Health

(WASHINGTON) — Pfizer’s COVID-19 treatment Paxlovid has been hailed as a breakthrough in the fight against COVID-19. The pills have shown to dramatically reduce the risk of being hospitalized or dying for people who are at high-risk of COVID-19.

But mounting evidence suggests Paxlovid may not benefit everyone equally. The company recently announced the results of a new study that found the drug did not meaningfully benefit people without underlying medical conditions or no previous infection of COVID.

This comes weeks after the Biden administration announced plans to purchase 20 million treatment courses of the drug as it focuses on the Test-to-Treat initiative as part of the National COVID-19 Preparedness Plan.

Some infectious disease experts interviewed by ABC News said the new study could influence the way doctors prescribe the drug, potentially declining to prescribe it to vaccinated, otherwise healthy patients.

But overall, demand for the drug is likely to remain high because 60% of Americans are living with a chronic disease that qualifies them for the drug under its current authorization.

“Paxlovid is something that is targeted towards high-risk individuals, so the fact that it doesn’t have a benefit to low-risk individuals isn’t surprising to me,” Dr. Amesh Adalja, an infectious disease specialist at the Johns Hopkins University Center for Health Security, told ABC News.

The Centers for Disease Control and Prevention has provided guidance that the drug is recommended for treatment of mild to moderate COVID-19 among people at high risk for severe disease.

“At this stage, the current recommendation under the EUA is for Paxlovid to be given to any high-risk patient who has symptomatic COVID, whether vaccinated or unvaccinated, as long as it is within five days of the onset of symptoms,” Dr. Todd Ellerin, chief of medicine and director of infectious diseases at South Shore Health, told ABC News.

“If you’re older, particularly over age 65, if you have underlying illnesses, if you’re immunocompromised, those groups I think will continue to be targeted for Paxlovid,” Dr. William Schaffner, a professor of infectious diseases at Vanderbilt University Medical Center, told ABC News.

While the CDC has published a list of medical conditions that would put someone at high risk for severe illness, some experts argue there may be ambiguity.

“High-risk isn’t necessarily only objective criteria, like age, heart disease, etc. It’s also a situation, like socioeconomic status and some of those disparities that exist. When you add all that up, I think that a large swath of people do qualify for Paxlovid potentially as high-risk,” Dr. Peter Chin-Hong, an infectious disease specialist at the University of California, San Francisco, told ABC News.

Pfizer CEO Albert Bourla said the drug would continue to be an important treatment option.

“With up to 40-50% of people around the world estimated to be high risk, we believe there remains a significant unmet need for treatment options to help combat this disease, and we will continue to prioritize efforts to advance the development of Paxlovid,” Bourla said in a press release.

Experts tried to compare that global context to the United States.

“When you look at the average body mass index (BMI) of men and women in the United States is 26, that puts you at a high-risk category and eligible for Paxlovid. So at least 50% of the country is eligible for Paxlovid that is infected with COVID,” Ellerin said.

The CDC defines overweight people as those with a BMI of 25-30 and obese as those with a BMI over 30.

Doctors said there are serious considerations to weigh before prescribing Paxlovid. Drug-drug interactions may lead to serious or life-threatening drug toxicities, including medications such as cardiovascular agents and anticonvulsants. Meanwhile, Paxlovid carries a low risk of something called “COVID-19 rebound,” where individuals experience a recurrence of symptoms or a new positive viral test after having tested negative, according to the CDC.

“When it comes to Paxlovid, at the individual level, there may not be so much downside, but we don’t want to be inappropriately giving drugs to people where there would be no benefit and potentially some downside,” said Dr. John Brownstein, Chief Innovation Officer at Boston Children’s Hospital and an ABC News medical contributor.

A recent, small study estimated that less than 1% of patients experience a rebound of symptoms.

Brownstein remains optimistic that further research will clarify guidance on how best to prescribe the drug.

“I think there is a lot that needs to be understood, we have a lot of real-world data and so I think it is reasonable to understand how well it’s working and because it is so widely available, this will not be a hard drug to study like many others. So, we should have a lot of evidence to support a very specific recommendation,” Brownstein said.

Youri Benadjaoud is an MPH candidate at Brown University and a contributor to the ABC Medical Unit.

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(NEW YORK) — Women are significantly more likely than men to experience long-term symptoms of COVID-19, a new review suggests.

