Emergent BioSolutions/EBS is the company whose products you don't want injected in you. So what if the company claims they can make a billion doses of Covid vaccine a year. Doses of usable vaccine?
EBS has been making Covid vaccine for Janssen, a subsidiary of Johnson and Johnson, which designed a Covid vaccine but is not actually manufacturing it. J and J's Covid vaccine was "authorized" but not approved or licensed by FDA last week.
While the FDA authorization letter didn't specify this, the NY Times discovered and the WaPo also reported that last week FDA withheld its authorization for the specific vaccine lots manufactured by EBS.
J and J just struck up a partnership with Merck to also produce the vaccine, presumably as a late replacement for the failing EBS product.
The FDA authorization only hints that authorization was withheld for some manufacturing facilities, by saying:
The manufacture of the authorized Janssen COVID‑19 Vaccine is limited to those facilities identified and agreed upon in Janssen’s request for authorization.
EBS is 99% about getting those fat government contracts, and 1% about making usable products. And frighteningly for all of us, they have contracts to make a total of 7 drugs and vaccines for Covid.
I reviewed the entire sad history of Emergent Biosolutions in my talk for the National Vaccine Information Center's 5th International Conference last October. My talk and all the others can now be viewed for free, here.
The NY Times has published two exposes on this company today. Please be sure to read these articles before deciding to accept any of their products. The NYT articles are:
and
"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...
2 comments:
"While the FDA authorization letter didn't specify this, the NY Times discovered and the WaPo also reported that last week FDA withheld its authorization for the specific vaccine lots manufactured by EBS."
Hello fellow MIT Biology major---well, until I took first term organic chemistry from Daniel Kemp and realized that was my calling in science. Your article would have been better if you'd included links to the NYT and Washington Post articles noting the issue with Emergent BioSolutions, which I've been hearing bad things about for a long time. So I did a little searching and confirmed it for the NYT, couldn't find a Post article:
"This week, states will receive 3.9 million Johnson & Johnson doses that were manufactured at a Dutch plant and bottled in Grand Rapids, Mich. Johnson & Johnson is expected to mass produce the vaccine at a new plant in Baltimore that is operated by a company called Emergent BioSolutions....
The Food and Drug Administration’s authorization for emergency use, granted late Saturday, covered the Dutch production lines and the Grand Rapids bottling operation. In about two weeks, federal regulators are expected to decide whether to amend that authorization to include the plants in Baltimore and Indiana, according to two people familiar with Johnson & Johnson’s operations who were not authorized to speak publicly.
At least until then, they said, supply would be uneven and limited."
And I can confirm my state isn't getting doses when they expected them.
Bad to hear Novavax contracted with them for production, it's one of the high efficacy vaccines according to the U.K. based Phase III trial, unlike AZ/Oxford which has been a general train wreck since Oxford created and started testing their vaccine platform almost a decade ago, and as far as I know no AZ/Oxford doses for export are being made by EBS, something I've been wondering about for a while. Will be interesting to see if the FDA approves EBS, general population vaccines that are poorly manufactured aren't going to be anything like their producing an already not very good vaccine for the military or a stockpile where its never tested in the real world.
THANK YOU!! I had read both the WaPo and NYT articles several days ago but just could not find them when I searched today. WaPo article gave credit to the NYT for this information.
Now we have to wait another 10 days or so to see if EBS gets the green light.
Is FDA actually performing inspections?
Is Joe Biden's visit to the plant next week supposed to signal to FDA that it better roll over?
Post a Comment