Johnson & Johnson delays rollout of single-dose Covid vaccine in EU over rare blood clot fears
PHARMACEUTICAL giant Johnson & Johnson (J&J) has delayed the rollout of a single-dose coronavirus vaccine in the EU amid rare blood clot fears.
The company today said it would be pausing the rollout of the jab in the US while it investigated blood clots in six women.
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Regulators in the EU have however stated that it is not yet clear as to whether or not there is a link to blood clots and the J&J vaccine.
Experts in the US have also said that halting the jab is through an “abundance of caution”.
Doses of the jab were due to be given out across the European Union this week.
Side effects are common will all medications and many people who have Covid vaccine will experience mild side effects such as pain at the site of injection, while others sometimes suffer from fatigue.
The halt of the jab comes as the United States has administered more than 6.8million doses of the J&J vaccine.
Experts today said that the pausing of the jab is a “highly precautionary move.”
‘ONE IN A MILLION’
Dr Peter English, Retired Consultant in Communicable Disease Control said the fact that such a small possible risk has been identified is very reassuring as it shows that pharmacovigilance systems are working.
He added: “The regulators will be trying to estimate how many such cases would have been expected by chance, and thus what the risk (if any) of vaccination would be.
“Even if all of the cases were caused by the vaccine, the risk of less than one in a million would have to be set against the benefits of protection from Covid-19 disease; a disease which, in itself, causes clotting in many cases.”
Halting the use of the jab in the EU is likely to further set back vaccine efforts across Europe after they were stalled earlier this month amid fears of blood clots after the use of the AstraZeneca jab.
On Friday European regulators have launched an investigation into J&J and the blood clotting associated with the jab.
The European Medicines Agency (EMA) said: “It is currently not clear whether there is a causal association between vaccination with Covid-19 Vaccine Janssen and these conditions.”
The EU was due to receive 55 million doses of the vaccine by the end of June.
It had previously been reported that the UK regulator, the Medicines & Healthcare products Regulatory Agency (MHRA), had been due to approve the jab in the next few days.
Today the MHRA said that no vaccine would be authorised for use in the UK unless the expected high standards of safety, quality and effectiveness have been met.
Dr Siu Ping Lam, MHRA Director of Licensing said: “Vaccine safety is of paramount importance and we will monitor and evaluate any safety reports received promptly and robustly before a decision is made, working and sharing safety data with international regulators as necessary.”
Earlier today the Food and Drugs Administration (FDA) in the US asked states to temporarily halt using J&J’s jab “out of an abundance of caution” after six women in the US developed a rare blood-clotting disorder.
However, the there has been no link to the women’s disorder and the vaccine.
“Right now, these adverse events appear to be extremely rare,” the FDA said in a joint statement with the CDC.
“Covid-19 vaccine safety is a top priority for the federal government, and we take all reports of health problems following Covid-19 vaccination very seriously.”
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All six cases occurred in women ages 18 to 48, with symptoms developing six to 13 days after they received the shot.
Doctors typically treat that type of blood clot with heparin, but health regulators noted that could be dangerous in this case and recommended a different treatment.
“Until that process is complete, we are recommending this pause,” the FDA and CDC added.
“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.”
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