Coronavirus: US to resume use of Johnson & Johnson vaccine
- The decision comes after a CDC panel voted 10-4 to lift a pause in the roll-out
- Experts say the jab’s benefits outweigh a rare risk of blood clots, with only 15 known US cases out of nearly 8 million given the vaccine
US health officials lifted an 11-day pause on Covid-19 vaccinations using Johnson & Johnson’s single-dose shot on Friday, after scientific advisers decided its benefits outweigh a rare risk of blood clot.
The government uncovered 15 vaccine recipients who developed a highly unusual kind of blood clot, out of nearly 8 million people given the J&J shot. All were women, most under age 50. Three died, and seven remain hospitalised.
But ultimately on Friday, the Food and Drug Administration and Centres for Disease Control and Prevention decided that J&J’s one-and-done vaccine is critical to fight the pandemic – and that the small clot risk could be handled with warnings to help younger women decide if they should use that shot or an alternative.
“Above all else, health and safety are at the forefront of our decisions,” CDC Director Dr Rochelle Walensky said in a statement. “Our vaccine safety systems are working. We identified exceptionally rare events – out of millions of doses” of the J&J shot and will continue to monitor them.
06:18
SCMP Explains: What’s in a Covid-19 vaccine?
The US decision – similar to how European regulators are rolling out J&J’s shot – comes after CDC advisers earlier Friday voted 10-4 to resume vaccinations but panellists made clear that they must come with warnings about the risk. The group debated but ultimately steered clear of outright age restrictions.
“This is an age group that is most at risk (of the clotting) that is getting vaccine predominately to save other peoples’ lives and morbidity, not their own. And I think we have a responsibility to be certain that they know this,” said Dr Sarah Long of Drexel University College of Medicine, who voted against the proposal because she felt it did not go far enough in warning women.
At issue is a weird kind of blood clot that forms in unusual places, such as veins that drain blood from the brain, and in patients with abnormally low levels of the platelets that form clots.
After watchdog backing, Johnson & Johnson to resume vaccine roll-out in Europe
The CDC and Food and Drug Administration initially spotted six people who developed such clots one to three weeks after J&J vaccination. On Friday, health officials said nine more cases came to light in the last week or so.
European scientists found clues that an abnormal platelet-harming immune response to AstraZeneca’s vaccine might be to blame – and if so, then doctors should avoid the most common clot treatment, a blood thinner called heparin.
That added to US authorities’ urgency in pausing J&J vaccinations so they could tell doctors how to diagnose and treat these rare clots. Several initial patients were treated with heparin before anyone realised that might harm instead of help.
Two-dose vaccines from Pfizer and Moderna, which are made differently and haven’t been linked to clot risks, are the mainstay of the US vaccination effort.
But J&J mass vaccination clinics were cancelled after the April 13 pause, and many states had been counting on the one-and-done option to also help protect hard-to-reach populations including people who are homeless or disabled.
“You can bring the vaccine to the person rather than having to bring the person to the vaccine. So there is a great desire to continue using this vaccine,” said Dr William Schaffner of Vanderbilt University.
The CDC’s advisers debated for hours to put the rare clot cases into perspective. Covid-19 itself can cause blood clots. So can everyday medications, such as birth control pills.
Blood clots from AstraZeneca vaccine? What about the pill? Doctors explain
And experts also recognised that virus cases were going to keep occurring during the pause “some of them in a population that would have been vaccinated with J&J. That’s part of the agony of making this decision,” Schaffner added.
How Americans handle J&J’s vaccine will influence other countries that don’t have as much access to other vaccination options. In the US, more than half of adults have received at least one vaccine dose, the vast majority with the Pfizer and Moderna shots.
But J&J faces an additional hurdle, as the FDA separately uncovered manufacturing violations at a Baltimore factory the company had hired to help brew the vaccine.
No shots made by Emergent BioSciences have been used – J&J’s production so far has come from Europe. But it’s unclear how the idled factory will affect J&J’s pledge to provide 100 million US vaccine doses by the end of May and 1 billion doses globally this year.
