The Food and Drug Administration (FDA) has revoked authorization of Johnson & Johnson’s Covid vaccine after it was paused over rare blood clot concerns, which sent demand plummeting.
The move was not unexpected because J&J’s parent company Jannsen had requested that federal regulators at the FDA withdraw authorization for its vaccine after it was revealed that the last tranche of doses – about 12.5 million – had expired.
As of year three of the Covid pandemic, nearly 231 million Americans have received either one J&J shot or two doses of an mRNA vaccine from Pfizer or Moderna.
Vaccination fatigue has swept the US, with millions of Americans frustrated by the fact that a shot does not guarantee immunity from the virus but rather protects against severe illness, and all those who had planned on getting fully vaccinated are believed to 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 hiccups and health concerns that severely eroded public trust, the pharmaceutical company has opted to step away from the Covid vaccine field.
Citing ever-shrinking demand, J&J told the FDA it would not update formulations of its shot to confront emerging strains better, a step that Moderna and Pfizer took last year to address the devastating omicron variant.
Dr Peter Marks, Director of the FDA’s Center for Biologics Evaluation and Research said: ‘Because FDA understands that… Janssen Biotech, Inc. has requested that FDA withdraw the EUA for the Janssen COVID-19 Vaccine, FDA has determined that it is appropriate to protect the public health or safety to revoke this authorization.’
A fraction of Americans have received J&J’s vaccine compared to the other vaccines approved for use in the US.
Nearly 367 million Americans have received a Pfizer shot while over 232 million have received a dose of Moderna’s vaccine. A paucity of the total shots administered in the US since early 2021 – just over 19 million – were made by J&J.
Johnson & Johnson’s vaccine was plagued by controversy since it entered the market in February 2021. By that time, more than 2.1 million mRNA shots had already been administered and those from Pfizer and Moderna became the gold standard.
Less than a month after the J&J vaccine was granted emergency use authorization from the FDA, it became mired in controversy over a small but growing number of severe blood clotting disorders called thrombosis with thrombocytopenia syndrome (TTS) in people who got the shot.
Thrombosis with thrombocytopenia syndrome is a severe condition characterized by thrombosis formation, or blood clots, combined with thrombocytopenia, a severely low platelet count that hinders 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 thrombotic thrombocytopenia (VITT), typically come on between four and 42 days following vaccination.
The FDA and the Centers for Disease Control and Prevention (CDC) issued a sweeping pause on administering the shots in April 2021, citing six cases of the rare clotting disorder.
The agencies performed an investigation into the cases and re-assessed the risk-to-benefit ratio, concluding that they ‘have confidence that this vaccine is safe and effective in preventing COVID-19’ and that ‘the available data show that the vaccine’s known and potential benefits outweigh its known and potential risks in individuals 18 years of age and older.’
Meanwhile, it had been revealed that the Baltimore-based Emergent BioSolutions manufacturing plant making the J&J vaccines had inadvertently ruined about 15 million doses after cross-contamination between that vaccine and a similar one from AstraZeneca meant for the UK.
US regulators stripped Emergent of its responsibility to produce the AstraZeneca vaccine and granted J&J full control over the manufacturing process of its shots at the Baltimore plant. When all was said and done, J&J was ordered to toss out 60 million doses of its vaccine out of contamination concerns.
Despite the federal government lifting the recommended pause on J&J’s shot after about a week and a half, the damage to its reputation had been done. Public trust in the single-dose vaccine eroded drastically and it soon became the object of derision.
Comedy superstar Dave Chappelle, for instance, quipped that he chose the ‘third best option’ when it came time to get vaccinated, adding, ‘I’ll have what the homeless people are having.’
The J&J vaccine was widely expected at first to be a boon for people experiencing homelessness and other disenfranchised people who could not guarantee to be able to get the requisite second shot of Moderna or Pfizer.
One online jokester quipped, ‘Johnson and johnson made the temporary tattoo of vaccines,’ and another said: Johnson and Johnson is The Godfather Part 3 of vaccinations.’
In December 2021, the panel of vaccine experts at the CDC 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 at highest risk for TTS.
Subsequently, in May of 2022, the FDA limited its use to adults 18 and older who were unable to get an mRNA vaccine due to an allergy to it or lack of availability.