vaccination – Cincy Link

US set to offer monkeypox vaccines to states with high case rates

cincylink — Wed, 12 Jul 2023 04:08:42 +0000

The Biden Administration is expected to detail plans to roll out more monkeypox vaccines across the U.S.The move comes after pressure from states, who have been pushing the Administration to release more doses of monkeypox vaccine from the Strategic National Stockpile which is managed by the Office of the Assistant Secretary for Preparedness and Response at the Department of Health and Human Services.Related video above: LGTBQ community concerns over monkeypox stigmaThe plan will allocate doses based on case rates in a state, focusing on men who have sex with men and their partners, as well as anyone who thinks they might have been recently exposed to the virus, according to two sources familiar with the government's plans who were not authorized to speak with reporters.Currently, 10 states would be considered to be in the first tier for priority in ordering vaccines.The plans are expected to be officially announced later Tuesday evening.They come in the middle of Pride month, a month filled with parties celebrating gender and sexual diversity, and a season that many in public health have worried will only fuel the spread of the monkeypox virus which is spread by close contact, including sex.The vaccination plan may require the U.S. to use two different types of vaccines.The first is a newer, modern vaccine called Jynneos which is manufactured by a Danish company called Bavarian Nordic. It was evaluated and developed and to treat monkeypox infection. The U.S. currently has 64,000 doses of this vaccine in the stockpile. The government will make 56,000 of those doses available to states in phase one of the rollout. More doses of this vaccine have been ordered and are expected to be delivered later this year.The problem is that the U.S. may not have enough doses of Jynneos to vaccinate all who might need it, so public health officials are also considering whether to use a second older type of vaccine called ACAM. The ACAM vaccine was developed to treat smallpox. It's given by using a two-pronged needle that's repeatedly dipped into the vaccine and used to prick the skin on the upper arm, causing a small sore or "pock" to form."It's a very kind of like, old-school technology that basically I don't know any clinicians that actually know how to do that. So it's actually very difficult to roll out because you have to train people in a new vaccine methodology," said Dr. Jay Varma, professor and director of the Cornell Center for Pandemic Prevention and Response in New York City.The other complication is that the ACAM vaccine uses a live, but weakened version of a virus to inoculate a person."It's presumed not to be safe to be able to be used in people with HIV," Varma said. The primary risk group for monkeypox — men who have sex with men — also have high rates of HIV infection.During a call with reporters Tuesday, Dr. Rochelle Walensky, director of the U.S. Centers for Disease Control & Prevention, said five additional labs are in place to accelerate testing. She also urged states to make tests readily available and said additional outreach is underway to make health care workers more aware of what monkeypox looks like and how to treat it.When it comes to vaccines, Walensky said vaccines should be provided for anyone who has been exposed to monkeypox, through both official contract tracing or for those who have been in a location or at an event where there was a case and there was potential exposure.Vaccination after exposure is meant to reduce the risk of developing the virus, Walensky explained, and vaccination should occur within two weeks of exposure. Hearst Television contributed to this report.

The Biden Administration is expected to detail plans to roll out more monkeypox vaccines across the U.S.

The move comes after pressure from states, who have been pushing the Administration to release more doses of monkeypox vaccine from the Strategic National Stockpile which is managed by the Office of the Assistant Secretary for Preparedness and Response at the Department of Health and Human Services.

Related video above: LGTBQ community concerns over monkeypox stigma

The plan will allocate doses based on case rates in a state, focusing on men who have sex with men and their partners, as well as anyone who thinks they might have been recently exposed to the virus, according to two sources familiar with the government's plans who were not authorized to speak with reporters.

Currently, 10 states would be considered to be in the first tier for priority in ordering vaccines.

The plans are expected to be officially announced later Tuesday evening.

They come in the middle of Pride month, a month filled with parties celebrating gender and sexual diversity, and a season that many in public health have worried will only fuel the spread of the monkeypox virus which is spread by close contact, including sex.

The vaccination plan may require the U.S. to use two different types of vaccines.

The first is a newer, modern vaccine called Jynneos which is manufactured by a Danish company called Bavarian Nordic. It was evaluated and developed and to treat monkeypox infection. The U.S. currently has 64,000 doses of this vaccine in the stockpile. The government will make 56,000 of those doses available to states in phase one of the rollout. More doses of this vaccine have been ordered and are expected to be delivered later this year.

The problem is that the U.S. may not have enough doses of Jynneos to vaccinate all who might need it, so public health officials are also considering whether to use a second older type of vaccine called ACAM. The ACAM vaccine was developed to treat smallpox. It's given by using a two-pronged needle that's repeatedly dipped into the vaccine and used to prick the skin on the upper arm, causing a small sore or "pock" to form.

"It's a very kind of like, old-school technology that basically I don't know any clinicians that actually know how to do that. So it's actually very difficult to roll out because you have to train people in a new vaccine methodology," said Dr. Jay Varma, professor and director of the Cornell Center for Pandemic Prevention and Response in New York City.

The other complication is that the ACAM vaccine uses a live, but weakened version of a virus to inoculate a person.

"It's presumed not to be safe to be able to be used in people with HIV," Varma said. The primary risk group for monkeypox — men who have sex with men — also have high rates of HIV infection.

During a call with reporters Tuesday, Dr. Rochelle Walensky, director of the U.S. Centers for Disease Control & Prevention, said five additional labs are in place to accelerate testing. She also urged states to make tests readily available and said additional outreach is underway to make health care workers more aware of what monkeypox looks like and how to treat it.

When it comes to vaccines, Walensky said vaccines should be provided for anyone who has been exposed to monkeypox, through both official contract tracing or for those who have been in a location or at an event where there was a case and there was potential exposure.

Vaccination after exposure is meant to reduce the risk of developing the virus, Walensky explained, and vaccination should occur within two weeks of exposure.

Hearst Television contributed to this report.

