COVID-19 Vaccines For Children

COVID-19 Vaccines For Children

Vaccines have significantly reduced many childhood diseases, says the U.S. Food and Drug Administration (FDA). Vaccines prevent infectious diseases in babies, children, and adolescents. 

The U.S. CDC recommends everyone ages 5 and older get a vaccine to help protect against severe COVID-19. Eligible children can receive reduced dosages of the mRNA COVID-19 vaccine. However, when turning 12 years old, they should receive the full, adult dosage.

According to the CDC, as of November 24, 2021, there have been 621 deaths attributed to COVID-19 (vaccination and comorbidity status undisclosed) in people under 18 in the U.S. since January 2020. Additionally, the CDC reported 170 deaths involving both COVID-19 and pneumonia. The CDC publishes current 'COVID-19 Weekly Deaths by Age, Race/Ethnicity, and Sex' trends on this webpage.

Moreover, the CDC recently confirmed 'Rare serious adverse events have been reported after COVID-19 vaccination, myocarditis after Comirnaty (Pfizer-BioNTech) and SpikeVax (Moderna) COVID-19 vaccination. On November 19, 2021, the CDC vaccine committee reviewed additional heart-risk data after mRNA vaccinations.

The WHO reported on November 24, 2021, 'Although benefit-risk assessments clearly underpin the benefit of vaccinating all age groups, including children and adolescents, the direct health benefit of vaccinating children and adolescents is lower compared with vaccinating older adults due to the lower incidence of severe COVID-19 and deaths in younger persons. Safety signals such as myocarditis, albeit rare, are reported more frequently in young persons aged 16-24 years, particularly males. The risk of myocarditis in adolescents and/or children has not yet been determined.'

The U.K.'s Joint Committee on Vaccination and Immunisation is recommending one dose to people under 15 years of age. A paper recently published by the Oxford Vaccine Group presents a global dataset that looks at childhood vaccination policies worldwide.

COVID-19 Vaccines For Children News

November 22, 2021 - Pfizer Inc. and BioNTech SE announced topline results from a longer-term analysis of the safety and efficacy of their COVID-19 vaccine in individuals 12 through 15 years of age showing that a two-dose series of the Comirnaty Vaccine (30-µg per dose) was 100% effective against COVID-19, measured seven days through over four months after the second dose.

November 10, 2021 - The EMA announced it had started evaluating an application to extend the use of Moderna’s COVID-19 vaccine, Spikevax, to children aged 6 to 11.

November 5, 2021 - According to Germany's PEI data, a total of five such suspected COVID-19 vaccine cases by the end of September 2021, which relate to deaths of children and adolescents two to 24 days after vaccination with the Biotech / Pfizer vaccine. According to the PEI, at least three of the adolescents had serious pre-existing conditions. 

November 3, 2021 - The U.S. CDC Director Rochelle P. Walensky, M.D., M.P.H., announced her endorsement of children 5 to 11 years old being vaccinated with the Pfizer-BioNTech mRNA vaccine. HHS Secretary Xavier Becerra issued his statement supporting children’s protection during this pandemic.

November 2, 2021 - Dr. Alejandra Gurtman, Vice President Vaccine Clinical Research and Development Pfizer Inc. presented 'BNT162b2 (COVID-19 Vaccine, mRNA) Vaccine –in Individuals 5 to <12 Years of Age' during the CDC vaccine committee advisory meeting.

October 22, 2021 - Pfizer published a meeting document for the U.S. FDA's Vaccines and Related Biological Products Advisory Committee on October 26, 2021. The number of participants in the current clinical development program is too small to detect any potential risks of myocarditis associated with vaccination. The Pfizer-BioNTech COVID-19 Vaccine (for five years to <12 years of age) is administered as a primary series of two doses of 10 µg of BNT162b2 in 0.2 mL each, given three weeks apart to individuals 5 to <12 years of age.

October 19, 2021 - The U.S. CDC Morbidity and Mortality Weekly Report found among hospitalized U.S. patients aged 12–18 years, vaccine effectiveness of 2 doses of Pfizer-BioNTech vaccine against COVID-19 hospitalization during June–September 2021, was 93%.

October 18, 2021 - The EMA started evaluating an application to extend the Comirnaty vaccine use for children aged 5 to 11. And Canada announced a similar request.

October 12, 2021 - The U.S. FDA's Vaccines and Related Biological Products Advisory Committee announced a meeting on October 26, 2021, that will discuss a request to amend Pfizer-BioNTech's Emergency Use Authorization for the administration of the COVID-19 vaccine to children 5 through 11 years of age.

