Tag: Adolescents

Categories
Health

Moderna Apples for Authorization of Its Covid Vaccine for Adolescents

Moderna Apples for Authorization of Its Covid Vaccine for Adolescents

Moderna applied to the Food and Drug Administration on Thursday for emergency clearance to use its coronavirus vaccine in 12-17 year olds. If approved as expected, the vaccine would offer a second option to protect teenagers from the coronavirus and speed the return to normal for middle and high school students.

The company has already applied for approval from Health Canada and the European Medicines Agency and plans to apply for approval in other countries, CEO Stéphane Bancel said in a statement. FDA approval usually takes three to four weeks.

Last month, the FDA expanded the emergency approval of Pfizer and BioNTech’s vaccine for use in children ages 12-15. This vaccine was already available to anyone over the age of 16. About 7 million children under the age of 18 have received at least one dose of the vaccine to date, and about 3.5 million are fully protected.

Moderna’s vaccine was approved for use in adults in December. His application to the FDA for young teenagers is based on study results published last month. This clinical trial enrolled 3,732 children, ages 12-17, with 2,500 receiving two doses of the vaccine and the remainder receiving a saltwater placebo.

The study found no cases of symptomatic Covid-19 in fully vaccinated adolescents, which is 100 percent effectiveness, the same number that Pfizer and BioNTech reported for this age group. The study also found that a single dose of the Moderna vaccine was 93 percent effective. Participants did not experience any serious side effects beyond those seen in adults: injection site pain, headache, fatigue, muscle pain, and chills.

An independent safety monitoring committee will follow all participants for 12 months after their second injection to assess long-term protection and safety.

Categories
Health

Moderna Vaccine Extremely Efficient in Adolescents, Firm Says

Moderna Vaccine Highly Effective in Adolescents, Company Says

The authorization of a second vaccine for adolescents could help convince more parents, some of whom have expressed reluctance about having their children vaccinated, that the shots are safe, experts said. “Most parents vaccinate their children,” Dr. O’Leary said. “With the Covid vaccines, we’ve seen a little bit more hesitancy, but the further along we get demonstrating safety and effectiveness, the more people we’re seeing wanting the vaccine.”

It would also give parents and teenagers a choice between vaccines, although experts noted that the Pfizer and Moderna vaccines appear to be equally safe and effective.

“This really give parents, I think, a little bit more confidence,” said Rupali Limaye, an expert on vaccine use and hesitancy at Johns Hopkins University. “If they’ve had personal experience, for example, with one of the mRNA products and not the other, they might feel more comfortable then saying, ‘You know, I had a great experience with Moderna, so I really want my child to get Moderna.’”

But because the Pfizer and Moderna vaccines both require two shots, spaced several weeks apart, ensuring that all teens have access to the vaccine may remain a challenge. “I think we’ll still unfortunately not be able to reach more underserved populations that are facing vaccine disparities, because it’s still the two-dose regimen,” Dr. Limaye said. Authorizing a one-dose vaccine, like the Johnson & Johnson shot, for use in adolescents may help close these gaps, she said.

The U.S. already has enough doses to vaccinate adolescents many times over. There are approximately 25 million American children between the ages of 12 and 17, according to estimates from the U.S. Census Bureau. That is roughly the same number of shots that Pfizer and Moderna are distributing, in total, per week in the U.S.

“Right now, we have more than enough supply to vaccinate our teens,” said Dr. Celine Gounder, an infectious disease specialist at Bellevue Hospital Center in New York. “So it’s not so much that the Moderna vaccine is critical for having supply for our population, but rather, having a second vaccine come online for that age group that could be available to the rest of the world — I think that is important.”

Many other countries, however, will not be ready to vaccinate their adolescents for quite some time. Although more than 1.7 billion vaccine doses have been administered globally, there are enormous inequities between countries; 84 percent of doses have gone to people in high- and upper-middle-income countries. Just 0.3 percent have gone to low-income countries.

Categories
Health

5 issues to know earlier than CDC panel votes on use in adolescents

5 things to know before CDC panel votes on use in adolescents

A student receives her first Pfizer Biontech COVID vaccine at Ridley High School on May 3, 2021 as part of a clinic for students ages 16-18.

Pete Bannan | MediaNews Group | Daily times via Getty Images

A key CDC advisory body is due to vote on Wednesday on whether to recommend the use of Pfizer and BioNTech’s Covid-19 vaccine for children ages 12-15.

The widely awaited approval from the CDC’s Advisory Committee on Immunization Practices is the final step before US officials put their thumbs up on states to allow millions of teenagers to be vaccinated as early as Thursday.

Allowing teenagers to get the shots will accelerate the nation’s efforts to fight infection and return to some form of normalcy, say public health officials and infectious disease experts. It also allows states to vaccinate middle school students before summer camps start and school starts in the fall.

