Johnson & Johnson Covid vaccine restricted in US due to concerns over blood clots

THE US Food and Drug Administration (FDA) has been forced to restrict the use of the Covid vaccine produced by Johnson & Johnson due to concerns over blood clots.

The announcement made by the FDA on Thursday, May 5 said that upon further examination of the Johnson & Johnson Covid vaccine, data showed that adults inoculated with the Janssen jab were more at risk of developing life-threatening blood clots within two weeks of vaccination.

According to a statement from the American agency, authorised use of the J&J vaccine has been limited to individuals 18 years of age and older for whom other authorised or approved COVID-19 vaccines are not accessible or clinically appropriate, and to individuals 18 years of age and older who elect to receive the Janssen COVID-19 vaccine because they would otherwise not receive a jab against the virus.

“We recognise that the Janssen COVID-19 Vaccine still has a role in the current pandemic response in the United States and across the global community. Our action reflects our updated analysis of the risk of thrombosis with thrombocytopenia syndrome (TTS) following administration of this vaccine and limits the use of the vaccine to certain individuals,” said Peter Marks, M.D., PhD, director of the FDA’s Centre for Biologics Evaluation and Research.

“Today’s action demonstrates the robustness of our safety surveillance systems and our commitment to ensuring that science and data guide our decisions. We’ve been closely monitoring the Janssen COVID-19 Vaccine and the occurrence of TTS following its administration and have used updated information from our safety surveillance systems to revise the EUA.”

He added: “The agency will continue to monitor the safety of the Janssen COVID-19 Vaccine and all other vaccines, and as has been the case throughout the pandemic, will thoroughly evaluate new safety information.”

The announcement is another setback for the vaccine developer, who has had the jab paused previously due to its links with blood clotting.

Following its authorisation for emergency use in the US on February 27, 2021, the Janssen COVID-19 vaccine was halted by the FDA and the Centres for Disease Control and Prevention (CDC) on April 13, 2021, so they could investigate six reported cases of TTS and “to help ensure that health care providers were made aware of the potential for TTS and could plan for proper recognition and management due to the unique treatment required for TTS.”

As noted by the agency, on April 23, 2021, following a thorough safety evaluation, including two meetings of the CDC’s Advisory Committee on Immunisation Practices (ACIP), the FDA and CDC lifted the recommended pause.

“The agencies confirmed a total of 15 cases of TTS had been reported to the Vaccine Adverse Event Reporting System (VAERS), including the original six reported cases, out of approximately 8 million doses administered,” the FDA noted in their statement.

The CDC had previously recommended in December 2021, that due to safety concerns, US health care providers should prioritise Moderna and Pfizer shots over the Johnson & Johnson jab.

Furthermore, on February 8, 2022, it was reported that J&J had quietly halted the production of its Covid vaccine. In fact, the company reportedly shut down the only plant – in Leiden, Netherland – making usable vaccine batches late last year.

According to a New York Times report, Johnson and Johnson, who on February 4 agreed to pay out a huge settlement after being accused of fuelling the opioid crisis in the US, had been using the facility to develop an experimental vaccine and potentially more profitable drug unrelated to the Covid-19 pandemic.

A spokesman for the company said at the time that the halt was only temporary and production was expected to start back up after a few months. He said that Johnson & Johnson was “focused on ensuring our vaccine is available where people are in need.”

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