FDA approval of Pfizer COVID-19 vaccine not doing much to boost inoculations in Sonoma County

People cite a wide range of reasons for declining the coronavirus vaccines here in Sonoma County and elsewhere, but one common explanation has been, “They don’t have real FDA approval.”

For months, health workers have doled out shots of Pfizer-BioNTech, Moderna and Johnson & Johnson under emergency use authorizations from the U.S. Food and Drug Administration. That authorization was given after the formulas had gone through three stages of vigorous study. Full approval requires a fourth stage, one that examines a larger pool of vaccine and placebo recipients over a longer period of time.

The FDA’s announcement earlier this week that it was formally approving the Pfizer mRNA vaccine seemed like it could be a huge step in the effort to convince the wary to get immunized. A few days in, though, the unvaccinated aren’t necessarily beating down the doors of clinics for shots of Pfizer.

“I’ve only had one family so far say that the FDA approval helped them decide to schedule a vaccine appointment,” said Sutter Health pediatrician Brian Prystowsky, a major driver in the local vaccination campaign. “I wish I had better news to report.”

More than 82,000 Sonoma County residents remain unvaccinated, and doctors like Prystowsky have been trying desperately to convince them (or their parents, in the case of minors) to sign up, in hopes of saving lives and of reducing the burden on hospital ICU units.

They received a blow Thursday as county health officials reported four new COVID-19 deaths, including three people who were vaccinated. All four individuals were hospitalized and had underlying health conditions, officials said. They bring the COVID-19 fatality total to 353 since the start of the pandemic.

The most recent deaths include a vaccinated man between 50 and 64 who died Aug. 7; a vaccinated woman between 50 and 64 who died Aug. 16; and a vaccinated woman over 64 who died Aug. 12. An unvaccinated woman in the 18-49 age range died Aug. 13, officials said.

Coronavirus infections among vaccinated people, known as breakthrough cases, have been rare. Deaths following a breakthrough case have been even more so. To date, there have been 1,773 breakthrough cases in Sonoma County, which amounts to 0.56% of fully vaccinated individuals 12 and older. Infections those residents make up 12.7% of all cases since the beginning of the year, when the local immunization effort started.

Monday, shortly after the FDA announced its decision, the Press Democrat asked readers on its website, “If you’ve been holding off getting vaccinated against COVID-19, will the FDA’s recent approval of the Pfizer vaccine now convince you to get it?”

As of Thursday afternoon, 18 people had replied. One response fawningly praised the FDA and should probably be dismissed as sarcasm. Among the other replies, not a single person said they were budging. The final score was a 17-0 victory for skepticism, and a disappointment for vaccine advocates.

“The FDA approval does not convince me to get it,” a commenter who identified herself as Rachel posted. “The whole approval process was rushed, and there is too much pressure and fast-tracking to trust that this approval makes the vax any safer in the public’s eye.”

“I will absolutely not get it. EVER!” Briana wrote. “The FDA has approved many things that are bad for our health. Like food additives (MSG, BHT, Aspartame). There is many treatments for COVID, there’s no need for a vaccine that has caused so many side effects and deaths already.”

Doctors and public health officials are well-armed with rebuttals to those specific concerns, but their pleas have largely gone unheeded.

The county’s vaccination data doesn’t offer a clear indication that FDA approval has moved the needle. The number of first-dose vaccinations administered in the county Tuesday (1,053) and Wednesday (932) were two of the three highest daily figures in the past 10 days. But you would expect a true bounce to show the Pfizer numbers, specifically, going up. That hasn’t been the case. Doses of Pfizer given out Monday, Tuesday and Wednesday (235, 838 and 745, respectively) were actually a bit lower than the same days in the previous week.

Of course, not every local vaccination clinic has all three vaccines to administer on any given day, so it’s a bad idea to infer too much from daily data.

At a clinic run by Fox Home Health at the Roseland Community Center on Thursday, reaction was mixed. “People have been coming in saying, ‘I want the real one,’” said Marian Avila-Hamann, a Fox nurse.

Avila-Hamann added that the health group is having to hold off people clamoring for booster shots — another FDA recommendation that is in the works for sometime this fall — because there isn’t enough supply yet to accommodate them.

Inside the clinic, Viviana Vega, a 41-year-old Windsor resident, acknowledged that the change in status convinced her to request Pfizer. “You hear stories with the others, like Johnson & Johnson causing heart problems,” Vega said while resting comfortably moments after getting her first dose. “This felt a little more secure.”

But the main reason for her change of mind was a mandate by her employer. A caregiver for Becoming Independent, Vega has until Sept. 30 to be fully vaccinated. Santiago Luna, who is 43 and cleans offices, got a similar mandate from his company.

“I wasn’t afraid (of the vaccine),” Luna said in Spanish at the Roseland clinic. “I was just waiting.”

He was there with his wife, Irma Maciel, and her mother, Rafaela Guerrero-Flores. All of them got first doses Thursday. Guerrero-Flores, 80, said she had been afraid to get the shot because people were telling her it would make her sick. But God finally lent an approval that, to her, was much more important than the FDA’s.

“Maybe He gave me time to think about it,” Guerrero-Flores said in Spanish, “because He told me it was OK.”

Another Sonoma County resident is still thinking about it. The FDA’s stamp of approval isn’t enough to sway her.

“I’m not anti-vaccination,” said Elizabeth, who requested that her last name not be published because of the fierce emotions swirling around this issue. “My kids are vaccinated, I’m vaccinated (for childhood illnesses like measles and mumps). But I am anti-COVID vaccine at this time, just because of how quickly they got it out, and how hard they’re pushing it. And the very limited data that’s out there for it.”

Elizabeth is a rarity, an American who studies information on the coronavirus vaccines and is neither adamantly in favor of or opposed to them. She fully believes the virus itself is more dangerous than the shots. And she has no patience for the conspiracy theories spawned in the past nine months — like the one going around now that insists the vaccine approved by the FDA this week is not the same one that has been going into arms since mid-December. (It is the same shot, but will be marketed commercially under a different name, Comirnaty.)

Elizabeth just isn’t ready yet. And she opposes mandating vaccines for attendance or employment. The mother of four children between the ages of 2 and 12, Elizabeth takes classes at SRJC. This semester, the school is applying a “soft mandate” that offers students the option of weekly testing as an alternative to vaccination. It will go to a hard mandate next semester.

By then, Elizabeth said, she’ll likely be comfortable enough with the available evidence to get vaccinated. Meanwhile, what concerns her most is the way the vaccination debate is driving a wedge into her community.

“It’s a tiny bit scary to talk about, because of how very opinionated both sides can be,” Elizabeth noted. “I get both sides. I joke with my friends. I say people who have gotten the vaccine and say things like ‘the unvaccinated are what’s keeping this pandemic going,’ they must have gotten a shot of a__hole, too. They don’t have a right to feel superior.”

You can reach Phil Barber at 707-521-5263 or phil.barber@pressdemocrat.com. On Twitter @Skinny_Post.