A Centers for Disease Control and Prevention (CDC) advisory group has recommended use of the Pfizer COVID-19 vaccine for people 16 and older after the U.S. Food and Drug Administration (FDA) issued full approval on Aug. 23.
"To have a fully approved new vaccine on the market in the U.S. within a year-and-a-half is spectacular,” said Austin pediatric infectious disease specialist Donald Murphey, MD, who chairs the Texas Medical Association’s Council on Science and Public Health.
Although vaccine hesitancy persists, these developments may help physicians address patients’ concerns about the Pfizer vaccine’s emergency-use status. “It’s the same as every vaccine on the market,” Dr. Murphey said, likening it to flu shots and tetanus boosters.
During its Aug. 30 meeting, CDC’s Advisory Committee on Immunization Practices (ACIP) also discussed booster doses of the COVID-19 vaccines but did not issue any eligibility recommendations.
Although preliminary data suggest vaccine protection may wane over time, especially in light of the highly transmissible delta variant, ACIP members say there are not yet enough data to warrant boosters given that initial vaccine series continue to prevent high rates of hospitalization and death.
According to the Texas Department of State Health Services (DSHS), more than 99% of the 8,787 people who died of COVID-19 in Texas between Feb. 5 and July 14 were unvaccinated, as reported in July by the Texas Tribune. A DSHS spokesperson told Texas Medicine Today on Tuesday that it was in the process of working “on a deeper analysis” of COVID-19 deaths by vaccination status.
ACIP members also worry that distributing booster doses could interfere with ongoing efforts to combat vaccine hesitancy. “The most important thing that we can do with respect to vaccines is continue to work as hard as we possibly can to encourage more people to get the primary series,” said ACIP member Beth Bell, MD.
An ACIP recommendation on booster doses is contingent upon FDA approval. Although the agency recently authorized additional doses for certain immunocompromised individuals, it has yet to authorize boosters for the general population. Physicians who administer boosters “off-label” to ineligible patients could be at risk for lawsuits, ACIP warns.
Although the Biden administration recently announced a plan to offer boosters to the general public as soon as Sept. 20, President Joe Biden has said the plan is contingent upon FDA approval and ACIP’s eligibility recommendation. ACIP members say the announcement, which preempted federal regulators’ formal endorsement, has sown confusion.
“It’s a tough issue,” Dr. Murphey said.
ACIP will reconvene in mid-September to review additional data on the safety and effectiveness of boosters. Pending FDA approval, members will subsequently meet to consider issuing a recommendation for boosters, especially for certain high-risk populations, such as health care workers and long-term care facility residents.