The Food and Drug Administration (FDA) has withdrawn approval of Johnson & Johnson’s Covid vaccine after it was paused due to rare blood clot problems, causing demand to plummet.
The move was not unexpected as J&J’s parent company, Jannsen, had asked federal regulators at the FDA to revoke the vaccine’s license after it was revealed that the last tranche of doses — about 12.5 million — had expired.
Since the third year of the Covid pandemic, nearly 231 million Americans have received one J&J shot or two doses of a Pfizer or Moderna mRNA vaccine.
Vaccine fatigue has swept the US, with millions of Americans frustrated by the fact that an injection does not guarantee immunity against the virus, but rather protects against serious illness, and anyone who planned to get fully vaccinated would have done so by now.
With a renewed wave of demand for J&J’s single-dose vaccine highly unlikely, coupled with a beleaguered history of production disruptions and health concerns that have seriously eroded public confidence, the pharmaceutical company has chosen to step away from the field of Covid-19. vaccines.
J&J’s single vaccine faced numerous production problems early on, resulting in the removal of approximately 60 million doses
A scarcity of Americans have received J&J’s vaccine compared to the numbers who have received either of Pfizer’s and Moderna’s mRNA vaccines
Citing dwindling demand, J&J told the FDA it would not update its shot’s formulations to better cope with emerging strains, a move Moderna and Pfizer took last year to introduce the devastating Omicron variant. to take.
Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research said: ‘Because the FDA understands that… Janssen Biotech, Inc. has requested the FDA to revoke the EUA for the Janssen COVID-19 vaccine, the FDA has determined that it is appropriate to protect public health or safety to revoke this authorization.”
A fraction of Americans have received the J&J vaccine compared to the other vaccines approved for use in the US.
Nearly 367 million Americans have received a Pfizer shot, while more than 232 million have received a dose of the Moderna vaccine. A small fraction of the total number of shots administered in the US since early 2021 – just over 19 million – have been made by J&J.
Johnson & Johnson’s vaccine has been plagued with controversy since it hit the market in February 2021. more than 2.1 million mRNA injections had already been administered and those from Pfizer and Moderna became the gold standard.
Less than a month after the J&J vaccine received emergency approval from the FDA, it became embroiled in controversy over a small but growing number of serious blood clotting disorders called thrombosis with thrombocytopenia syndrome (TTS) in people who received the shot.
Thrombosis with thrombocytopenia syndrome is a serious condition characterized by thrombus formation, or blood clots, combined with thrombocytopenia, a severely low platelet count that interferes with the body’s ability to stop a wound from bleeding.
Symptoms of TTS, also known as vaccine-induced prothrombotic immune thrombocytopenia (VIPIT) or vaccine-induced immune thrombocytopenia (VITT), usually appear between four and 42 days after vaccination.
The FDA and the Centers for Disease Control and Prevention (CDC) took a drastic pause in administering the injections in April 2021, citing six cases of the rare clotting disorder.
The agencies conducted an investigation into the cases and reassessed the risk-benefit ratio. to conclude that they are “confident that this vaccine is safe and effective in preventing COVID-19” and that “the available data show that the known and potential benefits of the vaccine outweigh the known and potential risks in individuals aged 18 years and older’.
Meanwhile, it had been revealed that the Baltimore-based Emergent BioSolutions plant that made the J&J vaccines had accidentally messed up about 15 million doses after cross-contamination between that vaccine and a similar vaccine from AstraZeneca, intended for the UK.
US regulators stripped Emergent of its responsibility to produce the AstraZeneca vaccine and gave J&J full control over the manufacturing process of its injections at its Baltimore plant. When all was said and done, J&J was ordered to throw away 60 million doses of its vaccine over concerns of contamination.
By the third year of the pandemic, public enthusiasm for vaccines has waned, and those who haven’t gotten an injection now probably won’t
Despite the federal government lifting the recommended break on J&J’s shot after about a week and a half, the reputational damage was done. Public confidence in the single-dose vaccine drastically declined and soon became the object of ridicule.
For example, comedy superstar Dave Chappelle joked that he chose the “third best option” when it came time to get vaccinated, adding, “I’ll have what the homeless have.”
Initially, it was widely expected that the J&J vaccine would be a boon to those who were homeless and other disenfranchised people who could not guarantee they would be able to receive the required second injection from Moderna or Pfizer.
One online prankster quipped, “Johnson and Johnson made the temporary tattoo of vaccines,” and another said, “Johnson and Johnson is The Godfather Part 3 of Vaccines.”
In December 2021, the CDC’s panel of vaccine experts voted to recommend the use of the Moderna and Pfizer mRNA vaccines over the J&J amid growing reports of TTS. They pointed out that the problem is rare, occurring in about one case in every 100,000 doses given to women aged 30 to 49, the group most at risk for TTTS.
Then, in May 2022, the FDA restricted its use to adults ages 18 and older who could not receive an mRNA vaccine due to an allergy or lack of availability.