J&J Covid-19 vaccine pause under review as US advisers weigh clot reports
Advisers to the US Centers for Disease Control and Prevention (CDC) on Friday are considering if it is safe to resume injections of Johnson & Johnson's Covid-19 vaccine, even as senior US health officials prepare for a green light.
The vaccine was paused by the CDC and US Food and Drug Administration last week after reports of rare but serious blood clots associated with low blood platelets. Top health officials have said they hope for a return to the vaccine's use after the panel meets.
CDC Director Rochelle Walensky said during a press briefing on Friday morning that the agency had prepared a risk/benefit analysis for the panel that included weighing that some individuals would choose not to be vaccinated if they cannot have the one-shot J&J vaccine.
The FDA and the CDC both "feel strongly that we need to act swiftly," Walensky said.
With just one shot, J&J's vaccine allows individuals to be fully vaccinated after two weeks, making it popular with younger people and those who are hard to reach or are transient. It is also stored in a standard refrigerator, making it a useful tool for low-income countries and rural areas unable to keep other vaccines frozen at extremely low temperatures.
The CDC and FDA called for the pause last week after reports of six cases of rare brain blood clots accompanied by low blood platelets out of nearly 8 million doses administered in the United States.
On Friday, CDC staff and experts presented data on these cases and expanded their analysis to include reports in which severe blood clots occurred in other parts of the body besides the brain but were also associated with low blood platelets.
It said there were 13 such cases among women under age 50 - a rate of 7 per million doses given - and two cases in women aged 50 and older - a rate of less than 1 per million shots given. Its analysis found no such cases in men.
State health officials on Thursday said the CDC was investigating the death of an Oregon woman in her 50s and the hospitalization a Texas woman with symptoms similar to those found in the clotting cases - both of whom had received J&J's shot.
A TREATABLE CONDITION
The United States has ordered enough doses of vaccines from Pfizer Inc/BioNTech and Moderna Inc to cover all U.S. adults. But many senior health officials including U.S. infectious disease chief Dr. Anthony Fauci, have signaled they hope to resume use of the J&J vaccine.
The European Medicines Agency on Tuesday recommended adding a warning about unusual blood clots with low blood platelet counts to the vaccine's product label, saying the benefits of the shot outweighed its risks.
The drugmaker has said it would resume rolling out the vaccine in the region. Each country will decide whether and how to use the shot. Germany, for instance, will allow J&J vaccination with no limitations.
US National Institutes of Health Director Dr. Francis Collins told ABC News' "Good Morning America" on Friday that the Europeans' decision to move ahead while adding a warning was "encouraging."
"This is a treatable condition if you recognise it right away," Collins told ABC.
J&J has faced several setbacks since its shot gained US emergency authorization in February, first drawing scrutiny over its halting process to scale up production, and then over the rare cases of clots in a handful of recipients.
FDA inspectors this week cited a long list of serious cleanliness and safety issues at an Emergent BioSolutions plant making the J&J vaccine.
Johnson & Johnson shares were up 0.5% in midday trading.
European regulators said the blood clots in patients who received the J&J vaccine bear close resemblance to 169 cases in Europe reported with the AstraZeneca Plc vaccine.