Researchers from Johnson & Johnson’s Office of the Chief Medical Officer for Women’s Health analyzed data from studies involving 1.3 million patients.

The results, published Tuesday in the journal Current Medical Research and Opinion, showed females are 22% more likely to develop long COVID than males.

“Knowledge about fundamental sex differences … of COVID-19 is crucial for the identification … of effective therapies and public health interventions that are inclusive of and sensitive to the potential differential treatment needs of both sexes,” the authors said in a news release.

Long COVID occurs when patients who have cleared the infection still have symptoms lasting more than four weeks after recovering. In some cases, these symptoms can persist for months, or even years.

Patients can experience a variety of lingering symptoms including fatigue, difficulty breathing, headaches, brain fog, joint and muscle pain, and continued loss of taste and smell, according to the Centers for Disease Control and Prevention.

It’s unclear what causes people to develop long COVID but there are several theories among experts including lingering virus in the body, damage to nerve pathways caused by the virus and the immune system remaining active following infection.

The study found the most common symptoms for women within four weeks of testing positive included ear, nose and throat (ENT) issues; muscle aches and pain; shortness of breath and psychiatric or mood disorders such as depression.

Meanwhile, men were more likely to have renal disorders such as acute kidney injury.

Not only were symptoms during COVID-19 infection different among males and females but the symptoms were also different after the development of long COVID.

For women, they had higher rates of long-term symptoms including fatigue; ENT; gastrointestinal; neurological; skin and psychiatric and/or mood disorders.

Women were at least twice as likely to have ENT long-term symptoms and 60% more likely to have gastrointestinal symptoms.

On the other hand, men had higher rates of renal disorders as well as endocrine disorders, including diabetes.

Several studies in the past have looked at differences in hospitalization, ICU admission and death from COVID-19 broken down by sex.

But the researchers noted that, out of more than 600,000 articles analyzed for this study — published between December 2019 and June 2021 — only 35 provided data about COVID-19 symptoms and aftereffects in enough detail to understand how males and females may experience the disease differently.

“Unfortunately, most studies did not evaluate or report granular data by sex, which limited sex-specific clinical insights that may be impacting treatment,” they wrote.

It’s unclear why women are more susceptible to long COVID than men, but the authors said it could be due to differences in how women’s immune systems respond to infection compared to those of men.

“Females mount more rapid and robust innate and adaptive immune responses, which can protect them from initial infection and severity,” they wrote. “However, this same difference can render females more vulnerable to prolonged autoimmune-related diseases.”

Additionally, the team said women may be at greater risk of COVID-19 because certain professions, such as nursing and education, are largely made up of females, which could — in turn — make them more likely to develop long COVID.

What’s more, “there may be disparities in access to care based on gender that could affect the natural history of the disease, leading to more complications and [aftereffects],” the authors wrote in the release.

The team said it hopes more researchers include detailed data about COVID-19 symptoms and effects broken down by sex in their studies to further study how differently men and women are affected and if different treatments are needed.

The authors did not immediately reply to ABC News’ request for comment.

Dr. Roberto Herrera contributed to this report.

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(NEW YORK) — As a heat wave slams the U.S. this week, it’s important to remember the dangers of leaving children in hot cars.

A child died in Harris County, Texas, on Monday after being left in a hot car for several hours, according to the Harris County Sheriff’s Office. This marked the fifth child to die in a hot car this year, according to national nonprofit KidsAndCars.org.

A record 54 children died in hot cars in 2018, followed by 53 fatalities in 2019, according to KidsAndCars.org.

It’s especially important to be mindful of hot car safety as more parents return to the office and their routines, KidsAndCars.org director Amber Rollins said. A change in routine can often prompt an accidental hot-car death, she explained.

Rollins said she’s also worried about parents who return to work with a hybrid schedule (working at home some days and in the office other days.)

“When your routine is shifting all over the place … that’s one of the most serious risk factors,” she said.

The science behind hot cars

Children’s bodies heat up much faster than adults’ do, according to the nonprofit National Safety Council.

Children’s internal organs begin to shut down once their core body temperature reaches 104 degrees, and it takes very little time for a car to get too hot for children, according to a report published by the council in 2018.

On an 86-degree day, for example, it would take only about 10 minutes for the inside of a car to reach a dangerous 105 degrees, researchers said.

What you can do

Rollins offers these tips for drivers:

— Always keep cars locked even if you don’t have children.

— Always keep keys out of children’s reach.

