Friday, March 26, 2021

Is Emergent BioSolutions authorized? Why have they shipped Covid vaccine for bottling? No one's telling/ Roll Call

The Capitol Hill rag Roll Call is just as flummoxed as I am over the Janssen/ Johnson and Johnson Covid vaccine being produced by Emergent BioSolutions.  The FDA told them to ask J and J about it, but J and J declined to answer.  Below is the first part of a long article that in the end tells you very little.  

However, disgraced Robert Kadlec, former Asst Sec for Preparedness and Emergency Response who gave more contracts to Emergent (his former client) than to any other company, and couldn't afford to procure a machine that made N95 masks nor buy masks or PPE because he was wasting his billions on anthrax and smallpox vaccines from Emergent--well, he is back in business on the Hill.

Kadlec got a job with disgraced Senator Burr, the Pharma industry Senator who was investigated for insider trading last February 2020, after getting secret briefings about the pandemic. Cronies who play together, stay together.

From Roll Call

A pharmaceutical contractor under scrutiny for its ties to former government officials could be one of the bottlenecks holding up the production of millions of Johnson & Johnson COVID-19 vaccines.

Emergent BioSolutions, the U.S. company making “drug substance,” the active ingredient in the vaccines, is still awaiting regulatory approval, according to a person familiar with the process. Emergent-made doses were not included in the paperwork Johnson & Johnson submitted to the Food and Drug Administration.

Johnson & Johnson is due to deliver 20 million doses by the end of March, but just 4.7 million have been delivered, according to the Centers for Disease Control and Prevention.

The FDA declined to respond to questions, directing questions to Johnson & Johnson.

“We expect to ship 20 million doses by the end of March,” Johnson & Johnson spokesperson Jake Sargent said in an email, declining to share details on when supply will begin to ramp up and to what degree the delay is related to Emergent....


Anonymous said...

The article from The Hill is curious to say the least. It almost sounds like they're describing a giant Ponzi scheme.
Sure would like to get a sample of the "drug substance" for independent analysis.

Yvette said...

Meanwhile on vaccine certification - the UK has issued a call for evidence on covid status certification, "to consider the ethical, equalities, privacy, legal and operational aspects of a potential certification scheme" and welcomes input - closing March 29 (short notice - it opened March 15)

Apparently even the EU doesn't think vaccine passports should exist. It's discussed under the draft resolution for "Covid-19 vaccines: ethical, legal and practical considerations."

See section 7.5.1 Amendment 1 (with 96 voting in favour and 15 against this amendment)

"In the draft resolution, after paragraph 7.5.1, insert the following paragraph:

“use vaccination certificates only for their designated purpose of monitoring vaccine efficacy, potential side-effects and adverse events;”


Vaccination certificates should not be used as a “vaccination passport” (at borders, in aviation, or for access to services). Such use would be unscientific in the absence of data on the effectiveness of the vaccines in reducing transmission, the length of any acquired immunity, as well as the percentage of “failure” to produce immunity due to new variants, viral load and delayed second doses. Such use would also pose privacy concerns, and, taking into account the limited availability of vaccines, may perpetuate and reinforce exclusionary and discriminatory practices."

Anonymous said...

I wonder if we know if J and J is manufacturing through this plant yet? I get that, from you DR Nass and your work that even if they do get FDA approval, we would wonder if the quality control is really there at this plant.

Anonymous said...

Apparently today they still don't have the "authorization" to manufacture, but perhaps they are just "practicing." ??

"This quality control process identified one batch of drug substance that did not meet quality standards at Emergent Biosolutions, a site not yet authorized to manufacture drug substance for our COVID-19 vaccine. This batch was never advanced to the filling and finishing stages of our manufacturing process.

This is an example of the rigorous quality control applied to each batch of drug substance. The issue was identified and addressed with Emergent and shared with the United States Food & Drug Administration (FDA).

Quality and safety continue to be our top priority. Therefore, as we continue to work with FDA and Emergent toward the Emergency Use Authorization of the Emergent Bayview Facility, Johnson & Johnson is providing additional experts in manufacturing, technical operations and quality to be on-site at Emergent to supervise, direct and support all manufacturing of the Johnson & Johnson COVID-19 vaccine."