A Centers for Disease Control and Prevention committee voted to let Americans once again receive Johnson & Johnson’s single-shot COVID-19 vaccine without any additional stipulations.
J&J’s stock JNJ gained 0.3% in after-hours trading on Friday.
The CDC’s influential Advisory Committee on Immunization Practices met for the second time on Friday to discuss the risks and benefits of J&J’s vaccine following reports of blood clots in combination with low platelets in six women who got the shot. At that time, roughly 7 million people in the U.S. had been immunized with that vaccine.
And so despite the extreme rarity of the severe illness that followed immunization with the J&J vaccine, federal officials on April 13 recommended pausing the vaccine while clinical data was examined. ACIP convened last Friday to discuss the risks and benefits of the shot but ultimately extended the pause until this meeting.
The committee voted 10-4-0 to uphold the vaccine’s initial emergency-use authorization from the Food and Drug Administration, with many of the committee members talking about the greater risks associated with COVID-19. The EUA allows any adults in the U.S. who are at least 18 years old to get shot. Some Wall Street analysts had previously predicted that the vaccine would be no longer recommended for women younger than 50.
That said, four committee members voted no on the recommendation.
“I absolutely think this is a serious adverse event,” said Dr. Grace Lee, a pediatrics professor at the Stanford University School of Medicine and a member of the committee. “We need to continue to ensure that awareness is raised.”
Dr. Tom Shimabukuro, who is part of the CDC’s COVID-19 Vaccine Task Force, said Friday that there six cases of cerebral venous sinus thrombosis (CVST) in combination with thrombocytopenia, which are low blood platelets, at the time of the pause.
He noted that there are now 15 confirmed cases of CVST and low platelets among the 7.9 million people in the U.S. who got the J&J shot. All are women, and two are older than 50 years old. Three of the women died.
Much of the broader debate during Friday’s all-day meeting focused on weighing the risks of a vaccine that can protect against a still widely-circulating virus against a very rare risk of severe blood clots.
Committee members also debated whether to offer women between the ages of 18 and about 50 years old the option of instead taking the mRNA vaccines developed by Pfizer Inc.
or Moderna Inc.
(No cases of CVST in combination with low platelets have been reported among those vaccinated with these vaccines.)
Earlier this week, J&J executive sought to reassure investors about next steps for its single-shot vaccine in the U.S.
“We hope by making people aware as well as putting clear diagnostic and therapeutic guidance in place that we can restore confidence in our vaccine,” Paul Stoffels, J&J’s chief scientific officer, told investors during an earnings call on Tuesday.
The same goes for federal health officials.
U.S. Surgeon General Dr. Vivek Murthy said last week that “these decisions are never simple and this one was taken after a very careful assessment of the risks and benefits of calling for such a pause, the actions taken by CDC and the FDA this week should give Americans confidence that our safety system is working for them.”
J&J’s stock is up 5.1% for the year, while the broader S&P 500
has gained 10.1%.