— Place an item you can’t start the day without in the back seat.

— If a child goes missing, check the inside and trunk of all cars in the area immediately.

— Teach children to honk the horn if they get stuck.

— If you spot a child or pet alone inside a car, “do something,” Rollins said. “If they are in distress, you need to get them out immediately and begin to cool them.”

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(NEW YORK) — Weighted swaddles and blankets are popular among parents trying to get their infants to sleep, but they should not be used on sleeping babies, according to new recommendations released by the American Academy of Pediatrics (AAP).

The AAP on Tuesday released updates to its safe sleep guidelines for the first time in five years.

The updated guidelines are based on the study of nearly 160 scientific articles since 2015 that cover risk factors and statistical trends for sleep-related infant death.

Among the new AAP’s new safe sleep recommendations are that weighted blankets, weighted sleepers and weighted swaddles should not be placed “on or near” a sleeping infant and infants should not wear hats indoors except in the first hours of life or in the neo-natal intensive care unit (NICU).

The AAP also recommends, as it has in the past, that caregivers always place infants to sleep on their backs on a firm, flat surface and should never add “blankets, pillows, padded crib bumpers, or other items to an infant’s sleeping environment.”

In addition, caregivers should not use infant sleep products with inclined seat backs of more than 10 degrees and should not use infant car seats, bouncers and other inclined products for sleep, according to the guidelines.

Around 3,400 babies in the U.S. die each year while sleeping in sudden and unexpected deaths, according to the AAP and the Centers for Disease Control and Prevention (CDC).

In May, President Joe Biden signed into law legislation that bans the manufacturing and sales of crib bumper pads and inclined sleepers with an inclined sleep surface of greater than 10 degrees.

Crib bumpers are defined by the law as “padded materials inserted around the inside of a crib and intended to prevent the crib occupant from becoming trapped in any part of the crib’s openings.”

Earlier this month, the U.S. Consumer Product Safety Commission warned consumers to not let their children sleep in child rockers after at least 14 deaths were linked to certain Fisher-Price and Kids2 rockers.

“Parents and caregivers should never use inclined products, such as rockers, gliders, soothers, and swings, for infant sleep and should not leave infants in these products unsupervised, unrestrained, or with bedding material, due to the risk of suffocation,” CPSC said.

The AAP offers these additional sleep safety recommendations for babies:

1. Until their first birthday, babies should sleep on their backs for all sleep times. “We know babies who sleep on their backs are much less likely to die of SIDS than babies who sleep on their stomachs or sides. The problem with the side position is that the baby can roll more easily onto the stomach. Some parents worry that babies will choke when on their backs, but the baby’s airway anatomy and the gag reflex will keep that from happening. Even babies with gastroesophageal reflux (GERD) should sleep on their backs.”

2. Use a firm sleep surface. “A crib, bassinet, portable crib, or play yard that meets the safety standards of the Consumer Product Safety Commission (CPSC) is recommended along with a tight-fitting, firm mattress and fitted sheet designed for that particular product. Nothing else should be in the crib except for the baby. A firm surface is a hard surface; it should not indent when the baby is lying on it. Bedside sleepers that meet CPSC safety standards may be an option, but there are no published studies that have examined the safety of these products. In addition, some crib mattresses and sleep surfaces are advertised to reduce the risk of SIDS. There is no evidence that this is true, but parents can use these products if they meet CPSC safety standards.”

3. Keep baby’s sleep area in the same room where you sleep for the first six months or, ideally, for the first year. “Place your baby’s crib, bassinet, portable crib, or play yard in your bedroom, close to your bed. The AAP recommends room sharing because it can decrease the risk of SIDS by as much as 50% and is much safer than bed sharing. In addition, room sharing will make it easier for you to feed, comfort, and watch your baby.”

4. Only bring your baby into your bed to feed or comfort. “Place your baby back in his or her own sleep space when you are ready to go to sleep. If there is any possibility that you might fall asleep, make sure there are no pillows, sheets, blankets, or any other items that could cover your baby’s face, head, and neck, or overheat your baby. As soon as you wake up, be sure to move the baby to his or her own bed … Bed-sharing is not recommended for any babies.”

5. Never place your baby to sleep on a couch, sofa, or armchair. “This is an extremely dangerous place for your baby to sleep.”

