Sunday, April 4, 2021

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 money will Emergent receive as a result of this contract modification?  How much will the taxpayers have to foot?  

UPDATE April 5:  It took a week of negotiation to arrange for J and J to manage the Emergent factory, and to move out the A-Z vaccine. Why a week?  Because Emergent had to come out of its failure with lots of extra money. Mark my words. From the WaPo:

A senior administration official, who spoke on the condition of anonymity to discuss the sensitive matter, said health officials had negotiated for more than a week for an arrangement, announced late Saturday, under which Johnson & Johnson would take over responsibility for manufacturing at the plant.

From today's NY Times:

The Biden administration on Saturday put Johnson & Johnson in charge of a Baltimore contract plant that ruined 15 million doses of its Covid-19 vaccine, and moved to stop the facility from making another vaccine, developed by AstraZeneca, senior federal health officials said.

The extraordinary move by the Department of Health and Human Services will leave the Emergent BioSolutions facility solely devoted to making the Johnson & Johnson single-dose vaccine and is meant to avoid future mix-ups, according to two senior federal health officials. Johnson & Johnson confirmed the changes, saying it was “assuming full responsibility” for the vaccine made by Emergent.

The change came in response to the recent disclosure that Emergent, a manufacturing partner to both AstraZeneca and Johnson & Johnson, accidentally mixed up the ingredients from the two different vaccines, which forced regulators to delay authorization of the plant’s production lines.

Federal officials are worried that the mix-up will erode public confidence in the vaccines, just as President Biden is making an aggressive push to have enough vaccine doses to cover every American adult by the end of May. At the same time, there is deep concern about the safety of the AstraZeneca vaccine, amid a health scare that has prompted some European countries to restrict its use...

Experts in vaccine manufacturing said that in the past, the Food and Drug Administration had a rule to prevent such mishaps by not allowing a facility to make two live viral vector vaccines, because of the potential for mix-ups and contamination...

UPDATE April 5: from Fierce Pharma, it is starting to look like the US government may jettison the Astra-Zeneca Covid vaccine.  After all, who would take it, given what is known about brain blood clots from its European rollout?
"With the Biden administration ordering Johnson & Johnson to take over an error-prone Emergent BioSolutions plant in Baltimore, AstraZeneca needs to secure new manufacturing capacity. The United States will assist in that search.
AstraZeneca is working with the government's Biomedical Advanced Research and Development Authority to “maximize and accelerate US production of COVID-19 vaccines,” the company said in a statement.  
Emergent’s Baltimore-Bayview facility had been helping with vaccine production for AstraZeneca. Another CDMO, Catalent, is helping to produce the shot for the British drugmaker at another plant in Baltimore.
AstraZeneca has agreed to supply the U.S. with 300 million vaccine doses, but last week NIAID Director Anthony Fauci said supply from the company may not be necessary to vaccinate the population.


Dr Chris King said...

Dr Nass, thank you again for staying on top of all this and pulling together resources I may not otherwise have come across. Once I've skimmed the news to see where my attention is supposed to be diverted today, your blog is my first read of the day. I have shared items from your blog several times already.

Many thanks for your efforts!!

lynnbrad said...

It is my first read daily, as well. Many thanks, Dr. Nass. Lynn Bradbury