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C.D.C. Advisers Endorse Pfizer Vaccine for Youngsters Ages 12 to 15

C.D.C. Advisers Endorse Pfizer Vaccine for Children Ages 12 to 15

The federal government took one final step on Wednesday to bring Pfizer BioNTech coronavirus vaccine to teenagers in the United States, remove an obstacle to school reopening, and cheer millions of families tired of pandemic restrictions are.

An advisory committee of the Centers for Disease Control and Prevention voted The CDC director, Dr. Rochelle Walensky is expected to review the recommendations and approve them later on Wednesday.

“Getting Covid-19 vaccines approved for children ages 12-15 is an important step in removing barriers to vaccinating children of all ages,” said Dr. Yvonne Maldonado, who represents the American Academy of Pediatrics on the Federal Advisory Committee on Immunization Practices.

Many parents eagerly await the availability of vaccines for children, at least in part to expedite their return to school. About a third of eighth graders, usually 13 or 14 years old, still study completely remotely.

In some states, such as Maine, vaccination of teenagers has already started. Others plan to offer the vaccine as early as Thursday. There are nearly 17 million 12 to 15 year olds in the United States, which is 5.3 percent of the population.

Almost every state now has a flood of vaccine doses that could be quickly distributed to teenagers. The dose used to immunize adults is safe and effective for these adolescents too, as clinical studies have shown.

“Sometimes we lose the importance of children and adolescents in the midst of a pandemic – especially older adults are so much in focus,” said Dr. Grace Lee, Committee member and Professor of Pediatrics at Stanford University.

While the risk of serious illness in children is low compared to adults, the coronavirus has infected more than 1.5 million children and sent more than 13,000 to hospitals, according to the CDC, more than were hospitalized for flu in an average year

“It is currently one of the top ten causes of child death since the pandemic began,” noted Dr. Maldonado.

Young children are believed to be less likely to spread the virus than adults, but their ability to transmit it increases with age. Teenagers, especially in high school, can spread the virus just as easily as adults. Children aged 12-17 make up an increasing proportion of Covid cases in the country.

Vaccinating children should increase immunity levels in the US population and help reduce the number of cases.

“Any person with Covid-19 is giving the virus an opportunity to spread, further mutate and further expose our communities,” said Dr. Bill Gruber, Senior Vice President at Pfizer. “The decisions of the health authorities this week bring us one step closer to protecting young people and achieving herd protection.”

Pfizer announced in March that the vaccine appears to be at least as effective in 12-15 year olds as it is in older teenagers and adults. Apart from a slight increase in the frequency of fever, the shots also appeared to have comparable, mostly negligible side effects.

The company plans to monitor study participants for two years after the second dose to assess the long-term safety and effectiveness of the vaccine.

Updated

May 12, 2021, 4:58 p.m. ET

The Food and Drug Administration reviewed the clinical data and on Monday approved the Pfizer vaccine for use in these children. This allowed parents and children to wait weeks for a faster return to normal.

“While it is true that children are generally spared serious illnesses, the fact that they could not be vaccinated has created significant disruptions in their lives that have real developmental ramifications,” said Dr. Amesh Adalja, a senior scientist at the Johns Hopkins Center for Health Security. “By vaccinating this age cohort, these children can get back to their normal lives.”

In a speech at the White House on Wednesday, President Biden pointed out the benefits of the Covid vaccine for children 12 and older and said it was “safe, effective, easy, quick and free”.

“Starting tomorrow, more than 15,000 pharmacies will be ready to vaccinate this age group,” said Biden, adding that pharmacies would make it easier for teenagers to get the first shot in one location and a second shot in another location if needed.

Some experts have raised ethical concerns about vaccinating children who are at low risk for the virus, although healthcare workers and older adults remain at risk in many countries.

“If just thinking as a parent, if I had teenagers, I would probably love to vaccinate my children,” said Jennifer Nuzzo, an epidemiologist at the Johns Hopkins Center for Health Security.

Class disturbed

Updated May 5, 2021

The latest on how the pandemic is changing education.

But she added, “I am very concerned about a situation where the few countries in the world that had enough vaccines to protect their adults continue to hoard those vaccines for use in low-risk children.”

School reopenings have spiked across the country as parents, teachers, unions and school authorities worried about outbreaks. Research shows that children are largely spared serious illnesses and are not significant drivers of the spread of the coronavirus, as is the case with influenza.

