Janssen/ Johnson & Johnson

FDA gives Emergent BioSolutions a consolation prize: it must throw out 60 million vaccine doses but can sell 10 million, which will be labeled as failing GMP standards/ NY Times

Now this is a really odd FDA decision.  FDA is acknowledging that the 10 million doses it is authorizing is adulterated.  But adulterated doses can’t be sold.  But EUA products don’t generally get sold, except to the US government.  I am scratching my head.  I thought all these doses were …

FDA gives Emergent BioSolutions a consolation prize: it must throw out 60 million vaccine doses but can sell 10 million, which will be labeled as failing GMP standards/ NY Times Read more »

The Johnson and Johnson (Janssen) Covid-19 vaccine is being manufactured by the anthrax vaccine company. This is its history / Meryl Nass

Emergent BioSolutions will be in the spotlight today during a House Select Subcommittee Meeting on the Corona Virus Crisis, today at 10:30 am. It can be watched here. Hybrid Hearing on “Examining Emergent BioSolutions’ Failure to Protect Public Health and Public Funds” Below, I provide the backstory aka checkered past …

The Johnson and Johnson (Janssen) Covid-19 vaccine is being manufactured by the anthrax vaccine company. This is its history / Meryl Nass Read more »

The Vaccine Lies that Bind: FDA, EBS, J and J and the regulators of the EU, South Africa, Canada and Mexico

I have repeatedly warned about vaccine that might have illegally sneaked out the back door of the Emergent BioSolutions Bayview Baltimore plant.  How did Emergent-made J and J vaccine, from a factory that was out of GMP compliance on every single one of its FDA inspections, and never received authorization …

The Vaccine Lies that Bind: FDA, EBS, J and J and the regulators of the EU, South Africa, Canada and Mexico Read more »

Emergent BioSolutions to be Called to Account by Congress on May 19

A few short months ago, Emergent Biosolutions was riding high.  Their stock was at $125/share.  They were a $7 billion dollar company.  They were the epitome of how to turn failure into success: never bringing a product they created to market   selling almost exclusively to the government;  selling single-source products, …

Emergent BioSolutions to be Called to Account by Congress on May 19 Read more »

Johnson & Johnson suffers another setback as FDA tells Md. vaccine maker to suspend production/ WaPo

From the WaPo our fears are confirmed–vaccine has been leaking out of this plant despite the fact that the plant was never authorized by FDA.  Still wondering if this was related to some of those clinic shut-downs?The storyline is that the unapproved vaccine went to Canada and Mexico.  Are you …

Johnson & Johnson suffers another setback as FDA tells Md. vaccine maker to suspend production/ WaPo Read more »

Forget the variants, things are going well; but beware of the J and J vaccine when the EBS plant is finally authorized

  In the past week in the U.S. from the WaPo New daily reported cases rose 0.1%  New daily reported deaths fell 15.7%  Covid-related hospitalizations rose 5.3% Read more Among reported tests, the positivity rate was 4%. The number of tests reported fell 4.9%  from the previous week Once FDA authorizes the Emergent BioSolutions plant, tens of millions of doses that were produced there during the period of rampant mismanagement …

Forget the variants, things are going well; but beware of the J and J vaccine when the EBS plant is finally authorized Read more »

European Medicines Association now looking into blood clots and capillary leak syndrome from the J and J vaccine

There is not a lot of data to go on, But during the clinical trials there were more thrmobembolic events in the vaccine group compared to placebo, as well as 3 or 4 arterial clots in the vaccine group but not the placebo group. EMA probing cases of blood clots …

European Medicines Association now looking into blood clots and capillary leak syndrome from the J and J vaccine Read more »

It is a lot worse at Emergent BioSolutions than has so far been said/ NY Times

Potential vaccine recipients are very fortunate that Sheryl Gay Stolberg is still on this beat at the NY Times, after twenty years.  Emergent BioSolutions is a biodefense boondoggle barely pretending to be a pharmaceutical firm.  No one in their right mind would want to be injected with one of their …

It is a lot worse at Emergent BioSolutions than has so far been said/ NY Times Read more »

Just a reminder: Emergent gets paid well, even if clinical trials fail/Fierce Pharma

Reminder–from my post 6 months ago:  October 14: from FiercePharma: Emergent has two contracts with J&J. The first, for setup and tech transfer, is worth $135 million in 2020 and 2021. The second, for drug-substance manufacturing, will pay out $480 million in the first two years…  When added to the value …

Just a reminder: Emergent gets paid well, even if clinical trials fail/Fierce Pharma Read more »

Biden administration puts J and J in charge of the Emergent BioSolutions vaccine plant, and cancels Emergent’s Astra-Zeneca vaccine production

Finally the Biden administration is getting serious about Emergent BioSolutions’ Covid vaccine-making.  I hope they have finally understood that this is not a company that  plays by the rules.  This is a company that has turned repeat failures into a multi-billion dollar business.  Emergent succeeds by failing.  How much extra …

Biden administration puts J and J in charge of the Emergent BioSolutions vaccine plant, and cancels Emergent’s Astra-Zeneca vaccine production Read more »

Scroll to Top