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Measles outbreak in central Ohio ends after 85 cases, all among children who weren’t fully vaccinated

cincylink — Sat, 03 Jun 2023 06:09:28 +0000

A measles outbreak in central Ohio that sickened 85 children has been declared over, officials at Columbus Public Health announced Sunday. None of the children died, but 36 were hospitalized.The outbreak of measles infections, which was first reported in early November, spread among children who were not fully vaccinated and was mostly driven by a lack of vaccination in the community. Among the 85 cases, all but five were ages 5 and younger.Measles cases in central Ohio emerged quickly in November and early December, but the number of new cases being identified appeared to slow during the winter holidays. Local health officials waited until no new cases were reported within 42 days -- or two incubation periods of the measles virus -- before declaring the outbreak over.Health officials fought the outbreak by "sounding the alarm," including being transparent about the state of the outbreak, informing the public about how easily the measles virus can spread and promoting the importance of getting young children vaccinated against the virus, said Dr. Mysheika Roberts, health commissioner for the city of Columbus, who led the outbreak response."In addition, we've had family members of individuals who have been infected with measles who have been very vocal and said they made a mistake -- they should have gotten their child vaccinated. And I think that has helped as well," she said.Experts recommend that children receive the measles, mumps and rubella -- known as the MMR -- vaccine in two doses: the first between 12 months and 15 months of age and a second between 4 and 6 years old. One dose is about 93% effective at preventing measles if a person comes into contact with the virus. Two doses are about 97% effective.In the United States, more than 90% of children have been vaccinated against measles, mumps and rubella by age 2, according to the U.S. Centers for Disease Control and Prevention.Measles was declared eliminated in the United States in 2000, and since then, most cases in the U.S. have emerged in communities with low rates of vaccination against the virus.Even if a disease is eliminated, outbreaks can still occur if an unvaccinated person travels to or from a country where the disease is still common, becomes infected and brings it back to the United States, introducing the virus into a community. That traveler can transmit measles to anyone who is unvaccinated."While we expect importations of measles cases into the United States to continue, the risk for measles for the majority of the population would still remain low," the CDC says on its website. "That is because most people in the United States are vaccinated against measles."How health officials stopped outbreak in its tracksWhen the outbreak began, the CDC sent a small team to Columbus to assist with tracking measles cases and pinpointing how the virus was spreading. Once a new case was identified, health officials worked quickly to determine who had been in contact with that person, whether the contacts were vaccinated against measles and, if not, whether they had been infected.About 90% of unvaccinated people who are exposed to measles will become infected, according to Columbus Public Health, and about 1 in 5 people in the U.S. who get measles will be hospitalized."Altogether, we had six CDC people helping us at one point in time on the ground, and that was very effective," Roberts said. "I think that really helped us slow the progression of this virus in our community."She added that the outbreak took Columbus Public Health officials off-guard."We've had low vaccination rates for MMR in our community for years, but we've never had a measles outbreak like we have now. So it did take us by surprise," Roberts said.There was not one single community or demographic of people within central Ohio that was at an increased risk of measles infections or had low vaccination rates. Rather, small pockets of communities where families decided not to get their children vaccinated were influenced by "false information that was distributed about the MMR vaccine being associated with autism," Roberts said, and that's what drove the outbreak.'One of the most contagious viruses that we've identified'Measles can spread through the air when an infected person coughs or sneezes or shares germs by touching objects or surfaces. Even after an infected person leaves a room, measles virus can live for up to two hours in the air.Symptoms can include fever, cough, runny nose, watery eyes and a rash of red spots. In rare cases, it may lead to pneumonia, encephalitis or death.Making sure children get the recommended MMR vaccinations as part of their routine childhood immunizations can help reduce their risk of measles, said Dr. Tanya Altmann, founder of Calabasas Pediatrics in California and author of "Baby & Toddler Basics," who is an adjunct clinical professor at Children's Hospital Los Angeles."Measles is one of the most contagious viruses that we've identified, and if one person has measles and there's somebody unvaccinated around them, there's a 90% chance they're going to get it," she said, adding that all of the children infected during the measles outbreak in Ohio were all not fully vaccinated."It really just takes one unvaccinated person to travel into a community, and they can have a measles outbreak if there isn't a high enough vaccination rate in that community," Altmann said.

A measles outbreak in central Ohio that sickened 85 children has been declared over, officials at Columbus Public Health announced Sunday. None of the children died, but 36 were hospitalized.

The outbreak of measles infections, which was first reported in early November, spread among children who were not fully vaccinated and was mostly driven by a lack of vaccination in the community. Among the 85 cases, all but five were ages 5 and younger.

Measles cases in central Ohio emerged quickly in November and early December, but the number of new cases being identified appeared to slow during the winter holidays. Local health officials waited until no new cases were reported within 42 days -- or two incubation periods of the measles virus -- before declaring the outbreak over.

Health officials fought the outbreak by "sounding the alarm," including being transparent about the state of the outbreak, informing the public about how easily the measles virus can spread and promoting the importance of getting young children vaccinated against the virus, said Dr. Mysheika Roberts, health commissioner for the city of Columbus, who led the outbreak response.

"In addition, we've had family members of individuals who have been infected with measles who have been very vocal and said they made a mistake -- they should have gotten their child vaccinated. And I think that has helped as well," she said.

Experts recommend that children receive the measles, mumps and rubella -- known as the MMR -- vaccine in two doses: the first between 12 months and 15 months of age and a second between 4 and 6 years old. One dose is about 93% effective at preventing measles if a person comes into contact with the virus. Two doses are about 97% effective.

In the United States, more than 90% of children have been vaccinated against measles, mumps and rubella by age 2, according to the U.S. Centers for Disease Control and Prevention.

Measles was declared eliminated in the United States in 2000, and since then, most cases in the U.S. have emerged in communities with low rates of vaccination against the virus.

Even if a disease is eliminated, outbreaks can still occur if an unvaccinated person travels to or from a country where the disease is still common, becomes infected and brings it back to the United States, introducing the virus into a community. That traveler can transmit measles to anyone who is unvaccinated.

