Serious concerns erupted after Johnson & Johnson manufactured 15 million vaccinations with the active ingredient of AstraZeneca Covid-19 vaccination that has not been approved for use in the United States, This figure represents 3/4th of the estimated production goal for Johnson & Johnson for the month of March.
Emergent Biotech, a subscontractor for both J&J & AstraZenca, manufactures the active ingredient for both companies Covid-19 vaccinations, a complex and multi-step process that requires two months to grow the cell material for the Johnson & Johnson vaccine.
(Story update April 19, 2021, Emegent Biosolutions Plant Shutdown by FDA in Severe Blow to Johnson & Johnson Covid-19 Vaccine Program, Emergent Produces Active Ingredient for J& J Covid-19 vaccinations)
Update: April 22,2021: Other Doses Compromised According to FDA Report
“There is no assurance that other batches have not been subject to cross-contamination,” the F.D.A.’s 12-page report states.
Update April 12, 2021: New York Times report up to an additional 62 million doses may be contaminated with the AstraZeneca active ingredient, a review is in process.
Emergent Biotech is now under inquire for securities fraud, on behalf of investors in the company.
A simple error and mix-up, this is not.
Johnson & Johnson vaccination production was halted at it Maryland facility after it was discovered that the plant had manufactured 15 million vaccine doses with the active ingredient in the AstraZenca vaccination. The company's target for March was production of 20 million Covid-19 vaccinations, so this number constitutes a majority of the company's stated March goal per the Baltimore Sun;
"New Jersey-based J&J (NYSE: JNJ) has said it will deliver more than 20 million doses to the U.S. by the end of March, and 100 million doses in the first half of 2021. The company last year inked a five-year, $480 million agreement with Maryland's Emergent BioSolutions Inc. to manufacture its Covid-19 vaccine at Emergent's facilities in East Baltimore"
The incident occurred at Emergent BioSolutions, a subcontractor for Johnson & Johnson in Baltimore, Maryland:
"Workers at a plant in Baltimore manufacturing two coronavirus vaccines accidentally conflated the ingredients several weeks ago, contaminating as many as 15 million doses of Johnson & Johnson’s vaccine and forcing regulators to delay authorization of the plant’s production lines".
Emergent BioSolutions partnered with both Astrazeneca and Johnson & Johnson to manufacture the companies' Emergency Use Covid-19 vaccinations. Emergent produces the active ingredients for both companies Covid-19 vaccinations.
'Under the agreement, valued at approximately $135 million, Emergent will provide drug substance manufacturing services with its molecule-to-market CDMO offering, supported by investments from Johnson & Johnson beginning in 2020, and will reserve certain large-scale manufacturing capacity to pave the way for commercial manufacturing of Janssen’s adenovirus-based COVID-19 vaccine beginning in 2021.
To support Johnson & Johnson’s goal of supplying one billion doses of a COVID-19 vaccine, a long-term commercial manufacturing agreement is under negotiation for large-scale drug substance manufacturing anticipated to begin in 2021.
Large-scale manufacturing of drug substance for Johnson & Johnson’s vaccine candidate will be done at Emergent’s Baltimore Bayview facility, a Center for Innovation in Advanced Development and Manufacturing (CIADM) designed for rapid manufacturing of vaccines and treatments in large quantities during public health emergencies. Emergent’s CIADM is a result of a public-private partnership with the U.S. Department of Health and Human Services (HHS)'
''GAITHERSBURG, Md., June 11, 2020 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE:EBS) today announced it will deploy its molecule-to-market contract development and manufacturing (CDMO) services to support the manufacturing of AstraZeneca’s vaccine candidate for COVID-19, AZD1222, a viral vector-based, weakened version of adenovirus containing the genetic material of SARS-CoV-2 spike protein, developed by Oxford University’s Jenner institute working with the Oxford Vaccine Group"
Astrazeneca is not approved for use in the United States, and numerous countries have paused or ceased administration of the Astrazenca vaccination entirely due to blood clotting issues and deaths reported post vaccination with the product. There have been similar reports of adverse reactions with the Johnson & Johnson Covid-19 vaccine.
New York Times had printed a story in early April documenting millions of AstraZenca vaccines were sitting around in warehouses despite no FDA approval for the drug. AstraZeneca has since been banned and halted in numerous countries due to blood clotting issues.
"J&J locked arms with Emergent in April 2020, enlisting the lesser-known company to manufacture the vaccine J&J was developing with federal money. At the time, Emergent’s Bayview facility wasn’t scaled for making millions of doses of a potential COVID-19 vaccine, according to the FDA records, which describe the plant as a contract testing laboratory that “did not manufacture products for distribution.”