“This misperception of risk will clearly divert vaccination priorities from the optimal strategic use of vaccines worldwide,” said Drs Adaliah.

The committee also recommended giving the Covid-19 vaccine along with other major vaccines that teenagers may have missed during the year. The agency had recommended waiting two weeks before and after immunization against Covid-19 before receiving other vaccines.

Parents’ reluctance can be the main hurdle. According to a recent survey by the Kaiser Family Foundation, more than 40 percent of parents of teenagers said that they would not vaccinate their children or would only vaccinate them if required by a school.

Some of these parents might change their minds as other children are safe to receive vaccines and resume personal schooling or return to team sports such as soccer and basketball that involve close contact, the researchers suggested.

Others can wait to meet school requirements. Public schools in all 50 states require certain vaccines, but officials may not be able to enforce compliance until the Pfizer BioNTech vaccine has received full FDA approval.

The vaccine now has an emergency approval. Pfizer has applied for full approval from the FDA, but this process is expected to take several months. Even after approval, students can opt out based on medical reasons or religious beliefs.

State and local leaders must make special efforts to reach children in low-income families or in color communities. Black and Hispanic adults have one of the lowest vaccination rates: by May 3, only 25 percent of blacks and 27 percent of Hispanics had been vaccinated, compared with 39 percent of whites.

In order to make the vaccine available to these communities, transport and storage of the cans must be facilitated. The Pfizer BioNTech vaccine can only be stored in standard refrigerators for five days. The companies plan to ship smaller packs for use in doctor’s offices and are developing a formulation that can be refrigerated for up to 10 weeks.

Pfizer and BioNTech plan to file applications for approval of the vaccine in children ages 2-11 in September.

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FDA clears use in children ages 12 to 15

Daily U.S. data on April 20

The Food and Drug Administration on Monday approved Pfizer and BioNTech’s motion to allow their Covid-19 vaccine to be given to children ages 12-15 in an emergency so states can vaccinate middle school students before the fall.

The U.S. agency, which grants the use of the shot in teenagers, will also accelerate the country’s efforts to fight infection, say public health officials and infectious disease experts.

The two-dose vaccine is already approved for use in people aged 16 and over. The Centers for Disease Control and Prevention’s Vaccine Advisory Board scheduled a meeting on Wednesday to review the recordings for children. If approved by the CDC as expected, it could be distributed to teens as early as this week.

Acting FDA Commissioner Dr. Janet Woodcock said the decision “moves us closer to a return to a sense of normalcy and an end to the pandemic”. She assured parents that the agency “did a rigorous and thorough review of all available data” before approving it for teenage use.

The companies announced in late March that the vaccine was 100% effective in a clinical study involving more than 2,000 adolescents. They also said the vaccine produced a “robust” antibody response in the children that outperformed that in a previous study in older teenagers and young adults. The side effects were generally consistent with those seen in adults, they added.

Vaccinating children is seen as critical to ending the pandemic. The nation is unlikely to achieve herd immunity – if enough people in a given community have antibodies to a given disease – until children can be vaccinated, health officials and experts say.

According to the government, children make up around 20% of the total US population. According to experts, between 70% and 85% of the US population must be vaccinated against Covid to achieve herd immunity and some adults may refuse to get the shots. Although now more experts say herd immunity becomes less likely as variants spread.

The Chief Medical Officer of the White House, Dr. Anthony Fauci, said in April that the US could start vaccinating older children against Covid-19 from the fall, while elementary school-age children may get their shots early next year.

The vaccine is given in two doses three weeks apart, according to the FDA, with the same regimen according to the FDA for people aged 16 and over.

FDA approval for children under the age of 12 could come in the second half of this year. In a presentation to coincide with the company’s earnings release on May 4th, Pfizer expects to file for approval of its toddler vaccine in September and toddler vaccine in November. The filing process for full FDA approval for people aged 16 and over has already begun, the company announced on Friday.

In late March, Pfizer and BioNTech started a clinical trial testing their vaccine in healthy 6-month-old to 11-year-old children. Moderna and Johnson & Johnson, whose vaccines are approved for people aged 18 and over, are also testing their recordings in younger age groups.