6. Keep soft objects, loose bedding and other items out of the baby’s sleep area. “These include pillows, quilts, comforters, sheepskins, blankets, toys, bumper pads or similar products that attach to crib slats or sides. If you are worried about your baby getting cold, you can use infant sleep clothing, such as a wearable blanket. In general, your baby should be dressed with only one layer more than you are wearing.”

7. Swaddle your baby safely. “Make sure that the baby is always on his or her back when swaddled. The swaddle should not be too tight or make it hard for the baby to breathe or move his or her hips. When your baby looks like he or she is trying to roll over, you should stop swaddling.”

8. Try giving a pacifier at nap time and bedtime. “This helps reduce the risk of SIDS, even if it falls out after the baby is asleep. If you are breastfeeding, wait until breastfeeding is going well before offering a pacifier. This usually takes 2-3 weeks. If you are not breastfeeding your baby, you can start the pacifier whenever you like. It’s OK if your baby doesn’t want a pacifier. You can try offering again later, but some babies simply don’t like them. If the pacifier falls out after your baby falls asleep, you don’t have to put it back.”

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(NEW YORK) — More than 1 million Americans have died from COVID-19, but recent data shows that deaths and severe disease are not increasing with the same vigor despite a surge in infections.

The U.S. has reported more than 700,000 new cases in the last week, but experts say totals are likely significantly undercounted as states shutter public testing sites and more Americans use at-home COVID-19 tests.

The number of virus-positive patients currently receiving care in hospitals across the country remains around 30,000 Americans, and on average, more than 4,200 virus-positive Americans are entering the hospital each day.

Although the number of people requiring hospitalization has doubled in the last two months, the total has plateaued in recent weeks, rather than surging significantly as they did in early January, when there were more than 160,000 patients receiving care.

Thus, even with infection rates surging, hospitalization and death rates have not seen a substantial increase, which experts say is likely the result of COVID-19 vaccines and booster shots blunting the impact of severe disease.

“What has been remarkable in the latest increase in infections we’re seeing is how steady serious illness and particularly deaths are eight weeks into this,” Dr. Ashish Jha, the White House COVID-19 response coordinator, told The Associated Press late last month. “COVID-19 is no longer the killer that it was even a year ago.”

Approximately 300 COVID-19-related deaths are currently reported each day, and about 1,800 Americans have been reported lost to the virus in the last week.

In the Northeast, which experienced a significant viral surge throughout the spring, there has yet to be a subsequent increase in COVID-19 deaths.

Even with undercounting, death rates are currently nowhere near where they stood at their peak in January 2021, when there were more than 3,400 deaths reported each day, or during the omicron peak in February, when the U.S. was reporting about 2,700 deaths every day.

Although an ABC News analysis of federal data shows that there has been an increase in breakthrough infections and deaths, the unvaccinated still remain at higher risk for severe disease compared to the vaccinated and boosted.

In April, unvaccinated adults were six times more likely to die of COVID-19 compared to vaccinated individuals and, in May, two times more likely to test positive, according to data from the Centers for Disease Control and Prevention.

Similarly, among Americans over the age of 50, the unvaccinated had a risk of dying that was 42 times higher than people who had been fully vaccinated and double boosted.

Even with encouraging news, health experts stressed that every death is still a tragedy, and Americans must continue to consider ways to protect themselves and the most vulnerable as they learn to live with the virus.

“We cannot allow ourselves to become numb to these numbers,” World Health Organization Director-General Tedros Adhanom Ghebreyesus said last week. “There is no acceptable level of deaths from COVID-19 when we have the tools to prevent, detect and treat this disease.”

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(NEW YORK) — The central U.S. is facing extreme heat on Monday, with temperatures forecast to skyrocket to 106 degrees in Minneapolis, 104 in Omaha, 104 in Dallas and 103 in Houston.

The sweltering conditions will then move east, with temperatures forecast to reach 99 in New Orleans and 98 in Raleigh on Wednesday.

Here are tips to stay safe from the Centers for Disease Control and Prevention:

Wear sunscreen

Take precautions to prevent sunburn, which can make you dehydrated and affect your ability to cool down.

Use sunscreen that’s SPF 15 or higher 30 minutes before going outside. Sunscreens that say “broad spectrum” or “UVA/UVB protection” are best.

Stay hydrated

Drink extra fluids, and don’t wait until you’re thirsty.

Avoid very sugary drinks and alcohol, which can cause your body to lose more fluid, and be wary of extra-cold drinks that may cause stomach cramps.

