Virus World

Moderna Inc said on Sunday it has been told that the U.S. Food and Drug Administration will require additional time to complete its assessment of the company's COVID-19 vaccine for use in adolescents aged 12 to 17 years.  The FDA informed Moderna that the review may not be completed before January 2022, the company said in a statement, dealing a potential setback to the timing of an emergency use authorization (EUA) for that age group. Moderna Chief Executive Stephane Bancel told Reuters last week that based on conversations with the agency, he believed the vaccine would be authorized for those 12 to 17 in the next few weeks. The U.S. biotech company said it was told late on Friday that the FDA needed the additional time to evaluate recent international analyses of the risk of a type of heart inflammation called myocarditis after vaccination, a rare side effect that has primarily affected young males.

Moderna said it is conducting its own review of new external analyses on the increased myocarditis risk in those less than 18 years of age as they become available. Moderna applied for U.S. authorization of its shot for those aged 12 to 17 in June. Americans of those ages are eligible for the similar COVID-19 vaccine from Pfizer Inc (PFE.N) and partner BioNTech SE after it was cleared by the FDA and Centers for Disease Control and Prevention in May. Moderna also said it will delay filing its request for an EUA for a half strength 50-microgram dose of the vaccine for children ages 6 to 11 while the FDA completes its review of the 12-17 filing. 

Reporting by Sneha Bhowmik in Bengaluru; Editing by Bill Berkrot

Moderna's Covid-19 vaccine is safe and appears to be effective in adolescents, the company said Tuesday. In a Phase 2/3 trial of 3,732 children ages 12 to 17 in the United States, blood tests showed that the vaccine produced an immune response that was equivalent to earlier findings in adults. The trial wasn't designed to look specifically at efficacy. However, initial observations found that none of the children who received the vaccine got sick with Covid-19 starting 14 days after their second dose. Four of the children who received the placebo tested positive for Covid-19, which Moderna says is "consistent with a vaccine efficacy of 100%." The company notes that figure could change as more data is collected.  In the trial, a case was defined as someone who had at least two coronavirus symptoms or one symptom and a positive Covid-19 test. The company also reviewed how well the vaccine worked after just one dose. The results suggest the vaccine was 93% effective after one dose at preventing mild cases of Covid-19, involving only one symptom of coronavirus disease instead of two or more symptoms. Moderna announced the results Tuesday in a news release, and the results have not yet been peer reviewed or published.

BACKGROUND

Until very recently, vaccines against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) had not been authorized for emergency use in persons younger than 16 years of age. Safe, effective vaccines are needed to protect this population, facilitate in-person learning and socialization, and contribute to herd immunity.

METHODS

In this ongoing multinational, placebo-controlled, observer-blinded trial, we randomly assigned participants in a 1:1 ratio to receive two injections, 21 days apart, of 30 μg of BNT162b2 or placebo. Noninferiority of the immune response to BNT162b2 in 12-to-15-year-old participants as compared with that in 16-to-25-year-old participants was an immunogenicity objective. Safety (reactogenicity and adverse events) and efficacy against confirmed coronavirus disease 2019 (Covid-19; onset, ≥7 days after dose 2) in the 12-to-15-year-old cohort were assessed.

RESULTS

Overall, 2260 adolescents 12 to 15 years of age received injections; 1131 received BNT162b2, and 1129 received placebo. As has been found in other age groups, BNT162b2 had a favorable safety and side-effect profile, with mainly transient mild-to-moderate reactogenicity (predominantly injection-site pain [in 79 to 86% of participants], fatigue [in 60 to 66%], and headache [in 55 to 65%]); there were no vaccine-related serious adverse events and few overall severe adverse events. The geometric mean ratio of SARS-CoV-2 50% neutralizing titers after dose 2 in 12-to-15-year-old participants relative to 16-to-25-year-old participants was 1.76 (95% confidence interval [CI], 1.47 to 2.10), which met the noninferiority criterion of a lower boundary of the two-sided 95% confidence interval greater than 0.67 and indicated a greater response in the 12-to-15-year-old cohort. Among participants without evidence of previous SARS-CoV-2 infection, no Covid-19 cases with an onset of 7 or more days after dose 2 were noted among BNT162b2 recipients, and 16 cases occurred among placebo recipients. The observed vaccine efficacy was 100% (95% CI, 75.3 to 100).

CONCLUSIONS

The BNT162b2 vaccine in 12-to-15-year-old recipients had a favorable safety profile, produced a greater immune response than in young adults, and was highly effective against Covid-19. (Funded by BioNTech and Pfizer; C4591001 ClinicalTrials.gov number, NCT04368728. opens in new tab.)

Published in NEJM (May 27, 2021):

https://doi.org/10.1056/NEJMoa2107456 

The FDA on Monday expanded the emergency use authorization for Pfizer's Covid-19 vaccine to include people ages 12 to 15. This is the first Covid-19 vaccine in the United States authorized for use in younger teens and adolescents; the vaccine had previously been authorized for people age 16 and older. Covid-19 vaccines from Moderna and Johnson & Johnson are authorized for use in people age 18 and older.  To support the extended use, the FDA reviewed data submitted by Pfizer. The company said at the end of March that a clinical trial involving 2,260 12-to-15-year-olds showed the vaccine's efficacy is 100% and it is well tolerated. "It was a relatively straightforward decision," Dr. Peter Marks, Director of FDA's Center for Biologics Evaluation and Research, the arm of the FDA that regulates vaccines, told reporters Monday evening.  The FDA looked at the Pfizer safety and efficacy data. The agency also looked at the immune responses of some of the children who were vaccinated, and compared them to the immune responses of older teens and adults who got the shot. "The response to the vaccine was excellent and in fact it was even better, really, in the younger age group than it was in the 16-25 age group," Marks said. Enter your email to subscribe to the Results Are In Newsletter with Dr. Sanjay Gupta. "The safety profile was very similar in 12-15-year-olds as in 16-25-year-olds."