A committee from the Centers for Disease Control and Prevention voted to allow Americans once again to receive the single-shot COVID-19 vaccine from Johnson & Johnson without any additional stipulations. JNJ’s shares of J&J were up 0.3% in after-hours trading on Friday.
CDC’s influential Advisory Committee on Immunization Practices met for the second time Friday to discuss the risks and benefits of the J&J vaccine following reports of blood clots in combination with low platelets in six women who received the vaccine. At that time, approximately 7 million people in the United States had been immunized with that vaccine. And so, despite the extreme rarity of the serious illness that followed vaccination with the J&J vaccine, federal officials recommended on April 13 to stop the vaccine while clinical data were examined. ACIP met last Friday to discuss the risks and benefits of the injection, but eventually extended the hiatus until this meeting. The committee voted 10-4-0 to keep the initial authorization for emergency use of the vaccine from the Food and Drug Administration, and many of the committee members spoke about the increased risks associated with COVID-19. The EUA allows any adult in the US who is at least 18 years old to receive the vaccine. Some Wall Street analysts had previously predicted that the vaccine would no longer be recommended for women under the age of 50. That said, four committee members voted no on the recommendation. “I absolutely believe this is a serious adverse event,” said Dr. Grace Lee, a professor of pediatrics at Stanford University School of Medicine and a member of the committee. “We need to keep making sure that awareness is raised.” Dr. Tom Shimabukuro, who is part of the CDC’s COVID-19 Vaccine Working Group, said Friday that there are 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 US who received the J&J injection. They are all women and two are over 50 years old. Three of the women died. Much of the broader discussion during Friday’s all-day meeting focused on weighing the risks of a vaccine that may protect against a virus that is still widely circulating against a very rare risk of serious blood clots. Committee members also debated whether to offer women between the ages of 18 and 50 the option of taking the mRNA vaccines developed by Pfizer Inc. PFE, + 0.05% or Moderna Inc. MRNA, + 3.29%. (No cases of CVST in combination with low platelets have been reported among those vaccinated with these vaccines). Earlier this week, the J&J executive sought to reassure investors about the next steps for its single-injection vaccine in the U.S. as well as implement clear diagnostic and therapeutic guidance that will allow us to restore confidence in our vaccine, ”Paul Stoffels, J & J’s chief scientific officer, told investors during an earnings call Tuesday. The same goes for federal health officials. US Surgeon General Dr. Vivek Murthy said last week that “these decisions are never simple and this was made after a very careful assessment of the risks and benefits of asking for such a break, the actions taken by the CDC and FDA this week should give Americans confidence that our security system is working for them. “J&J shares are up 5.1% for the year, while the S&P 500 SPX, + 1, 09%, has gained 10.1%.