Upgrades in technology and personnel were required before Bayview could begin making what is known as “drug substance” material for the vaccine, a two-month process during which the required biological cells are grown'
Emergent has a history of violations and was cited by Federal authorities last April with problems with Anthrax testing, during the same time Emergent was awarded the Johnson & Johnson contract financed with federal money;
"The FDA inspected Emergent’s Bayview plant in April 2020, just as the agreement with J&J was being announced. The federal agency criticized Emergent for problems with its testing of a potential treatment for anthrax, according to the records obtained by the AP';
The company's responsibility for creating the active ingredient and the complexity of generating and growing the biological cells raises serious question around why 15 million doses were impregnated with the Astrazeneca's active ingredient.
It would not be just a simple swap of the ingredient between vaccinations, but a multi-week and multi-step error to get the wrong active ingredient into the Johnson & Johnson vaccines as the company has to manufacture (grow) the active ingredient, itself on a mass scale.
"Workers at Emergent BioSolutions, the manufacturer for AstraZeneca and J&J, conflated the main ingredients for coronavirus vaccines, according to the paper. The J&J doses that are being distributed across the U.S. now were all created in the Netherlands under federal approval, so the error won’t effect the current flow of vaccines"
However, the article also states that only 4,000,000 vaccines were to be provided by the Netherland manufacturer for March, so clarification is needed on where the other 16,000,0000 doses for the US distribution originated:
"J&J's first round of roughly 4 million doses was manufactured at its Dutch plant, according to reporting in the Baltimore Sun. But the Baltimore facility is expected to supply future doses to be distributed across the U.S."
"The company says it is pleased to have delivered “enough single-shot vaccines by the end of March to enable the full vaccination of more than 20 million people in the United States” and plans to deliver 100 million single-shot doses by the end of May"
Further investigation and clarification is needed on the exact number of Johnson & Johnson Covid-19 vaccinations distributed from Emergent's Maryland production facility.
Answers are needed on where the remaining 16 million doses originated outside of the four million distributed from the Netherland facilities, and if any of the Johnson & Johnson vaccines, J& J reports as distributed, did in fact originate from the Maryland facility. And, if so, were any of the vaccinations administered to the American public due to discrepancies. The company has admitted directly it has delivered 20 million vaccines.
According to the New York Time, Emergent has manufactured tens of millions of doses of Covid-19 vaccinations for AstraZeneca in anticipation of US approval of the controversial vaccination:
"Emergent BioSolutions, a company in Maryland that AstraZeneca has contracted to manufacture its vaccine in the United States, has also produced enough vaccine in Baltimore for tens of millions more doses once it is filled into vials and packaged, the official said"
There is serious question as to why Emergent went ahead with manufacturing dosages of AstraZeneca before approval of the vaccination in the United States at such a large volume. The future of the Astrazenca remains in doubt after Norwegian academics and physicians found a direct correlation between the AstraZenca & blood clots last week:
This story comes at a time when there is growing concern of vaccine safety issues with all of the current US approved Covid-19 vaccinations with over 50,700 post vaccination adverse events recorded on the VAERS system and over 2,100 deaths.
A quarter of deaths are occurring within a day post vaccination, and more than half of all deaths are reported to be occurring within one week post Covid-19 vaccination.
Many of these deaths involve symptoms listed as FDA side effects of the vaccinations including blood disorders, stroke, cardiac events, and anaphylactic reactions. Concern is growing that the public health officials are not implementing appropriate follow up investigations into these deaths with autopsies failing to be ordered after highly suspect cases, and no adequate monitoring system or uniform criteria for measuring post vaccine adverse events by public health organizations.
Over 32o deaths reported within minute to hours post vaccination, 398 deaths reported within one day post vaccination, 180 reported within two days, 132 at three days, 108 at four days, 81 events recorded at five days, 52 deaths reported at six days, and 70 deaths post vaccination at seven days per VAERS CDC.
83% of VAERS reports are generated from health care provider reports, state reporting agencies, and pharmaceutical companies, the data is credible and majority of reports include notes from relevant agencies.
The New York Times highlighted in February the concerns with the FDA failure to institute an appropriate safety monitoring before mass administration with emergency use only approved Covid-19 vaccinations. Countries with established monitoring systems for vaccine adverse advents are capturing much large number of reports, amplifying concerns that post-injuries and deaths are not being appropriately monitored. For example, the UK Assets system recorded over 116,000 adverse events, as of March 16, 2021, post Covid-19 Pfizer alone with over 3,000 blood disorders registered.
For context, in 1976, the Swine Flu vaccination program was halted in nine states after three deaths were associated with the vaccination program and the entire vaccination program was halted shortly thereafter.
The US response has deviated from many European countries which as halting or ceasing the administrations of Covid-19 vaccinations after less case reports of vaccine associate injury and deaths.
Due to these concerns, health care professionals have created a petition to inform the public around extensively documented and evidence based issues with the Covid-19 testing and vaccination program. The petition may be viewed and signed HERE:
There are currently over 1,00o signatures from the health professional community including medical doctors of diverse specialties, research scientists, registered nurses, physicians assistants, hospital chaplains, respiratory therapists, nurse practitioners, case managers, physicists and many other in relevant fields, as well citizen signatories who are supportive of the health care professional goals.