The FDA’s announcement also comes in the context of President Joe Biden’s push to reopen schools for personal learning. Biden’s government has already announced that it will invest $ 10 billion in Covid testing for schools to accelerate returns to face-to-face courses across the country.

Vaccinating children can also give the green light to after-school activities such as sports, arts, and other personal activities.

While parents feel relieved that their children can be vaccinated, some health experts have questioned whether doses should be kept for children who are considered less at risk for serious illness while leaving vulnerable people around the world unprotected.

Dr. Craig Spencer, director of global health and emergency medicine at Columbia University Medical Center, said there need be no either-or choice between vaccinating children and distributing shots to the rest of the world. The US can do both, he said. But he’s frustrated that the US has stopped focusing on getting the rest of the world vaccinated.

“If I were to ask you whether a 12 year old with no medical problems or a 57 year old healthcare worker who cares for Covid patients every day should be vaccinated, the answer is very clear, right?” he said. “Why does this calculation change when it comes to a health worker from another country?”

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BioNTech expects information on youngsters ages 5 to 11 as early as finish of summer season

These colleges now say Covid vaccines will be required for fall 2021

16-year-old Thomas Gregory will be vaccinated with the Pfizer-BioNTech Covid-19 vaccine by Nurse Cindy Lamica at UMass Memorial Health Care’s COVID-19 Vaccination Center at the Mercantile Center in Worcester, Massachusetts on April 22, 2021.

Joseph Precious | AFP | Getty Images

Data on how well the Pfizer-BioNTech Covid-19 vaccine works in children ages 5-11 could be available by the end of this summer, the scientist who helped develop the shot told CNBC.

If clinical trials go well and the Food and Drug Administration approves, young children could be vaccinated by the end of the year, said BioNTech Co-Founder and Chief Medical Officer Dr. Ozlem Tureci, late Thursday.

“We expect the data by the end of summer or fall this year. We will then submit it to the regulatory authorities and, depending on how quickly they react, we will receive approval by the end of the year to also immunize younger children.” ” She said.

In late March, Pfizer and BioNTech began a clinical trial testing their vaccine in healthy children aged 6 months to 11 years. This is a critical step in gaining regulatory approval to vaccinate young children and fight the pandemic.

In the first phase of the study, companies will determine the preferred dosage level for three age groups – between 6 months and 2 years, 2 and 5 years, and between 5 and 11 years. Dosages are assessed 11 first in children ages 5 to 11 before researchers move on to the other age groups, they said.

Since companies rate the older age group first, data on children under 5 could be “a little later,” Tureci told CNBC.

The two-dose vaccine is already approved for use in people aged 16 and over. Earlier this month, Pfizer and BioNTech asked the FDA to allow their Covid-19 vaccine to be given to children ages 12-15 in an emergency.

The companies announced in late March that the vaccine was 100% effective in a study of more than 2,000 adolescents. They also said the vaccine produced a “robust” antibody response in the children that outperformed that in a previous study in older teenagers and young adults. The side effects were generally consistent with those seen in adults, they added.

Vaccinating children is seen as critical to ending the pandemic. The nation is unlikely to achieve herd immunity – if enough people in a given community have antibodies to a given disease – until children can be vaccinated, health officials and experts say.

According to the government, children make up around 20% of the total US population. According to experts, between 70% and 85% of the US population must be vaccinated against Covid to achieve herd immunity and some adults may refuse to get the shots.

In addition to testing the vaccine in young children, Pfizer and BioNTech are testing whether a third dose of the vaccine would provide a better immune response against new variants of the virus.

Ugur Sahin, CEO of BioNTech, told CNBC on Thursday that he was “confident” that the vaccine would be effective against B.1.617, a highly contagious variant of coronavirus first identified in India.

Still, he said, people will likely need a third shot of his two-dose vaccine as immunity to the virus wanes. Researchers see a decrease in antibody responses to the virus after eight months, he added.

“If we give a boost, we could actually increase the antibody response beyond what we started with, and that could give us a real comfort of protection for at least 12 months, maybe 18 months,” said Sahin. “And that is really important at a time when all variants are coming.”

Sahin also said he anticipates demand for the shot will continue to rise, adding that the company will increase production capacity of the vaccine to 3 billion doses by the end of 2021. In December, Sahin expects the company’s production target to increase to 400 million cans per month.

