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FDA Revokes Authorization of J&J’s COVID-19 Vaccine Due to Blood Clot

Last Updated on June 10, 2023 by Nurse Vicky

FDA Revokes Authorization of J&J’s COVID-19 Vaccine Due to Blood Clot Concerns and Reduced Demand

The FDA has decided to retract the authorization of the Johnson & Johnson (J&J) COVID-19 vaccine. This decision was due to reports of rare cases of blood clotting and a significant decline in demand for the vaccine. The development comes after approximately 19 million Americans have already received the J&J vaccine.

Background:

The controversy surrounding J&J’s COVID vaccine began early on due to health concerns and reports of contamination, which caused the public’s trust in the vaccine to diminish considerably. Notably, these concerns led to a brief suspension in 2021 following the reporting of severe blood clots in vaccine recipients.

Details on the FDA’s Decision:

Johnson & Johnson’s parent company, Jannsen, requested that the FDA withdraw the vaccine’s authorization when it was disclosed that the remaining 12.5 million doses had expired.

This was not surprising, as approximately 231 million Americans had already received either a single J&J shot or two mRNA vaccine doses from Pfizer or Moderna.

As vaccination fatigue has started to affect the U.S., and considering the challenges faced by J&J’s single-dose vaccine, including production problems and health concerns, the pharmaceutical company has decided to step back from the COVID-19 vaccine field.

The issues faced early in the vaccine’s life, such as the disposal of about 60 million doses due to manufacturing difficulties, have further complicated J&J’s situation.

Comparative Analysis of Vaccines:

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In terms of the number of people vaccinated, J&J’s vaccine trails behind other vaccines authorized for use in the U.S. Approximately 367 million Americans have received a Pfizer shot, and over 232 million have received a dose of Moderna’s vaccine.

On the other hand, only about 19 million of the total shots administered in the U.S. since early 2021 were made by J&J.

Issues Surrounding J&J’s Vaccine:

The J&J vaccine was plagued by controversy since it entered the market in February 2021, with more than 2.1 million mRNA shots already having been administered. These shots, produced by Pfizer and Moderna, set a high standard that J&J found difficult to match.

The controversy further intensified when a rare but severe blood clotting disorder called thrombosis with thrombocytopenia syndrome (TTS) was linked to the vaccine.

Symptoms of TTS typically appear between four and 42 days after vaccination, leading the FDA and the Centers for Disease Control and Prevention (CDC) to pause administering the vaccine temporarily.

Despite reassurances from both agencies that the vaccine was safe and effective in preventing COVID-19, the damage was done. Public trust in the vaccine suffered, leading to a drastic reduction in demand.

The situation was exacerbated when a Baltimore-based manufacturing plant ruined approximately 15 million doses due to cross-contamination with the AstraZeneca vaccine.

Public Perception and the Future:

The reputation of the J&J vaccine suffered significantly despite the lift of the recommended pause by the federal government. Its single-dose nature became the object of ridicule, with comedy superstar Dave Chappelle even making a joke about it.

However, it’s important to note that the J&J vaccine was initially considered a game-changer for people experiencing homelessness and others who may have had difficulty accessing the second dose of the Moderna or Pfizer vaccines.

In December 2021, the CDC’s panel of vaccine experts recommended the Moderna and Pfizer mRNA vaccines over the J&J vaccine due to increasing reports of TTS. As of May 2022, the FDA restricted the use of the J&J vaccine to adults aged 18 and older who were unable to receive an mRNA vaccine due to allergy or unavailability.

 

Conclusion:

The revocation of the FDA authorization for the Johnson & Johnson COVID-19 vaccine marks a significant moment in the ongoing battle against the pandemic.

This situation underscores the importance of rigorous safety measures and transparency in vaccine development and distribution. The current scenario also underlines the necessity for effective public communication strategies to ensure public trust in vaccinations remains high.

In the face of dwindling public enthusiasm for vaccines, health organizations and governments worldwide must redouble their efforts to disseminate accurate information and ensure that as many people as possible are vaccinated. Only by doing so can we hope to bring an end to this devastating global pandemic.

References:

  1. U.S Food and Drug Administration: Johnson & Johnson COVID-19 Vaccine
  2. Centers for Disease Control and Prevention: Information about Johnson & Johnson’s Janssen COVID-19 Vaccine
  3. Pfizer-BioNTech COVID-19 Vaccine
  4. Moderna COVID-19 Vaccine
  5. Understanding mRNA COVID-19 Vaccines

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