Virus
So you are OK with $628 million in our tax dollars being sent to Emergent in June 2020 which yielded not a single usable dose of COVID vaccine. The Trump administration awarded this money despite it being clear that Emergent could not reliably fulfill the contract. I guess you are OK with this waste of tax dollars on a political insider deal.
i think this is just proof that the govt mismanages every dollar they get their hands on and that taxes should be lowered until they prove that they can manage a much smaller amount of money. if you cant manage 10,000 you cant manage 100,000 the government is always a day late and a dollar short
There are incorrect or misleading statements in this post above. Their are no untested vaccines being mass produced for wide spread use in the U.S. All of the vaccines approved by the FDA for mass production have been tested for safety and efficacy: tests in animals, then large scale clinical tests in humans. The Survival rate quoted as 99.9% only applies to those under age 40, and even then symptomatic infection has led to very serious illness in a significant number of cases. Although vaccinated individuals obtain a significantly lowered probability of symptomatic infection, from an epidemiological standpoint the effectiveness of vaccination rises non-linearly with the fraction of the population vaccinated. To stop the transmission of a virus, a large fraction of a population must be vaccinated. If a sufficient number are not vaccinated, only those who have been vaccinated will be protected and the non-vaccinated will remain vulnerable. Only if a large fraction of the population is vaccinated will the risk of infection fall to near the vanishingly small risk of serious ill effects from the vaccination itself. Even with most of the population vaccinated, until the tipping point is reached, where the virus can no longer sustain itself, the statistical odds are against those who remain un-vaccinated and therefore vulnerable to infection. One also should consider that if they wish to travel to other countries where the virus is still present and they are unvaccinated, they will be vulnerable -- assuming they are allowed to travel..Remaining unvaccinated is a foolish choice.
This is of course illogical. This unfortunate incident is only evidence of the self evident, i.e., when large numbers of people, directed by politicians and the laws they create, manage large numbers of dollars, the probability of either corruption or an honest mistake occurring goes up! There is no evidence whatsoever that a corporation as large as the U.S. government that handles as much money and contracts as the U.S. Government does would be any more free of corruption, mismanagement, or mistakes than is the U.S. Government. In fact it is my opinion that the real situation is just the opposite, and that the U.S. Government , all considered, is amazingly free of corruption, mismanagement and mistakes at the operational level. Almost all of maladies including inefficiencies seem to have been caused by the policy makers themselves, i.e., those elected, while those citizens that perform the day to day workings of the Government are amazingly efficient, honest and capable. I would conclude further that most of those in elected positions are doing what their constituents want them to do, even if it's ridiculous. If we want to improve government, we'll find the greatest opportunity to do so among those we elected, and not among the rank and file government worker. . . And God help us if we ever decide to turn over to the private sector many more of the critical functions that government now performs for us ! We have one glowing example of that mistake, privatizing prisons! That should be enough for us to learn our lesson.
What is your time limit for the number of years a vaccine must be in use, and what is this based on, before you are happy with the absence of long term effects. I do know that death from Covid is at least one of its rather short term effects, but I have little knowledge of what it's long term effects will be. Apparently you prefer to take on the risk of Covid's known short term effects rather than chance the unknown long-term risks of covid-vaccination. Vaccines are based on bio-sciences. We can not know what we don't know. The best we can do is base our judgement on what we do know. I don't see that ever changing, do you?
Until it’s been around for 25 years I won’t take any “vaccine”. This mrna stuff is new and hasn’t been used on humans before. Also you’re arguing saying that not wanting the long term effects of the China virus negatively impacting you in the future. Well, even after your “vaccine” you can still get and transmit the virus. Your main point for getting it is obsolete. Also, i had covid last summer. So I already am immune to it also it has a 99.9+% SURVIVAL RATE. There is 0 short term risk here. Unknown Long term effects of the untested mrna “vaccine” are not worth an 0.001% extra chance at surviving something 99.9% of people will survive