US health agencies lifted the pause on Johnson & Johnson’s Covid-19 vaccine on Friday, 10 days after urging providers to hold off on using the shot while they reviewed serious and rare cases of blood clots among several people who had received it.
The Food and Drug Administration (FDA) and the Centres for Disease Control and Prevention (CDC) said in a statement that they have determined that the pause that was put in place on April 13 should end and that use of the vaccine should resume.
The agencies said that they found the shot was safe and effective at preventing Covid-19. They added that the chance of developing the rare blood-clot syndrome is very low, but that they will continue to investigate.
Regulators issued a revised fact sheet for healthcare providers with information about the risk of the syndrome.
All 15 cases of clotting were observed in women, with 13 under the age of 50, according to the presentation. Meanwhile, 12 of the 15 cases involved rare brain blood clots. As of April 21, about 4 million women in the US had received the Johnson & Johnson vaccine.
A panel of medical experts reaffirmed their support for Johnson & Johnson’s Covid-19 vaccine on Friday afternoon.
Regulators put dosing with the vaccine on hold 10 days ago to gather more information following reports of blood clots.
More than eight million Americans have been given Johnson & Johnson’s vaccine. The panel reviewed evidence from 15 people who suffered the rare side effect after receiving the shot. Three died, while seven remain in hospital and five were discharged.
Health officials have been under pressure to make a determination on the vaccine and end the pause. One panellist, Wilbur Chen, said earlier this week that he wants to see use of Johnson & Johnson’s shot resume, though exactly how will depend on the data shared during the meeting.
“I don’t want to have it sit on the shelf for any longer,” said Mr Chen, who is also a professor at the University of Maryland School of Medicine.
About 10 million doses of Johnson & Johnson's vaccine across the US are ready to be used, according to CDC data, but just how quickly they will find their way into people’s arms is unclear.
For one, momentum in the national immunisation campaign appears to be slowing. Three million shots a day are now being administered, down from a peak of 3.4 million. About 40 per cent of US adults have already received one dose of a Covid-19 vaccine, and only 75 per cent of the roughly 28 million doses being shipped out weekly would be used at the current pace.
CDC Director Rochelle Walensky said Friday that many people would still want a Johnson & Johnson shot.
Unlike two-dose vaccines developed by Pfizer and Moderna, Johnson & Johnson’s coronavirus vaccine requires a single shot and can be kept in refrigerators, making it a preferred tool for those who interact less frequently with the health system or live in hard-to-reach places.
“I do think that there’s plenty of people who are interested in the [Johnson & Johnson] vaccine if just for convenience as well as for a single-dose option,” Dr Walensky said.
Panellists wrestled with whether the benefits of Johnson & Johnson’s vaccine – preventing hospital admission and death – outweigh the risk of developing a clot.
One of the most commonly cited concerns about keeping Johnson & Johnson’s vaccine sidelined was the disproportionate impact on vulnerable communities, including the homeless. Many state and local health departments were using Johnson & Johnson’s vaccine, which requires only one dose and is easier to store than other available Covid-19 vaccines, to reach these groups.
While the cases reviewed Friday suggest the blood clots are most common in young women, panelists warned the clots may still occur in men. One man in Johnson & Johnson's clinical trial developed a clot. And two of the 15 cases recorded thus far occurred in women over 50, raising the possibility that the syndrome can also appear in older people.
European Union regulators have already decided to move forward with Johnson & Johnson's vaccine and Friday issued an analysis showing that the benefits of AstraZeneca's vaccine, also linked to clotting, outweigh its risks.
The European Medicines Agency said the blood clots should be listed as a very rare side effect of Johnson & Johnson's vaccine so doctors and people who receive it can be aware of the symptoms.
