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Safety, Immunogenicity, and Efficacy of the BNT162b2 Covid-19 Vaccine in Adolescents

From www.nejm.org - May 30, 2021 11:47 AM

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

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Pfizer Vaccine for Teens: US FDA Authorizes Covid-19 Vaccine for People Ages 12 to 15

From www.cnn.com - May 11, 2021 10:41 AM

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."

"FDA has done everything we can to ensure that the Covid-19 vaccines we have authorized have met the agency's high standards for quality, safety and effectiveness. We know that every time an American, including members of our own families, receives a Covid-19 vaccine dose, you are putting your trust in us," FDA Acting Commissioner Dr. Janet Woodcock told the briefing. The FDA's independent Vaccines and Related Biological Products Advisory Committee did not meet to vote on whether to recommend the expansion of the EUA to 12-to-15-year-olds. But the US Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices is scheduled to meet Wednesday to advise CDC on whether to recommend use of the vaccine in this age group. CDC Director Dr. Rochelle Walensky will then decide whether the agency will recommend the vaccine's use in the new group. Vaccinations for 12-to-15-year-olds are not expected to begin until after that recommendation. The Biden administration has said it will quickly mobilize to ready vaccinations for 12-to-15-year-olds through the federal pharmacy program, pediatricians and family doctors. States make the decision on who gives the vaccines, and when. "It may be that the local pharmacy will not be able to administer because they may not be able to give a vaccine to someone younger than 16 or 17 years of age," Marks said. "And with good reason. A 12-year-old is not the same, emotionally, as an 18-year-old. There is a difference there. So there may be differences from state to state and from location to location."

The FDA does not decide that question, Marks added. "Our authorization is for across all the United States, its territories, so it applies everywhere. It's just who will administer the vaccine may vary from jurisdiction to jurisdiction. We don't regulate the practice of medicine at FDA. We regulate these products. How they are administered may be regulated different in some states in terms of who can give a vaccine to a 12-year-old," added Marks. State licensing boards make these decisions, said Woodcock. "These are the state licensing boards, OK. They have the board of pharmacy, the board of medicine," Woodcock said. "And then there are different criteria under that. And local rules and regulations are what we are talking about. And then they permit the conditions of practice. So the states regulate those conditions of practice." Expanding authorization to people 12 to 15 opens Covid-19 vaccination to another 5% of the US population, nearly 17 million more people. The expanded authorization means 85% of the US population is eligible to receive a Covid-19 vaccine. "The light at the end of the tunnel is growing, and today it got a little brighter," President Joe Biden said in a statement. Pfizer said last week it expects to submit for emergency use authorization for its Covid-19 vaccine for children ages 2 to 11 years old in September. Its vaccine safety and efficacy study in children ages 6 months to 11 years old is ongoing. The FDA also scheduled a meeting of its Vaccines and Related Biological Products Advisory Committee for June 10 to discuss the potential extension of EUA to children under 12.

"During the meeting the agency will provide a status update on our approach to emergency use authorization (EUA) for COVID-19 vaccines intended for use in individuals 12 through 17 years of age," the FDA said in a statement Monday. "The committee will also discuss the data needed to support an EUA and a biologics license application (BLA) for a COVID-19 vaccine intended for use in children less than 12 years of age. The committee will not discuss any specific products," it added. A BLA would mean full FDA approval. Vaccines made by Moderna and by Johnson & Johnson are currently authorized for use in people 18 and older. "We recognize that the next critical step is having vaccines available for use throughout the pediatric population," Marks said in a statement. "As with the initial COVID-19 vaccine authorizations, we want to ensure that the public has a clear understanding of our expectations for the data and information needed to support requests for emergency use authorization and biologics license applications for vaccines intended to prevent COVID-19 in this pediatric age range."

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Moderna Says its Covid-19 Vaccine is Safe and Appears Effective in Adolescents

From www.cnn.com - May 25, 2021 10:15 AM

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.

The company said the vaccine was "generally well tolerated" and that no significant safety concerns were identified. Side effects included headache, fatigue, muscle pain and chills after administration of the second dose. Pain at the injection site was also sometimes observed. Moderna says it plans to submit the results to the US Food and Drug Administration in early June along with a request for authorization to use the vaccine in adolescents. It also plans to submit the data to a peer-reviewed publication. The Moderna vaccine is already authorized for use in people ages 18 and older. After Moderna asks the FDA for emergency use authorization of its vaccine for adolescents, the agency will review data submitted by the company, potentially consulting its advisers. If the data is solid, the FDA will give the vaccine the green light for this vaccine to be used in younger people. The FDA has already expanded the emergency use authorization for Pfizer/BioNTech's Covid-19 vaccine to include people ages 12 to 15 earlier this month. The vaccine had previously been authorized for people ages 16 and older. Because these vaccines have been used safely in adults, vaccine experts said that was a relatively easy process. The Pfizer decision was made without a meeting of the FDA's independent Vaccines and Related Biological Products Advisory Committee. The US Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices met a few days later to recommend use Pfizer's vaccines in adolescents. Both Pfizer and Moderna are currently testing their vaccines in younger children, ages 6 months to 11 years. Because those age groups may require varying doses, the process will likely take a little longer. Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, recently said elementary age children likely won't be vaccinated until the end of the year.

Moderna Press release (May 25, 2021):

https://investors.modernatx.com/news-releases/news-release-details/moderna-announces-teencove-study-its-covid-19-vaccine

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Moderna Says its COVID-19 Vaccine is 96% Effective in Teens - CBS News

From www.cbsnews.com - May 7, 2021 10:56 AM

Drugmaker said Phase 2 trial of its coronavirus vaccine showed promising results in teens 12- to 17-years-old. Moderna's COVID-19 vaccine is 96% effective in teenagers 12- to 17-years-old, the drugmaker said Thursday. The company announced results of the Phase 2 trial in reporting first-quarter earnings. Its vaccine generated $1.7 billion in revenue in its fiscal first quarter.

Evidence that Moderna's vaccine is effective in teens comes as rival Pfizer is expected to receive federal authorization by early next week to use its COVID-19 vaccine in adolescents. Federal approval of one or more vaccines against the disease could enable many American middle and high school students to be vaccinated before the start of the 2021-22 school year. Currently, COVID-19 vaccines are only approved for use in people 16 and older.

Moderna said that its vaccine trial for younger people, which had more than 3,200 participants, included 12 cases that started 14 days after the first dose. The company said no serious side effects were found, although common side effects included pain at the injection site and, after the second dose of vaccine, headache, fatigue, myalgia and chills. The pharmaceutical firm said it's continuing to collect data in the teen trial and "is in discussions with regulators about a potential amendment to its regulatory filings."

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