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What do FDA's changes in COVID-19 boosters mean for you?

Nicole Villalpando
Austin American-Statesman

The Food and Drug Administration on Monday changed the emergency use authorization for the Pfizer COVID-19 vaccine. It now allows people who received the Pfizer vaccine to get a booster at five months, instead of six, after they received their second dose.

The FDA also recommended boosters for kids 12 to 15. Previously, boosters were allowed only for people 16 and older. 

And it advised that kids 5 to 11 who have had a solid organ transplant or have a similar level of being immune compromised receive a third dose 28 days after the second dose.

The Centers for Disease Control and Prevention approved these recommendations as well.

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Dr. Allison Lopez gives Oliver Howell his first dose of a COVID-19 vaccine in November. The FDA has changed the emergency use authorization for Pfizer COVID-19 vaccine to allow for kids 12 to 15 to get a booster and those 5 to 11 to get a third dose if they are immune-compromised.

What's happening with COVID-19 and the omicron variant in Austin? 

Austin Public Health moved Austin from Stage 3 to Stage 4 safety guidelines last week. The surge from the omicron variant has begun. 

On Monday, Austin Public Health announced that 314 people were hospitalized locally for COVID-19, 65 were in intensive care units and 24 were on ventilators. The seven-day moving average for new hospitalizations was 66. It was 15 during Christmas week. 

Our local positivity rate was 18.3%. Anything above 10% is considered high. It was 7.7% during Christmas week. 

Our transmission rate was 434.6. That's the number of cases per 100,000 people. It was 36.5 at the beginning of December.

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This variant is especially affecting children. Dell Children's Medical Center has seen an increase in the number of kids coming in for COVID-19, said Dr. Meena Iyer, the chief medical officer at Dell Children's.

The kids being hospitalized now range from needing some oxygen and antiviral medications to needing to be in the ICU and on a ventilator. It's hard to predict which kids will need that higher level of care, Iyer said. "It really depends on the state of the illness and their comorbidities," she said. 

The number of cases has made it more difficult at the hospital, as has the number of staff members who are having to quarantine for five days because of an exposure to COVID-19 or a positive test after being screened.

Iyer said she expects our local COVID-19 situation to continue to worsen in the next few weeks based on previous variant surges. 

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People who received Pfizer vaccinations can now get a booster at five months instead of needing to wait six months. Diane Ginsburg, clinical professor and associate dean of the college of pharmacy at the University of Texas, prepares Pfizer COVID-19 vaccines in November.

Why are vaccinations and boosters important?

In the past month local hospitals have been seeing the unvaccinated come through their doors. 

At Dell Children's, all of its kids hospitalized for COVID-19 have been unvaccinated, Iyer said. These patients also tend to have comorbidities such as obesity or a chronic illness.

Yes, with the omicron variant, there have been more breakthrough cases in people who are fully vaccinated and even vaccinated and boosted, but "if they had not gotten (the vaccine), they would be so much sicker," Iyer said. 

She likens getting COVID-19 after getting vaccinated to having a flu shot and still getting the flu. It usually is a milder case and is less likely to result in a hospital stay.

When should I get a booster shot?

Monday's FDA recommendations affect only people who got the Pfizer vaccine. Changes officially began after the CDC approved the recommendations.

If you received the Pfizer vaccine and are 12 or older, you can get a booster now five months after your second vaccination. The booster is a full dose of the original vaccine.

If you received the Moderna vaccine, which is available only for people 18 and older, you can get a booster six months after your second vaccination. That booster is half of the original dose.

If you received the Johnson & Johnson vaccine, which is available only for ages 18 and older, you can get a booster two months after you received that one-dose vaccine. That booster is a full dose of the original vaccine.

For people 18 and older, you can get any of these three vaccines as your booster. For people 12 to 17, Pfizer is the only vaccine available as both the primary vaccine series and the booster.

What about side effects with the booster?

There is a myth that the vaccine and booster can cause COVID-19, Iyer said. People should reach out to their pediatricians or family care doctors if they have questions or go to reliable places such as the CDC and the American Academy of Pediatrics for information.

The side effects with the booster have been similar to the initial rounds of vaccines — headache, fever, sore arm. The one notable difference, the FDA said, is that the rare side effect of myocarditis in teens and young adults, mostly males, tends to happen more with the second dose than the first dose or the booster.

Iyer said that at Dell Children's they have yet to treat a child or teen with myocarditis after getting the vaccine, but they have treated plenty of cases of COVID-19. 

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Why five months instead of six for Pfizer?

The FDA follows the science based on the data it has. Pfizer always has presented its most recent data before Moderna or Johnson & Johnson. 

Since Pfizer initially submitted its data on boosters, the omicron variant has become the predominant one circulating. The FDA said real-world data became available about that variant and the cases being seen in the U.S. Pfizer provided peer-reviewed studies on the effectiveness of a booster with this variant. 

The FDA also looked at safety results from Israel for people 16 and older who received a booster five months after the initial doses. 

This move is to try to get more people the necessary protection from the omicron variant — a recent vaccine or a booster. 

Which kids qualify for a third dose?

Kids who have had a solid organ transplant, are on dialysis, have cancer, or have another chronic illness that causes them to take an immune suppressing medication or high dose steroid would qualify for the third dose.

Those kids are getting a third dose because they have trouble mounting enough of an immune response with the first two doses. 

Check with your child's specialist or pediatrician if you're not sure whether your child qualifies. 

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Where can I get a booster shot? 

Local pharmacies have vaccines available. It helps to make an appointment online and to make sure the pharmacy has the right vaccine for you. Kids who are 12 to 17 have to receive a Pfizer booster. Immune compromised 5- to 11-year-olds need to receive the lower pediatric dose of Pfizer for their third shot, just like their first and second doses.

Austin Public Health has every type of COVID-19 vaccine and booster available at its clinics. You do not need an appointment. The hours and locations are: 9 a.m. to noon Tuesday, Wednesday and Friday and 2 to 7 p.m. Thursday at the Delco Activity Center, 4601 Pecan Brook Drive; and 2 to 7 p.m. Wednesday and Thursday and 11 a.m. to 3 p.m. Saturday at Old Simms Elementary gym, 1203 Springdale Road. 

The Austin school district has vaccine clinics for students, staffers, family members and community members. It will have the pediatric Pfizer vaccine and the Pfizer booster from 8 a.m. to noon Saturday at the AISD Performing Arts Center.

It will have the pediatric Pfizer, the regular Pfizer and Moderna vaccinations, and both Pfizer and Moderna boosters from 4 to 8 p.m. Jan. 13 at Northeast Early College High School and from 4 to 8 p.m. Jan. 20 at Navarro Early College High School.  

It will have the pediatric Pfizer, regular Pfizer vaccination and booster from 4 to 8 p.m. Jan. 19 at Paredes Middle School, from 4 to 8 p.m. Jan. 26 at Mendez Middle School and from 8 to 11 a.m. Jan. 29 at the AISD Performing Arts Center. 

More dates are available at austinisd.org/student-health/covid-19/vaccine.

What can we do to protect against omicron as school starts?

Iyer recommends getting vaccinated and boosted depending on where you fit in the timeline and recommendations for your age. Wear masks, preferably medical quality such as surgical, N95 or KN95. The cloth masks don't have the same level of protection against transmission with this variant. Wash your hands regularly and maintain social distance.