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Pfizer says shot is 100% efficient in children ages 12 to 15

Pfizer says shot is 100% effective in kids ages 12 to 15

A nurse, Cindy Mendez, wearing a protective mask, holds a syringe containing a dose of Pfizer-BioNTech COVID-19 vaccine during the coronavirus disease (COVID-19) pandemic at NYC Health + Hospitals Harlem Hospital in the Manhattan neighborhood of New York City. New York, February 25, 2021.

Jeenah Moon | Reuters

Pfizer said on Wednesday that its Covid-19 vaccine was 100% effective in a study in adolescents ages 12-15.

Albert Bourla, CEO of Pfizer, said the company hoped to submit the new data on the vaccine, which was being developed in partnership with German drug maker BioNTech, “as soon as possible” to the Food and Drug Administration and other regulatory agencies that children in the age group can get vaccinated before the next school year.

“We share the urgency to expand our vaccine approval to younger populations and are encouraged by clinical trial data from adolescents 12-15 years of age,” Bourla said in a press release.

The study enrolled 2,260 participants in the United States. 18 confirmed Covid-19 infections were observed in the placebo group and no confirmed infections were observed in the group that received the vaccine, the company said. This resulted in a vaccine effectiveness of 100%. The shot is also well tolerated, with side effects generally the same as in adults.

The company also said the vaccine produced a “robust” antibody response in children that outperformed that in a previous study of 16-25 year olds.

Vaccinating children is critical to ending the pandemic, say public health officials and infectious disease experts. The nation is unlikely to achieve herd immunity – if enough people in a given community have antibodies to a given disease – until children can be vaccinated, experts say.

According to the government, children make up around 20% of the US population. According to experts, between 70% and 85% of the US population must be vaccinated against Covid to achieve herd immunity and some adults may refuse to get the shots.

Dr. Scott Gottlieb, a former FDA commissioner, said he expected it would take the U.S. agency about a month to review the new data. If the FDA process goes well, the vaccine could be available to children between the ages of 12 and 15 by the fall, he told CNBC’s Squawk Box.

Isaac Bogoch, an infectious disease specialist who served on various data and security monitoring bodies, described the results as “wonderful news”. This is a “big step forward” in protecting more people from the virus and making schools safer for children.

“We are talking about improving the safety of youth activities such as youth sports and art, as well as after-school activities for youth,” he said.

Pfizer’s vaccine has already been approved for use in the United States in people aged 16 and over. Clinical studies testing the vaccine in children whose immune systems may react differently than adults had yet to be completed.

The Chief Medical Officer of the White House, Dr. Anthony Fauci, speaking to a House committee earlier this month, said the U.S. could vaccinate older children against Covid-19 starting this fall, while elementary school-age children may get their shots early next year.

Moderna, which also has a US-approved vaccine, announced on March 16 that it has started testing its shot in children under the age of 12. Moderna started a study in December testing children ages 12-17.

Johnson & Johnson plans to test its single-shot vaccine in infants and even newborns after it was first tested in older children, according to the New York Times.

Pfizer announced last week that it had started a clinical trial testing its Covid-19 vaccine in healthy children aged 6 months to 11 years.

In the first phase of this study, the company will determine the preferred dosage level for three age groups – between 6 months and 2 years, 2 and 5 years, and between 5 and 11 years. The children will initially receive a dose of 10 micrograms of the vaccine before gradually moving to higher doses, according to the company. Participants also have the option of ingesting 3 micrograms doses.

Pfizer said Wednesday it plans to apply to the FDA for an amendment to its current emergency approval to include adolescents ages 12-15. All participants in the study will be monitored for two more years after their second dose, the company said.

Pfizer and BioNTech plan to submit the data for scientific review.

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Pfizer says its Covid vaccine trial for youths ages 12 to 15 is totally enrolled

Pfizer says its Covid vaccine trial for kids ages 12 to 15 is fully enrolled

Walgreens pharmacist Jessica Sahni will hold the vaccine against Pfizer BioNTech coronavirus disease (COVID-19) at the New Jewish Home in New York on December 21, 2020.

Yuki Iwamura | Reuters

Pfizer said it had fully enrolled its Covid-19 vaccine study in children ages 12-15, an important step before the vaccine could be used in that age group.

The study, an extension of the study used to support the company’s emergency approval for the vaccine in people aged 16 and over, enrolled 2,259 children between the ages of 12 and 15, Pfizer told CNBC on Friday. The entry on a government clinical trial website has been updated to determine that subjects are no longer being recruited.