Avoiding hot and heavy meals also can reduce your body’s overall temperature.

Limit time outside

Cut down on exercise during heat waves and rest often and in shady areas.

Try to limit your time outside to when it is cooler, like in the early morning and evening.

Check the car

Never leave children in a parked car — even if windows are cracked open.

Monitor high-risk loved ones

Anyone can suffer from heat-related illness at any time, but these people are at greater risk:

— Babies and young children

— Overweight people

— Those 65 years old or older

— People who overexert during work or exercise

— Those who suffer from heart disease or high blood pressure and those who take certain medications, including for depression, insomnia or poor circulation

Watch for signs of illness

Symptoms of heat stroke include:

— Body temperature of 103 degrees or higher

— Hot, red, dry or damp skin

— Fast, strong pulse

— Headache

— Dizziness

— Nausea

— Confusion

— Passing out

— No longer sweating

Symptoms of heat exhaustion include:

— Heavy sweating

— Cold, pale, clammy skin

— Fast, weak pulse

— Nausea or vomiting

— Muscle cramps

— Feeling tired or weak

— Headache

— Passing out

If someone shows symptoms of heat stroke or heat exhaustion, call 911, move them somewhere cooler and use towels to cool down their body.

Don’t forget about your furry friends!

Here are some tips from the American Society for the Prevention of Cruelty to Animals for how to keep your pets safe in the heat: provide plenty of fresh water so they don’t get dehydrated; don’t over-exercise pets; never leave pets alone in a parked car; and watch for symptoms of overheating, which include excessive panting, difficulty breathing, increased heart and respiratory rate and drooling.

Animals with flat faces, like pugs, can’t pant as well and are more at risk of heat stroke. These pets, as well as older and overweight pets, should be kept inside as much as possible.

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(NEW YORK) — A panel of advisers at the Centers for Disease Control have greenlit the Pfizer and Moderna COVID-19 vaccines for kids as young as 6 months old, finding them both safe and effective.

CDC Director Rochelle Walensky issued a recommendation for how doctors, nurses and pharmacists should administer the shots on Saturday.

The CDC panel’s review and joint support for the vaccines comes after the FDA’s committee of independent experts also voted to recommend the Moderna and Pfizer vaccine on Wednesday, and the FDA authorized the vaccines on Friday.

Vaccines will start shipping out over the weekend and are on track to arrive as soon as Monday, a spokesperson with the Department of Health and Human Services said.

Kids could begin to get their shots Monday if the CDC director signs off, but given the federal holiday in honor of Juneteenth, some offices may be closed and it’s more likely that shots ramp up starting on Tuesday.

“As doses are delivered, parents will be able to start scheduling vaccinations for their youngest kids as early as next week, with appointments ramping up over the coming days and weeks,” President Joe Biden said in a statement applauding the news on Friday.

Ten million doses were made available by the federal government to states for pre-ordering over the last few weeks. Of those, 3.8 million doses have been ordered so far, according to HHS, including 2.5 million Pfizer doses, about half of the doses available, and 1.3 million Moderna doses, about a quarter of the doses made available.

Officials cautioned that preordering is generally slow when a new age group becomes eligible for shots as doctors and clinics get their vaccine programs up and running, but they expected orders to ramp up in the coming weeks.

Both Pfizer and Moderna’s CEOs said in statements they’re proud to finally be able to offer a vaccine option for parents of the youngest kids.

“Children need to live highly social lives to develop and flourish. With this authorization, caregivers for young children ages 6 months through 5 years of age finally have a way to safeguard against COVID risks in classroom and daycare settings,” said Stéphane Bancel, CEO of Moderna.

Albert Bourla, CEO of Pfizer, said they are “grateful” to those who enrolled children in the clinical trial to make the authorization possible.

And while the vaccines are both valuable options for COVID protection, some parents have struggled to decide which vaccine would be best for their child.

The nation’s leading health officials said Friday they’d give their kids whichever shot was available first. Dr. Robert Califf, the FDA commissioner, said he has two grandchildren under 5: “They’ll get the first one that’s available,” he said.

“The differences between the two are so much less than the fundamental benefit to risk balance,” he said in a press conference.

Dr. Peter Marks, the FDA’s vaccine chief, said the same but acknowledged the nuances that particularly attentive parents might consider.

“It may be that the Moderna vaccine brings an immune response slightly more rapidly. On the other hand, the three-dose Pfizer regiment may also bring a greater immune response after the third dose, and there are some subtle differences in the safety profile,” Marks said.