The Center for Disease Control and Prevention Panel meeting will take place two days after the Food and Drug Administration announced that it would approve Pfizer and BioNTech’s application to allow young teenagers to be vaccinated in an emergency. The vaccine is already approved for use in people aged 16 and over. It’s given in two doses three weeks apart in teenagers, the same regimen for 16 years and older, according to the FDA.

Here’s what to expect.

When do you vote?

According to a draft agenda, the meeting will take place from 11 a.m. to 5 p.m. The vote usually takes place towards the end.

Prior to voting, medical experts will evaluate clinical trial data from Pfizer and BioNTech and provide their views on the vaccine, including whether the benefits outweigh the risks for use in adolescents. The companies announced in late March that the vaccine was 100% effective in a clinical study involving more than 2,000 adolescents. The side effects were generally consistent with those seen in adults, they added.

What happens next?

Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, told reporters Monday he expected the first shots for young teenagers to be given as early as Thursday until the panel is approved and approved by the CDC director.

The distribution of vaccines will be different across the US, officials told reporters, as states have different regulations about who can give shots to younger age groups. The Biden government has announced plans to send vaccines directly to pediatrician offices and make doses available in other locations such as community centers.

Is the Vaccine Safe?

In a statement on Monday, incumbent FDA commissioner Dr. Janet Woodcock told parents that the agency “did a rigorous and thorough review of all available data” before clearing it for use on younger teenagers.

The FDA said the side effects in adolescents were consistent with those reported in clinical trial participants aged 16 and over. It was suggested that the vaccine should not be given to anyone who has had a history of severe allergic reactions, including anaphylaxis, a severe and potentially life-threatening allergic reaction.

The most commonly reported side effects, according to the FDA, were pain at the injection site, joints and muscles, fatigue, headache, chills, and fever. With the exception of pain at the injection site, more teens reported side effects after the second dose than after the first, the agency said. The side effects usually lasted one to three days.

When do younger children get access?

Studies are currently being carried out to test Covid vaccines in children under the age of 12. However, researchers believe these studies will take longer as they gradually examine younger age groups and experiment with lower doses after the vaccines are shown to be safe in older children.

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.

Moderna and Johnson & Johnson, whose vaccines are approved for people aged 18 and over, are also testing their recordings in younger age groups.

Do children need recordings for school and activities?

Possibly. For example, schools can legally require that students be vaccinated, according to Dorit Reiss, a law professor at UC Hastings College of Law.

Several colleges and universities have already stated that they need Covid vaccinations for students returning in the fall. It is possible that vaccinations are required to participate in after-school activities such as sports, arts, and other personal activities after school.

The federal government is unlikely to prescribe vaccines for children or other groups, public health experts say.

The CDC has previously said schools can safely reopen without vaccinating teachers or students. Biden’s government has announced it will invest $ 10 billion in Covid testing for schools to accelerate the return to one-to-one tuition across the country this fall.

Categories
Health

‘It’s a giant deal’ for America’s push to reopen, says NIH Director on Pfizer vaccine approval for adolescents

Pfizer and BioNTech begin the process of seeking full U.S. approval for their Covid vaccine

The director of the National Institutes of Health, Dr. Francis Collins, called the Food and Drug Administration approval for emergency use of Pfizer and BioNTech’s Covid vaccine for children ages 12-15 as “a big deal” in America’s drive to reopen.

“This is exciting news,” said Collins. “We know that since this pandemic started, one and a half million teenagers have been infected with Covid-19, and not all have been as good as most. And some of them have ended up where they have been with this long Covid We are not doing any better , even weeks or months after the illness, so we really want to protect young people. “

The Centers for Disease Control and Prevention’s Vaccine Advisory Board has scheduled a meeting on Wednesday to review recordings for children. If approved by the CDC as expected, it could be distributed to teens as early as this week.

More than 44% of all adults in the US are fully vaccinated, and according to the CDC, around 58% have now received at least one dose of the Covid vaccine. The White House aims to increase that number to 70% by July 4th.

Collins told CNBC’s “The News with Shepard Smith” that the US is “on a pretty good path” and that the nation should be able to see CDC regulations to relax indoor masks.

“It’s just about finding the right way to balance the desire not to create another wave. This is the last thing we need right now with the fact that people are really fed up with masks to wear, “said Collins.

Categories
Health

FDA Set to Authorize Pfizer Vaccine for Adolescents by Early Subsequent Week

FDA Set to Authorize Pfizer Vaccine for Adolescents by Early Next Week

WASHINGTON – The Food and Drug Administration is preparing to approve the use of the Pfizer BioNTech coronavirus vaccine in adolescents ages 12-15 by early next week, according to federal officials familiar with the agency’s plans, and opens the US vaccination campaign to millions more people.