The vaccine developed with German partner BioNTech was approved in December for people aged 16 and over. Studies in younger age groups are needed to ensure the correct dose as well as safety and effectiveness in these different groups, said Dr. Evan Anderson, a pediatrician at Emory University School of Medicine.

“I am very uncomfortable sending my children back to school where, despite the school’s best efforts, there is a real risk of getting Covid-19,” Anderson told CNBC in October.

While children are less affected by Covid-19 than adults, they still catch the virus and get sick. Some even died. According to a report from the American Academy of Pediatrics and the Children’s Hospital Association, more than 2.5 million cases of Covid-19 in children were reported as of Jan. 14, about 13% of all cases.

“Children can still get sick and die from Covid-19,” said Dr. Paul Offit, director of the Vaccine Education Center and an infectious disease doctor at Philadelphia Children’s Hospital. “In the past year, as many children died of Covid-19 as of influenza. And we recommend an influenza vaccine for children.”

Offit also pointed out that children can suffer from a disease related to Covid-19 called multisystem inflammatory syndrome, “which can be debilitating”.

According to the Centers for Disease Control and Prevention, as of Jan. 8, there were 1,659 cases of the syndrome in children named MIS-C and 26 related deaths. There were a total of 78 deaths from Covid-19 in children under 4 years old and 178 in children between 5 and 17 years old, according to CDC data, although those numbers do not explain all deaths from the United States

Children compete for class at PS 361 on the first day of returning to class during the coronavirus disease (COVID-19) pandemic in the Manhattan neighborhood of New York City, New York, United States, on December 7, 2020.

Carlo Allegri | Reuters

Pfizer declined to say when it expected results from the study, which would depend on the observed infection rate, to compare the rates in the placebo group with those who received the vaccine. With infection rates higher in the US since the fall – the 7-day average of daily cases now stands at 187,500, according to a CNBC analysis of the Johns Hopkins University data – vaccine effectiveness studies have shown their ads are getting faster.

However, enrollment for adolescent studies has been slower than hoped, at least for Moderna’s study in children ages 12-17, Moncef Slaoui, chief advisor to Operation Warp Speed, the Trump administration’s vaccine effort, said at their last meeting on Dec. January.

By then, around 800 children had been included in the study for over a month, of which around 3,000 were needed. Moderna’s vaccine was approved for people aged 18 and over in December, weeks after its teenage study began. Pfizer lowered the age of his trial to 12 years in October.

“While enrollment was lower during the holiday season, we expect an increase in the new year as planned,” said Moderna spokeswoman Colleen Hussey on Friday. “We are on track to provide updated data by mid-2021.”

AstraZeneca, whose vaccine developed by Oxford University is in late-stage trials in the US and approved in the UK, told CNBC Friday that it plans to continue UK trials in a new protocol for children ages 5-18 from the coming months. “”

Johnson & Johnson, whose results are expected in the third phase in adults, said it was in talks with regulators about including pediatric populations in its development plan. The same technology used for the Covid-19 vaccine was found to have been used in vaccines given to more than 200,000 people, including people over 65, infants, children, HIV-positive adults, and pregnant women .

Typically, vaccine trials are conducted in younger age groups after they have been shown to be safe and effective in older groups. The manufacturers of Covid-19 vaccines have indicated that they will follow this plan here as well.

Moderna’s chief executive Stephane Bancel said earlier this month the company is unlikely to have data on children ages 11 and younger who would include a lower dose before next year. He said he expected data for children 12 years and older could be available before September.

U.S. public health officials such as White House Chief Medical Officer Dr. Anthony Fauci, said they hope that by fall 75% to 80% of the US population could be vaccinated so life can return to some form of normal.

About 78% of the US population, or 255 million people, are over 18 years old, according to a CNBC analysis of the census data. Another 25 million people are between 12 and 17 years old.

Fauci did not immediately respond to a query about the need to include children in vaccinations in order to meet his goal of 75% to 80% coverage.

“It is important that all children are vaccinated, and manufacturers cannot conduct these trials fast enough,” Angela Rasmussen, virologist and subsidiary at the Georgetown Center for Global Health Science and Safety, told CNBC on Friday. “The more people of all ages are vaccinated, the better.”