WASHINGTON Over the past 10 months, as tens of millions of children and teenagers received the Pfizer-BioNTech vaccine, the companies main rival, Moderna, sat on the sidelines, its shot limited to adults.
But Moderna may now be poised for a comeback at a critical juncture in the nations vaccination campaign. The company is expected to send federal officials initial data this week on how well its coronavirus vaccine works for the nations youngest children.
About 18 million children under the age of 5 are the only Americans not yet eligible for vaccination. And while uptake for older children has been slow, many parents are still anxiously awaiting the chance to protect their babies, toddlers and preschoolers.
Moderna is going head-to-head with Pfizer-BioNTech for the opportunity to vaccinate this group, hoping it has found what some scientists are calling the Goldilocks dose: strong enough to offer lasting protection, but not so strong that it causes widespread worrisome side effects, such as high fevers.
Moderna has opted for a regimen of two doses at a quarter the strength of its adult dose for children under 6. Pfizer is expected to seek authorization next month for a three-shot regimen for children under 5, with doses one-tenth as strong as those for people aged 12 and up.
Moderna is also expected to release data soon from its clinical trial on the next age group up: children aged 6 to 11.
Dr. Yvonne Maldonado, a Stanford professor of pediatric infectious diseases and a lead investigator at the Stanford site of Pfizers pediatric vaccine trials, said new data from both Moderna and BioNTech in the coming weeks will offer critical insight into the effectiveness of their pediatric shots. She said researchers are watching carefully to see if Modernas stronger doses result in more robust immune responses than Pfizers shots have elicited in young children.
A series of new studies raising questions about how long Pfizers lower doses protect elementary-school-age children has piqued interest among federal scientists and vaccine experts in Modernas choices.
Dr. Ofer Levy, a pediatric expert at Harvard Medical School and a member of the Food and Drug Administrations independent vaccine advisory committee, said he thought Pfizer might have selected too low a dose for 5- to 11-year-olds in the understandable priority to maximize safety.
To date, Pfizer has been the only player in vaccinating younger Americans, winning authorization to vaccinate 12- to 15-year-olds last May, followed by 5- to 11-year-olds in October. Its authorization for adults also covers 16- and 17-year-olds.
Moderna sought authorization to vaccinate teenagers last June, but the F.D.A. delayed considering the request because of concerns about the risk of myocarditis, a condition involving inflammation of the heart that has been tied to both the Moderna and the Pfizer shots.
More than 22 million people in the United States under 18 are now fully vaccinated with the Pfizer vaccine, but uptake has been leveling off. Only roughly one in four children ages 5 to 11 are fully vaccinated, for example, even though shots have been offered to that group for more than four months.
But there is still a demand to protect the youngest children as more of the country unmasks, more parents return to workplaces and the summer travel season approaches.
Compared with adults, there is no question that in children the benefit of an effective vaccine is less, because fewer get really sick, said Dr. Eric Rubin, an infectious disease expert at the Harvard T.H. Chan School of Public Health and a member of an advisory panel to the Food and Drug Administration.
But it will benefit some individuals, he said. It will save some lives. According to the Centers for Disease Control and Prevention, 336 children in the United States under the age of 5 have died of Covid since the start of the pandemic.
Hopes that the youngest children would soon be covered surged last month after regulators pressed Pfizer-BioNTech to submit preliminary results from its three-dose trial. The F.D.A. wanted to get the vaccination campaign underway with two doses while awaiting final results on three.
March 18, 2022, 7:05 p.m. ET
But that effort collapsed when new data from Pfizer that encompassed more of the Omicron surge showed convincingly that two doses failed to protect adequately against symptomatic infection.
Now, more detailed results from Pfizers and Modernas trials are materializing at roughly the same time. And while neither company knows yet whether its vaccines will prove effective enough for the youngest age group, but both say their research shows they are safe.
We have not seen anything untoward right now, so we feel confident in the safety profile, Dr. Paul Burton, Modernas chief medical officer, said in an interview.
Amy Rose, Pfizers spokeswoman, has said that after careful research, Pfizer-BioNTech chose the safest and most tolerable dose for young children. The companies have said they are hopeful that a three-shot regimen will provide strong protection for children under the age of 5. Pfizer is testing a 10-microgram dose for 5- to 11-year-olds, a third of the adult and teenage dosing; and 3 micrograms for children under 5.
Moderna is proposing substantially higher dosing than Pfizer in all three pediatric age groups: 100 micrograms, the full adult dose, for those ages 12 to 17; 50 micrograms in children 6 to 11, and 25 micrograms in those under 6. Regulators are considered likely to review the firms data for all three age groups simultaneously.