“But again, these are relatively subtle, and unless you really want to dive into the subtlety, to a first approximation the correct answer here is whatever vaccine your health care provider pediatrician has, that’s what I would give my child,” Marks said.

Data from Moderna, which is a two-shot series, showed its vaccine was about 40% to 50% effective at preventing mild infections after both shots.

But representatives for Moderna said they expected a third shot, or booster, would be available to kids in the coming months — either the current vaccine, or the omicron-specific vaccine the company is developing for the fall — which could increase efficacy.

Pfizer’s vaccine is one-tenth the size of the adult dose, given as a three-shot series.

The company’s early data showed it was 80% effective in preventing symptomatic COVID-19. But that protection largely didn’t kick in until the third shot — the data showed very minimal protection after doses one and two.

Marks also cautioned that the data from Pfizer was based on a much smaller group of children and that the FDA was waiting to see more follow-up data to know for sure what the efficacy rate was — though they remained confident there would be no concerns based on other data.

He urged parents to get their kids vaccinated regardless of past COVID infections, detailing new studies that showed the omicron variant in particular didn’t offer the same lasting immunity after infection as the vaccine does, and said parents should not wait for the fall, when there could be a new-and-improved vaccine, because getting vaccinated now would build up “foundational immunity.”

“I would strongly recommend that with the availability of this primary series, which provides excellent foundational immunity against a broad range of COVID-19 variants, that I would have children start this right now. And if it turns out that there is a very major change in strains that needs to occur in the fall, we will adjust and make sure that there is an option available for the youngest children and throughout the pediatric age range as appropriate,” Marks said.

“But for right now, this is something where we would recommend that people start this now because it will provide that foundational level of immunity.”

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(WASHINGTON) — The Food and Drug Administration has authorized the Pfizer and Moderna COVID-19 vaccines for kids as young as six months old, finding them both safe and effective.

“Many parents, caregivers and clinicians have been waiting for a vaccine for younger children and this action will help protect those down to 6 months of age. As we have seen with older age groups, we expect that the vaccines for younger children will provide protection from the most severe outcomes of COVID-19, such as hospitalization and death,” FDA Commissioner Robert Califf said in a press release Friday.

This comes after the FDA’s committee of independent experts voted to recommend the Moderna vaccine for kids under 6, which is a two-dose vaccine, and the Pfizer vaccine for kids under 5, which is a three-dose vaccine, on Wednesday. Both votes were unanimous.

The final step in the process is a recommendation from CDC Director Rochelle Walensky, after which shots can be administered in doctors’ offices, clinics, hospitals, pharmacies and other locations.

The FDA authorization means the federal government can begin shipping doses out to states to get ready to go in arms.

“Those trusted with the care of children can have confidence in the safety and effectiveness of these COVID-19 vaccines and can be assured that the agency was thorough in its evaluation of the data,” Califf said in the Friday statement.

This is a developing story. Please check back for updates.

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(TALLAHASSEE, Fla.) — Florida was the first state to advise against vaccinating healthy kids for COVID-19.
Florida was the only state in the U.S. that didn’t preorder any COVID-19 vaccines for young children, federal officials said Thursday.

The Florida Department of Health did not want to be involved in a “convoluted vaccine distribution process,” a representative from the department told ABC News in a statement on Wednesday.

“The Florida Department of Health (Department) has made it clear to the federal government that states do not need to be involved in the convoluted vaccine distribution process, especially when the federal government has a track record of developing inconsistent and unsustainable COVID-19 policies,” the representative said.

In March, the state’s Surgeon General, Dr. Joseph A. Ladapo, announced Florida would become the first state to officially advise against vaccinating healthy children for COVID-19.

“Already the rates were low. So, we’re kind of scraping at the bottom of the barrel particularly with healthy kids, in terms of actually being able to quantify with any accuracy and any confidence, the infinite potential of benefit,” Ladapo said at the time.

The representative for the state health department reiterated the health department still does not recommend the COVID-19 vaccine for all children.

“It is also no surprise we chose not to participate in distribution of the COVID-19 vaccine when the Department does not recommend it for all children,” the representative wrote.

Doctors will be able to order vaccines as they are needed, the department said. However, the representative noted that there are currently no orders in the Department’s ordering system for the COVID-19 vaccine for these young kids.

On Thursday, the White House quickly pushed back on Florida’s decision not to order any shots for young children.

