The FDA decided to withdraw authorization for Johnson & Johnson's COVID-19 vaccine.
Johnson & Johnson Covid-19 Janssen Vaccine boxes sat in a locked refrigerator at the US Department of Veterans Affairs VA Boston Healthcare System's Jamaica Plain Medical Center in Boston, Massachusetts, on March 4, 2021. - The mobile vaccination team is in its fifth week of at-home vaccinations and has vaccinated 183 veterans so far.
This was confirmed by Peter Marks, the Food and Drug Administration's top vaccine regulator. Marks sent a letter to Janssen Biotech, the Johnson & Johnson-owned company behind the vaccine, on June 1.
"The U.S. Food and Drug Administration (FDA) withdraw the EUA for the Janssen COVID-19 Vaccine issued on February 27, 2021," said Marks via his official letter.
FDA Withdraws Authorization From J&J's COVID-19 Vaccine
According to Ars Technica's latest report, Janssen Biotech already informed FDA that the last vaccine purchased in the U.S. already expired.
Pharmacist Antoun Houranieh held a vial of the Johnson & Johnson Covid-19 Janssen Vaccine at the US Department of Veterans Affairs VA Boston Healthcare System's Jamaica Plain Medical Center in Boston, Massachusetts, on March 4, 2021. - The mobile vaccination team is in its fifth week of at-home vaccinations and has vaccinated 183 veterans so far.
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The health firm added that the U.S. government no longer demands new J&J COVID-19 vaccines. Aside from this, Janssen Biotech also confirmed that they no longer plan to update the J&J vaccine to address emerging COVID-19 strains.
Since the U.S. no longer needs the J&J vaccine, FDA revoked EUA 27205 for the Janssen COVID-19 vaccine.
"As of the date of this letter, the Janssen COVID-19 Vaccine is no longer authorized for emergency use by FDA," confirmed Peter Marks.
Issues With J&J Vaccine
The J&J vaccine, a promising sing-dose COVID-19 medicine, faced numerous issues just weeks after receiving its FDA authorization back in 2021.
One of the problems linked to it is the rare blood clotting disorder. Because of this, the production of the J&J vaccine was paused for around 11 days after the rare disorder was confirmed.
Aside from the blood clotting condition, the J&J COVID-19 vaccine also faced criticisms because of the scandal surrounding Emergent BioSolutions; the government contractor for Janssen's vaccine.
Numerous reports claimed that J&J COVID-19 vaccine doses suffered from quality-control problems and contamination because of Emergent BioSolutions.
Another problem that decreased the demand for the J&J vaccine was when CDC (Centers for Disease Control and Prevention) suggested that mRNA-based vaccines should be the preferred vaccine options for COVID-19.
FDA advisors plan to conduct a meeting regarding the reformulations that will apply to these mRNA COVID-19 vaccines.
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