October 12, 2021 - Bharat Biotech's Covaxin COVID-19 vaccine confirmed India's Subject Expert Committee expert panel granted emergency use approval for children between two and 18.

October 12, 2021 - Mexico News Today reported a Mexican judge ruling that about 10 million people under 18 years of age must be immunized with the Pfizer (Comirnaty) mRNA vaccine.

October 11, 2021 - A serosurvey completed by the ICMR in India found almost 60% of children were already infected with Covid-19. 'The children's death rate is 2 in a million, which is very low. However, there's no such study to justify that vaccine will be very beneficial for children,' Dr. Sanjay K Rai, Professor at the Centre for Community Medicine in AIIMS Delhi, told news agency ANI.

October 8, 2021 - Scandinavian Countries Discontinue Offering the SpikeVax Vaccine to Young Men.

October 7, 2021 - CNBC reported Pfizer Inc. had asked the U.S. Food and Drug Administration to authorize its Covid-19 vaccine for children ages 5 to 11.

October 6, 2021 - The U.K.'s Health Security Agency published updated information regarding adolescent vaccinations.

October 6, 2021 - The journal NEJM published an Original Article: Myocarditis after BNT162b2 mRNA Vaccine against Covid-19 in Israel. CONCLUSIONS - The incidence of myocarditis, although low, increased after the receipt of the BNT162b2 vaccine, particularly after the second dose among young male recipients. And the clinical presentation of myocarditis after vaccination was usually mild.

October 6, 2021 - The journal NEJM published an ORIGINAL ARTICLE: Myocarditis after Covid-19 Vaccination in a Large Health Care Organization. CONCLUSIONS - Among patients in an extensive Israeli health care system who had received at least one dose of the BNT162b2 mRNA vaccine, the estimated incidence of myocarditis was 2.13 cases per 100,000 persons; the highest incidence was among male patients between the ages of 16 and 29 years. Most cases of myocarditis were mild or moderate in severity. This study was funded by the Ivan and Francesca Berkowitz Family Living Laboratory Collaboration at Harvard Medical School and Clalit Research Institute.

October 1, 2021 - The Louisiana Department of Health sadly confirmed 17 children younger than 18 have died from COVID in Louisiana.

September 28, 2021 - BioNTech S.E. and Pfizer Inc. announced they had submitted data to the U.S. Food and Drug Administration from the Phase 2/3 trial of their COVID-19 vaccine in children 5 to <12 years of age.

September 20, 2021 - Pfizer Inc. and BioNTech S.E. announced results from a Phase 2/3 trial showing a favorable safety profile and robust neutralizing antibody responses in children 5 to 11 years of age using a two-dose regimen of 10 µg administered 21 days apart, a smaller dose than the 30 µg dose used for people 12 and older. 

September 15, 2021 - ORIGINAL RESEARCH was published: Factors Associated With COVID-19 Disease Severity in the U.S. Children and Adolescents. Among children and adolescents hospitalized with COVID-19, greater disease severity was associated with Black or other non-White race; age greater than four years; and obesity; type 2 D.M., cardiovascular, neuromuscular, and pulmonary conditions. CONCLUSIONS: Among children and adolescents presenting to U.S. children's hospital E.D.s with COVID-19, 20% were hospitalized; of these, 21% received care in the ICU. Older children and adolescents had a lower risk for hospitalization but more severe illness when hospitalized. In addition, there were differences in disease severity by race and ethnicity and the presence of selected comorbidities. These factors should be taken into consideration when prioritizing mitigation and vaccination strategies.

September 14, 2021 - The Lancet published a school-based study of COVID-19 contacts in England who have been asked to self-isolate at home, missing vital educational opportunities. Infection rates in school-based communications were low, with very few school contacts testing positive.

September 13, 2021 - England's chief medical officer Chris Whitty recommended that children between the ages of 12 and 15 be offered just one dose of an mRNA COVID-19 vaccine. More than a week ago, Britain's Joint Committee on Vaccination and Immunization issued a statement saying the "margin of benefit" to inoculating children. The current update relates to JCVI's review of considerations for the vaccination of children aged 12 to 15 years who do not have underlying health conditions that put them at increased risk from COVID-19. As a result, a precautionary approach was agreed upon given the very low risk of serious disease in those aged 12 to 15 years without an underlying health condition that puts them at increased risk.

September 10, 2021 - The U.S. FDA's Director Janet Woodcock, M.D.said in a press release, 'It's important that the public recognize that, because young children are still growing and developing, thorough and robust clinical trials of adequate size must be completed to evaluate the safety and the immune response to a COVID-19 vaccine in this population.'

