Study evaluates if booster dose of J&J is necessary 0:45
. – Vaccine advisers from the U.S. Centers for Disease Control and Prevention (CDC) will meet Thursday to make recommendations on how to address new safety concerns related to the Johnson & Johnson covid-19 vaccine and to review preliminary data on whether vaccine boosters will be needed in the future, especially for people with compromised immune systems.
The Advisory Committee on Immunization Practices (ACIP) is scheduled to meet from 11 am to 4:30 pm ET. There are no plans for the panel to vote on the items on the agenda.
ACIP is a panel comprised of outside medical experts in the fields of vaccinology, immunology, pediatrics, internal medicine, nursing, virology, public health, infectious diseases, and other subspecialties. The CDC generally accepts their recommendations once the votes have been cast.
ACIP has provided crucial guidance throughout the pandemic, including advice on the emergency use authorization for the three COVID-19 vaccines currently available in the US, the authorization of the Pfizer vaccine for children 12 and under. 15 years and in April to end the J&J vaccine pause due to a rare blood clotting disorder that has occurred in a small number of vaccine recipients.
On Thursday, ACIP will address several new topics regarding the safety and durability of covid-19 vaccines.
To begin, ACIP will review recent data on cases of Guillain-Barré syndrome (GBS) among people who have been vaccinated against COVID-19 with the J&J vaccine.
Federal health officials say there have been about 100 preliminary case reports of GBS, a rare neurological disorder in which the body’s immune system damages nerve cells, causing muscle weakness and sometimes temporary paralysis, among the nearly 13 millions of people who have received the vaccine.
The US Food and Drug Administration (FDA) updated the J&J vaccine label last week to include GBS as a rare risk. Tomorrow’s ACIP discussion will focus on the question of whether, given this adverse event, the benefit of the J&J vaccine still outweighs the risk of GBS. ACIP is expected to say yes.
Tomorrow’s meeting was precipitated by this newly identified adverse event, Dr. William Schaffner, a professor in the Division of Infectious Diseases at Vanderbilt University Medical Center and a member of the ACIP, told CNN. “There will be no formal votes and we will conclude that the risk of covid is very high and the risks of the vaccine very low. Real, but very low,” he added.
ACIP will also address the issue of coronavirus vaccine boosters and priority will be given to reviewing data on the need for booster vaccines for immunosuppressed individuals.
Recent reports have suggested that covid-19 vaccines are not effective enough in people with weakened immune systems, and last week, the CDC revised its guide for fully vaccinated individuals.
They warned immunosuppressed people that vaccines may not be as effective for them, and they are encouraged to continue safety precautions as if they were not vaccinated. However, the CDC has yet to formally recommend boosters for anyone.
ACIP’s goal tomorrow is to weigh the need for reinforcements and review what data is currently available and published. “What [ACIP] will show tomorrow is that the evidence is very scarce, “says Schaffner, which ultimately means that the group will not vote for reinforcements.
Earlier this month, Pfizer announced that it would seek authorization to provide a third dose of its covid-19 vaccine as a booster, citing data from Israel on the continued spread of the coronavirus and limited efficacy against the most transmissible delta variant.
Health officials, including Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, continue to say the US needs more data before recommending coronavirus vaccine boosters for anyone.
“The CDC and FDA said that based on the data that we know at this time, we don’t need a booster,” Fauci told CNN’s Chris Cuomo last week. “That doesn’t mean that’s not going to change. In fact, at some point we may need to give reinforcements across the board or to select groups, such as the elderly or people with underlying conditions.”