Claiming that "we're in a hurry" because there's not enough supply of the two COVID-19 vaccines already authorized for emergency use - Pfizer's and Moderna's - members of FDA's committee agreed without dissent to allow a third COVID injection into the U.S. mix.
While the media drummed up enthusiasm for the expanded options, the Washington Post on March 2 offered an even splashier scoop: a "historic" production partnership between J&J and Merck, two pharma giants ordinarily portrayed as "fierce competitors."
Employing hyperbolic language about the "wartime effort" and good "corporate citizenship," public health leaders instantly celebrated the "unusual" arrangement for its potential to double "what Johnson & Johnson could make on its own."
Experts bill J&J's one-dose injections, which are storable for several months at refrigerator temperatures, as the ideal solution for vaccine programs challenged by the trickier storage and handling requirements of the two-dose Pfizerand Moderna shots - an "advantage [that] goes up in neon," Dr. William Schaffner, an internist and infectious disease specialist with Vanderbilt University's Department of Health Policy, told News7 Boston.
Rather than use the messenger RNA (mRNA) technology being deployed for the first time in the Pfizer and Moderna injections, J&J's vaccine (made by the company's Janssen Pharmaceuticals subsidiary) features a genetically engineered "viral vector" design reliant on a weakened common-cold virus called adenovirus 26.
Adenovirus vaccines have a lengthy history of use in the U.S. military, but the FDA's emergency green light for J&J's COVID injection represents the first time the agency has authorized an adenovirus-vectored vaccine for civilian use.
As J&J describes them, adenoviruses are "good for transporting things into humans." In the case of the COVID vaccine, the aim is to shuttle genetic instructions - DNA coding for the coronavirus spike protein - into the cells and force the cells to make spike protein. In theory, these "self-made spike proteins" are then supposed to train the body to "detect and terminate any real SARS-CoV-2 infections before the virus wreaks havoc."
Although the mode of delivery is different from the lipid nanoparticles (what CNN describes as "delicate little balls of fat") that function as a carrier system for the Pfizer and Moderna mRNA vaccines, all three FDA-authorized COVID vaccines share the same novel goal of getting the body to manufacture spike protein - a goal that represents a radical departure from traditional vaccines.
A University of Tennessee microbiologist told Knox News that J&J's approach is immunologically powerful, stating that the modified adenovirus vector is "about as subtle as a wrecking ball" and "very visible to the immune system."
According to a May 2020 article in Chemical & Engineering News, the adenovirus approach - with 30 years of study behind it - has a "checkered past," including as a "failed gene therapy."
Undaunted by adenoviral vectors' ability to generate dramatic and even fatal inflammatory effects, vaccine researchers embraced the strategy, only to discover that booster shotsmight "unleash an antibody attack on the vaccine itself."
In 2007, Merck encountered yet another problem when it conducted clinical trials for an adenoviral-vectored HIV vaccine that, paradoxically, increased the risk of HIV infection in a subset of recipients - a cautionary tale that "put a big kiboshon adenoviruses" for some years thereafter.
In response to the FDA's emergency authorization of J&J's COVID-19 vaccine, the Catholic Archdiocese of New Orleans and Catholic leaders in St. Louis immediately pronounced the injection "morally compromised," citing the company's "extensive use of abortion-derived cell lines" and urging local Catholics not to take it. These objections are in the same vein as a letter submitted to the FDA a year ago by the U.S. Conference of Catholic Bishops, which expressed concern about the development of COVID-19 vaccines reliant on "ethically problematic" cell lines.
The cell line in which Janssen grows its adenovirus vector is a human embryonic cell line called PER.C6. The retinal tissue that launched the cell line was obtained following the elective abortion of a healthy, 18-week-old fetus. The AstraZeneca-Oxford COVID vaccine uses a different human embryonic cell line called HEK293T to propagate its adenovirus.
To produce a continuous cell line of this type - what is called an "immortalized" cell line - scientists must artificially manipulate the original cells, which otherwise would have finite lifespans. This is accomplished by introducing chemical exposures or rendering them cancerous. Because this manipulation introduces genetic changes into the cells, "cell populations and cellular mechanisms are altered."
A senior FDA official warned over two decades ago about the inherent risks of using continuous cell lines for vaccine development, noting that such cell lines, "by definition" have abnormalities, and worriedly acknowledging their "potential for growing tumors in laboratory animals."
An FDA document published in late 2020 shows that these issues are far from resolved; explicitly referring to cell lines such as PER.C6 and HEK293T, the FDA author states: "The use of tumorigenic and tumor-derived cells is a major safety concern" and observes that the cell lines contain "latent" or "quiet" threats that "might become active under vaccine manufacturing conditions."
The fact sheet for healthcare providers administering the J&J COVID vaccine specifies that each dose of vaccine "may ... contain residual amounts of host cell proteins ... and/or host cell DNA," but the simplified fact sheet intended for vaccine recipients and their caregivers does not.
That means that unless vaccine recipients seek out the healthcare provider fact sheet, they'll be unaware of this potentially crucial piece of information.
The Italian vaccine research and advocacy organization, Corvelva, which has conducted detailed studies of DNA from aborted fetal cell lines in vaccines, warns that such DNA is abnormal and potentially tumor-causing. Corvelva concludes that vaccines of this type "should be considered defective and potentially dangerous to human health."
Along with a variety of other inactive ingredients, the J&J COVID vaccine also includes polysorbate-80, a stabilizer that studies have shown capable of transporting other substances across the blood-brain barrier.
Merck, for example, paid out $4.85 billion in 2007 after pleading guilty to criminal charges over illegal marketing of its lethal drug Vioxx. The company has gone on to face numerous other allegations of fraud, deceit and negligence, including for its measles, mumps and rubella (MMR) and human papillomavirus (HPV) vaccines.
For its part, J&J's recent criminal history includes:
A 2013 order by the U.S. Department of Justice to pay $2.2 billion in civil and criminal fines related to the antipsychotic drug Risperdal and two other drugs, following aggressive off-label marketing and other dubious practices such as fraud and kickbacks.
A 2019 award by a Philadelphia jury of $8 billion in punitive damages to a man alleging that J&J failed to warn that Risperdal could lead to breast growth in boys. Thousands of other lawsuits against J&J feature the same allegation.
A $572 million judgment against J&J by the state of Oklahoma in 2019 for the company's role in the opioid crisis.
$3.9 billion set aside for 25,000 lawsuits related to J&J's asbestos-tainted baby powder. And a 2018 Missouri verdict, "one of the largest punitive-damages awards in U.S. legal history," was reached after internal documents showed that the company had been aware of the baby powder contamination since the 1970s.
In the wake of these scandals, The Guardian wrote in 2019 that "experts are concerned that one of the world's most recognizable names and most reliable and valuable companies is caught in no less than an existential crisis." Citing the "product misfires," "court judgments" and stark reputational decline, the British news outlet asked, "what happened to Johnson & Johnson?"
With the advent of J&J's COVID vaccine (an injection already being hawked as a "vaccine for the world" and the potential "end of the pandemic"), it appears that The Guardian has its answer: J&J will send its former woes down the memory hole, an obliging media will ignore the spotty safety record of past adenovirus vaccine attempts (including J&J's paused clinical trial last October) and a to-be-determined number of COVID-frightened Americans - tempted by the ease of a single shot - will line up for J&J's investigational injection that, in the FDA's own words, is "not licensed for any indication."
Sadly, many of these individuals will be unaware that, unlike with dangerous drugs, they cannot sue indemnified COVID vaccine manufacturers should anything go wrong.