Tag Archives: robust antibody responses

U.S. CDC panel backs COVID-19 vaccine now cleared for adolescents

By Michael Erman and Manojna Maddipatla

(Reuters) -U.S. states are set to begin using the vaccine from Pfizer Inc and BioNTech SE to inoculate younger adolescents against COVID-19 after advisers to the U.S. Centers for Disease Control and Prevention (CDC) backed the plan in a unanimous vote on Wednesday.

The U.S. Food and Drug Administration on Monday authorized the vaccine for children aged 12 to 15, offering relief to parents eager to get their children back to schools and summer camps, and the action by the CDC group is an important, but not required, final seal of federal regulatory approval.

Some states, including Georgia, Delaware and Arkansas, began offering the vaccine to younger teens on Tuesday.

The Advisory Committee on Immunization Practices (ACIP), which provides recommendations to the CDC, voted 14-0 to back the vaccine, after reviewing trial evidence that showed no one in the 12-15 age group who received the vaccine got COVID-19, and there were no cases of Bell’s Palsy or severe allergic reactions.

Moreover, the vaccine produced robust antibody responses in the age group and showed 100% efficacy in the trial, with no cases of symptomatic COVID-19 among the fully vaccinated adolescents.

“This will provide protection for 12 to 15 year old’s,” said Dr. Henry Bernstein, a member of the advisory committee and professor of pediatrics at Zucker School of Medicine at Hofstra/Northwell. “It will decrease transmission within their family. It will contribute to community immunity, and it allows the kids to more safely go back to camps this summer, and back for in-person school.”

About a third of all Americans have been fully-vaccinated according to the CDC data. But the pace of vaccination has slowed in the recent weeks.

The rollout of a vaccine for adolescents should help further limit the spread of the virus at a time when more contagious variants are circulating, and could shorten the road to normalcy for Americans.

“I think we should be in full school, full in-person school, in the fall,” CDC Director Rochelle Walensky said at a CNBC health summit on Tuesday.

Children have been considered by health officials as being at a lower risk for severe COVID-19, but they can still spread the virus. More than 1.5 million cases have been reported among 12- to 17-year-olds, and as more adults become vaccinated, adolescents are accounting for a higher proportion of total cases.

Adjusted for underreporting, the working group estimated 22.2 million U.S. COVID-19 infections in those aged 5 to 17.

Pfizer is running a separate trial testing the vaccine in children as young as 6-months-old, and has said it expects data on its use in 2- to 11-year-olds in September. The 2,260 participants in the 12-to-15 age group – half of whom were given placebo – were tested as an expansion of Pfizer’s more than 46,000-person trial.

The committee will hear from Pfizer about the vaccine’s safety and efficacy in adolescents and will consider the views of a handful of CDC officials on its implementation.

(Reporting by Manojna Maddipatla in Bengaluru; Editing by Caroline Humer, Peter Henderson and Bill Berkrot)

U.S. FDA set to authorize Pfizer COVID-19 shot for ages 12-15 early next week – NYT

(Reuters) – The U.S. Food and Drug Administration is preparing to authorize Pfizer Inc and German partner BioNTech SE’s COVID-19 vaccine for adolescents aged between 12 and 15 years by early next week, the New York Times reported on Monday, citing federal officials familiar with the agency’s plans.

An approval is highly anticipated after the drugmakers said in March that the vaccine was found to be safe, effective and produced robust antibody responses in 12- to 15-year-olds in a clinical trial.

Responding to a Reuters request for comment, the FDA said its review of expanding the vaccine’s emergency use authorization is ongoing, but did not provide further details.

The vaccine has already been cleared in the United States for people aged 16 and above.

Pfizer declined to comment on the NYT report.

The U.S. Centers for Disease Control (CDC) Director Rochelle Walensky said earlier in April that the vaccine could be approved by mid-May.

If an approval for the 12-15 year old’s is granted, the CDC’s vaccine advisory panel will likely meet the following day to review the clinical trial data and make recommendations for the vaccine’s use in adolescents, the report added.

A potential approval of the vaccine would boost the country’s immunization drive and help allay fears of parents anxious to protect their children from COVID-19.

Moderna Inc and Johnson & Johnson are also testing their vaccines in 12- to 18-year old’s, with data from Moderna’s trial expected to come soon.

Pfizer and Moderna have also launched trials in even younger children, aged six months to 11 years old. Both companies have said they hope to be able to vaccinate children under 11 as soon as early 2022.

(Reporting by Trisha Roy in Bengaluru; Editing by Devika Syamnath)