September 8, 2021 - A non-peer-reviewed study: mRNA Vaccination-Associated Myocarditis in Children Ages 12-17: A Stratified National Database Analysis. Conclusions Post-vaccination CAE rate was highest in young boys aged 12-15 following dose two. For boys 12-17 without medical comorbidities, the likelihood of post-vaccination dose two CAE is 162.2 and 94.0/million, respectively. This incidence exceeds their expected 120-day COVID-19 hospitalization rate at both moderate (August 21, 2021 rates) and high COVID-19 hospitalization incidence.

September 8, 2021 - The Journal of Infectious Diseases published a test-negative study: mRNA Vaccine Effectiveness against COVID-19 among Symptomatic Outpatients Aged ≥16 Years in the United States, February – May 2021. The Comirnaty and SpikeVax mRNA-based COVID-19 vaccines had a collective 91% vaccine efficacy against SARS-CoV-2 infection in Americans 16 years and older.

September 7, 2021 - The JAMA Network published the findings from a new study: Characteristics of SARS-CoV-2 Infections in Israeli Children During the Circulation of Different SARS-CoV-2 Variants. These results demonstrate that SARS-CoV-2 spread more effectively and more rapidly among young children during the time of B.1.1.7 variant circulation in Israel.

September 7, 2021 - The AAP policy Recommendations for Prevention and Control of Influenza in Children, 2021-2022, from the Committee on Infectious Diseases, is available at https://doi.org/10.1542/peds.2021-053744, and the technical report is at https://doi.org/10.1542/peds.2021-053745. They also will be published in the October 2021 issue of Pediatrics. Note: Because it is unknown whether the reactogenicity of COVID-19 vaccines will be increased with the coadministration of flu vaccine, the reactogenicity profile of the vaccines should be considered.

September 6, 2021 - AFP News reported Cuba started distributing COVID-19 vaccines in the 2-11 age group in the central province of Cienfuegos.

September 3, 2021 - Health ministers from the four nations have asked the U.K.'s Chief Medical Officers to advise on the vaccination of young people aged 12 to 15. The independent Joint Committee on Vaccination and Immunisation has advised that the health benefits from COVID-19 vaccination are marginally greater than the potential known harms. However, it has advised the U.K. government to seek further input from the Chief Medical Officers.

August 26, 2021 - 'There is no evidence that the Delta variant is causing more severe disease than previous strains,' says Dr. Sean O'Leary, vice-chair of the American Academy of Pediatrics (AAP) committee on infectious diseases. Less than 2% of children who have caught COVID-19 during this wave landed in the hospital—roughly the same percentage as during earlier phases of the pandemic, according to a TIME analysis of AAP and U.S. Department of Health and Human Services data.

August 23, 2021 - The American Academy of Pediatrics strongly discourages the practice of administrating the Comirnaty vaccine off-label for children aged 11 and younger.

August 12, 2021 - The U.S. FDA amended the EUAs for Pfizer-BioNTech COVID-19 and the Moderna COVID-19 Vaccines to allow for the use of an additional dose in specific immunocompromised individuals, including those 12 years of age.

August 11, 2021 - The NEJM published an Orginal Article that found the mRNA-1273 vaccine had an acceptable safety profile in adolescents in this study. The immune response was similar to that in young adults, and the vaccine was efficacious in preventing Covid-19. No serious adverse events related to mRNA-1273 or placebo were noted.

August 11, 2021 - A study jointly led by Public Health England, the London School of Hygiene and Tropical Medicine, and the Office for National Statistics was carried out in June 2021 across 141 primary and secondary schools within the North West London area in England. The percentage of primary school pupils who tested positive on the day was 0.27%, showing very little change from May 2021. In secondary schools, 0.42% of students tested positive, representing a significantly lower level than the autumn term 2020. And in secondary schools, 0.27% of staff tested positive for COVID-19, similar levels in March 2021 and significantly lower than the autumn term 2020. For Round 6, the number of positive test results from primary school staff was too small to present due to statistical disclosure criteria.

August 10, 2021 - The journal JAMA published a new study: Association of Myocarditis With BNT162b2 Messenger RNA COVID-19 Vaccine in a Case Series of Children. In this small case series study, myocarditis was diagnosed in children after COVID-19 vaccination, most commonly in boys after the second dose. In this case series, in short-term follow-up, patients were mildly affected. The long-term risks associated with postvaccination myocarditis remain unknown.

August 9, 2021 - Swissmedic confirmed it has carefully checked the application submitted by Moderna Switzerland GmbH for the indication extension and has extended the temporary approval of the Covid-19 vaccine Spikevax from Moderna for the prevention of coronavirus disease for adolescents aged 12 to 17 years. As with people over 18 years of age, the vaccine must be administered twice, 4 weeks apart.

