The Advisory Committee on Immunization Practices voted 10-4 with 1 abstention to resume the rollout and administration of the Janssen shot.
Today, the United States Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) voted to reaffirm recommendation of the COVID-19 vaccine created by Janssen Pharmaceuticals, a subsidiary company of Johnson & Johnson.
The vote comes after a pause on the vaccine was initiated earlier this month out of an abundance of caution, when cases of rare blood clot disorders were linked to the shot.
The meeting began with a review of the data on the risk for severe adverse reactions with the Janssen vaccine.
The vaccine adverse event reporting system (VAERS) had documented 15 cases of thrombosis with thrombocytopenia syndrome (TTS), which is blood clots with low-levels of platelets, between March 19 and April 21.
In comparison, the AstraZeneca vaccine has had several more cases, Moderna has had only 3 but with normal blood platelet levels, and Pfizer-BioNTech has had none.
Of the known cases, all occurred in persons under the age of 64, the majority being women who were not pregnant or post-partum, and no history of coagulation issues were reported. The events took place within 3 weeks of vaccination and no specific risk factors have been determined.
One explanation that was suggested was that an immune response causes the blood clots and low blood platelets, which can lead to a condition similar to one sometimes seen in patients treated with heparin, called heparin induced thrombocytopenia (HIT).
A brief public comment session was then held, which saw mostly positive remarks by medical professionals, public health specialists, researchers and the general public. Many praised the CDC on their decision to pause the use of the J&J vaccine, stating that it is evidence the agency is working properly and has put the safety of the public first.
However, some criticized the CDC for the pause, claiming it did nothing but increase vaccine hesitancy in an already overly worried population.
Despite a few comments on perceived issues with COVID-19 vaccines and vaccinations in general, most speakers talked positively about Janssen’s vaccine, and seemed to welcome its reinstatement into the inoculation efforts of the country.
Following the public comments, Mathai Mammen, MD, PhD, Global Head of Janssen Research and Development, and Joanne Waldstreicher, MD, Johnson & Johnsons Chief Medical Officer, presented updated information on the vaccine.
They discussed the large amount of doses administered in comparison to the rare side effects experienced by very few people, and the continuing collaboration between them and health authorities for surveillance of any future issues.
Also touched upon was the fact the vaccine only requires 1 shot and can be transported more efficiently than other COVID-19 vaccines, which makes it a vital and important option for many underrepresented populations.
After the National Center for Immunization and Respiratory Diseases (NCIRD) gave its assessment, which deemed the vaccine had a favorable risk-benefit profile, and a lengthy discussion between ACIP members, a vote for an updated recommendation was undertaken.
The ACIP voted 10-4 with 1 abstention to reaffirm recommendation of the vaccine in persons 18 years of age and older in the US population under the FDA’s Emergency Use Authorization (EUA).
Going forward, additional information will be provided to healthcare professionals, instructing them on how to properly treat TTS when symptoms are seen in those who have received the vaccine.