Johnson & Johnson’s single-shot COVID-19 vaccine is less effective against coronavirus variants than the original virus, according to a study posted online Tuesday.
The study, published by bioRxiv but not yet peer reviewed, indicated the vaccine’s effectiveness in neutralizing the Delta and Lambda variants was “significantly decreased.”
However, studies published by Johnson & Johnson earlier this month suggest that its vaccine protects against the Delta strain. It “generated strong, persistent activity against the rapidly spreading Delta variant,” spokeswoman Seema Kumar told The New York Times, which first reported the bioRxiv findings.
The study suggests the 13 million people who received the J&J vaccine may need a second dose — or a dose from either the Pfizer/BioNTech or Moderna shots, the authors said.
“The message that we wanted to give was not that people shouldn’t get the J&J vaccine, but we hope that in the future, it will be boosted with either another dose of J&J or a boost with Pfizer or Moderna,” Nathaniel Landau, the leader of the study and a virologist at NYU’s Grossman School of Medicine, told The Times.
Previous studies have found the two-dose mRNA vaccines made by Pfizer/BioNTech and Moderna effectively protect against the highly contagious Delta strain, which has become the dominant variant in New Jersey and across the U.S.
More than 99% of the hospitalizations and deaths in New Jersey are occurring among unvaccinated people, the state has said in recent weeks. But immunization rates have slowed.
The study is just the latest bad news for New Brunswick-based Johnson & Johnson.
Use of its vaccine was temporarily suspended this spring after reports of life-threatening blood clots. Millions of doses had to be destroyed after contamination issues at a manufacturing plant in Baltimore. And the company continues to be plagued by lawsuits over its talcum-based baby powder, which it no longer sells in the United States, and its role in the opioid epidemic.
Johnson & Johnson’s COVID vaccine missteps continue. Will the N.J. giant’s reputation recover?
Shannon Kelly tried to catch her breath, but her hacking cough wouldn’t allow it.
”I had every single symptom except for a fever,” she said. “I mean, I have shortness of breath. I’ve been in bed. I’ve been sleeping. My cough is terrible.”
The normally healthy 25-year-old struggled to speak Tuesday from her bedroom at her parents’ home in Tabernacle. After being sick for about a week, Kelly learned on April 10 that she has COVID-19.
She had good reason to be. On March 11, Kelly said she received Johnson & Johnson’s single-dose coronavirus vaccine at a CVS in Clementon. The board certified behavior analyst for a private preschool organization became a rare “breakthrough” case, one of the unlucky people who got the vaccine but still contracted the disease.
Then on Tuesday, Kelly’s boyfriend texted her more bad news — use of that vaccine was temporarily suspended by U.S. health regulators after reports of life-threatening blood clots among a handful of its nearly 7 million recipients.
It was only the latest black eye for the once-hallowed Johnson & Johnson brand.
The New Brunswick-based pharmaceutical giant once held the best reputation in the industry. But the decision this week by the U.S. Food and Drug Administration and the Centers for Disease Control and Prevention to halt the use of its vaccine is just another public stumble.
Johnson & Johnson has weathered a series of devastating blows in recent years with billions paid in lawsuits and waning trust in the company, according to some experts.
There were a number of opioid lawsuits, including in 2019 when an Oklahoma judge said J&J created a “public nuisance” with its misleading marketing and promotion of prescription painkillers and ordered it to pay $572 million (later reduced to $465 million). There was litigation over the safety of its talcum powder — including in 2018, when a New Jersey jury ordered the company and its talc supplier to pay $117 million in damages to a man claiming he developed cancer. Johnson & Johnson no longer sells its talc-based baby powder in the United States.
In March, a contamination issue at a manufacturing plant in Baltimore forced the company to destroy 15 million COVID-19 vaccine doses and halt production. Earlier this month, there were reports of people experiencing adverse reactions from the vaccine in Colorado. And now the CDC and FDA halted the vaccine once hailed as a “game-changer” after at least six women between the ages of 18 and 48 developed potentially serious blood clots. One of the women died.
The setbacks sting all the more for a company famous for its trusted household brands such as Band-Aid bandages, Johnson’s “no more tears” baby shampoo and Tylenol. For decades, it took pride in its legendary credo: “We believe our first responsibility is to the patients, doctors and nurses, to mothers and fathers and all others who use our products and services.”
But some experts say the company has put profits ahead of safety.
“JNJ’s famous credo became less of credo and more of a public relations crutch that company executives refer to when they defend the company against their string of failures — from Tylenol manufacturing shutdowns at dirty plants, to morcelators, talcum powder and opioid ingredients,” said Erik Gordon, a professor at the University of Michigan’s Ross School of Business, in an email. “The problem at JNJ isn’t resources, it is culture.”
Johnson & Johnson was heralded for how it handled the 1982 Tylenol crisis, when seven people died in Chicago after extra-strength capsules were laced with cyanide by a saboteur who was never caught. But its status as the gold standard in corporate responsibility has been tarnished by the litany of recent lapses.
Johnson & Johnson once held the nation’s top corporate reputation as recently as 2008, according to an annual survey by the Harris Poll. In 2020, it ranked 68th after falling from No. 33 the previous year.