Some parents have counted down the weeks since Pfizer announced results of its teenage study showing the vaccine was at least as effective in this age group as it was in adults. Vaccinating children is key to increasing immunity in the population and reducing the number of hospitalizations and deaths.

The approval in the form of an amendment to the existing emergency approval for the Pfizer vaccine could come as early as later this week. If so, the Centers for Disease Control and Prevention’s vaccine advisory board is expected to meet the following day to review the clinical trial data and make recommendations on the use of the vaccine in adolescents.

The enlargement would be a major development in the country’s vaccination campaign and welcome news for some parents looking to protect their children during summer activities and before the start of the next school year. This is also another challenge for policy makers who have difficulty vaccinating a large percentage of adults who are reluctant to get the shot. Many more may refuse to vaccinate their children.

Pfizer reported a few weeks ago that none of the adolescents in the clinical trial who received the vaccine developed symptomatic infections, a sign of significant protection. The company said volunteers produced strong antibody responses and had roughly the same side effects seen in people aged 16-25.

Stephanie Caccomo, a spokeswoman for the Food and Drug Administration, said she was unable to comment at the time the agency made the decision.

“We can assure the public that we are working to look into this request as quickly and transparently as possible,” she said.

Over 100 million adults in the US have been fully vaccinated. However, approval would come in the middle of a delicate and complex push to reach the 44 percent of adults who have not yet received a single shot.

With much of the world demanding the surplus of US-made vaccines, the use of the Pfizer BioNTech shot in adolescents will also raise questions about whether care should be targeted at an age group largely spared heavy vaccines seems Covid19.

“I think we need to have a national and global conversation about the ethics of our vaccinated children, who are at low risk of serious complications from the virus, when there aren’t enough vaccines in the world to protect high-risk adults from dying “Said Jennifer B. Nuzzo, an epidemiologist at the Johns Hopkins Center for Health Security.

Updated

May 3, 2021, 8:53 p.m. ET

President Biden has come under increasing pressure to shed some of the country’s vaccine supplies. Some federal officials have also urged the government to decide soon how much vaccine is needed so that the doses do not expire or be shipped to the states and not used. The federal government has bought 700 million doses of three state-approved vaccines to be dispensed before the end of July, well in excess of what would be required for any American.

White House officials said last week that the intention is to make up to 60 million doses of the AstraZeneca vaccine available to other countries as long as federal regulators deem the doses to be safe. The vaccine has not yet been approved by American regulators. However, global health groups and public health experts said engagement was not enough.

Dr. Rupali J. Limaye, a Johns Hopkins University researcher investigating vaccine use and reluctance, said the United States should donate any surplus Pfizer BioNTech shots – and any surpluses from other manufacturers – to India and other countries that are had severe outbreaks and asked for help.

“From an ethical point of view, we shouldn’t give people like them priority over people in countries like India,” said Dr. Limaye about teenagers.

If the United States continues its supply of Pfizer-BioNTech, it should be reserved for adults while health officials grapple with the phase of the vaccination campaign that requires more individualized local contact.

“We still have to move past hesitant adults and start at the same time maybe 14 or 15,” said Dr. Limaye. “But the priority should still be adults.”

The current vaccine supply in the United States is substantial. As of Monday, about 65 million doses had been dispensed but not given, according to the CDC, including 31 million doses of the vaccine from Pfizer-BioNTech, nearly 25 million doses from Moderna, and 10 million doses from Johnson & Johnson

The Pfizer and Moderna vaccines each require two doses. Pfizer is approved for ages 16 and up, Moderna for ages 18 and over.

Dozens of millions more Pfizer BioNTech cans – about three weeks long, according to a federal official – have been made and are in various stages of readiness. They wait for the final tests before they are shipped.

Moderna expects results from its own clinical study in adolescents aged 12 to 17 years old soon, followed by results in children aged 6 months to 12 years later this year.

The approval of the Food and Drug Administration should ease the concerns of middle and high school administrators scheduled for the fall. If students can be vaccinated by then, it could lead to more normal gatherings and allow administrators to plan further ahead in the academic year.

Categories
Health

The Pfizer-BioNTech Vaccine Is Stated to Be Powerfully Protecting in Adolescents

The Pfizer-BioNTech Vaccine Is Said to Be Powerfully Protective in Adolescents

The Pfizer BioNTech coronavirus vaccine is extremely effective in adolescents ages 12 to 15, perhaps even more effective than it is in adults, the companies reported on Wednesday. No symptomatic infections were found in children who received the vaccine in a recent clinical study. The children showed strong antibody reactions and did not show any serious side effects.

The results, if persistent, could accelerate the return to normal for millions of American families. Depending on government approval, vaccinations for middle school, high school and elementary school children might start not long before the start of the next school year.

The companies announced the results in a press release that did not include detailed data from the study that had not yet been peer-reviewed or published in a scientific journal. Still, the news was praised and excited by experts.