"While we expect importations of measles cases into the United States to continue, the risk for measles for the majority of the population would still remain low," the CDC says on its website. "That is because most people in the United States are vaccinated against measles."

How health officials stopped outbreak in its tracks

When the outbreak began, the CDC sent a small team to Columbus to assist with tracking measles cases and pinpointing how the virus was spreading. Once a new case was identified, health officials worked quickly to determine who had been in contact with that person, whether the contacts were vaccinated against measles and, if not, whether they had been infected.

About 90% of unvaccinated people who are exposed to measles will become infected, according to Columbus Public Health, and about 1 in 5 people in the U.S. who get measles will be hospitalized.

"Altogether, we had six CDC people helping us at one point in time on the ground, and that was very effective," Roberts said. "I think that really helped us slow the progression of this virus in our community."

She added that the outbreak took Columbus Public Health officials off-guard.

"We've had low vaccination rates for MMR in our community for years, but we've never had a measles outbreak like we have now. So it did take us by surprise," Roberts said.

There was not one single community or demographic of people within central Ohio that was at an increased risk of measles infections or had low vaccination rates. Rather, small pockets of communities where families decided not to get their children vaccinated were influenced by "false information that was distributed about the MMR vaccine being associated with autism," Roberts said, and that's what drove the outbreak.

'One of the most contagious viruses that we've identified'

Measles can spread through the air when an infected person coughs or sneezes or shares germs by touching objects or surfaces. Even after an infected person leaves a room, measles virus can live for up to two hours in the air.

Symptoms can include fever, cough, runny nose, watery eyes and a rash of red spots. In rare cases, it may lead to pneumonia, encephalitis or death.

Making sure children get the recommended MMR vaccinations as part of their routine childhood immunizations can help reduce their risk of measles, said Dr. Tanya Altmann, founder of Calabasas Pediatrics in California and author of "Baby & Toddler Basics," who is an adjunct clinical professor at Children's Hospital Los Angeles.

"Measles is one of the most contagious viruses that we've identified, and if one person has measles and there's somebody unvaccinated around them, there's a 90% chance they're going to get it," she said, adding that all of the children infected during the measles outbreak in Ohio were all not fully vaccinated.

"It really just takes one unvaccinated person to travel into a community, and they can have a measles outbreak if there isn't a high enough vaccination rate in that community," Altmann said.

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Here’s how omicron changed the plans for children’s vaccinations