We really stand behind those doses, Dr. Burton said. Although federal officials say both Pfizer and Modernas vaccines wane in potency over time, some studies of adults have suggested that Modernas protection holds up longer. I think it comes down to dose, Dr. Burton said.
He said initial results showed a 50-microgram Moderna dose prompted a robust immune response in children 6 to 11. While the overall number of infections was small, researchers hope that trial will help reveal how well the vaccine prevents illness, not just how high it boosts antibody levels.
Dr. Philip Krause, who recently retired as a senior vaccine regulator at the F.D.A., said the agency spent significant time last year worrying about the safety of Modernas vaccine for those under 18, with some studies showing a higher risk of myocarditis from the companys shot than from Pfizers.
The question is always: What is the dose that gives rise to an immune response that we think is likely to be protective? he said. You couldnt actually test to figure out the rate of myocarditis since its rare, but you could ask, What are we sacrificing in immune response by lowering the dose, and do we think thats important?
Partly because of concerns about myocarditis, the C.D.C. recently encouraged some people 12 or older, particularly boys and men between 12 and 39, to wait eight weeks between their first and second Pfizer or Moderna shots. Studies have shown that teenage boys and young men are most at risk of developing the side effect.
Dr. Burton said that overall the research had proved reassuring, including recent British data that showed myocarditis was very rare and typically mild in both Pfizer and Moderna recipients.
But Dr. Walid F. Gellad, a drug safety expert at the University of Pittsburgh, said it remained unclear whether Modernas higher dosing might elevate the risk of myocarditis in young children. The companys pediatric studies are most likely much too small to identify the risk of the side effect, he and other experts said.
Modernas new push also comes after several studies raised questions about the protection that two doses of Pfizer-BioNTechs vaccine provide for children 5 to 11. Researchers in New York States health department recently found that protection against infection from two doses faded significantly within weeks.
C.D.C. researchers separately found that during the Omicron wave, the effectiveness of two doses of the Pfizer shot against moderate forms of the disease in children ages 5 to 11 dropped significantly.
The studies have kindled a debate among vaccine experts about whether a stronger dose would have been better or whether those children need third doses. Booster shots are now authorized for everyone 12 and up. Pfizer expects results from its study of a three-dose regimen for the younger children next month.
Dr. Gellad said it was possible the Pfizer dose for 5- to 11-year-olds may have been too weak, but that scientists could not yet be certain. He said he expected regulators would be especially careful in considering higher doses for young children given the comparatively low risks of them catching Covid now and getting severely ill.
Amid all the questions, one thing is clear: The back and forth over which vaccine will be better for young children could discourage uptake.
Alison M. Buttenheim, a behavioral health expert at the University of Pennsylvania, said those considering vaccination found comfort in certainty. Otherwise, thats just going to pave the way to say, Im going to hold off, she said. A lot of people are uncomfortable with evolving science.
Read the original here:
Which Coronavirus Vaccine Will Work in the Youngest Children? - The New York Times
- 2024 CDC COVID-19 guidelines: Isolation, masks, what you should know - The Arizona Republic - February 29th, 2024 [February 29th, 2024]
- Long Covid and Impaired Cognition More Evidence and More Work to Do | NEJM - nejm.org - February 29th, 2024 [February 29th, 2024]
- Prospective Memory Assessment before and after Covid-19 | NEJM - nejm.org - February 29th, 2024 [February 29th, 2024]
- A pandemic that won't go away as COVID enters its 5th year, NZ needs a realistic strategy - The Conversation - February 29th, 2024 [February 29th, 2024]
- Older US adults should get another COVID-19 shot, advisers say - Detroit News - February 29th, 2024 [February 29th, 2024]
- Vaping increases susceptibility to COVID-19 infection, study finds - News-Medical.Net - February 29th, 2024 [February 29th, 2024]
- Older U.S. adults should get another covid-19 shot, advisers say - TribLIVE - February 29th, 2024 [February 29th, 2024]
- Vapers More Susceptible to COVID-19 Infection Than Tobacco Smokers, Reveals Study | Weather.com - The Weather Channel - February 29th, 2024 [February 29th, 2024]
