Anthrax Vaccine Manufacturer Finally Authorized by FDA to deliver Covid Vaccines (which are mislabeled as being made by Janssen/ Reuters

Emergent BioSolutions, a company that has never developed a product, but is famous for several very public vaccine fails and a defective nerve gas autoinjector, always gets the sweetheart deal.  The US Government gave the company $628 million last year to retool their Baltimore factory (purchased in 2012 with federal funding) and shoehorned Janssen/ J and J, Novavax and Astra-Zeneca to use Emergent to do the manufacturing of the Covid vaccines they had developed.

Emergent BioSolutions (EBS) made thousands of soldiers chronically ill with its anthrax vaccines.  Congress held a series of hearings and published a book about it, titled “Unproven Force Protection.” In its 22 years of operation, EBS went from an $18 million company to a $5-7 Billion dollar company.  Its business model is to produce sole source, no bid products for the US biodefense stockpile.  Most of the products are never used, and must be discarded after expiration. Which allows the company to restock the US government’s supply every few years, guaranteeing a very reliable income.

Today, the entire mainstream media seems to have been ordered not to use the name Emergent BioSolutions when reporting this story–about how the company just got its manufacturing plant for the Janssen vaccine okayed by FDA, so EBS can finally ship the Covid vaccine for US distribution.  Pay attention to the weasel wording in Reuter’s story.  Instead of being called “Emergent BioSolutions’ factory,” it is called “a large plant” and its location is unspecified.

Last month the Janssen vaccine made in Belgium was authorized by FDA, but the EBS version of the vaccine did not pass FDA’s muster.  But today, after promising 20 million vaccine doses by the end of March, it looks like Emergent and Janssen (a subsidiary of Johnson and Johnson) will make good on their promise.

What this means for the American public is that from now on, everyone who gets the Janssen “one and done”shot will actually be getting a dose made by Emergent BioSolutions in Baltimore.
Why is that a problem?  Ignoring the issues associated with the design of the adenovirus-vector DNA vaccine, the company doing the manufacturing has an unscrupulous past.  It was perfectly happy to make huge profits shipping out vaccines for soldiers that had visible mold and bacterial growth, as well as stopper material, in the vials. It was happy to supply FDA with doctored data.  And in order to do the highly remunerative deals with the USG for Covid vaccines, Emergent rehired its old President (Bob Kramer) and retained its Founder/Chairman of the Board (Fuad el-Hibri) :  both of whom led the company during the bad old anthrax vaccine days.

J&J plant authorization clears way for big boost in U.S. COVID-19 shots

By Michael ErmanCarl O’Donnell

NEW YORK (Reuters) – A large plant being used to manufacture Johnson & Johnson’s COVID-19 vaccine was cleared by U.S. regulators on Tuesday, setting the stage for the weekly U.S. supply to surge more then 20 percent.

About 27 million COVID-19 vaccine doses will be allocated to U.S. states and other localities this week, including 4 million from J&J, White House spokeswoman Jen Psaki told reporters. That is the largest allocation yet, up from 22 million last week.

Earlier, the Indiana plant at which Catalent Inc is helping to manufacture the J&J vaccine received U.S. regulatory authorization, the companies said.

J&J’s shipments had slowed considerably since the first week of the month, but the new authorization will enable it to ship out millions of doses.

J&J tapped contract manufacturers Catalent and Emergent BioSolutions Inc to scale up production and meet its global supply targets. Catalent provides the final stage – called fill and finish – while Emergent makes the drug substance.

The U.S. Food and Drug Administration authorized the one-shot J&J vaccine in February, but only for its production facility in the Netherlands and a small fill-and-finish plant in the United States.

Based on that authorization, the company shipped nearly 4 million doses in the beginning of March. Shipments dropped sharply since then as J&J awaited the additional authorizations.

The company had previously promised to deliver 20 million vaccine doses by the end of March.

As of Tuesday morning, 82.7 million people in the United States had received at least one vaccine dose, around a quarter of the population, according to data from the Centers for Disease Control and Prevention.

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Anonymous
Anonymous
8 months ago

Here is a NYT story on Emergent from March 6 of this year.

https://www.nytimes.com/2021/03/06/us/emergent-biosolutions-anthrax-coronavirus.html

Excerpts below

How One Firm 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.

Published March 6, 2021Updated March 8, 2021

WASHINGTON — A year ago, President Donald J. Trump declared a national emergency, promising a wartime footing to combat the coronavirus. But as Covid-19 spread unchecked, sending thousands of dying people to the hospital, desperate pleas for protective masks and other medical supplies went unanswered.

