US finally moves forward on COVID vaccine booster plan, for Pfizer only
After weeks of turbulent regulatory discussions, COVID-19 vaccine boosters are finally rolling out across the United States following the final tick of approval from Rochelle Walensky, director of the Centers of Disease Control and Prevention (CDC). The current booster program only applies to those previously administered the Pfizer vaccine, with decisions on Moderna and Johnson & Johnson to come soon.
The CDC’s official vaccine guidance followed a meeting of its Advisory Committee on Immunization Practices (ACIP), which recommended boosters be given to all adults over the age of 65, and those over the age of 18 with pre-existing medical conditions. The CDC’s formal announcement did diverge from ACIP’s recommendations on the matter of boosters for those who are at high-risk of COVID-19 due to "occupational or institutional settings."
On this point ACIP, much like the FDA’s own independent advisory panel, voted against a broad booster plan for those populations. One member of ACIP said last week, “we might as well give it to everybody,” if certain occupational settings qualify one for a booster.
The final formal CDC booster guidance only covers those who received an initial course of the Pfizer vaccine and recommends a third dose to four specific populations. All adults over the age of 65 should receive a booster shot at least six months after their initial course, and adults aged between 50 and 64 with underlying medical conditions should also receive a booster six months after the initial course.
Those aged between 18 and 49 with underlying medical conditions are also now allowed to access boosters. However, the language used in the CDC advice doesn't say this group "should" receive a booster but rather they "may" receive a booster.
The fourth recommendation is the most controversial one, stating, “people aged 18-64 years who are at increased risk for COVID-19 exposure and transmission because of occupational or institutional setting may receive a booster shot of Pfizer-BioNTech’s COVID-19 vaccine at least 6 months after their Pfizer-BioNTech primary series, based on their individual benefits and risks.”
It is unusual for the CDC to not directly follow the recommendations of ACIP. In a statement from Walensky accompanying the CDC’s guidance she says the agency’s final decision is there to, “best serve the nation’s public health needs.”
“As CDC Director, it is my job to recognize where our actions can have the greatest impact,” says Walensky. “At CDC, we are tasked with analyzing complex, often imperfect data to make concrete recommendations that optimize health. In a pandemic, even with uncertainty, we must take actions that we anticipate will do the greatest good.”
The definition of “occupational or institutional settings” is broad, encompassing everything from people working in retail or healthcare settings to those in prisons or homeless shelters. Beth Bell, a global health expert from the University of Washington, worries the mixed messaging from the past few weeks could be misinterpreted by some.
"My hope is that all of this confusion – or what may feel like confusion – doesn't send a message to the public that there is any problem with the vaccine," Bell said to AP News. "I want to make sure people understand these are fantastic vaccines and they work extremely well."
President Biden urged all eligible Americans to go and get their booster shots as soon as possible, with around 20 million people currently qualifying for the third vaccine dose, with that number increasing by another 40 million over the coming weeks. Both Biden and Walensky also stated decisions on boosters for those initially receiving Moderna or Johnson & Johnson vaccines will be evaluated over the “coming weeks” as more data comes to light.