cincylink — Fri, 04 Feb 2022 18:27:11 +0000

About 18 million children under the age of 5 in the United States could soon be eligible to get a COVID-19 vaccine — but first, the child-sized shot must go through a rigorous authorization process that's taking a different path than the COVID-19 vaccines that came before.On Tuesday, Pfizer and BioNTech announced that they had initiated a rolling submission to the U.S. Food and Drug Administration of data for their vaccine for children ages 6 months up to 5 years. The companies expect to complete the request for emergency use authorization soon.It will still go through a thorough safety and efficacy review by U.S. health agencies and experts, but it's a different plan than what was expected late last year.In December, Pfizer announced that it decided to add a third dose to the primary vaccine regimen for young children. It said the original two-dose series did not provide the expected immunity in 2- to 5-year-olds.Still, this week's request seeks authorization for the two-dose vaccine, which could make the vaccine available sooner. Pfizer and BioNTech plan to continue testing a three-dose regimen in this younger age group and say they will submit the additional data on a third dose in the coming months.The company decided to submit for authorization of the two-dose vaccine now "with pediatric COVID-19 cases surpassing 10 million and at the request of the FDA," it said."Having a safe and effective vaccine available for children in this age group is a priority for the agency and we're committed to a timely review of the data, which the agency asked Pfizer to submit in light of the recent omicron surge," acting FDA Commissioner Dr. Janet Woodcock said in a news release.What changed since DecemberIn December, Pfizer said that the vaccines appeared to protect the youngest children — infants and toddlers up to 2 — at the same levels seen in teens and young adults, slashing symptoms in 90% of kids who got the shot. However, the 3-microgram dose did not produce the same immune response in 2- to 5-year-olds.The dose for infants and young children is about one-third of the dose given to children age 5 to 11 and a tenth the size of the dose given to people 12 and older.The company decided to expand its trial to include a third dose, rather than the two doses older children and adults receive in a primary vaccine series.What changed between December and this week's authorization request, public health leaders said, was the omicron variant.During the omicron surge, cases among children "spiked dramatically," the American Academy of Pediatrics said Monday. There have been over 3.5 million child cases reported in January alone."It turns out that has actually facilitated the collection of more important additional clinical data that we did not have in December," U.S. Surgeon General Dr. Vivek Murthy said at a White House COVID-19 briefing Wednesday. "Whether that changes the risk-benefit profile is what the FDA will be assessing, but there has been developments since December on the data front."Tracking COVID-19: • Free at-home COVID-19 tests coming for people on Medicare• More countries are now easing COVID-19 restrictions. Here are the steps some are taking• Spotify to add advisories to podcasts discussing COVID-19Some suggest that the FDA may be pursing a strategy of authorizing the first two doses of a vaccine that may not offer substantial protection until after a third dose, hoping to start kids on the series even as data on third shots is still pending.Children have a lower risk of serious outcomes from a COVID-19 infection compared with elderly or immunocompromised adults. But about 1% of children who catch COVID-19 will be hospitalized. Infections can also lead to long-term consequences in children as they do in adults, increasing the risk for diabetes, autoimmune disease and a delayed reaction to infection called multisystem inflammatory syndrome, which requires hospital care."If the goal of the vaccine is to get baseline immunity in the kids — to prevent really bad outcomes and you're really not using the vaccine as a tool to prevent infection in the first place — two doses could do that," former FDA Commissioner Dr. Scott Gottlieb, who sits on the board of Pfizer, said on CBS on Sunday. "I think that may be why federal health officials are rethinking this. If, in fact, they decide to authorize this on the basis of two doses, it could be out much sooner, perhaps as early as early March."Others agree that it could be a smart approach."When I was on hospital service last, there was a 7-month-old in the intensive care unit," Dr. Paul Offit, a pediatrician and vaccine expert at Children's Hospital of Philadelphia, told CNN. "If you can prevent that safely, and that's number one, and effectively, number two, then prevent it" with a vaccine.Offit sits on the panel of experts that advises the FDA on its vaccine authorizations and will be one of the first to review the new data on the vaccine. The FDA's independent vaccine advisers will meet Feb. 15 to discuss the company's data on the youngest children and make a recommendation on the vaccine.The path to authorizationTo authorize COVID-19 vaccines for emergency use, the FDA has previously set a bar of 50% effectiveness, meaning the shots have to prevent disease or decrease severity in at least 50% of the people who get them.Since the data has not been released, it's unclear whether the Pfizer/BioNTech vaccine for younger children meets that standard after two doses.Most experts CNN spoke with said they couldn't think of another vaccine review process quite like this.One somewhat similar example is the Johnson & Johnson vaccine, which was authorized at one dose while the company tested a second, although the first dose proved sufficient to meet the FDA's authorization requirements.The Pfizer/BioNTech coronavirus vaccine is expected to produce a "good efficacy signal" in children younger than 5, Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said Wednesday."The FDA is looking at the data very carefully, and in their typical fashion, they will be very careful in scrutinizing the data and making a recommendation of the decision based on that data," Fauci said.That decision to go ahead and ask for the authorization, though, is still considered odd by some health experts."This does seem very unusual," said Dr. Eric Rubin, a member of the FDA's vaccine advisory committee and assistant professor microbiology and molecular genetics at Harvard Medical School."Regulators have to weigh risk and benefit. And in this case, we know a lot about the risks in older individuals, and they're very low, including older children," Rubin said. "It doesn't have to be that great, as long as we have something that's safe, and then a theoretical benefit could be that you are set up well for future vaccines. But having said all that, it does seem like a very unusual route to take."Rubin thinks that with so many parents eager to get their kids vaccinated, there may also be some lobbying underway."FDA doesn't seem to be immune to political pressures," he said. "And I know that there are some who are saying that it would be good to get a couple doses of vaccine into kids now, in assuming that the third dose is going to be the one that makes a difference."'We need a vaccine for kids'Dr. Helen Talbot, an associate professor of medicine at Vanderbilt University and a member of the CDC's independent vaccine advisory board, the Advisory Committee on Immunization Practices, also hasn't seen the data. But she too believes there may be some pressure from parents."There's families of kids less than 5 who are really pushing. They feel like they're the last ones that don't have access, and there's nothing available for them," Talbot said. She knows this personally, since she gets a lot of emails asking about it, too.Talbot said her questions are around safety data and the potential benefits and risks.She is concerned about people in the middle who aren't quite sure if they want to get their child vaccinated. Only about 3 in 10 parents say they'll get their child under 5 vaccinated against COVID-19 right away, according to survey results from the Kaiser Family Foundation that were released Tuesday. Communication may be key to help parents understand why they should vaccinate their small children, particularly if two doses may not be as protective as three."The FDA is really going to have to be able to eloquently explain the decision," she said.For his part, Dr. Jay Portnoy, a member of the FDA's advisory panel on vaccines, says he's glad to see the FDA speeding up its process."I'm actually relieved," said Portnoy, who's a pediatrician at Children's Mercy Hospital in Kansas City. "Right now, our hospital is filled, not all Covid patients but many COVID patients, including our intensive care unit."Portnoy says parents are anxious and worried."They're forced to send their kids to school, and the schools aren't allowed to mandate masks or anything else," he said."So what is a parent to do? That's just from my perspective. It's about time. We need a vaccine for kids."What happens after authorizationWhite House COVID-19 response coordinator Jeff Zients said Wednesday that the administration is ready to "hit the ground running" to vaccinate young children as soon as Pfizer receives a green light from the federal government.Zients said the U.S. has enough kid-size needles and supplies to administer the vaccines. The administration is also working with local public health partners to make thousands of locations nationwide ready to vaccinate these children."We know many parents are eager to get their kids the protection of the vaccine. We know others have questions. So we're working with our partners to ensure all parents have access to the facts and information they need to make the right decision," Zients said.Pfizer has said it's testing a third dose administered eight weeks after a second dose. Data on a potential third dose, an updated authorization and third-dose rollout would come later on.This may not be the last change to the COVID-19 vaccine schedule.Former CDC Director Dr. Tom Frieden said this week that it may be a while before scientists figure out the best vaccine schedule for children."What the vaccine schedule should be is much more complicated, and that may take months or even years to optimize," Frieden, president and CEO of Resolve to Save Lives, told CNN's Anderson Cooper."It's probably a three-dose schedule for lots of people, but we really don't know that yet," Frieden said. "Nor do we know the right interval between doses. That's going to be with time, but we do know that vaccines are remarkably effective."

On Tuesday, Pfizer and BioNTech announced that they had initiated a rolling submission to the U.S. Food and Drug Administration of data for their vaccine for children ages 6 months up to 5 years. The companies expect to complete the request for emergency use authorization soon.

It will still go through a thorough safety and efficacy review by U.S. health agencies and experts, but it's a different plan than what was expected late last year.

In December, Pfizer announced that it decided to add a third dose to the primary vaccine regimen for young children. It said the original two-dose series did not provide the expected immunity in 2- to 5-year-olds.

Still, this week's request seeks authorization for the two-dose vaccine, which could make the vaccine available sooner. Pfizer and BioNTech plan to continue testing a three-dose regimen in this younger age group and say they will submit the additional data on a third dose in the coming months.

The company decided to submit for authorization of the two-dose vaccine now "with pediatric COVID-19 cases surpassing 10 million and at the request of the FDA," it said.

"Having a safe and effective vaccine available for children in this age group is a priority for the agency and we're committed to a timely review of the data, which the agency asked Pfizer to submit in light of the recent omicron surge," acting FDA Commissioner Dr. Janet Woodcock said in a news release.