“By being the only state — this is Florida — not preordering, which means that pediatricians, for example, in Florida will not have immediate ready access to vaccines, some pharmacies and community health centers in the state get access through federal distribution channels, but those options are limited for parents. We encouraged Florida on several occasions to order vaccines … and we will continue to do so,” White House press secretary Karine Jean-Pierre said during a press briefing on Thursday.

Jean-Pierre said the White House has been working with states for “some time” to ensure that if the vaccines are authorized by the Food and Drug Administration and the Centers for Disease Control and Prevention, the doses will be “shipped to places like pediatricians and children’s hospitals, places where parents would get health care for their youngest or as quickly as possible.”

With Florida not preordering vaccines, it will make it more difficult for parents to get a hold of vaccines for their young children, Jean-Pierre added.

Dr. John Brownstein, an epidemiologist at Boston Children’s Hospital and an ABC News contributor, concurred, adding that access to the shots will be critical to uptake.

“Vaccines access and confidence are tightly linked. If you make it harder for parents to vaccinate their kids, it will reduce the likelihood they will, especially if on the fence. By not making preorders available to Florida vaccination clinics, you are doing a disservice to so many families who have waited over two years to vaccinate their youngest kids,” Brownstein said.

Issues of equity may also be exacerbated, as some lower-income families may have a harder gaining access to the shots, Brownstein said.

“This rollout was already going to be the most challenging yet, especially with pharmacies playing a more limited role. By removing the state from the ordering equation, you are shifting a cumbersome process to pediatric frontline health care that is already stretched way too thin,” Brownstein added. “More challenging access will unfortunately only serve to exacerbate health disparities. Minority and low-income communities that already have a more challenging time accessing vaccines will have less options available.”

A committee of advisors to the FDA voted on Wednesday to recommend the Moderna vaccine for children under 6, which is a two-dose vaccine, and the Pfizer vaccine for kids under 5, which is a three-dose vaccine.

If FDA leadership chooses to officially authorize the vaccines, the administration can start shipping out vaccines to states. On Friday and Saturday, the CDC’s advisers will meet to review the data on both vaccines for children.

Thus far, states have preordered 3.8 million doses of vaccines for the youngest children, according to the U.S. Department of Health and Human Services.

ABC News’ Cheyenne Haslett and Sasha Pezenik contributed to this report.

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(WASHINGTON) — COVID-19 vaccinations for kids under age 5 could be available as early next week after an advisory committee for the Food and Drug Administration (FDA) voted Wednesday to recommend authorization for both Pfizer and Moderna’s vaccines.

Before shots can be administered to kids, the FDA must issue its official authorization, which could happen within days.

This Friday and Saturday, an advisory committee for the Centers for Disease Control and Prevention (CDC) will meet and then present its recommendation to CDC Director Dr. Rochelle Walensky, who gives the final green light.

At the start of the pandemic, scientists studied vaccines in adults first because they have a higher risk of dying of COVID-19. That means parents of children under the age of 5 have waited over two years, since the start of the pandemic, for a COVID-19 vaccine for their kids.

Now that the vaccine is one step closer to being available, parents may have questions about everything from which vaccine and how many doses their child should receive to how safe and effective the vaccines are.

Here are answers from pediatricians across the country to common questions from parents.

1. Which vaccine should my child get, Pfizer or Moderna?

The short answer is that both the Pfizer and Moderna vaccines are safe and good options for kids under 5, pediatricians say.

“Basically, they’re both very good choices,” Dr. Yvonne Maldonado, professor of pediatrics at Stanford University and chair of the American Academy of Pediatrics Committee on Infectious Diseases, told ABC News. “It’s always a great idea to have a choice for vaccines.”

Among the factors that will come into play on vaccine choice include which vaccine is available locally, parents’ preference and pediatricians’ recommendations, according to Maldonado.

The main difference between the two is that Moderna’s vaccine is delivered in two shots, taken 28 days apart, and Pfizer’s vaccine requires three shots over the course of around three months.

Pfizer’s data shows that fuller protection against COVID-19 does not kick in until the third shot, meaning a child who gets that vaccine will take longer to be protected against the virus.

Moderna says its vaccine is about 40 to 50% effective after two shots, and the company expects to roll out a booster, or third shot, in the coming months.

The Pfizer vaccine has already been available for those who are 5 and older but would now be available for kids ages 6 months through 4 years.

