Vaccine advisers to the US Centers for Disease Control and Prevention will meet Thursday to make recommendations on how to address new safety issues concerning the Johnson & Johnson Covid-19 vaccine and to review preliminary data on whether Covid-19 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 a.m. to 4:30 p.m. ET. There are no plans for the panel to vote on issues included on the agenda.
ACIP is a panel composed of outside medical experts in the fields of vaccinology, immunology, pediatrics, internal medicine, nursing, virology, public health, infectious diseases and other subspecialties. CDC typically accepts its recommendations once votes have been cast.
ACIP has provided crucial guidance throughout the pandemic including advice on emergency use authorization for the three Covid-19 vaccines currently available in the US, authorization of Pfizer’s vaccine for 12-15 year-olds and, in April, to end the pause of the J&J vaccine due to a rare blood clotting disorder that has occurred in a small number of vaccine recipients.
On Thursday, ACIP will take up several new issues regarding safety and durability of Covid-19 vaccines. To start, 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 coronavirus vaccine. Federal health officials say there have been some 100 preliminary reports of cases 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 million people who have received the vaccine.
The US Food and Drug Administration already last week updated the label of the J&J vaccine to list GBS as a rare risk. ACIP’s discussion tomorrow will center 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 it does.
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 ACIP member, told CNN. “There will be no formal votes and will come to the conclusion 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 take on the subject of coronavirus vaccine boosters with priority given to reviewing data on the need for booster vaccines for immunocompromised people. 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 guidance for fully vaccinated individuals. It warned people who are immunocompromised that the vaccines may not be as effective for them, and they are encouraged to continue with safety precautions as if they were not vaccinated. However, the CDC has not yet formally recommended boosters for anyone.
ACIP’s goal tomorrow is to weigh in on the need for boosters and review what data is currently available and published. “What [ACIP] will demonstrate tomorrow is that the evidence is very sparse,” says Schaffner, which ultimately means that the group will not vote on boosters.
Earlier this month, Pfizer announced it would be seeking 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 the limited efficacy against the more 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 the FDA said that based on the data that we know right now, we don’t need a boost,” Fauci told CNN’s Chris Cuomo last week. “That doesn’t mean that that won’t change. We might need, as a matter of fact, at some time to give boosters either across the board or to certain select groups, such as the elderly or those with underlying conditions.”
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