Some seeking booster shots before U.S.' approval

While tens of millions of Americans continue to decline even a first dose of covid-19 vaccine, a small but growing number have sought additional shots even as the Food and Drug Administration has not yet approved them and as it remains unclear who needs a booster shot and when.

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Amy Piccioni is not a doctor or a scientist, but as word of breakthrough coronavirus infections in vaccinated people started spreading this summer, she waded through an array of technical and often contradictory information about the need for coronavirus booster shots. Then she decided for herself: She would not wait for federal regulators to clear the booster shots before getting one.

"It takes a long time for scientists to admit that some people need a booster," said Piccioni, 55, who received the one-dose Johnson & Johnson vaccine in November through a clinical trial and then timed her booster shot around a visit to her father in July, thinking it would protect her on the plane. She walked into a local Walgreens, asked for a Pfizer shot and got it, with no questions asked.

"All I could think about was how low the vaccination rate is in some areas," said Piccioni, who lives near Del Mar, Calif., and is in good health. "Those doses don't last forever, so I felt no guilt about taking one that probably would have expired."

Studies in the U.S. have found that the vaccines continue to provide robust protection against severe cases of covid-19, especially for those younger than 65, even as evidence grows that their effectiveness against infection wanes over time. On Monday, an international group of scientists, including two from the FDA, wrote a review saying that none of the data so far provided credible evidence in support of boosters for the general population.

Still, many seeking early boosters fear that breakthrough infections could inconvenience or sicken them -- or worse, they say, someone they love. Most do not feel they are taking a dose from someone else, as vaccines are widely available in the U.S., and a local pharmacy is not in a position to shift shots to nations that need them.

SEEKING SHOTS

The number of Americans who are not immunocompromised but have obtained extra shots is unclear. About 1.8 million people have done so since mid-August, according to the Centers for Disease Control and Prevention, but that count is likely to include many with weakened immune systems. The FDA authorized additional shots for that group last month.

Also last month, the Biden administration announced that it hoped to start offering boosters starting next Monday to people who had received a second dose of the Pfizer-BioNTech or Moderna vaccine at least eight months before. But the leaders of the FDA and the CDC then said they needed more time to evaluate safety and other data. Janet Woodcock, the acting FDA commissioner, has urged people not to seek booster shots on their own, but to wait for a regulatory ruling that they are safe and necessary.

For many Americans -- particularly those over 65, who were among the first to be vaccinated -- the shifting plans were just another case of inconsistent information from the government about the pandemic.

"Frankly, I did not trust the government to act on the science," said Lynn Hensley, who assigned herself a booster in July, six months after her second shot. "I'm 78 and consider myself at a greater risk. I feel like I can just read what's out there and make up my own mind."

She went to a temporary county vaccination clinic in the Fox River Valley area of Wisconsin.

"They did ask me if it was my first or second shot, and I told them it was my first," she said. "I did feel bad about it. But I didn't feel bad enough."

Pharmacies deny that they are knowingly letting people flout the guidelines.

"Patients are asked to attest that all information provided, including health status, is truthful and accurate while scheduling a vaccination appointment on CVS.com and when they receive their vaccination," said Ethan Slavin, a spokesman for the company. Slavin said that "we can't speak to anecdotal reports" that CVS is giving boosters to customers.

Public health experts generally take a dim view of booster self-selection. Like vaccine refusal, they say, it does not take into consideration the broader fight against the pandemic, which they believe should be focused on vaccinating the 25% of Americans who are eligible but unvaccinated, or on vaccinating poor nations.

"This flies in the face of what is required in a pandemic," said Dr. Kirsten Bibbins-Domingo, a public health researcher at the University of California, San Francisco. "The challenge is, particularly in a pandemic, individual choice is important, but the entire strategy has to do with our collective choices and responsibility."

MARYLAND ORDER

The Maryland Department of Health decided to take action before the FDA: It issued an order last week permitting immediate boosters for all residents 65 and older who live in group settings such as nursing homes. Michael Ricci, a spokesman for Gov. Larry Hogan, pointed to the CDC's recommendation last month that "moderately to severely immunocompromised" people should have extra shots.

"We are relying on that expansive view to deem the seniors in congregate settings as immunocompromised," he said. "We are directing those facilities to offer the booster shot to anyone who wants one."

Federal guidance on masks, vaccine mandates, the risk of outdoor transmission and other virus-related issues has shifted often over the course of the pandemic. At times, within both the Trump and Biden administrations, there has been open disagreement among health officials on how to proceed, as well as confusing guidance that has subsequently been reversed.

As a result, Americans across the political spectrum are relying on pieces of information, like an announcement by Israel's Ministry of Health in July that the effectiveness of the Pfizer-BioNTech vaccine against symptomatic infection -- though not against serious illness -- waned over time. Others have trusted their intuition, whether that means taking dangerous livestock medications to "cure" the virus or seeking a booster before it is officially recommended.

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