August 5, 2021 - Lee Savio Beers, MD, FAAP President, wrote a letter to the U.S. FDA stating: On behalf of the American Academy of Pediatrics (AAP), a non-profit professional organization of more than 67,000 primary care pediatricians, pediatric medical subspecialists, and pediatric surgical specialists dedicated to the health, safety, and well-being of all infants, children, adolescents, and young adults, I write to urge the Food and Drug Administration to continue working aggressively towards authorizing safe and effective COVID-19 vaccines for children under age 12 as soon as possible.

August 4, 2021 - The U.K.'s Joint Committee on Vaccination and Immunisation announced it is advising 'all 16 and 17-year-olds to receive their first of the two-dose regimen Pfizer-BioNTech (Comirnaty) vaccine. However, the second vaccination schedule is under review.

August 3, 2021 - Wiley Online published an Original Article: Multisystem inflammatory syndrome in children during severe acute respiratory syndrome coronavirus-2 pandemic in Turkey: A single-center experience. Children with MIS-C might have variable clinical presentations. Acute anterior uveitis might be a prominent presentation of MIS-C and require ophthalmological examination. It is essential to make patient-based decisions and apply a stepwise approach to treat this life-threatening disease.

August 2, 2021 - The United Arab Emirates (UAE) announced the approval of the Sinopharm COVID-19 vaccine for children aged 3-17. In May 2021, the UAE Ministry of Health and Prevention approved the emergency use of the Pfizer-BioNTech Comirnaty vaccine for children between the ages of 12 and 15 following a strict assessment.

July 27, 2021 - The Israeli Health Ministry informed healthcare providers that they could administer coronavirus vaccines to children aged 5-11 who have serious background illnesses. Authorizations for individual children must be granted by the healthcare provider and then be validated by the ministry. The Health Ministry said the medical conditions that could warrant such authorization include extreme obesity (BMI over the 99th percentile for age and sex), severe chronic lung illness, neurodevelopment disorders, congestive heart failure, sickle cell anemia, and severe autoimmune diseases.

July 27, 2021 - "Since we never immunized children this age and we decided on a special dose – 10 micrograms instead of 30 mcg. of the Pfizer-BioNTech (Comirnaty) vaccine – we still don't know," Dr. Doron Dushnitzky, a pediatric specialist with Leumit Health Services and a member of the Midaat Association for Informed Health, told The Jerusalem Post.

July 26, 2021 - The NYTimes reported, 'At the urging of federal regulators, Phizer and Moderna are expanding their clinical trials for children ages 5 to 11, as a precautionary measure designed to detect rare side effects including heart inflammation problems that have been confirmed in vaccinated people younger than 30. As of July 21, 2021, the United Kingdom Medicines & Healthcare Regulatory Agency monitors serious allergic reactions, Guillain-Barré Syndrome, and reports of myocarditis or pericarditis with the Pfizer/BioNTech vaccine, COVID-19 Vaccine Moderna, and the COVID-19 Vaccine AstraZeneca.

July 23, 2021 - Local media reported that the second dose of Covaxin has already been administered to children aged 6-12 years at the All India Institute of Medical Sciences (AIIMS) in New Delhi. As per sources, the results of clinical trials are expected to come in one month after completing trials of all age groups.

July 21, 2021 - The NEJM published a CORRESPONDENCE: Household Transmission of SARS-CoV-2 from Children and Adolescents. This retrospective study showed that the efficient transmission of SARS-CoV-2 from school-age children and adolescents to household members led to the hospitalization of adults with secondary cases of Covid-19. In addition, in households in which transmission occurred, half the household contacts were infected.

July 21, 2021 - How readily does COVID-19 spread on school buses? Universal testing and contact tracing revealed no transmission linked to bus transportation. 'As members of the Virginia Chapter of the American Academy of Pediatrics School Re-Opening Task Force, we recognize that schools are under pressure to make data-driven operational decisions.  We hope the model we describe and our data can be of assistance in demonstrating that school buses can safely operate at normal capacity even at high community COVID-19 caseloads."

July 17, 2021 - The Telegraph reported the U.K. has decided against mass COVID-19 vaccinations for all children and will focus on at-risk people.

July 15, 2021 - The A.P. reported Dr. Marco Cavaleri, the EMA's head of vaccines strategy, said its expert committee was currently evaluating Moderna' 's application to extend the use of its coronavirus vaccine for children 12 to 17 years old. "We expect that the committee will conclude by the end of next week," he said.

July 15, 2021 - Tennessee local media reported, 'The Tennessee Department of Health will halt COVID-19 adolescent vaccine outreach.' An internal memo had been sent outlining how children can legally receive the vaccine without parental consent.

