US faces pressure to decide J&J COVID-19 vaccine's fate
What's the story
US agencies are under pressure to take a call on the resumption of the use of Johnson & Johnson's COVID-19 vaccine. The vaccine's use was paused last week amid concerns that it had caused rare blood clot reactions among recipients. However, experts argue if the benefits of the vaccine outweigh the risks, considering only six women out of the millions developed the adverse reaction.
Details
CDC's advisory committee to reconvene this Friday
The Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control and Prevention (CDC) will reconvene on Friday to decide whether they have enough data to say who can/cannot receive J&J's vaccine. The options before the committee include extending last week's pause of the vaccine, ordering restrictions by age or gender, or a full resumption of the vaccine's roll-out.
Information
ACIP has 15 voting members
The ACIP has 15 voting members including immunologists and public-health experts from outside the agency. It shapes how vaccines are used in the US state and local health departments. Individual doctors also rely on its recommendations.
Context
Last week, ACIP took no action
The US government had recommended a pause on the J&J vaccine's roll-out last week after six women aged 18-48 developed a rare blood-clotting disorder. The committee had taken no action last week, choosing to wait and see if more cases of the rare blood clots would come up. Incidentally, a clotting incident involving a young man was also reported during a late-stage clinical trial.
Arguments
Benefits outweigh risks, says Europe's drug regulator
The pause on the vaccine has sparked a debate on whether a possible link to the rare blood clots should keep the vaccine from millions who need it desperately. 6% of 272 million doses administered in the US were J&J shots. Meanwhile, 31.8 million people have contracted COVID-19. 0.57 million have died. On Tuesday, Europe's drug regulator said the vaccine's benefits outweigh the risks.
Arguments
Panel chair raises possibility of extension on pause
Wilbur Chen—a voting member of the committee—told Bloomberg he would like to see the vaccine used. Chen had earlier supported the pause as the panel did not have enough data. Panel chair Jose Romero has raised the possibility that the pause may be extended if no more information comes to light. Others said extending the pause would send a clear message against the vaccine.
Advantages
J&J's vaccine uses single shot; can be refrigerated
While the US also has Moderna's and Pfizer's less controversial vaccines, J&J's vaccine uses a single shot, which has a clear advantage in mass vaccinations among hard-to-reach populations, such as homeless people. The vaccine is also easy to store at 2-8°C. However, with the pause on the vaccine's roll-out, several manufactured doses are simply sitting on shelves.
Information
List blood clots as rare side-effect: Europe's drug regulator
The European Medicines Agency, the European Union's drug regulator, had suggested listing the blood clots as a rare side-effect. A Food and Drug Administration (FDA) representative had also made a similar suggestion at last week's ACIP meeting.