- How we met: She was in the next hospital bed and I loved her accent - The Guardian - February 29th, 2024 [February 29th, 2024]
- Fleet To Hit Record Size In 2024 But Still Suffering Covid Hangover - Forbes - February 29th, 2024 [February 29th, 2024]
- How vaccine hesitancy is contributing to rising rates of measles and COVID - PBS NewsHour - February 29th, 2024 [February 29th, 2024]
- How did COVID-19 impact cancer incidence trends in the US? - News-Medical.Net - February 29th, 2024 [February 29th, 2024]
- CT-based Assessment at 6-Month Follow-up of COVID-19 Pneumonia patients in China | Scientific Reports - Nature.com - February 29th, 2024 [February 29th, 2024]
- Covid in 2024: What to Know About Guidelines, Symptoms and Vaccines - WSJ - The Wall Street Journal - February 29th, 2024 [February 29th, 2024]
- Unlocking coronavirus structure through M protein research - News-Medical.Net - February 29th, 2024 [February 29th, 2024]
- SARS-CoV-2 fragments may cause problems after infection - National Institutes of Health (NIH) (.gov) - February 29th, 2024 [February 29th, 2024]
- People 65 and up should now get another COVID-19 vaccine, CDC recommends - cleveland.com - February 29th, 2024 [February 29th, 2024]
- Welcome to the 2024 CFA Annual Report | Covid-19 | news-journal.com - Longview News-Journal - February 29th, 2024 [February 29th, 2024]
- Exploring the reported adverse effects of COVID-19 vaccines among vaccinated Arab populations: a multi-national ... - Nature.com - February 29th, 2024 [February 29th, 2024]
- R.I. COVID-19 cases increased by 337 last week, with 2 deaths - Providence Business News - February 29th, 2024 [February 29th, 2024]
- Older US adults should get another COVID-19 shot, advisers say - NBC Bay Area - February 29th, 2024 [February 29th, 2024]
- Cognitive Deficits Seen in COVID-19 Patients Regardless of Symptom Duration - HealthDay - February 29th, 2024 [February 29th, 2024]
- CDC recommends seniors get another Covid-19 shot - Baltimore Sun - February 29th, 2024 [February 29th, 2024]
- Odds of Severe COVID-19 High for Hematologic Cancer Patients During Pandemic - HealthDay - February 29th, 2024 [February 29th, 2024]
- COVID-19 may have small but lasting effects on cognition and memory | Imperial News - Imperial College London - February 29th, 2024 [February 29th, 2024]
- More free home COVID-19 tests available from US government - WCVB Boston - November 20th, 2023 [November 20th, 2023]
- Seniors made up 63 percent of covid hospitalizations earlier this year - The Washington Post - November 20th, 2023 [November 20th, 2023]
- Fifth Covid-19 wave sees biggest bump in virus detection since ... - New Zealand Herald - November 20th, 2023 [November 20th, 2023]
- KFF COVID-19 Vaccine Monitor November 2023: With COVID ... - KFF - November 20th, 2023 [November 20th, 2023]
- What to Know About the New Dominant Covid Variant - The New York Times - August 12th, 2023 [August 12th, 2023]
- Should You Get Another Covid Booster Now, or Wait Until the Fall? - The New York Times - August 12th, 2023 [August 12th, 2023]
- A 'mini cyclone' helps detect coronavirus in the air - Science News Explores - August 12th, 2023 [August 12th, 2023]
- Infection prevention and control in the context of coronavirus ... - World Health Organization - August 12th, 2023 [August 12th, 2023]
- Serum ferritin level during hospitalization is associated with Brain ... - Nature.com - August 12th, 2023 [August 12th, 2023]
- Rhode Island Man Sentenced to Three Years in Prison for Theft and ... - Department of Justice - August 12th, 2023 [August 12th, 2023]
- Posts Exaggerate Significance of Swiss Study on Heart Risk and ... - FactCheck.org - August 12th, 2023 [August 12th, 2023]
- Wenstrup Presses Department of Education for Answers on Misuse ... - House Committee on Oversight and Reform | - August 12th, 2023 [August 12th, 2023]
- Biden Administration Fails to Share Intel on COVID-19 Origins, but Independent Evidence Is Piling Up - Heritage.org - June 24th, 2023 [June 24th, 2023]
- Do I need a booster vaccine if I recently had COVID? What if I'm not sure what I had? - The Conversation - June 24th, 2023 [June 24th, 2023]
- Psychics, wrestlers and churches: How online shopping and Covid changed mall tenants - Buffalo News - June 24th, 2023 [June 24th, 2023]
- Report: Incarcerated populations up 4% post-COVID - CorrectionsOne - June 24th, 2023 [June 24th, 2023]
- The National Average for Gross Revenue at ECP Locations Decreased for the Week of June 12 18, Jobson's Latest ... - Vision Monday - June 24th, 2023 [June 24th, 2023]
- ODNI Releases Report on the Potential Links Between the Wuhan ... - Office of the Director of National Intelligence - June 24th, 2023 [June 24th, 2023]