July 13, 2021 - The JAMA published an article: Prevalence of Serious Bacterial Infections Among Febrile Infants 90 Days or Younger in a Canadian Urban Pediatric Emergency Department During the COVID-19 Pandemic. 'The present analysis found that the proportion of concomitant SBIs among young infants with SARS-CoV-2 infection was similar to the proportion of bacterial coinfection with other respiratory viruses before the pandemic.'

July 6, 2021 - The U.S. CDC confirmed the VAERS reported 1,226 cases of myocarditis after mRNA vaccination was received from December 29, 2020, - June 11, 2021. Among persons with reported myocarditis after mRNA vaccination, the median age was 26 years, mostly young men, with a median symptom onset interval of 3 days after vaccination.

July 5, 2021 - Charting mandatory childhood vaccination policies worldwide.

July 1, 2021 - The Association of American Medical Colleges stated, 'As scientists test vaccines in young children, evidence continues to emerge about how the disease harms kids, how expanded immunizations of others might protect them, and what impact a vaccine might have.'

June 28, 2021 - The Public Health Agency of Sweden is offering vaccination against COVID-19 for certain groups of patients in the 12–15 age group. These are children with certain medical conditions and with an increased risk of becoming seriously ill from a viral infection. The medical conditions in question are listed on the website of the Swedish Paediatric Society.

June 28, 2021 - The Lancet published a study that found the 'CoronaVac vaccine was well tolerated and safe and induced humoral responses in children and adolescents aged 3–17 years. Neutralizing antibody titers induced by the 3·0 μg dose were higher than those of the 1·5 μg dose. The results support using a 3·0 μg dose with a two-immunization schedule for further studies in children and adolescents.'

June 28, 2021 - "Among those hospitalized, 11% were <30 years and 60% were ≥60 years," Chau Nguyen MS, CIC, FAPIC Epidemiologist, Infection Control and Prevention Spectrum Health System, the lead investigator, reported. In terms of inpatient mortality rate, “for patients <30 years was 0% versus 13% for patients ≥60 years (p-value <0.001).”

June 11, 2021 - Which countries have mandatory childhood vaccination policies?

June 10, 2021 - Germany's vaccine advisory committee recommended that only adolescents with pre-existing conditions receive the Pfizer-BioNTech COVID-19 vaccine.

June 10, 2021 - The U.S. CDC reported over 200 cases of myocarditis and pericarditis among 16-to-17-year-olds after receiving an mRNA vaccination.

June 10, 2021 - The U.S. FDA Center for Biologics Evaluation and Research is conducting a virtual meeting of the 15 voting members of the Vaccines and Related Biological Products Advisory Committee. During the meeting, the FDA provided a status update on its risk-benefit approach to issuing emergency use authorization (EUA) for experimental COVID-19 vaccines intended for use in individuals and the data needed to support a EUA and a biologics license application for a COVID-19 vaccine intended for use in children older than six months of age.

June 9, 2021 - A new analysis showed a sustained decrease in immunization rates among teens throughout the pandemic in 2020. This includes 8.8 million missed adolescent vaccine doses.

June 7, 2021 - The JAMA Network published an Original Investigation: Underlying Medical Conditions Associated With Severe COVID-19 Illness Among Children. Conclusions and Relevance - This cross-sectional study found a higher risk of severe COVID-19 illness among children with medical complexity and certain underlying conditions, such as type 1 diabetes, cardiac and circulatory congenital anomalies, and obesity.

May 25, 2021 - Moderna, Inc. announced that the Phase 2/3 study of its COVID-19 vaccine in adolescents had met its primary immunogenicity endpoint, successfully bridging immune responses to the adult vaccination.

May 10, 2021 - Adolescents ages 12–17 can receive the experimental Pfizer-BioNTech COVID-19 vaccine and be vaccinated with appropriate assent. Sites administering COVID-19 vaccines should follow current state/jurisdictional policies and practices for other routine immunizations in this age group.

May 6, 2021 - Novavax COVID-19 vaccine Phase 3 study: A Study to Evaluate the Efficacy, Immune Response, and Safety of a COVID-19 Vaccine in Adults ≥ 18 Years With a Pediatric Expansion in Adolescents (12-17 Years) at Risk for SARS-CoV-2.

March 24, 2021 - The Lancet published a study that concluded: 'Our evidence indicates that children continue to be mostly, but not completely, spared the worst outcome of the pandemic, particularly compared with older adults who have been much harder hit. However, we continue to caution that the virus is likely to change over time and that these conclusions should be kept under review.'