by Fabio Giuseppe Carlo Carisio for VT Europe
What can trigger the contamination of the human adenovirus vector-based Janssen vaccine with the chimpanzee one used by AstraZeneca for its inactivated virus-based Covid-19 antidote?
The question is absolutely disturbing and projects the daily emergency of the global immunization plan, focused on vaccines that are still totally experimental, towards a biochemical science fiction horizon, unfortunately, has already become reality with the birth of the Chinese twins with DNA modified thanks to the Crisp-9 technology. allowed her inventors to win the Nobel Prize in Chemistry in 2019.
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A sensational investigation by the New York Times tears the veil on the scandal of a pharmaceutical company in Baltimore (Maryland), Emergent BioSolutions, revealing that the lack of suitable quality certifications for the anti-Covid vaccines of the factory, partner in the production cycle of the “serums” designed from the Anglo-Swedish AstraZeneca with Jenner-Oxford and from the American J&J with the contribution of the Belgian subsidiary Janssen, it was not only a bureaucratic and formal problem.
As many as 15 million Johnson & Johnson doses, the second half of the NYT official sources, were destroyed because they were tainted. And before that, millions more AstraZeneca’s because they do not comply with purity and safety standards.
But a huge mystery hovers over the batches of Janssen vaccine (trade name of the product J&J) because they were produced in February during the processing cycle of those batches found to be contaminated with the inactivated Vaxzevria virus (new trade name of the AstraZeneca patent adopted after the finding of rare cases of thrombosis, even fatal).
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This is why, as the New York Times writes, the Baltimore problem extends to three continents where health authorities have suspended the administration of those batches as a precaution to verify their effective safety after the American Food and Drug Administration prevented them distribution in the USA.
Strict controls have also been placed on Emergent BioSolutions, which has been a government-funded company for years and has been very active in lobbying Washington politicians to secure financial speculation on vaccines, including a massive supply of an antidote against anthrax in prevention of a only hypothetical bioterrorist alarm.
Millions of those doses ended up in Canada, South Africa and the European Union, without knowing which countries they arrived in and how health officials will discover any contaminated batches in the face of a pressing request from European governments on the availability of vaccines.
The real danger is that the same pandemic emergency that has led international pharmaceutical control agencies to rapidly authorize experimental antiCovids (with the exception of the Russian Sputnik V used in 60 nations of the world but not yet in the European Union with the exception of Serbia and San Marino) leads the health authorities to hasty checks with the real risk that some contaminated batches end up being administered.
GEOPOLITICAL WAR-GAMES ON VACCINES
Precisely for this reason the US has already got its hands on claiming that none of those suspected contamination vaccines have been distributed in the Confederate states. Also because the production of those of AstraZeneca is not a Washington problem because this antidote has not yet been authorized in the States that rely on the two vaccines financed by Bill Gates (Moderna and Pfizer-Biontech) and on the latest arrival Janssen of J&J.
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Before going into detail, it is good to understand that there are colossal economic and geopolitical interests at stake given that Gates and Pfizer were among some of the most important donors of American President Joseph Biden and, therefore, in the background of a journalistic scoop on the plant funded from his predecessor Donald Trump, the virulent germs of a global financial war on vaccines could also lurk, already underway since the Microsoft tycoon effectively forced Big Pharma to unite in a cartel to support the immunization project in poor countries COVAX of WHO, managed by Gates’ NGO GAVI and administered by a former GSK manager, who controls Pfizer’s pharmaceutical sales network, in macroscopic conflicts of interest.
«Quality-control problems at a Baltimore plant manufacturing Covid-19 vaccines have led health officials on three continents to pause the distribution of millions of Johnson & Johnson doses, as the troubles of a politically connected U.S. contractor ripple across the world» reporters Chris Hamby, Sharon LaFraniere and Sheryl Gay Stolberg wrote in the New York Times yesterday, Thursday 6 May 2021.
«Doses made at the plant owned by Emergent BioSolutions have not been cleared by the Food and Drug Administration for use in the United States, and the Biden administration has repeatedly assured Americans that none of the Johnson & Johnson shots administered domestically were made there» adds NYT which then raises the alarm.
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«But millions of doses have been shipped abroad, including to Canada, the European Union and South Africa. Regulators in various countries are now working to ensure that those doses are safe after the disclosure in March that workers at the Baltimore plant accidentally contaminated a batch of Johnson & Johnson’s vaccine with the harmless virus used to manufacture AstraZeneca’s. Both vaccines were produced at the same site. The mistake forced Emergent to throw out up to 15 million Johnson & Johnson doses after tests showed that the batch failed to meet purity requirements» explain the journalists of the newspaper of the Big Apple in the third report on the issue that goes well beyond the problems of bureaucratic certifications.
According to the New York Times, E.U. officials, as well as those in Canada and South Africa, said there was no evidence that any of the doses they had received were tainted. But the problems identified in Baltimore have slowed their vaccination efforts while they perform additional quality assessments as a precaution.
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However, this caution was already justified by the fact that, as highlighted in our previous investigations, the balance of adverse reactions of vaccines exploded in March (according to data from EudraVigilance, the pharmacovigilance body of the European Medicines Agency) with a very high rate of undesirable effects for AstraZeneca and J&J antidotes, despite being administered to very few people at the time. While hundreds of deaths from Covid-19 have also been recorded among the vaccinated, especially with Pfizer’s “gene therapy”.
