Sun Apr 4th, 2021 at 08:25:51 AM EST
FDA has not approved manufacturing of vaccines by Emergent BioSolutions Inc. and has yet to approve the Oxford AstraZeneca vaccine. It is BARDA, a division of the U.S. HHS which took steps and intervened in the manufacturing of Johnson & Johnson to reach standards of quality at the plant.
The AstraZeneca Factory in Baltimore
Emergent BioSolutions has a factory in Baltimore that operates under an innovative long-term private-partnership agreement with BARDA. Essentially BARDA subsidized the factory in return for an option to use it in an emergency-Operation Warp Speed exercised that option and in June-July AstraZeneca signed a licensing agreement with Emergent for large-scale manufacturing of its vaccine.
Emergent BioSolutions Hosts Biopreparedness Roundtable for NATO
Parliamentarians | Press Release - July 2010 |
A long history of poor compliance and governance of quality standards and a number of violations were recorded by the FDA.
Maryland company whose Baltimore factory compromised Johnson & Johnson COVID vaccine doses had history of violations
Emergent's revenues skyrocketed during the Trump administration, from about $523 million in 2015 to more than $1.5 billion in 2020. Emergent has invested heavily in lobbying the federal government, according to disclosure records that show the company spent $3.6 million on lobbying in 2020 alone.
Emergent is one of about 10 compagnies that Johnson & Johnson is using to speed up manufacturing of its recently approved coronavirus vaccine, the company said. The Bayview factory where the tainted vaccine ingredient was found had not yet been approved by the FDA, so no vaccine in circulation is affected. Emergent declined to comment.
Emergent BioSolutions plant that ruined Johnson & Johnson vaccine doses had prior FDA violations | Seattle Times |
Emergent's $628 million Warp Speed deal was made as part of a long-standing contract between the company and the office in the Department for Health and Human Services (HHS) responsible for preparing for public health threats.
At the time of the award, that office was led by Assistant Secretary Robert Kadlec. The Post previously reported that before joining the Trump administration, Kadlec was paid as a consultant to Emergent and formed a startup company with Emergent's chairperson.
Kadlec did not mention either role in a questionnaire about his career that he completed for the Senate when it considered his nomination by Trump in 2017.
Robert Kadlec consultant to Emergent BioSolutions ...
BARDA: Rick Bright's complaint points to the influence of industry over the Trump administration's coronavirus response
How One Firm Put an `Extraordinary Burden' on the U.S.'s Troubled Stockpile | NY Times |
But even as he fretted over the stockpile's lack of preparedness for a pandemic, Dr. Kadlec said, he felt compelled to continue preparing for anthrax and other bioterrorism threats. His office awarded roughly $3 billion in long-term contracts to Emergent in the months before the Covid-19 crisis, and last year decided to buy the company's unlicensed anthrax vaccine -- relying on the same emergency authority that has allowed the use of unlicensed coronavirus vaccines and treatments.
AstraZeneca, Emergent BioSolutions sign $87M deal to produce U.S. supply of COVID-19 vaccine | Fierce Pharma – June 11, 2020 |
AstraZeneca made waves last week when it signed a massive $750 million deal to ramp production of a University of Oxford COVID-19 vaccine up to 2 billion doses per year. Now, as part of a Trump administration effort to get shots into U.S. hands as soon as possible, AstraZeneca has agreed to another major manufacturing tie-up.
AstraZeneca and Emergent BioSolutions have inked an $87 million deal to manufacture doses of the University of Oxford's adenovirus-based COVID-19 shot for U.S. supply, the companies said.
The manufacturing accord is part of the Trump administration's Operation Warp Speed initiative to develop and rapidly scale production of targeted vaccines before the end of 2020.
As part of the agreement, Emergent will reserve large-scale manufacturing capacity for Oxford's vaccine candidate, AZD1222, at its Baltimore Bayview facility through 2020. The company will also provide contract development manufacturing services to aid AstraZeneca's goal of producing more than 2 billion shots per year by 2021, Emergent said.
AstraZeneca pledges $174M to ramp up coronavirus vaccine supply deal with Emergent | Fierce Pharma – July 27, 2020 |
Despite signing massive deals around the world to produce the University of Oxford's COVID-19 vaccine, AstraZeneca has been relatively quiet stateside. Now, the British drug maker will expand its partnership with a Maryland CDMO to get its U.S. shot manufacturing up and running at full steam.
With a $174 million manufacturing pact signed, Maryland-based Emergent BioSolutions will help produce bulk drug substance for AstraZeneca and Oxford's adenovirus-based COVID-19 shot starting this year.
There goes a large part of the AstraZeneca vaccine manufacturing success story literally … down the drain.
Johnson & Johnson Has Emergency FDA Approval, AstraZeneca Still In Pipeline
In addition, the FDA argument is rational, as a one-shot Covid-19 vaccine is preferred over the two-shot from the British Oxford AstraZeneca …
Covid-19: Johnson & Johnson Put in Charge of Plant That Ruined Millions of Vaccine Doses | NY Times |
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.
It’s Easter Sunday … how will Tory boss Boris Johnson, his acolytes and his British boulevard media react??
A bad week for Conservatives after Mark Rutte’s headache, dropping Baseball’s All Star Game venue at Atlanta and the Yellow Card issues of the AZ vaccine across Europe.