- U.S. Intelligence Agencies May Never Find Covid's Origins, Officials ... - The New York Times - June 24th, 2023 [June 24th, 2023]
- Covid-19 likely came from lab leak, says news report citing US energy ... - March 4th, 2023 [March 4th, 2023]
- Classified Energy Department report finds lab leak likely cause of ... - March 4th, 2023 [March 4th, 2023]
- Mayor Kirk Watson tests positive for COVID-19 - KEYE TV CBS Austin - February 5th, 2023 [February 5th, 2023]
- Biden's plan for ending the emergency declaration for COVID-19 signals a pivotal point in the pandemic 4 questions answered - The Conversation... - February 5th, 2023 [February 5th, 2023]
- Study finds one habit can significantly lower your odds of getting sick from COVID-19 - KATU - February 5th, 2023 [February 5th, 2023]
- How will life change once the COVID-19 emergency ends? - KFOX El Paso - February 5th, 2023 [February 5th, 2023]
- Shipping Corporation of India and Seven Islands Shipping re-join membership of INSA - ETInfra.com - January 30th, 2023 [January 30th, 2023]
- COVID-19 Response | United Nations - December 28th, 2022 [December 28th, 2022]
- Top German virologist says COVID-19 pandemic is over - Hindustan Times - December 28th, 2022 [December 28th, 2022]
- China says impossible to track COVID spread as virus surges - Al Jazeera English - December 14th, 2022 [December 14th, 2022]
- What are the most common COVID symptoms now? Its no longer fever, loss of taste - AL.com - December 14th, 2022 [December 14th, 2022]
- Entropy and life - Wikipedia - November 27th, 2022 [November 27th, 2022]
- Negentropy - Wikipedia - November 27th, 2022 [November 27th, 2022]
- Coronavirus: OC reported 1,602 new cases and six more deaths over the past week, as of Nov. 17 - OCRegister - November 19th, 2022 [November 19th, 2022]
- How COVID-19 damages lungs: The virus attacks mitochondria, continuing an ancient battle that began in the primordial soup - The Conversation - October 30th, 2022 [October 30th, 2022]
- How to save this winter on heating costs - WKYC.com - October 23rd, 2022 [October 23rd, 2022]
- 'Fonseca' book review: The Goan artist's biography misses the art of the matter - The New Indian Express - October 23rd, 2022 [October 23rd, 2022]
- Researchers' tests of lab-made version of Covid virus draw scrutiny - STAT - October 21st, 2022 [October 21st, 2022]
- Coronavirus: Orange County reported 1,427 more cases and seven more deaths in the past week as of Oct. 20 - OCRegister - October 21st, 2022 [October 21st, 2022]
- 3 Illinois Counties at High Community Level for COVID-19 as 1 Million Bivalent Booster Shots Have Been Administered - NBC Chicago - October 21st, 2022 [October 21st, 2022]
- What Is Coronavirus? | Johns Hopkins Medicine - October 17th, 2022 [October 17th, 2022]
- Gaston County reported 177 additional COVID-19 cases this week - Gaston Gazette - October 17th, 2022 [October 17th, 2022]
- Coronavirus Roundup: The Biden Administration Renews the Public Health Emergency for COVID-19 - GovExec.com - October 17th, 2022 [October 17th, 2022]
- Circulation of Public Warning Alert on COVID-19 vaccines fraudulently using PAHO's name and logo - World - ReliefWeb - October 17th, 2022 [October 17th, 2022]
- Time to Get Your Flu Shot and Your COVID-19 Booster Too - Health.mil - October 17th, 2022 [October 17th, 2022]
- Evasive COVID-19 subvariants that you dont know about are spreading fast - Poynter - October 17th, 2022 [October 17th, 2022]
- Deer and mink can harbor Covid-19: Why animal virologists say we need to worry - Inverse - October 17th, 2022 [October 17th, 2022]
- Europe likely entering another COVID wave, says WHO and ECDC - Reuters - October 17th, 2022 [October 17th, 2022]
- Without a nasal vaccine, the U.S. edge in fighting Covid is on the line - POLITICO - October 17th, 2022 [October 17th, 2022]
- COVID-19 Daily Update 10-17-2022 - West Virginia Department of Health and Human Resources - October 17th, 2022 [October 17th, 2022]
- Coronavirus: Government seeking to extend powers behind COVID restrictions until 2025 - Newshub - October 17th, 2022 [October 17th, 2022]
- Shocking: EcoHealth Alliance receives another round of funding for coronavirus bat research in Asia - The Center Square - October 17th, 2022 [October 17th, 2022]
- Opportunities in Health Education in the Post-COVID-19 Era: Transforming Viral to Vital - Cureus - October 17th, 2022 [October 17th, 2022]
- Fauci says COVID-19 was politicized by triple whammy of outbreak, division and 2020 election - WJTV - October 17th, 2022 [October 17th, 2022]
- How long does immunity from the new COVID bivalent boosters last 'in the real world'? - San Francisco Chronicle - October 17th, 2022 [October 17th, 2022]
- Respiratory illnesses have spiked among children. Here's what parents need to know. - Yahoo News - October 17th, 2022 [October 17th, 2022]