US FDA back virus shots for children as young as 6 mths

Food and Drug Administration building is shown Thursday, Dec 10, 2020 in Silver Spring, Md. (MANUEL BALCE CENETA / AP)

SAO PAULO / FRANKFURT / BERLIN  / YAOUNDE – Advisers to the US Food and Drug Administration on Wednesday unanimously recommended the agency authorize COVID-19 vaccines from Moderna Inc and Pfizer Inc/BioNTech SE for millions of the youngest American children.

The Pfizer/BioNTech vaccine was authorized for children ages 5 to 11 in October, but only about 29 percent of that group is fully vaccinated

The committee's recommendation is an important step toward immunizing children under the age of 5 and as young as 6 months old who have not yet been eligible for the shots.

The FDA is likely to authorize the shots soon. The US government is planning for a June 21 start to its under-5 vaccination campaign should the vaccines receive FDA authorization, White House COVID-19 response coordinator Ashish Jha said last week.

ALSO READ: EU states add pressure on Pfizer to cut unneeded vaccine supplies

COVID-19 is generally more mild in children than adults, but FDA officials told the panel that the number of US COVID-19 deaths so far in small children – roughly 442 under age 5 – "compared terribly" to the 78 deaths reported during the swine flu pandemic of 2019-2010.

Once the FDA authorizes the vaccines for the age group – 6 months to 4 years old for Pfizer/BioNTech and 6 months to 5 years old for Moderna – the US Centers for Disease Control and Prevention will make its recommendations on use of the shots in young children. A committee of the CDC's outside advisers is scheduled to meet on Friday and Saturday.

While many American parents are eager to vaccinate their children, its unclear how strong the demand will be for the shots. The Pfizer/BioNTech vaccine was authorized for children ages 5 to 11 in October, but only about 29 percent of that group is fully vaccinated.

A health worker poses with a syringe with dose of a COVID-19 vaccine at the Museum of Tomorrow where adults and children between the ages of five and eleven are being vaccinated against the novel coronavirus, in Rio de Janeiro on Jan 18, 2022. (CARL DE SOUZA / AFP)


COVID-19 cases in the Americas jumped 11 percent last week from the previous one, with 1.2 million new cases and 4,069 new deaths, the Pan American Health Organization said at a news conference on Wednesday.

Of the 34 countries and territories in the Americas with available data, COVID-19 hospitalizations increased in 15 of them over the last week, and ICU admissions rose in 10 countries and territories, PAHO Director Dr. Carissa Etienne said

South America saw the biggest rise in cases, with a 20 percent jump, while Central America saw a 32 percent decrease in new cases and deaths, PAHO said. Central America had the highest increase in COVID-related deaths in PAHO's last report on June 1. 

The US saw a 2 percent increase in hospitalizations and a 4.2 percent rise in ICU admissions for the seventh week in a row. Mexico reported over 31,000 cases, a 71 percent increase, PAHO Director Dr. Carissa Etienne said.

In the Caribbean, cases rose by 3.7 percent, while deaths decreased by 19 percent compared to the previous week. In the 22 countries and territories with available data in the Americas, nine countries reported increases in COVID-19 hospitalizations, Etienne said.

Of the 34 countries and territories in the Americas with available data, COVID-19 hospitalizations increased in 15 of them over the last week, and ICU admissions rose in 10 countries and territories, she said.

"Our health systems are coping because the majority of people in the Americas are vaccinated against the virus, and better protected against severe disease and death," Etienne said.

"However, too many people remain unvaccinated and they are at much greater risk of needing a hospital bed or even dying from COVID-19."


Cameroon on Wednesday effectively started charging for polymerase chain reaction COVID-19 test, according to the country's Minister of Public Health Malachie Manaouda.

Manaouda said Tuesday that the test will now cost 30,000 xaf (approximately $48).

Payment will be effected through a platform for the dematerialization of public receipts, but also on physical sites allowing the generation of a unique code and a receipt, he said.

The officials did not explain why the test that was previously free of charge will now be paid for.

In this Feb 02, 2021 photo, a health worker holds a vial with the Pfizer-BioNTech COVID-19 vaccine against the novel coronavirus at the vaccination center in Freising, southern Germany, on Feb 2, 2021. (Christof STACHE / AFP)


The European Medicines Agency on Wednesday launched a rolling review of a variant-adapted COVID-19 vaccine developed by Pfizer and BioNTech, as cases of new sub-variants of the coronavirus's Omicron lineage are on the rise.

When available, clinical trial data will be added to the rolling submission, which is designed to speed up any approval, BioNTech and Pfizer said in a joint statement.

The pair added they would also begin submitting data on the planned variant-adapted vaccine to the US Food and Drug Administration over the next few weeks.

"The rolling review will continue until there is enough data for a formal application," the EU regulator said in a separate statement.

The companies said they were still working on several variant-adapted vaccines and the final composition was subject to discussions with regulators.

In this file photo taken on April 16, 2021,
a doctor (2nd right) takes a swab sample from a man to test for COVID-19 at a testing station inside a pub in Berlin’s Friedrichshain district. (TOBIAS SCHWARZ / AFP)


Germany's Minister of Health Karl Lauterbach expressed his concern Wednesday about the current increase in COVID-19 infections, warning that a summer wave has started.

"The announced summer wave has unfortunately become a reality. This also means little relief for the next few weeks," Lauterbach told the Rheinische Post newspaper.

The nationwide seven-day incidence rate per 100,000 inhabitants rose to 472.4 on Wednesday, almost twice as high as a week ago, according to the Robert Koch Institute for infectious diseases.

For the first time since April, daily COVID-19 infections in Germany exceeded 100,000 on Tuesday, according to the RKI.

The new surge is largely attributed to the two more contagious Omicron subvariants, BA.5 and BA.4. Within a week, the share of BA.5 in Germany doubled to 10 percent, according to the RKI's latest weekly report.

Lauterbach encouraged the elderly and vulnerable people to take booster vaccinations, which can prevent severe symptoms even if they do not necessarily prevent infections.