Despite this, just today, NBC News announced a breaking news regarding the American company. «Pfizer and BioNTech asked the Food and Drug Administration Friday for full approval of the companies’ Covid-19 vaccine. If approved, it would be the first Covid-19 vaccine in the United States to hold that distinction. The vaccine was the first to be granted an emergency use authorization in December for use in the U.S. Full approval could make vaccination mandates more widespread».
But back to the Baltimore case of J&J production: «Some doses from a single batch of the vaccine produced at Emergent are being administered in Europe, without problem, officials said. In addition, about six million to nine million more doses are now on hold there and in the other countries because they came from batches that were produced in the same manufacturing suite and over the same two-day period in late February when the contamination occurred, according to health officials familiar with the situation».
«The F.D.A. has now called into question the equivalent of about 70 million doses from the plant, most of it intended for domestic use, and may decide that none of that vaccine can be released in the United States, those officials said» add journalists Hamby, LaFraniere and Stolberg.
REASONS OF CONTAMINATION AMONG VACCINES
«One likely cause of the contamination is the failure of some employees to shower and change clothes as required when they moved between the factory zones dedicated to AstraZeneca and Johnson & Johnson, inspectors found. Safety tests identified traces of AstraZeneca’s virus in one batch of Johnson & Johnson’s vaccine before it ever left the factory, but the F.D.A. is concerned that similar checks might have missed some lower-level contamination of the other batches that were produced simultaneously, according to a federal official who spoke on the condition of anonymity in order to describe internal discussions».
In a statement to The New York Times, an F.D.A. spokeswoman said the agency was “in close communication with our foreign regulatory counterparts regarding this ongoing matter to ensure they’re aware of the situation.”
NYT therefore points out that it is underway a discussion among regulators about balancing the need to save lives with the risk of using the questioned doses, even as it remains unclear what, if any, health consequences there would be.
And it adds, cheering a little on the other vaccines, that regulators in the United States have latitude to be cautious: The nation is awash in doses from two other federally authorized manufacturers, Pfizer-BioNTech and Moderna. The European Union has also secured ample supplies of Pfizer’s and Moderna’s shots and, like the United States, expects that about 70 percent of its adults will have received at least one dose of vaccine by July.
«But the situation is different in countries like South Africa where the percentage of vaccinated residents is much lower and vaccine supplies are significantly tighter. In Canada, most provinces have opted to delay second doses of Pfizer, Moderna and AstraZeneca for four months, except for unusually vulnerable people, to maximize the number who are at least partly protected» Times highlights.
EUROPEAN DRUG REGULATOR STATEMENT
The European Union’s drug regulator, the European Medicines Agency, said in a statement to The Times that one batch of vaccine manufactured at the Emergent facility “is being used” after “a thorough testing of the batch and a review of the controls in place at the manufacturing site.” There is no indication of any problems with those doses.
That batch was distributed for use in the European Union only after meeting “the rigorous quality standards of our company and the European Medicines Agency,” Johnson & Johnson said in a statement.
Two more batches, amounting to about 2.5 million doses, are on hold as regulators in Europe and the United States investigate the cause of the contamination at the Emergent plant and ensure that problems have been fixed, the E.M.A. said. “When the investigations conclude, E.M.A. may decide on actions to prevent future contamination of batches,” the statement said.
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In South Africa, doses are sitting in a facility awaiting “a protracted safety verification process with international regulatory agencies,” the nation’s health minister said in a statement. “This is a precautionary measure following the adverse findings” at the Emergent plant, said the minister, who also expressed hope that the held-up doses could be cleared “by the middle of May.”
Under its contract with Johnson & Johnson, Emergent manufactured the active ingredient for the vaccine in bulk, and the substance was then sent to other facilities for final processing and packaging. One of the sites performing these final manufacturing stages is a plant run by the South African company Aspen Pharmacare. Johnson & Johnson announced in March that the site would support the company’s pledge to provide vaccine to countries throughout Africa.
The Canadian regulatory authority, Health Canada, said in a statement that officials were working with Johnson & Johnson and the F.D.A. to perform further assessments of vaccine manufactured at the Emergent facility and that the doses “will only be released for distribution once Health Canada is satisfied that they meet the Department’s high standards for quality, safety and efficacy.”
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The newly disclosed delays underscore the global impact of the problems at the Baltimore factory operated by Emergent, a government contractor known for its aggressive lobbying and political connections.
As previously reported by the NYT, the federal government last year banked on Emergent to be the main domestic manufacturer for both the Johnson & Johnson and AstraZeneca vaccines even as evidence of serious quality problems mounted.
Though the government of the Trump administration (hence the political nuance of the journalistic investigation) awarded Emergent a $163 million contract in 2012 to ready the Baltimore plant to make vaccines in response to a pandemic, «the company had not met a key requirement for demonstrating large-scale manufacturing ability as a June 2020 deadline neared. That month, however, federal officials nonetheless announced a new $628 million deal, most of it to reserve manufacturing capacity at the Baltimore plant for Covid-19 vaccine». This had caused the shares of the Maryland pharmaceutical company to skyrocket ..
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«Emergent has repeatedly touted its influence in Washington in presentations to investors. Six of its 10 board members have previously served in government, and since 2010, the company has spent an average of $3 million a year on lobbying — far outspending similarly sized biotech firms, and roughly matching the outlays of some larger pharmaceutical companies» concluded Times.
However little or nothing compared to the shady ties that emerged in connection with the experiments on the chimeric SARS superviruses infected with HIV pathogen during the Obama-Biden administration, in an intrigue with the CIAand the Bill & Melinda Gates Foundation … then continued in the immunization plan brought forward by Gates with Pfizer-BioNTech and Moderna in synergy with the new president Dem.
Fabio Giuseppe Carlo Carisio
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