Moderna’s vaccine has previously been available only for people ages 18 and older. The latest vaccine authorization will be for kids ages 6 months to 5 years.

2. Does it matter that Pfizer and Moderna’s vaccines have different doses?

No, according to Dr. Vandana Madhavan, a pediatric infectious disease specialist at Mass General Hospital and professor at Harvard Medical School.

“What is most important is that both vaccines have the lowest doses given to the youngest children so that they are protected without increased side effects,” she said. “The actual dose is less important than the level of protective antibody that a particular vaccines pushes the immune system to make.”

The Pfizer vaccine is 3 micrograms — one-tenth of the adult dose — given in three doses.

The Moderna vaccine is 25 micrograms — one-fourth of the adult dose — given in two doses.

3. Will my child have side effects from the vaccine?

The side effects in children who get vaccinated against COVID-19 are typically mild, according to Madhavan.

“The most common side effect from the COVID-19 vaccine in all age groups is a sore arm at the site of an injection,” said Madhavan. “Children might get a low-grade fever, generalized fatigue and crankiness but these side effects are less common and self-resolved, going away in a couple of days.”

4. Why does my child need to be vaccinated against COVID-19 at such a young age?

While COVID-19 has had a more deadly impact on older adults, there have still been nearly 500 deaths in kids under 5 and over 30,000 hospitalizations in the U.S.

“One of the main issues is parents thinking that COVID-19 is a very mild disease, and the vaccines are very unsafe,” said Dr. Diego R. Hijano, pediatric infectious disease specialist at St. Jude Children’s Research Hospital. “And we cannot emphasize that the opposite is true.”

Dr. Tanya Altmann, a California-based pediatrician and school physician, said getting a child vaccinated against COVID-19 can not only help prevent immediate illness but also protect them from longstanding complications from the virus.

“Kids under age 5 deserve and need protection just as older kids and adults against the potentially serious complications from COVID-19 infection,” said Altmann. “The vaccine has reduced hospitalizations from COVID-19 in all other age groups and emerging data also shows a decrease in long COVID.”

Madhavan stressed that it is important to get as many children vaccinated as possible amid summer travel and camps and a return to school in the fall.

“We can’t predict what the summer and fall will bring with respect to new variants and how transmissible, how serious these variants will be,” said Madhavan. “We do know that thus far, vaccines are very effective at preventing serious disease from all variants.”

5. How do experts know the vaccine is safe for young kids?

Both Pfizer and Moderna released data to the FDA prior to Wednesday’s advisory meeting. The data shows the vaccines proved safe in clinical trials for kids ages 6 months through 4 years, or 5 years for the Moderna shot.

Dr. Jay Portnoy, a professor of pediatrics at the University of Missouri-Kansas City School of Medicine and a member of the FDA advisory committee, called the vaccines “very safe to use.”

“Our question today is, does the benefit outweigh the risks of this vaccine? And I think that the evidence is pretty clear,” Portnoy said at Wednesday’s meeting. “For preventing severe disease, hospitalization, emergency visits, this vaccine is very effective, very safe to use.”

6. How do I get a vaccine for my child?

Parents should talk to their child’s pediatrician about where and how to get a vaccine.

Pediatricians’ offices, children’s hospitals and family doctors’ offices will all be among the top sites for kids under 5 to get vaccinated.

If the authorization process for Pfizer and Moderna’s vaccines moves forward as planned, vaccines could be available for kids as early as Tuesday.

“Remember, pediatricians get vaccines all the time. It’s a large part of what they do,” said Maldonado, adding that the American Academy of Pediatrics has already been working with the CDC and local health departments to coordinate the vaccine rollout for kids under 5. “They’re used to rolling out new vaccines on a regular basis.”

7. If my child had COVID, do they still need to get vaccinated?

Yes, pediatricians say.

“Individuals who have a combination of infection and vaccines have the best protection of all,” said Hijano, describing a concept called hybrid immunity. “They are better than those who only got the vaccines and significantly better than those who only got infected.”

According to Hijano, getting kids vaccinated, including those have already had COVID-19, will be especially important as the virus contains to change and new variants emerge.

Kids can get vaccinated as soon as they are out of isolation from COVID-19. They do not have to wait a certain amount of time, according to Hijano.

Priya Jaisinghani, M.D., is an endocrinologist at New York Presbyterian-Weill Cornell and a contributor to the ABC News Medical Unit.

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