With Walensky’s sign-off on the expert recommendations, doctors, drugstores and other sites can begin giving shots. The recommendation for the Pfizer-BioNTech shot, which was cleared by the FDA last month, is for older people and adults at high risk, including teachers, nurses and others who risk infection from contact with the public through their jobs.
Last time the CDC’s advisers met to discuss boosters, they determined these front-line workers may be at greater risk of infection, but not for developing severe COVID. While the advisers didn’t recommend boosters for this group, Walensky overruled them, broadening out the booster ruling to include those at risk because of their jobs.
Moderna’s booster dose is half the amount of its regular shot, and during the discussion, Michael Hogue, a committee liaison from the American Pharmacists Association, raised concerns that twice the number of needles stuck in the product vial might raise sterility problems.
Moderna is looking at repackaging the product for their children’s program, said Jacqueline Miller, Moderna’s therapeutic area head for infectious diseases. However, data support the safety of 20 entries into the vial, she said.
Using the standard vial for boosters “is a measure that we’re putting in place now given the current context of the delta surge and the need to make these booster doses available,” she said.
The FDA also said people who have been fully immunized and meet the criteria to get a booster can receive a supplemental dose made by a different manufacturer than the maker of their original shot.
Americans have been able to get an additional vaccine dose since Aug. 13, when regulators authorized an extra dose of messenger RNA vaccines for people with impaired immune systems. Since then, more than 11 million booster doses have been administered.
Clearance of J&J’s booster was highly anticipated by the 15 million people in the U.S. who received it, including the immunocompromised, who have been more vulnerable to COVID symptoms.
The booster program has drawn criticism from the head of the World Health Organization because of the difficulty of getting primary immunizations in many lower- and middle-income countries. Critics say distributing extra doses in rich countries exacerbates the inequity.©2021 Bloomberg L.P. Visit bloomberg.com. Distributed by Tribune Content Agency, LLC.