“Oh my god, I’m so happy to see this – it’s amazing,” said Akiko Iwasaki, an immunologist at Yale University. If the vaccine performance was A-plus in adults, the results in children were A-plus-plus.

The good news comes even if the country sees a renewed surge in infections and health officials again urge Americans to follow precautions and get vaccinated. On Monday, Dr. Rochelle Walensky, director of the Centers for Disease Control and Prevention, said rising cases left her feeling of “impending doom” while President Biden urged state and local officials to reinstate mask mandates.

Vaccination efforts are accelerating across the country. By Tuesday, 29 percent of Americans had received at least one dose of a coronavirus vaccine, and 16 percent had been fully vaccinated, according to the CDC

But the country cannot hope to achieve herd immunity – the point where immunity becomes so widespread that the coronavirus is slowing its passage through the population – without vaccinating the youngest Americans as well, some experts say. Children under the age of 18 make up approximately 23 percent of the population in the United States.

“The sooner we can get vaccines against as many people as possible, regardless of their age, the sooner we will feel like we are ending this pandemic for good,” said Angela Rasmussen, a virologist at Georgetown University in Washington.

Data from Israel suggest that vaccination in adults alone can significantly reduce the number of cases. “However, in order to reach the herd immunity threshold in the long term, we need to vaccinate children,” she said.

The study included 2,260 adolescents aged 12 to 15 years. The children received two doses of the vaccine three weeks apart – the same amounts and the same schedule as for adults – or a placebo with salt water.

The researchers registered 18 cases of symptomatic coronavirus infection in the placebo group and none among the children who received the vaccine. However, the low number of infections makes it difficult to accurately determine the effectiveness of the vaccine in the general population, said Dr. Rasmussen.

“But obviously it looks good for the vaccine if there are no Covid cases among the vaccinated people,” she added.

The adolescents who received the vaccine produced, on average, many more antibodies than those aged 16-25 in a previous study. The children experienced the same minor side effects as older participants, although the companies refused to be more specific.

Updated

March 31, 2021, 9:45 a.m. ET

Dr. Iwasaki said she expected antibody levels in teenagers to be comparable to those in young adults. “But they get even better readings from the vaccines,” she said. “That is really unbelievable.”

She and other experts warned that the vaccine may be less effective in children and adults against some of the variants that have come into circulation in the United States.

Pfizer and BioNTech started a clinical trial of the vaccine in children under the age of 12 just last week, and started vaccinating children ages 5 to 11. Scientists at the company plan to test the vaccine in even younger children ages 2 to 5 next week, followed by trials in children ages 6 months to 2 years.

Results from this three-phase study are expected in the second half of the year, and the companies hope to make the vaccine available to children under the age of 12 early next year.

“We share the urgency to expand the use of our vaccine to wider populations and are encouraged by data from clinical trials in adolescents 12-15 years of age,” said Albert Bourla, Pfizer chairman and CEO, in a statement.

Moderna has also tested its vaccine in children. Results of a study in adolescents aged 12 to 17 years are expected in the next few weeks and in children aged 6 months to 12 years in the second half of this year.

AstraZeneca started testing its vaccine in children 6 months and older last month, and Johnson & Johnson has announced that it will wait for the results of studies in older children before testing the vaccine in children under the age of 12.

Some parents have stated that they are reluctant to immunize their children because the risk of the virus is low. Children account for less than 1 percent of deaths from Covid-19, but about 2 percent of children with the disease require hospital care.

The new results may not affect all of these parents, but they can reassure parents who have been wary of vaccines, said Jennifer Nuzzo, an epidemiologist at the Johns Hopkins Center for Health Security.

“While I don’t think we have to wait for the children to be vaccinated to fully reopen schools, the ability to vaccinate children can help some families feel more secure when they return to school,” said they.

Pfizer and BioNTech plan to apply to the Food and Drug Administration for an emergency approval change for their vaccine in hopes of starting vaccinating older children before the start of the next school year. The companies also plan to submit their data for review and publication in a scientific journal.

You will monitor participants for two years after the second dose to assess the long-term safety and effectiveness of the vaccine. Vaccine side effects usually appear within the first six weeks, said Dr. Kristin Oliver, pediatrician and vaccine expert at Mount Sinai Hospital in New York. “Even so, it is good to know that security surveillance is continuing,” she said.

The CDC recommends that people do not receive any other vaccines for two weeks before and after receiving the two doses of the coronavirus vaccine.

But kids are getting more vaccines than ever before in the few weeks leading up to the school year, according to Dr. Oliver. Therefore, pediatricians and parents should try to get these other vaccinations earlier than usual.

The coronavirus vaccines should ideally be given by pediatricians with extensive experience immunizing children, added Dr. Oliver added. “Now is the time to plan how this rollout will take place in this age group,” she said.