What changed since December

In December, Pfizer said that the vaccines appeared to protect the youngest children — infants and toddlers up to 2 — at the same levels seen in teens and young adults, slashing symptoms in 90% of kids who got the shot. However, the 3-microgram dose did not produce the same immune response in 2- to 5-year-olds.

The dose for infants and young children is about one-third of the dose given to children age 5 to 11 and a tenth the size of the dose given to people 12 and older.

The company decided to expand its trial to include a third dose, rather than the two doses older children and adults receive in a primary vaccine series.

What changed between December and this week's authorization request, public health leaders said, was the omicron variant.

During the omicron surge, cases among children "spiked dramatically," the American Academy of Pediatrics said Monday. There have been over 3.5 million child cases reported in January alone.

"It turns out that has actually facilitated the collection of more important additional clinical data that we did not have in December," U.S. Surgeon General Dr. Vivek Murthy said at a White House COVID-19 briefing Wednesday. "Whether that changes the risk-benefit profile is what the FDA will be assessing, but there has been developments since December on the data front."

Tracking COVID-19:

• Free at-home COVID-19 tests coming for people on Medicare

• More countries are now easing COVID-19 restrictions. Here are the steps some are taking

• Spotify to add advisories to podcasts discussing COVID-19

Some suggest that the FDA may be pursing a strategy of authorizing the first two doses of a vaccine that may not offer substantial protection until after a third dose, hoping to start kids on the series even as data on third shots is still pending.

Children have a lower risk of serious outcomes from a COVID-19 infection compared with elderly or immunocompromised adults. But about 1% of children who catch COVID-19 will be hospitalized. Infections can also lead to long-term consequences in children as they do in adults, increasing the risk for diabetes, autoimmune disease and a delayed reaction to infection called multisystem inflammatory syndrome, which requires hospital care.

"If the goal of the vaccine is to get baseline immunity in the kids — to prevent really bad outcomes and you're really not using the vaccine as a tool to prevent infection in the first place — two doses could do that," former FDA Commissioner Dr. Scott Gottlieb, who sits on the board of Pfizer, said on CBS on Sunday. "I think that may be why federal health officials are rethinking this. If, in fact, they decide to authorize this on the basis of two doses, it could be out much sooner, perhaps as early as early March."

Others agree that it could be a smart approach.

"When I was on hospital service last, there was a 7-month-old in the intensive care unit," Dr. Paul Offit, a pediatrician and vaccine expert at Children's Hospital of Philadelphia, told CNN. "If you can prevent that safely, and that's number one, and effectively, number two, then prevent it" with a vaccine.

Offit sits on the panel of experts that advises the FDA on its vaccine authorizations and will be one of the first to review the new data on the vaccine. The FDA's independent vaccine advisers will meet Feb. 15 to discuss the company's data on the youngest children and make a recommendation on the vaccine.

The path to authorization

To authorize COVID-19 vaccines for emergency use, the FDA has previously set a bar of 50% effectiveness, meaning the shots have to prevent disease or decrease severity in at least 50% of the people who get them.

Since the data has not been released, it's unclear whether the Pfizer/BioNTech vaccine for younger children meets that standard after two doses.

Most experts CNN spoke with said they couldn't think of another vaccine review process quite like this.

One somewhat similar example is the Johnson & Johnson vaccine, which was authorized at one dose while the company tested a second, although the first dose proved sufficient to meet the FDA's authorization requirements.

The Pfizer/BioNTech coronavirus vaccine is expected to produce a "good efficacy signal" in children younger than 5, Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said Wednesday.

"The FDA is looking at the data very carefully, and in their typical fashion, they will be very careful in scrutinizing the data and making a recommendation of the decision based on that data," Fauci said.

That decision to go ahead and ask for the authorization, though, is still considered odd by some health experts.

"This does seem very unusual," said Dr. Eric Rubin, a member of the FDA's vaccine advisory committee and assistant professor microbiology and molecular genetics at Harvard Medical School.

"Regulators have to weigh risk and benefit. And in this case, we know a lot about the risks in older individuals, and they're very low, including older children," Rubin said. "It doesn't have to be that great, as long as we have something that's safe, and then a theoretical benefit could be that you are set up well for future vaccines. But having said all that, it does seem like a very unusual route to take."

Rubin thinks that with so many parents eager to get their kids vaccinated, there may also be some lobbying underway.

"FDA doesn't seem to be immune to political pressures," he said. "And I know that there are some who are saying that it would be good to get a couple doses of vaccine into kids now, in assuming that the third dose is going to be the one that makes a difference."

'We need a vaccine for kids'

Dr. Helen Talbot, an associate professor of medicine at Vanderbilt University and a member of the CDC's independent vaccine advisory board, the Advisory Committee on Immunization Practices, also hasn't seen the data. But she too believes there may be some pressure from parents.

"There's families of kids less than 5 who are really pushing. They feel like they're the last ones that don't have access, and there's nothing available for them," Talbot said. She knows this personally, since she gets a lot of emails asking about it, too.

Talbot said her questions are around safety data and the potential benefits and risks.

She is concerned about people in the middle who aren't quite sure if they want to get their child vaccinated. Only about 3 in 10 parents say they'll get their child under 5 vaccinated against COVID-19 right away, according to survey results from the Kaiser Family Foundation that were released Tuesday.

Communication may be key to help parents understand why they should vaccinate their small children, particularly if two doses may not be as protective as three.

"The FDA is really going to have to be able to eloquently explain the decision," she said.

For his part, Dr. Jay Portnoy, a member of the FDA's advisory panel on vaccines, says he's glad to see the FDA speeding up its process.

"I'm actually relieved," said Portnoy, who's a pediatrician at Children's Mercy Hospital in Kansas City. "Right now, our hospital is filled, not all Covid patients but many COVID patients, including our intensive care unit."

Portnoy says parents are anxious and worried.

