Tuesday, March 23, 2021

ERROR: Anthrax Vaccine Manufacturer Not Quite 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.

UPDATE March 25:  However, Politico says that it was only Catalent (the Bloomington, Indiana company that simply fills the vaccine vials) that was authorized by FDA this week, not Emergent.  Politico says it is a secret where the vaccine that Catalent is shipping out to the US was actually produced:
Emergent is already sending millions of doses to Catalent, the people said. But those shots cannot be used until Emergent receives its own FDA authorization. Catalent has not yet responded to questions about which company made the active ingredient for the doses it has begun shipping out. But a person familiar with the matter said J&J is currently using drug substance flown in from the Netherlands, not substance produced by Emergent, to manufacture its vaccine.
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.

UPDATE March 25:  Actually, the paragraph above is probably incorrect, but I can't be sure.  FDA, J and J and Emergent are hiding what is going on. This reminds me of anthrax vaccine given to soldiers during the Gulf War that was made in unlicensed facilities, but shipped and stored elsewhere, to obscure its actual provenance. Of course, information about those shots was classified, and few sickened soldiers were able to claim benefits.

From Politico

Adding to the confusion, FDA refused to confirm that it had authorized Catalent to produce J&J vaccine, saying that information about which contract manufacturers a pharmaceutical company enlists is considered "confidential commercial information" that it is legally prohibited from disclosing.

"The manufacture of authorized COVID-19 vaccines is limited to those facilities identified and requested for authorization by the sponsor," FDA said in a statement...

J&J did not include its manufacturing partners in its original emergency use application, so doses made by the partners have been sitting unused while tensions have ratcheted up between the federal government and the drugmaker over manufacturing delays...

Emergent told POLITICO earlier this week that it aims to provide one billion shots this year between its deals with J&J and AstraZeneca, another manufacturer aiming for emergency use in April. A person familiar with the process said “tens of millions” of doses are stored. An Emergent spokesperson confirmed that the company has already been shipping the avaccine's active ingredient for fill-finish.

Why is vaccine made by Emergent Biosolutions 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 and drugs, 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.

    *from Maryland Matters
"In the past year, Emergent BioSolutions has landed nine contracts to manufacture coronavirus-related products for companies, including manufacturing all or part of vaccines for Johnson & Johnson, Novavax and AstraZeneca plc.

The contract with J&J alone calls for Emergent to manufacture 1 billion doses of the COVID vaccine. The U.S. federal government plans this week to purchase an additional 100 million of J&J’s single-shot doses for Americans, on top of an original 100 million doses purchased last summer as part of Operation Warp Speed.

Emergent is one of 10 companies worldwide helping to produce the J&J vaccine, according to J&J’s website...

The COVID contracts helped to sharply boost Emergent earnings last year. The company reported revenue over $1.6 billion for 2020, up 41% from 2019. Its net income jumped to $305.1 million, up from $54.5 million in 2019."

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

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.


Anonymous said...

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


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. said...

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 said...

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.


Meryl Nass, M.D. said...

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. said...

The NYT is taking credit for cancelling Biden's visit to the EBS "large plant" and alerting us to its hisotry.