Sunday, 7 Aug 2022

Unwilling to Wait for Approval, Some Healthy Americans Seek Booster Shots

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 them before finding one.

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

“All I could think about was how low the vaccination rate is in some areas,” said Ms. 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.”

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

Studies in the United States have found that the vaccines continue to provide robust protection against severe Covid-19, especially for those younger than 65, even as evidence grows that their effectiveness against infection wanes over time. A review published on Monday by an international group of scientists, including two from the F.D.A., found 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 United States and a local pharmacy is not in a position to shift shots to nations that need them.

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 Food and Drug Administration authorized additional shots for that group last month.

Also last month, the Biden administration announced that it hoped to start offering boosters on Sept. 20 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 F.D.A. and the C.D.C. then said they needed more time to evaluate safety and other data. Janet Woodcock, the acting F.D.A. 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 vaccine 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.”

The Maryland Department of Health decided to take action ahead of the F.D.A.: It issued an order last week permitting immediate boosters for all residents 65 and older who live in group settings like nursing homes. Michael Ricci, a spokesman for Gov. Larry Hogan, pointed to the C.D.C.’s recommendation last month that “moderately to severely immunocompromised” people should have extra shots.

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“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 have 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, and 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.

“This is a result of poor risk communication and lack of political and scientific transparency over the last 18 months,” said Rachael Piltch-Loeb, a researcher and fellow in public health emergency preparedness and response at the Harvard School of Public Health. “It is also a reflection of people feeling a total lack of control of what is happening in society at this point. One of the things that can do to protect themselves is to take science into their own hands.”

Understand Vaccine and Mask Mandates in the U.S.

    • Vaccine rules. On Aug. 23, the Food and Drug Administration granted full approval to Pfizer-BioNTech’s coronavirus vaccine for people 16 and up, paving the way for an increase in mandates in both the public and private sectors. Private companies have been increasingly mandating vaccines for employees. Such mandates are legally allowed and have been upheld in court challenges.
    • Mask rules. The Centers for Disease Control and Prevention in July recommended that all Americans, regardless of vaccination status, wear masks in indoor public places within areas experiencing outbreaks, a reversal of the guidance it offered in May. See where the C.D.C. guidance would apply, and where states have instituted their own mask policies. The battle over masks has become contentious in some states, with some local leaders defying state bans.
    • College and universities. More than 400 colleges and universities are requiring students to be vaccinated against Covid-19. Almost all are in states that voted for President Biden.
    • Schools. Both California and New York City have introduced vaccine mandates for education staff. A survey released in August found that many American parents of school-age children are opposed to mandated vaccines for students, but were more supportive of mask mandates for students, teachers and staff members who do not have their shots.  
    • Hospitals and medical centers. Many hospitals and major health systems are requiring employees to get a Covid-19 vaccine, citing rising caseloads fueled by the Delta variant and stubbornly low vaccination rates in their communities, even within their work force.
    • New York City. Proof of vaccination is required of workers and customers for indoor dining, gyms, performances and other indoor situations, although enforcement does not begin until Sept. 13. Teachers and other education workers in the city’s vast school system will need to have at least one vaccine dose by Sept. 27, without the option of weekly testing. City hospital workers must also get a vaccine or be subjected to weekly testing. Similar rules are in place for New York State employees.
    • At the federal level. The Pentagon announced that it would seek to make coronavirus vaccinations mandatory for the country’s 1.3 million active-duty troops “no later” than the middle of September. President Biden announced that all civilian federal employees would have to be vaccinated against the coronavirus or submit to regular testing, social distancing, mask requirements and restrictions on most travel.

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