Boosters given without FDA approval
When the delta variant started spreading, Gina Welch decided not to take any chances: She got a third, booster dose of the COVID -19 vaccine by going to a clinic and telling them it was her first shot.
The U.S. government has not approved booster shots against the virus, saying it has yet to see evidence they are necessary. But Welch and an untold number of Americans have managed to get them by taking advantage of the nation’s vaccine surplus and loose tracking of those who have been fully vaccinated.
Welch, a graduate student from Maine who is studying chemical engineering, said she has kept tabs on scientific studies about COVID -19 and follows several virologists and epidemiologists on social media who have advocated for boosters.
“I’m going to follow these experts and I’m going to go protect myself,” said Welch, 26, who has asthma and a liver condition. “I’m not going to wait another six months to a year for them to recommend a third dose.”
While Pfizer has said it plans to seek U.S. Food and Drug Administration approval for booster shots, health authorities say that for now, the fully vaccinated seem well protected.
Yet health care providers in the U.S. have reported more than 900 instances of people getting a third dose of COVID
-19 vaccines in a database run by the Centers for Disease Control and Prevention, an Associated Press review of the system’s data found.
Because reporting is voluntary, the full extent of people who have received third doses is unknown. It’s also unknown if all of those people were trying to get a third dose as a booster.
“I don’t think that anyone really has the tracking ” in place to know how widespread it is, said Claire Hannan, executive director for the Association of Immunization Managers.
One entry in the CDC database shows a 52-yearold man got a third dose from a California pharmacy July 14 by saying he had never received one and by providing his passport, rather than a driver’s license, as identification. But when the pharmacy contacted the patient’s insurance provider, it was told he had received two doses in March.
Several studies are looking at booster shots for certain at-risk groups — people with weakened immune systems, adults older than 60 years and health care workers. But the verdict is still out on whether the general population might need them, said Dr. Michelle Barron, senior medical director for infection prevention at UCHealth, a not-forprofit health care system in Aurora, Colo. She said the best data in favor of possible boosters is for people whose immune systems are compromised.