US health official says authorities are recommending the vaccine resumes – but that more detail should be added to patient information about risks
The United States has resumed it’s Johnson and Johnson (J&J) Covid-19 vaccine rollout, after scientific advisers decided the benefits of the jab outweigh a rare risk of blood clot.
The vaccine was paused in the country for 11 days after 15 people – of the 8 million who have had the jab – developed a highly unusual kind of blood clot.
All were women, most under 50-years-old. Three people died, while seven remain in hospital.
The pharmaceutical giant also paused its rollout of the jab in Europe after the US announced it was investigating the issue – but EU regulators have since ruled the benefits of the vaccine outweigh the risk.
Coronavirus: What you need to know – Listen to the latest episode
On Friday, US federal health officials ruled that J&J’s vaccine was critical in the fight against coronavirus, and that the small clot risk could be handled with warnings to help younger women decide if they should use the jab or an alternative.
The Centers for Disease Control and Prevention (CDC) said the J&J vaccine has important advantages for some people who were anxiously awaiting its return.
The Food and Drug Administration updated online vaccine information leaflets for would-be recipients and health workers, so that the roll out could resume as early as Saturday in places.
«This is not a decision the agencies reached lightly,» FDA Acting Commissioner Janet Woodcock told reporters late on Friday.
CDC Director Dr. Rochelle Walensky added that the pause should increase confidence in vaccine safety, showing «that we are taking every one of those needles in a haystack that we find seriously.»
President Biden received his vaccination on camera in December – to encourage other Americans to get the jab
European regulators earlier this week made a similar decision, deciding the clot risk was small enough to allow the rollout of J&J’s vaccine.
Dr. Paul Stoffels, J&J’s chief scientific officer, pledged that the company would work with US and global authorities «to ensure this very rare event can be identified early and treated effectively.»
Both Pfizer and Moderna vaccines, which are made differently and haven’t been linked to clot risks, are the mainstay of the US vaccination effort.
But many states had been counting on the easier-to-store, one-dose option of J&J to also help protect hard-to-reach populations including people who are homeless or disabled.
The CDC’s advisers struggled to put the rare clot cases into perspective. Covid-19 itself can cause a different type of blood clots. So can everyday medications, such as birth control pills.