IAC summarizes July 22 ACIP meeting on COVID-19 vaccine: recommendations re-affirmed after Guillain-Barré syndrome safety review, additional doses for the immunocompromised discussed

On July 22, the Advisory Committee on Immunization Practices (ACIP) met to review data on reports of the rare occurrence of Guillain-Barré syndrome (GBS) following receipt of Janssen COVID-19 Vaccine (Johnson & Johnson). The Committee also discussed a potential recommendation for an additional dose of COVID-19 vaccine for immunocompromised people. Slides presented are available online. No votes were taken at the meeting.
 
Guillain-Barré syndrome (GBS)
GBS is a rare autoimmune disorder that causes muscle weakness and paralysis. An estimated 3,000–6,000 cases are reported in the U.S. annually. GBS has been associated with certain vaccines, occurring within 6 weeks of vaccination; however, it is most commonly triggered by a gastrointestinal or respiratory infection. It has been reported following SARS-CoV-2 infection. Most people fully recover from GBS, though it can be fatal. The background rate of GBS in the U.S. is about 1 case per 100,000 people per year, with rates increasing with age and rates higher in males than females.
 
GBS following Janssen COVID-19 Vaccine
The apparent risk of GBS following receipt of the Janssen vaccine is very low, but the frequency of reported cases to the Vaccine Adverse Event Reporting System (VAERS) was substantially higher than either the frequency of reports following mRNA COVID-19 vaccines or the expected background rates of GBS in the population. On July 12, the FDA revised the Janssen COVID-19 Vaccine Emergency Use Authorization Fact Sheets for providers and for recipients to include this information.
 
Through June 30, 2021, 12.6 million doses of the Janssen vaccine were administered in the U.S. The ACIP reviewed data on 98 cases of GBS reported to VAERS within 42 days of receipt of the Janssen vaccine. Of these 98 reports, 95 people were hospitalized and there was 1 death. The largest number of reports was in males 50–64 years of age. Data from VAERS are limited to spontaneous reports; further evaluation is underway to more fully characterize the risk of GBS.
 
In reviewing the risks and benefits of using the Janssen vaccine, several ACIP members noted that many patients have a strong preference for this single-dose vaccine, and that it is an important and effective option for protection against severe COVID-19 disease, hospitalization, and death. After reviewing the data, ACIP concluded that the benefits of Janssen COVID-19 Vaccine used according to current recommendations far outweigh the rare potential risks of GBS or thrombosis with thrombocytopenia syndrome (TTS).
 
CDC staff stated that CDC will update its Interim Clinical Considerations for the Use of COVID-19 Vaccines Currently Authorized in the United States to include information that people with a history of GBS may choose to receive any authorized COVID-19 vaccine after an explanation of risks and benefits. ACIP emphasized that the small risk of GBS should be transparently communicated to potential vaccine recipients. Providers should discuss options, including the availability of mRNA vaccines, which have not been associated with an increased risk of GBS. CDC will also update its clinical resources, including the Janssen vaccine standing orders and the prevaccination checklist, to assist in these communications.  

Considerations for immunocompromised people 
Approximately 2.7% of people in the U.S are immunocompromised due to a health condition or treatment with immunosuppressive medication. These individuals are more likely to become severely ill from infection with SARS-CoV-2 and to transmit the virus to others.

COVID-19 vaccine effectiveness is lower among immunocompromised individuals, making them more susceptible to breakthrough infection after vaccination. Several small studies have found that, among immunocompromised people who had no detectable antibody response after a 2-dose mRNA vaccine series, up to half had detectable antibodies after receiving an additional dose. Clinical data on breakthrough infections among recipients of a third dose were not available. No serious adverse events were reported after administration of the third dose. Internationally, France and Israel have recommended that immunocompromised people receive an additional dose, and the United Kingdom is considering a similar proposal.  
 
ACIP members discussed several items that would need to be considered before making a recommendation. An ACIP recommendation would follow FDA authorization of an additional dose. ACIP will continue to assess evidence for the safety, efficacy, and benefit of providing an additional dose of COVID-19 vaccine for immunocompromised people. In the interim, fully vaccinated immunocompromised people should continue to follow the standard recommendations for mask wearing, social distancing, and avoiding large crowds that generally apply to unvaccinated people.
 
Future ACIP Meetings
The next regularly scheduled ACIP meeting will be held October 20–21, although additional ACIP meetings are anticipated before then. Information about past and future ACIP meetings may be found on the ACIP website. 
 
Related Links

• FDA’s Janssen COVID-19 Vaccine Emergency Use Authorization (EUA) Fact Sheet for Providers Administering Vaccine (PDF) (7/8/21)
• FDA’s Janssen COVID-19 Vaccine Emergency Use Authorization (EUA) Fact Sheet for Recipients and Caregivers (PDF) (7/8/21)
• CDC’s Interim Clinical Considerations for the Use of COVID-19 Vaccines Currently Authorized in the United States web page
• CDC’s Janssen COVID-19 Vaccine Product Information web page 
• IAC’s COVID-19 web page