"They're forced to send their kids to school, and the schools aren't allowed to mandate masks or anything else," he said."So what is a parent to do? That's just from my perspective. It's about time. We need a vaccine for kids."

What happens after authorization

White House COVID-19 response coordinator Jeff Zients said Wednesday that the administration is ready to "hit the ground running" to vaccinate young children as soon as Pfizer receives a green light from the federal government.

Zients said the U.S. has enough kid-size needles and supplies to administer the vaccines. The administration is also working with local public health partners to make thousands of locations nationwide ready to vaccinate these children.

"We know many parents are eager to get their kids the protection of the vaccine. We know others have questions. So we're working with our partners to ensure all parents have access to the facts and information they need to make the right decision," Zients said.

Pfizer has said it's testing a third dose administered eight weeks after a second dose. Data on a potential third dose, an updated authorization and third-dose rollout would come later on.

This may not be the last change to the COVID-19 vaccine schedule.

Former CDC Director Dr. Tom Frieden said this week that it may be a while before scientists figure out the best vaccine schedule for children.

"What the vaccine schedule should be is much more complicated, and that may take months or even years to optimize," Frieden, president and CEO of Resolve to Save Lives, told CNN's Anderson Cooper.

"It's probably a three-dose schedule for lots of people, but we really don't know that yet," Frieden said. "Nor do we know the right interval between doses. That's going to be with time, but we do know that vaccines are remarkably effective."

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Husband & wife return home after being hospitalized with COVID-19 together

cincylink — Tue, 25 Jan 2022 11:07:04 +0000

A Nebraska native nearly lost both her parents to COVID-19 at the same time.Traci Pribyl, of Omaha, was on a ventilator for a month. Her husband, Robert, was in a hospital bed of his own trying to fight off the virus.A routine doctor's appointment for 71-year-old Robert Pribyl led to a COVID-19 diagnosis. It was early November. His doctor asked him to come back a couple of days later for a check-up, then immediately admitted him to the hospital."I felt weak, real weak,” he said.Little did he know, his 55-year-old wife Traci was home alone with the virus, and deteriorating fast.Their daughter flew in from Florida when Traci stopped answering texts. She had a nurse come by to give her mom an IV.“She had given Traci fluids and they said her vitals were horrible and so she called the squad. I believe that is what saved her life,” Robert said.Traci was rushed to the ER. Both Pribyls were now in the hospital fighting the virus.“I just told her, I said, 'mom, you're not doing so good. And I need you to be strong for me, because I’m trying, and I can't hold it together. But they're going to have to put you to sleep. Your body needs to rest,” Kirstin Pribyl said.Traci spent the next month on a ventilator.Kirstin said it was moment by moment for both parents."It is so traumatic. I just can’t stress that enough. It's very traumatic to watch this, to go through this, to make these decisions. I definitely thought that my world was going to start crashing down on me,” Kirstin said.Robert went home in two weeks. Traci was released Dec. 6.Even though he's older, Robert believes he was better off because of one thing.“She was not vaccinated, and I was,” Robert said. “But I am now,” Traci added. “They say it's not so bad if you're vaccinated. You can still catch it but you don’t have the severity of the disease,” Robert said.Traci said she wasn't sure about the vaccine and held off on getting it. She said that decision was “stupid.”“I don’t want to say I was cocky and invincible and that it wouldn’t happen to me, because everybody’s number is going to be pulled at some point, but I just didn’t realize it would be this bad and I would be in delirium,” she said.She said doctors told her it could take up to two years to fully recover. She said she doesn’t remember even taking Robert to the hospital, nor the entirety of her illness, until doctors were taking the tube out of her body.She's still waiting for her voice to come back.They encourage others to just get the shot.

OMAHA, Neb. —

A Nebraska native nearly lost both her parents to COVID-19 at the same time.

Traci Pribyl, of Omaha, was on a ventilator for a month. Her husband, Robert, was in a hospital bed of his own trying to fight off the virus.

A routine doctor's appointment for 71-year-old Robert Pribyl led to a COVID-19 diagnosis. It was early November. His doctor asked him to come back a couple of days later for a check-up, then immediately admitted him to the hospital.

"I felt weak, real weak,” he said.

Little did he know, his 55-year-old wife Traci was home alone with the virus, and deteriorating fast.

Their daughter flew in from Florida when Traci stopped answering texts.

She had a nurse come by to give her mom an IV.

“She had given Traci fluids and they said her vitals were horrible and so she called the squad. I believe that is what saved her life,” Robert said.

Traci was rushed to the ER. Both Pribyls were now in the hospital fighting the virus.

“I just told her, I said, 'mom, you're not doing so good. And I need you to be strong for me, because I’m trying, and I can't hold it together. But they're going to have to put you to sleep. Your body needs to rest,” Kirstin Pribyl said.

Traci spent the next month on a ventilator.

Kirstin said it was moment by moment for both parents.

"It is so traumatic. I just can’t stress that enough. It's very traumatic to watch this, to go through this, to make these decisions. I definitely thought that my world was going to start crashing down on me,” Kirstin said.

Robert went home in two weeks. Traci was released Dec. 6.

Even though he's older, Robert believes he was better off because of one thing.

“She was not vaccinated, and I was,” Robert said. “But I am now,” Traci added.

“They say it's not so bad if you're vaccinated. You can still catch it but you don’t have the severity of the disease,” Robert said.

Traci said she wasn't sure about the vaccine and held off on getting it. She said that decision was “stupid.”

“I don’t want to say I was cocky and invincible and that it wouldn’t happen to me, because everybody’s number is going to be pulled at some point, but I just didn’t realize it would be this bad and I would be in delirium,” she said.

She said doctors told her it could take up to two years to fully recover. She said she doesn’t remember even taking Robert to the hospital, nor the entirety of her illness, until doctors were taking the tube out of her body.

She's still waiting for her voice to come back.

They encourage others to just get the shot.