An investigation by The New York Times found a hidden explanation: Government purchases for the Strategic National Stockpile, the country’s emergency medical reserve where such equipment is kept, have largely been driven by the demands and financial interests of a handful of biotech firms that have specialized in products that address terrorist threats rather than infectious disease.

Chief among them is Emergent BioSolutions, a Maryland-based company now manufacturing Covid-19 vaccines for AstraZeneca and Johnson & Johnson. Last year, as the pandemic raced across the country, the government paid Emergent $626 million for products that included vaccines to fight an entirely different threat: a terrorist attack using anthrax.

Throughout most of the last decade, the government has spent nearly half of the stockpile’s half-billion-dollar annual budget on the company’s anthrax vaccines, The Times found. That left the government with less money to buy supplies needed in a pandemic, despite repeatedly being advised to do so.

Purchases are supposed to be based on careful assessments by government officials of how best to save lives, but many have also been influenced by Emergent’s bottom line, the documents and interviews reveal. One year, the government increased its order of Emergent’s main anthrax vaccine by $100 million after the company insisted it needed the additional sales to stay in business, according to two former federal officials. At the time that order was announced, in 2016, the reserve already had enough to vaccinate more than 10 million people. The stockpile has long been the company’s biggest and most reliable customer for its anthrax vaccines, which expire and need to be replaced every few years.

In the two decades since the repository was created, Emergent’s aggressive tactics, broad political connections and penchant for undercutting competitors have given it remarkable sway over the government’s purchasing decisions related to the vaccines, the interviews and documents show.

“They were totally feared by everybody,” Dr. Philip Russell, a top health official in the administration of President George W. Bush, said in an interview. He said that he clashed with Emergent when he backed VaxGen, and that his reputation came under attack, which was documented by The Times in 2006. (Dr. Russell died this January.)

When the pandemic hit, the AV7909 purchases only accelerated. In 2020, the government spent more than $370 million on Emergent’s anthrax vaccines — the largest sales total for the vaccines in the company’s history.

Last month, as the death toll from Covid-19 neared a half-million, Mr. Kramer, the company’s chief executive, told analysts there had been no “evidence of a slowdown or a delay or a deprioritization,” and echoed a statement he had made in April when asked whether the pandemic might interrupt Emergent’s sales to the stockpile.

“It’s pretty much business as usual,” he said then.

Meryl Nass, M.D.
Meryl Nass, M.D.
8 months ago

Yes, Sheryl Gay Stolberg, who was the main NYT reporter on the story, covered the anthrax vaccine debacle back in 1999. I recall her interviewing me then. So she had good background on the company, despite its name change from Bioport to Emergent, and she wrote a great expose.

Which caused Biden to cancel his trip to the plant around March 10, which would probably have coincided with an announcement of the EBS vaccine authorization.

Instead, everyone is now trying to cover up the fact the long-awaited vaccine stockpile is coming from a very sketchy company, and we are simply not going to mention them (EBS) and keep calling it the Janssen vaccine.

Dr Chris King
Dr Chris King
8 months ago

Dr Nass, where are we on the antibody-dependent enhancement of disease (ADE) front with the COVID-19 vaccines? If I understand the research correctly, this phenomenon halted attempts at vaccine development following SARS (COVID-02) and MERS (COVID-12). In brief, the vaccinated animals developed immunopathology when subsequently exposed to the virus.

Surely enough humans have been vaccinated by now, and enough SARS-CoV-2 is still circulating, that we should be starting to see ADE in vaccinated people if it's going to be the concern that the experimental animal studies suggested. Vaccine development for COVID-19 seems to have ignored it completely. If it is indeed occurring, what would that look like (presentation, incidence, significance) – and how would we know it's happening if we can't even rely on the accurate reporting of viral infections and COVID cases?

I'd love to hear your thoughts on this aspect of the mass vaccination ploy.

Thanks!

Meryl Nass, M.D.
Meryl Nass, M.D.
8 months ago

Last night someone shared two studies that showed an increased risk of getting Covid in the 7-13 day period after vaccination (1st study) or in the 2 week period following vaccination (2nd study), compared to pre-vaccination and compared to more than 2 weeks post-vaccination.

This is probably not ADE but suggests some enhanced susceptibility (or else that the shot was giving people Covid) briefly post-vaccination, which is rather curious. Was seen in a study of the Shingrix vaccination also.

I agree we should know more about ADE by now but we don't. The only public data from govts are the voluntary reports, and the data in them do not lend themselves to analysis of cause. Are federal agencies looking for ADE? I have seen no evidence that they are.

Meryl Nass, M.D.
Meryl Nass, M.D.
8 months ago

The NYT is taking credit for cancelling Biden's visit to the EBS "large plant" and alerting us to its hisotry.
https://finance.yahoo.com/news/york-times-credits-report-emergent-163459074.html

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