A committee of the Centers for Disease Control and Prevention voted to allow Americans to once again receive Johnson & Johnson’s single-dose COVID-19 vaccine without any additional regulations.
Shares of J&J JNJ a 0.3% increase in after-hours trading on Friday.
CDC’s Influential Advisory Committee on Immunization Practices met for the second time on Friday to discuss the risks and benefits of J&J vaccines following reports of clot associated with platelets. low in the six women injected. At that time, about 7 million people in the US had been vaccinated with that vaccine.
And so, despite the extremely rare state of serious illness following J&J vaccination, federal officials on April 13 offer to pause vaccines while clinical data have been checked. ACIP convened last Friday to discuss the risks and benefits of the footage but ultimately prolong the pause time until this meeting.
The committee voted 10-4-0 to uphold the original emergency vaccination authorization from the Food and Drug Administration, with more committee members talking about the greater risks involved. Related to COVID-19. The EUA allows any adult in the United States 18 years or older to be vaccinated. Some Wall Street analysts previously predicted that the vaccine would no longer be recommended for women younger than 50 years old.
That said, four committee members voted against the proposal.
“I totally think this is a serious adverse event,” said Dr. Grace Lee, professor of pediatrics at Stanford University School of Medicine and a member of the committee. “We need to continue to ensure that awareness is raised.”
Dr. Tom Shimabukuro, a member of the CDC COVID-19 Vaccine Task Force, said Friday that there were six cases of cerebral sinus thrombosis (CVST) associated with thrombocytopenia, or platelet count. low blood, at the moment of pause.
He noted that there have been 15 confirmed cases of CVST and low platelets out of the 7.9 million people in the US who received J&J injections. All are women, and two are over 50 years old. Three of the women died.
Much of the broader debate during Friday’s full meeting focused on weighing the risks of a vaccine that could protect against a virus that is still widely circulating against risk. Serious muscle clotting is very rare.
Committee members also debate whether to offer women 18 to about 50 the option of using the mRNA vaccine offered by Pfizer Inc. development or not.
or Moderna Inc.
(No cases of low platelet-associated CVST have been reported among those receiving these vaccines.)
Earlier this week, J&J executives sought to reassure investors about their next steps for a single-shot vaccine in the US.
“We hope by making people aware and giving clear diagnostic and treatment guidance so we can restore confidence in our vaccines,” said Paul Stoffels, scientific director at J&J, told investors on Tuesday’s earnings call.
The same goes for federal health officials.
US Surgeon General, Dr. Vivek Murthy said last week that “these decisions are never straightforward and this decision is made after a very careful assessment of the risks and benefits of Calling for such a halt, the actions taken by the CDC and the FDA this week should give Americans confidence that our safety systems are working for them. “
Shares in J&J rose 5.1% for the year, while the S&P 500 was broader