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Vaccine access for rural kids is lacking

cincylink — Fri, 14 Jan 2022 23:57:10 +0000

For millions of parents in the U.S., getting a COVID-19 vaccine for their kids is as simple as a few clicks, filling out some forms, and driving to a nearby clinic. But, for those in more rural parts of the country, access to vaccines can be a bit more of a struggle

"We were so hopeful even back this summer when we first started hearing about, like, how soon it might be approved for children," said Annie Edwards, a mother in rural Montana.

She's hopeful because she knows what it's like to have a sick kid. Her daughter Hannah was born at 27 weeks, weighing one pound. But, for the 57 million people like Edwards who live in rural America, vaccine approval means nothing if they can't find a shot. She drove to Billings, Montana, in December, which is a 500-mile round trip car ride to get her daughter the first dose.

"Why are we having to drive this far? Why is it this hard?" asked Edwards.

An hour before the second appointment, the store canceled because it ran out of vaccine doses.

"In rural areas, where people are spread out, there's much less opportunity for kids," said Dr. Jennifer Kates, senior vice president of the Kaiser Family Foundation.

Edwards echoed her frustration saying, "You know, we live in the United States of America, where we have the most access," she said. "This shouldn't be difficult."

Right now, Pfizer's vaccine is the only one approved for children. It's a smaller dose. Current minimum shipments come in a 10-vial pack, with 10 doses per vial. The company said that's to "better suit the needs of pediatric clinics." They can be stored for up to 10 weeks in refrigerators.

"Once you open the package, you have to use those within 12 hours. And if a provider wants to vaccinate one kid, they have to vaccinate 10 kids to not waste any, so that's a big challenge that we've seen with smaller providers and doctors' offices. They have to figure out, should I even do this," Kates said.

Edwards' pediatrician told her she's not vaccinating kids against COVID-19. A Kaiser Family Foundation poll found more than one-third of rural parents said their health care providers are not even recommending the vaccine for kids.

"If a pediatrician isn't encouraging it, that could really be a deterrent for a parent," Kates said. "And it could be the situation where the pediatrician themselves doesn't have the vaccine."

Punching many rural zip codes into vaccines.gov will lead you to a page showing no pediatric shots within 25 miles, with some availability 50 to 100 miles away.

"If you're a parent who's on the fence, you know, what's going to tip you if you then have to say, well, I'm going to drive 250 miles to do this thing that I'm a little bit wary of. Or even if you're an eager parent, if you don't have a car, if you can't take time off from work, what are you to do," said Kates.

"There are some places that have put in operation mobile clinics to try to reach kids in those outposts. But, that's sort of the exception, not the rule. It's incredibly difficult. And, of course, when they're the only person who's asking for it in their community, they don't have support. And that makes it even more difficult," Kates said.

It's a story pediatrician Kathy Rogers is familiar with. She came out of retirement to help administer vaccines.

"I can't sit this one out. This is too important," Rogers said.

Some of the children at her clinic have traveled up to four hours round trip, twice.

"It breaks my heart and I would like to go door-to-door and just offer it to people, and if they don't want it, fine," said Rogers.

"We have work that lies ahead for rural America, and in general for the country, but really in rural areas," Kates said.

Montana data shows no kids between 5 and 11 in McCone County are fully vaccinated, with many other counties at 5% or less. Stats show similar rates in parts of rural Idaho, with numbers as low as 1% in places. And it's the same story in parts of Wyoming.

"I don't understand how we're failing to get it dispersed in rural America," Edwards said. "Because that might be part of it. If I had access, if I could tell my neighbor, yeah, go down. You can get an appointment today, or you can get an appointment when you take your child to their well check or when you're getting their ears checked."

Multiple doctors say removing barriers likely means an unwanted side effect, like waste.

"You can try as hard as you can not to waste vaccine. But if I can give one vaccine to one person, even if I have to waste the whole other dose, I'm going to do that. Because like with Omicron, the infectivity of it is just like measles. It's so high that I protected more people by doing one vaccine than doing none just because I want to save the vial," Rogers said.

In addition to access, there's statistically more vaccine hesitancy in rural America, driving down demand. A Kaiser Family Foundation study found almost half of rural parents say they definitely will not get their 5- to 11-year-old vaccinated, compared to 22% of urban parents. But, if interest is low, Rogers said counties can and should work together to share doses, to reach as many as possible as Omicron keeps its grip on the country.

"If you don't get out there and do this for people, what does that say? We've got to take care of each other. And I take care of my family, but my community is my family. It's too important to know those health care workers all feel that way. And that's why some of them are quitting because they feel this so intimately," Rogers said.

Kates said some states, like Maine and Vermont, have gotten the vaccination effort right from the start, and there's more that can be done elsewhere.

"From a broader perspective, states and certainly the federal government, can look at how they can pre-position vaccines for remote areas. So, finding the right pharmacy sites, doing mobile clinics to go to people, setting up actual vaccine clinics periodically, where you're really advertising and pushing out that information to communities, it still means that not everyone's going to be easily reached, but you have to make those opportunities more frequent, and visible and easy for parents," Kates said.

Edwards hopes to get her daughter's second vaccine dose at a neighboring county's clinic soon.

"It's a drive, it's not close," she said. It will mean about 200 miles round trip for her, and she along with others don't think it should be this hard.

This story was originally published by Maritsa Georgiou on Newsy.

