Friday, May 7, 2021

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 to ship out vaccine for Americans, find its way to Europe, South Africa, Canada and Mexico?

How does that happen? When did it happen?

And since it did happen, why would I believe no Americans got the vaccine?  What was FDA's role in this fiasco?

Here's what the FDA's acting Commissioner said on April 21, breaking FDA's long silence about whether the plant was authorized or not:

"... the FDA has not authorized this facility to manufacture or distribute any of Johnson & Johnson’s COVID-19 Vaccine or components and, to date, no COVID-19 vaccine manufactured at this plant has been distributed for use in the U.S..."

Remember, this is not simply about mixing up an ingredient between the Astra-Zeneca and Johnson and Johnson vaccines.  There were many, many problems that led to the loss of millions more doses. The plant was maintained in a slovenly fashion. You can read the latest FDA inspection report here. An April 21 NY Times article summarized the findings:  

A series of confidential audits last year, obtained by The Times, warned about risks of viral and bacterial contamination and a lack of proper sanitation at the Baltimore plant. 

According to the May 6 NY Times:

The F.D.A. has now called into question the equivalent of about 70 million doses from the plant, most of it intended for domestic use, and may decide that none of that vaccine can be released in the United States, those officials said.


Some doses from a single batch of the vaccine produced at Emergent are being administered in Europe, without problem, officials said. In addition, about six million to nine million more doses are now on hold there and in the other countries 

Here is how the FDA's acting Commissioner tried to wriggle out of this mess. It sounds good at first:

For the vaccines already manufactured, the products will undergo additional testing and will be thoroughly evaluated to ensure their quality before any potential distribution. We will not allow the release of any product until we feel confident that it meets our expectations for quality. 

But there is a big problem here. Not just the fact that somebody already did allow the release of product. 

Testing finished vaccine lots cannot identify all the potential serious problems with vaccines.  If it could, it would not matter what shape the factory was in, because you could simply test each lot and throw away any that were bad. The reason FDA plant inspections are so important is because product testing is insufficient to identify potential problems with vaccines.

I clearly recall a GAO report to Congress by Dr. Sushil Sharma about anthrax vaccine (that incidentally had also been made by EBS), which explained this point.  What it means is that Janet Woodcock, the acting Commissioner, is attempting to mislead everyone by claiming that with additional testing, the lots produced while the plant was far out of compliance are not adulterated and can still be used. 

The regulators in the other nations that received the bad lots of J and J vaccine repeated her identical, fallacious excuse.

While Dr. Woodcock is trying to cover her derriere (probably FDA knew about and approved the shipments of vaccine to other nations) there is no way either the FDA nor Emergent can squirm out of the hole they have dug for themselves.  

From the NY Times:

Neither the F.D.A. nor its parent agency, the Department of Health and Human Services, would say what role, if any, the federal government played in the shipment of Johnson & Johnson doses abroad, or when and where they were shipped. White House officials did not respond to repeated requests for comment.

It is strange that after having failed so many prior inspections over 2 decades, Emergent BioSolutions was chosen to lead the US' response to Covid. It is slated to produce 4 vaccines and 5 other Covid medications. 

In a statement to The New York Times, an F.D.A. spokeswoman said the agency was “in close communication with our foreign regulatory counterparts regarding this ongoing matter to ensure they’re aware of the situation...”

Does this mean FDA notified them of the May 6 NY Times revelations, informed them the jig was up, and they needed to come up with a uniform story? 

Emergent referred questions to Johnson & Johnson and the F.D.A. “They control where the product goes after we manufacture it,” Matt Hartwig, a spokesman for the company, said in an email...

The European Union’s drug regulator, the European Medicines Agency, said in a statement to The Times that one batch of vaccine manufactured at the Emergent facility “is being used” after “a thorough testing of the batch and a review of the controls in place at the manufacturing site.” There is no indication of any problems with those doses.

That batch was distributed for use in the European Union only after meeting “the rigorous quality standards of our company and the European Medicines Agency,” Johnson & Johnson said in a statement...

Under its contract with Johnson & Johnson, Emergent manufactured the active ingredient for the vaccine in bulk, and the substance was then sent to other facilities for final processing and packaging...

The thing is, since Emergent knew it had not passed its inspections, it also knew its product could not be approved for use.  So why did it ship it out for final bottling and finishing? Why did J and J collude with them to do so?

Everyone involved in this sordid tale has now gotten burned.  It looks like there is plenty of blame to go around.  The only thing missing is a prosecution.  

The problem is pernicious secrecy. EBS, J and J, FDA and most likely the regulatory agencies of the EU, Canada, Mexico and South Africa had to have known there were problems with this vaccine.  But they chose instead to look the other way, until their charade was uncovered by the New York Times.

And even after recipients started dying from blood clots and bleeding, the regulators, EBS and Johnson and Johnson kept the truth of the substandard vaccine they had released for use close to their chests. 

And now the government regulators are still trying to fake us out by fancifully claiming they can test their way out of this. These same duplicitous apparatchiks were perfectly willing to inject trash into the arms of millions of their fellow citizens.  

And already in Canada, in June in Europe, and next week in the US, it might be injected into the waiting arms of 12 to 15 year olds.

UPDATE May 15:  From the May 11 Senate HELP Committee hearing:

Senator Burr: (46:30) [Senator Burr is the Senator from Pharma, and his aide is Dr. Robert Kadlec, who gave the multibillion dollar contracts to EBS for smallpox vaccine and other products]

Correct me if I’m wrong, I didn’t think the Emergent Baltimore facility had anything to do with AstraZeneca production. Am I wrong, Dr. Marks?

Dr. Peter Marks: (46:40) [who is head of the FDA's Center for Biologics Evaluation and Research]:
Senator Burr, no, the AstraZeneca vaccine was being produced in that {Emergent BioSolutions] facility. The FDA feels it’s imperative that before vaccine can be shipped to any other partner, it has to meet the quality standards that it would meet for any American as well.

Senator Burr: (46:57)
How long do you anticipate that testing the AstraZeneca vaccines that’s currently manufactured would take to verify?

Dr. Peter Marks: (47:04)
We are working on that as quickly as we can. We understand the imperative here. There is a working group across our office of regulatory affairs and our center and others at FDA that are working together to try to clear that, those doses, as quickly as we can. I can’t give you an exact time, but we understand the imperative to be able to have them available so that Dr. Kessler can arrange for them to be shipped to those in need.

So, the special treatment of questionable vaccine lots goes on. How will FDA determine whether to ship out these lots?  Where will they go? 


Anonymous said...

Thank you again for your clear reporting on this. Can't find this kind of hard-hitting summary anywhere else.

Dan Baron said...

🙂 Hi Meryl. You and George Simon remind me of each other. 😉

yvette said...

Thanks Meryl - even in the circles of people I follow who are vaccine skeptical, no one is talking about Emergent Biosolutions. Thank you for keeping this up front for us.