The company emphasizes that the pause on its vaccine is out of an abundance of caution.
“The safety and well-being of the people who use our products is our number one priority,” the company said in a statement. “We are aware of an extremely rare disorder involving people with blood clots in combination with low platelets in a small number of individuals who have received our COVID-19 vaccine. The United States Centers for Disease Control (CDC) and Food and Drug Administration (FDA) are reviewing data involving six reported U.S. cases out of more than 6.8 million doses administered. Out of an abundance of caution, the CDC and FDA have recommended a pause in the use of our vaccine.”
It’s unclear how long the pause will last, but officials say it likely will end in a few days, and the vaccine will again be administered in New Jersey and beyond.
But will fear inhibit people from getting it?
Despite the attractiveness of a one-dose option — the Moderna and Pfizer/BioNTech shots require two doses — Johnson and Johnson’s vaccine was found to be 66% effective in clinical trials, compared to an efficacy of about 95% for the other two approved in the U.S.
Breakthrough cases are expected for all three vaccines. Since April 13, 5,814 have been reported to the CDC out of more than 75 million vaccinated people in the United States.
In addition to Kelly, there’s at least one other Johnson & Johnson breakthrough case known in New Jersey — an Edison man reportedly hospitalized with COVID-19 nearly a month after getting the shot. But it remains unclear how that compares to the number of cases among people who got the Pfizer or Moderna vaccine.
Meanwhile, the blood clot concerns could have a lasting impact for Johnson & Johnson.
“If you want to survive at JNJ you have to hit your numbers,” Gordon said. “You can cut back on maintenance, safety and inspections, but you cannot miss your numbers. The vaccine was a chance for the company to earn points with the public, but the vaccine problems will be seen, perhaps wrongly but almost surely, as another JNJ product safety failure.”
Financial experts say the vaccine pause won’t necessarily impact the company’s considerable financial stature. Johnson & Johnson, which has 134,500 employees worldwide, generated $82.6 billion in sales last year from its three segments — pharmaceuticals, medical devices and consumer products.
But while its financial position remains strong — its stock closed slightly higher at $160.39 a share Thursday despite a sharp plunge earlier this week — the vaccine debacle could soil its reputation.
“A pause in the US on the use of Johnson & Johnson’s COVID-19 vaccine does not materially change the company’s strong financial profile,” Michael Levesque, a Moody’s senior vice president, said in a statement. “This is due to the profit-free nature of J&J’s vaccine during the pandemic phase, as well as significant global scale and diversity outside of vaccines.
“Nevertheless, the development and distribution of COVID-19 vaccines has both social opportunities and social risks related to reputational considerations.”
However, some feel the criticism of Johnson & Johnson’s vaccine has been overblown. Data, not perception, is the most important factor when it comes to the shot and blood clots.
“I wouldn’t lose sleep worrying over this,” said Dr. David Cennimo, an infectious disease expert at Rutgers New Jersey Medical School. “I think because it is such an exceedingly rare event.”
Cennimo noted that the blood clot risk is literally one in a million. He also said Pfizer and Moderna have had especially pristine rollouts, something he didn’t expect.
“They’re going to look at what really is happening, what is the real-world risk as of right now?” Cennimo said of the FDA and CDC.
Gerald Posner, author of “Pharma: Greed, Lies, and the Poisoning of America,” says Johnson & Johnson’s vaccine failures can largely be attributed to bad luck. But it has an obligation to get it right — especially with all the potential perks and curses that come with bringing a high-profile shot to market.
“There’s nothing specifically that I say, ‘OK, this is a J&J systemic problem, and here’s something that they cut back on in terms of quality control two years ago, and now it’s coming to bite them on the behind,’” said Posner, an investigative reporter and Pulitzer Prize nominee.
The companies that save lives with their COVID-19 vaccines will make money and reap “the halo effect” of good public relations, he added. But “if you stumble — if, for some reason, your vaccine either is linked in the public mind with serious adverse effects, even in small numbers, or you look as though you’re bumbling the rollout, I think it will definitely be worse for you than if you weren’t involved at all,” Posner said.
The next few days and weeks could decide how Johnson & Johnson’s vaccine is viewed.
The blood clot issues are similar to those experienced by recipients of the AstraZeneca shot, which used the same model — known as a viral vector vaccine. AstraZeneca’s vaccine, which has not been approved in the U.S., was paused in Europe earlier this year after reports of rare blood clots in some recipients. Some countries now favor other shots.
“But again, it’s extraordinarily rare … so it’s just — the due diligence is to take a breath and see what we have going on,” Cennimo said. “But I think once the (Johnson & Johnson) vaccine comes back on the market, and I’m absolutely thinking the vaccine’s going back on market, I think that people should be comfortable being vaccinated.”
Kelly has not suffered any blood clotting issues. And while she thought she was protected in March after receiving the vaccine, her ultimate goal was staying out of the hospital. So far, so good.
Right now, she just wants to feel better.
“I have a really bad cough still…” Kelly said. “I’m starting to get my taste and smell back a little bit, but it’s definitely not the same as it used to be. News Source
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