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Health experts encourage COVID-19 testing, vaccination as children head back to classes

cincylink — Wed, 29 Dec 2021 04:47:15 +0000

As many kids return from holiday break next week, there's a renewed focus on COVID-19 in schools.Health experts said it's important children get vaccinated and they also encourage testing after all those family gatherings.Cincinnati Children's Hospital will host a vaccination event at Union Terminal on Wednesday to help get kids protected for the new year."The next two weeks is really going to be watched very carefully and it's going to be sad because we are going to see a great increase in cases," public health expert, Dr. O'dell Owens, said.Following the Christmas celebrations and New Year's toasts, Owens said people should be on guard for COVID-19.He said that includes kids headed back to class."We have a history on every holiday that we've seen a surge, so this is not going to be any different. Especially with omicron being spread much more easily than the delta," he said.There are many districts that make use of a Test to Stay, Mask to Stay or Test to Play program aimed to keep healthy students in class or activities instead of quarantined due to an exposure.A Cincinnati Public Schools spokeswoman told WLWT that the health department will test students who may be symptomatic as long as the parents give the OK.They also said there is a weekly, voluntary K-12 screening available to all CPS elementary students with parent consent.Owens anticipates there could be a surge of testing needs to match an even bigger rise in COVID-19 cases."I think it's going to be tough. I think what you're seeing around the country is a lack of the test kits, you know, you have these long, long lines in all the major cities of people getting the regular tests," he said.That's why he encourages parents to mask up their kids, teach them good hand hygiene and consider the shots as classes resume."There is a war against this virus and the best way to fight this war is to be vaccinated fully. That means getting your two vaccinations and your booster and be open to the fact that you might need a booster next year," Owens said.The Cincinnati Children's Hospital vaccination clinic takes place on Wednesday at the Cincinnati Museum Center's Union Terminal.It runs from 9 a.m. to 2 p.m.Appointments are not needed.Officials said admission to the Museum Center is free to those who are vaccinated and parking is free.

CINCINNATI —

As many kids return from holiday break next week, there's a renewed focus on COVID-19 in schools.

Health experts said it's important children get vaccinated and they also encourage testing after all those family gatherings.

Cincinnati Children's Hospital will host a vaccination event at Union Terminal on Wednesday to help get kids protected for the new year.

"The next two weeks is really going to be watched very carefully and it's going to be sad because we are going to see a great increase in cases," public health expert, Dr. O'dell Owens, said.

Following the Christmas celebrations and New Year's toasts, Owens said people should be on guard for COVID-19.

He said that includes kids headed back to class.

"We have a history on every holiday that we've seen a surge, so this is not going to be any different. Especially with omicron being spread much more easily than the delta," he said.

There are many districts that make use of a Test to Stay, Mask to Stay or Test to Play program aimed to keep healthy students in class or activities instead of quarantined due to an exposure.

A Cincinnati Public Schools spokeswoman told WLWT that the health department will test students who may be symptomatic as long as the parents give the OK.

They also said there is a weekly, voluntary K-12 screening available to all CPS elementary students with parent consent.

Owens anticipates there could be a surge of testing needs to match an even bigger rise in COVID-19 cases.

"I think it's going to be tough. I think what you're seeing around the country is a lack of the test kits, you know, you have these long, long lines in all the major cities of people getting the regular tests," he said.

That's why he encourages parents to mask up their kids, teach them good hand hygiene and consider the shots as classes resume.

"There is a war against this virus and the best way to fight this war is to be vaccinated fully. That means getting your two vaccinations and your booster and be open to the fact that you might need a booster next year," Owens said.

The Cincinnati Children's Hospital vaccination clinic takes place on Wednesday at the Cincinnati Museum Center's Union Terminal.

It runs from 9 a.m. to 2 p.m.

Appointments are not needed.

Officials said admission to the Museum Center is free to those who are vaccinated and parking is free.

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Vaccine delivery in Alaska persisting through harsh terrain, resistance from community

cincylink — Sat, 25 Dec 2021 05:47:12 +0000

FAIRBANKS, Ak. — When vaccines rolled out across the country, getting shots to families in rural communities took extra time and coordination.

In Alaska, pharmacists have had to fly small planes and use sled dogs to deliver thousands of doses.

We visited Alaskan pharmacist Dan Nelson in Fairbanks months ago as vaccines first rolled out across the country.

He works for the Tanana Chiefs Conference, a group representing Alaska Native and American Indian tribes across Alaska’s interior. He said the initial vaccine rollout was very successful and made an impact on the lives of thousands.

“While we are not able to completely eliminate COVID or prevent COVID from happening out in rural areas, we were able to prevent a lot of hospitalizations and unnecessary deaths,” said Nelson. “So, I think that's something that we're probably most proud of here.”

However, he said, his community is still facing many challenges in controlling the virus.

“We really got hit hard by delta,” said Nelson. “Our rate of death from COVID for Alaska Natives is basically double the non-Native population. It was absolutely a scary time and not fun. I think with the omicron variant, I think that honestly, there's some complacency in the community, and I think that's something that we're needing to deal with.”

Just months ago, there was a very high demand for the shots. Today, that demand has decreased dramatically.

“All the vaccine hesitancy, and just I don't even think that captures the attitude, the outright resistance and kind of misinformation and stuff is absolutely a struggle that…it's not unique to Alaska,” said Nelson.

Nelson said the vaccine resistance across Alaska pushed his hospital to a breaking point: for a time, they ran out of antibody treatments.

“We often saw people that refuse to get vaccinated, but that was the first thing that they went to. Once they got COVID, it was, ‘I want the monoclonal,’ so that was kind of a disheartening setup because it was, really, we could have done an ounce of prevention rather than a pound of cure.”

He said he has been thankful that those hardest to reach have been more eager to get the shots.

“In most of our rural areas, it's over 70% vaccinated. Our numbers are quite a bit lower for the booster doses. The fact that I can go out to those villages now and just really be able to give people a hug and not worry about it, and then embrace them, and vice versa, I think, is just such a rewarding experience.”

When vaccines first became available, there was much excitement throughout the Tanana Chiefs Conference and the communities they serve. Yet, Nelson said he struggles to maintain hopefulness as 2021 ends and 2022 begins.

“I'll just be totally honest with you. I have not felt that way over the entire last year,” said Nelson. “I do think that overall, it's a positive outlook, and I think that we're looking at the upswing. I'd just like to hopefully get back to a place where people trust and believe their pharmacists and their doctors and nurses. Winning that war will be the most important thing and getting the upper hand against the virus.”

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A doctor explains what to expect after your child is vaccinated

cincylink — Sat, 06 Nov 2021 04:28:12 +0000

A doctor explains what to expect after your child is vaccinated

vaccination – Cincy Link

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