Some in the US are getting COVID-19 boosters without FDA approval

DENVER – When the delta variant started to spread, Gina Welch decided not to take any risks: she received a third booster dose of the COVID-19 vaccine by going to a clinic and telling them it was her first injection.

The US government has not approved booster shots for the virus, saying it has yet to see any evidence they are needed. But Welch and countless other Americans have managed to get them by taking advantage of the country’s excess vaccine and lack of tracking of those who have been fully immunized.

Welch, a graduate student from Maine who studies chemical engineering, said she has been keeping an eye on scientific studies on COVID-19 and following several virologists and epidemiologists on social media who have advocated for the boosters.

“I’m going to follow these experts and I’m going to go protect myself,” said Welch, a 26-year-old man with asthma and liver disease. “I’m not going to wait another six months to a year for them to recommend a third dose.”

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While Pfizer has announced plans to seek US Food and Drug Administration approval for the booster injections, health officials say that for now, fully vaccinated people appear to be well protected.

Yet healthcare providers in the United States have reported more than 900 cases of people receiving a third dose of COVID-19 vaccines in a database maintained by the Centers for Disease Control and Prevention, an Associated Press review of data. system found. Since reporting is voluntary, the total number of people who received third doses is unknown. It is also not known if all of these people were actively trying to get a third dose as a booster.

“I don’t think anyone really has the tracking” in place as to how widespread this is, ”said Claire Hannan, executive director of the Association of Immunization Managers.

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An entry in the CDC’s database shows a 52-year-old man received a third dose from a California pharmacy on July 14 saying he never received one and providing his passport, rather than a driver’s license, as an identity document. But when the pharmacy contacted the patient’s insurer, he was told he had received two doses in March.

In Virginia, a 39-year-old man received a third injection from a military supplier on April 27 after showing a vaccination card showing he had only received one dose. A review of the records revealed his previous vaccines. The patient then told the provider that the time between his first and second dose was more than 21 days.

Colorado Governor Jared Polis said at a recent press conference that he knew of residents who had received a third dose using fake names, but neither his office nor the state health department. could not provide any evidence.

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Despite the lack of FDA approval, public health officials in San Francisco said on Tuesday they would provide an additional dose of the Pfizer or Moderna vaccine to people who received the single-injection variety Johnson & Johnson – in the calling it a supplement rather than a booster.

Several studies are looking at booster shots for certain risk groups – people with weakened immune systems, adults over 60, and healthcare workers. But the verdict is still not on whether the general population might need it, said Dr Michelle Barron, senior medical director for infection prevention at UCHealth, a nonprofit based healthcare system. in Aurora, Colorado. She said the best evidence for possible boosters is in people with compromised immune systems.

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Israel is giving reminders to the elderly and several countries, including Germany, Russia and the United Kingdom, have approved them for certain people. The head of the World Health Organization recently urged richer countries to stop giving boosters to make sure doses of the vaccine are available in other countries where few people have received their first injections. .

Will Clart, a 67-year-old patient services worker at a Missouri hospital, received a third dose in May on his way to a local pharmacy. Clart said he gave the pharmacist all of his information, but the pharmacist didn’t realize until after he administered the vaccine that Clart’s name was in the immunization system.

“It looked like there was an advantage to that. And there was also some talk that we will eventually need a booster – mine had been out for five or six months so I thought I would go ahead, that will give me a booster, ”Clart said. .

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Ted Rall, a political cartoonist, explained in a Wall Street Journal op-ed that he received a recall due to a history of lung problems, including asthma, swine flu and repeated episodes of bronchitis and pneumonia .

“I made up my mind after reading a report that states were likely to throw away 26.2 million unused doses due to low demand. My decision had no effect on policy and I saved a dose of vaccine from the trash, ”said Rall.

Welch, the graduate student from Maine, blamed people who refused to be vaccinated for political reasons. About 60% of eligible people in the United States are fully immunized.

“Their absolute demand and their cries of freedom trample on our public health and our community health. “

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Nieberg is a member of the Associated Press / Report for America Statehouse News Initiative corps. Report for America is a national, nonprofit service program that places reporters in local newsrooms to cover undercover issues.