Germany’s COVID-19 jab panel: One shot enough for children

A child receives a dose of the COVID-19 Pfizer / Biontech vaccine for children aged 5-11 in the Sofiamed hospital in Sofia on Dec 22, 2021. (NIKOLAY DOYCHINOV / AFP)

ADDIS ABABA / WASHINGTON / GENEVA – FRANKFURT – Germany's vaccine advisory panel on Tuesday said one COVID-19 shot was enough for healthy five to 11 year-olds because most of them had already undergone an infection, be it known of undetected.

The view by the panel of 18 appointees known as STIKO contrasts with approval by European Union regulators for a two-shot regimen in that age group. US regulators last week even authorized a third, or booster shot for the group. 

"For children we have to assume that the rate of spreading of the infection is the highest. That's why it's reasonable to administer only one vaccination," STIKO panel member Martin Terhardt told a media briefing.

The expert panel's previous view on the age group, published in December, was to limit vaccinations to those at risk of developing severe COVID-19 or those living with an at-risk person, drawing criticism at the time for not keeping up with the of pace of the coronavirus. 

Children at risk of developing severe COVID-19 should get three shots and those living with an at-risk person should get two, the expert group added on Tuesday.

It did not highlight any disadvantages of giving more shots. Instead it said the risk of heart inflammation from a vaccination appeared to be markedly lower for younger children than in youngsters above 12 years or young adults.

An estimated 77.5 percent of five to 11 year olds in Germany had already had acquired some immunity against the virus either through known and undetected infections or via vaccination, the panel said in a document posted online.

Health workers register residents at a COVID-19 testing station in the Richmond suburb of Johannesburg, South Africa, on Feb 10, 2021. (PHOTO / BLOOMBERG)

Africa

The African continent reported 10,297 newly confirmed COVID-19 cases during the past 24 hours, the Africa Center for Disease Control and Prevention said Monday evening.

Figures from the Africa CDC showed that the number of confirmed COVID-19 cases across the continent rose from 11,596,707 Sunday to 11,607,004 as of Monday.

The death toll from the COVID-19 pandemic on the African continent has reached 252,915 while 10,949,245 people who have been infected with the disease have recovered, the specialized healthcare agency of the African Union said.

South Africa, Morocco, Tunisia and Egypt are among the countries with the most cases in the continent, according to the agency.

South Africa has recorded the most COVID-19 cases in Africa with 3,929,872 cases, while the northern African countries of Morocco and Tunisia reported 1,166,628 and 1,041,789 cases respectively, according to the agency.

In terms of the caseload, southern Africa is the most affected region, followed by the northern and eastern parts of the continent, while central Africa is the least affected region in the continent, according to the Africa CDC.

In this file photo taken on Dec 8, 2020, a member of staff draws the Pfizer-BioNTech COVID-19 vaccine out of a vial at the Southmead Hospital, Briston. (GRAEME ROBERTSON / AFP / POOL)

Pfizer

Drugmakers Pfizer Inc and BioNTech SE said on Monday that three doses of their COVID-19 vaccine generated a strong immune response in children under age 5 and was safe and well-tolerated in their clinical trial.

Pfizer and BioNTech said final efficacy data in the age group will be made public when it is available

The companies said they plan to soon ask global regulators to authorize the shot for the age group, children for whom no vaccine is currently approved in most of the world. They said they expect to complete their submission of data to the US Food and Drug Administration this week.

The clinical trial involved giving 1,678 children ages 6 months to under 5 years smaller doses of the vaccine than given to older children and adults. Pfizer and BioNTech said that three shots of a 3 microgram formulation of their vaccine generated a similar immune response in that age group as in 16 to 25-year-olds who had received two doses of the 30 microgram formulation of the vaccine in an earlier clinical trial.

"The study suggests that a low 3-microgram dose of our vaccine, carefully selected based on tolerability data, provides young children with a high level of protection against the recent COVID-19 strains," BioNTech Chief Executive Ugur Sahin said in a statement.

Rival vaccine maker Moderna Inc released trial data in March showing that its vaccine was safe and generated a similar immune response in young children as for adults.

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New York-based Pfizer Inc and Germany-based said that an early analysis of 10 symptomatic COVID-19 cases identified through April 29, while the Omicron variant was dominant, suggested a vaccine efficacy of 80.3 percent in the under-5 age group. This analysis was not conclusive, as the trial's protocol specified that efficacy should be calculated based on at least 21 cases.

Pfizer and BioNTech said final efficacy data in the age group will be made public when it is available.

The drugmakers had previously tested two doses of the 3 microgram vaccine in the children. But the two-dose trial failed to meet its primary endpoint after results for children ages 2 to 4 showed a weaker immune response than in adults.

The trial participants received their third dose at least two months after their second shot. Pfizer said the vaccine was well tolerated, with most adverse side effects being mild or moderate.

The Pfizer/BioNTech shot is currently authorized for use in all Americans ages 5 and older. Children ages 5 to 11 receive two 10 microgram doses as their primary course, while people aged 12 and older receive two 30 microgram doses.

It was not clear how many American parents will vaccinate their children in the age group. Only 29 percent of American children ages 5 to 11 are fully vaccinated, and COVID-19 is generally more mild in children than adults.

US regulators are already preparing to review the data in younger children as well as data submitted by Moderna for children under age 6. The FDA said on Monday that a committee of its external advisors will meet on June 15 in order to consider the use of the two vaccines in the youngest children.

Moderna has said two 25 microgram shots of its vaccine were around 37 percent effective in preventing infections in children ages 2 to 5 and 51 percent effective for children ages 6 months to 2 years.

WHO

The head of the World Health Organization reiterated here on Monday that the COVID-19 pandemic "is far from over."

"As I said yesterday, the pandemic is far from over. And even as we continue to fight it, we face the task of restoring essential health services, with 90 percent of member states reporting disruption to one or more essential health services," said WHO Director-General Tedros Adhanom Ghebreyesus.

Addressing the 75th World Health Assembly, Ghebreyesus said the COVID-19 pandemic had demonstrated why the world needed the WHO.

"We need a stronger and sustainably financed WHO, at the center of the global health security architecture," he said at the annual assembly.

US

The US Food and Drug Administration set June 14-15 as the new meeting date to review Moderna Inc's emergency authorization request for its COVID-19 vaccine for children aged 6 months to 5 years and Pfizer Inc's vaccine for those aged 6 months through 4 years.

The new dates for our pediatric COVID-19 vaccine advisory committee meetings will now be June 14 and June 15, the FDA said in a statement Monday.

"We know parents are anxious for us to determine if these vaccines are safe & effective. In light of the disclosure by Pfizer re: their data & anticipated dates for submission, we believe that we will complete review of both EUA requests within days of one another," it said.

The June 14 meeting will consider Moderna's emergency use authorization request for youth aged six to 17 years, the FDA said.

Meanwhile, more than 107,000 child COVID-19 cases were reported in the United States during the past week, up by about 72 percent from two weeks ago, according to the latest report by the American Academy of Pediatrics and the Children's Hospital Association.

It marks the sixth consecutive weekly increase in child COVID-19 cases in the United States, said the report published on Monday.

Almost 13.3 million children have tested positive for COVID-19 since the onset of the pandemic in the country with over 316,000 of them detected in the past four weeks, according to the report.

Nearly 5.4 million child COVID-19 cases have been reported nationwide so far in 2022.