LAST UPDATE | 13 Apr 2021
JOHNSON & JOHNSON IS to “proactively delay” the rollout of its Covid-19 vaccine to Europe as US health agencies recommended a precautionary pause in the use of the jab.
The Food and Drugs Administration (FDA) and the Centres for Disease Control and Prevention (CDC) earlier issued a joint statement to recommend the vaccine be paused “out of an abundance of caution” after six cases of a rare type of blood clot were reported.
The agencies said that six people who experienced the clots were between the ages of 18 and 48, were women, and that symptoms occurred 6 to 13 days after vaccination.
The company itself has said that it will be working with authorities in both the US and Europe in regard to the reported blood clots.
It says that it is aware of “an extremely rare disorder involving people with blood clots in combination with low platelets in a small number of individuals” who have received its Covid-19 vaccine.
Ireland is scheduled to receive 40,800 doses of the single-shot J&J Covid-19 vaccine this month, and over 600,000 in total up to the end of June. The first scheduled delivery of 14,000 doses was expected in Ireland tomorrow.
“Out of an abundance of caution, the CDC and FDA have recommended a pause in the use of our vaccine,” Johnson & Johnson said in a statement.
In addition, we have been reviewing these cases with European health authorities. We have made the decision to proactively delay the rollout of our vaccine in Europe.
“We have been working closely with medical experts and health authorities, and we strongly support the open communication of this information to healthcare professionals and the public.”
In their earlier statement, the FDA and CDC had said:
As of 12 April, more than 6.8 million doses of the Johnson & Johnson (Janssen) vaccine have been administered in the U.S. CDC & FDA are reviewing data involving six reported U.S. cases of a rare & severe type of blood clot in individuals after receiving the vaccine.
“In these cases, a type of blood clot called cerebral venous sinus thrombosis (CVST) was seen in combination with low levels of blood platelets (thromcocytopenia).”
The statement, which is from CDC Principal Deputy Director Dr Anne Schuchat and director of the FDA’s Centre for Biological Evaluation and Research, said that the adverse events “appear to be extremely rare”.
“Treatment of this specific type of blood clot is different from the treatment that might typically be administered,” Schuchat and Marks said.
“Usually, an anticoagulant drug called heparin is used to treat blood clots. In this setting, administration of heparin may be dangerous, and alternative treatments need to be given.”
The agencies said the pause is important to allow healthcare professionals to plan for the treatment needed for this particular type of blood clot.
The CDC is convening a meeting of its Advisory Committee on Immunization Practices (ACIP) tomorrow to review the six cases further and assess what their significance is.
The FDA will review that analysis while it also investigates the cases.
“Until that process is complete, we are recommending this pause,” the statement said.
“This is important to ensure that the health care provider community is aware of the potential for these adverse events and can plan due to the unique treatment required with this type of blood clot.”
The teams in the Department of Health, HSE & Taskforce are working flat out to incorporate the latest NIAC advice into our vaccination programme. We want to continue with the fastest possible rollout while ensuring safety is at the centre of everything we do. pic.twitter.com/N60QUN0sSv
— Stephen Donnelly (@DonnellyStephen) April 13, 2021
In Ireland, members of the National Public Health Emergency Team (NPHET) are currently giving an update to the Joint Oireachtas Committee on Health on our response to the pandemic.
Acting Chief Medical Officer Dr Ronan Glynn said he learned about the decision in the US as he was coming into the meeting with the Health Committee and that he will liaise with the Health Products Regulatory Authority (HPRA) to receive an update.
Dr Glynn said he is aware that the European Medicines Agency (EMA) is monitoring the situation.
Minister for Health Stephen Donnelly told RTÉ’s Six One News said that there would need to be a “serious reprofiling” of the vaccination programme if the J&J, or Jansen vaccine wasn’t approved for use in Ireland.
“It is important to say that the European Medicines Agency at this point has said that they are aware of six cases in the United States out of nearly 7 million vaccines that have been distributed.
“The EMA has said that they are not aware of a causal link – what they’re going to be doing is working very closely with the FDA in America because the J&J vaccine hasn’t been distributed here yet, and so there isn’t data from within the European member states itself.”
- With reporting by Rónán Duffy
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