COVID digest: BioNTech-Pfizer submit children's vaccine data

COVID-19 vaccine makers BioNTech and Pfizer have submitted initial trial data for a vaccine to cover 5 to 11 year olds. They plan to make a formal request to US regulators for emergency use.

The US Food and Drug Administration has said it would complete its data review as quickly as possible, with sources saying an authorization of the vaccine for 5-to-11-year-olds could come by the end of October, Reuters reported.

Data from the companies' trial showed the two-shot vaccine generated an immune response in 5 to 11 year old children that matched that of the 16 to 25 year old group, with the safety profile also comparable, Pfizer said.

The drugmakers are now testing the vaccine in children aged 2 to 5 and those aged 6 months to 2 years old, with data expected in the fourth quarter.

Here are the latest major developments on coronavirus around the world:

Europe

Germany reported 11,780 cases and 67 deaths on Wednesday. The total number of cases now stands at 4,215,351 and deaths at 93,571.

Spain will allow fans to fill open-air stadiums up to 100% capacity and indoor facilities up to 80% starting October 1, the Health Ministry said. The move comes as the country has been gradually lifting restrictions, despite a high number of infections.

Fans will still be subject to rules, such as maintaining a social distance of 1.5 meters (4.92 ft) between each other and wearing face masks. Spectators will be allowed to drink water, but not to eat or smoke.

Italy has given the go-ahead for travel to six non-European tourist spots. Italians will be able to travel quarantine-free to the Maldives, Seychelles, Mauritius, Egypt (but only Sharm El Sheikh and Marsa Alam), Dominican Republic and Aruba.

Travelers must have a 'Green Pass' showing COVID immunity - either due to vaccination or previous infection - and must also present a negative swab at least 48 hours before departure, the health ministry said.

The government of Poland said Wednesday that it would send 100,000 doses of AstraZeneca vaccine to Egypt. The Polish Foreign Ministry said the shipment is a "expression of solidarity" towards an "important partner" in North Africa. 

Police in Slovenia on Wednesday cracked down on thousands of protesters who oppose coronavirus restrictions. The demonstrators took to the streets against coronavirus vaccine passes, with police firing tear gas and water cannons in response. 

Slovenia also stopped using the Johnson & Johnson coronavirus vaccine after the death of a 20-year-old woman. She had experienced a serious health condition after receiving the J&J jab.  

The demonstrators at Wednesday's protests held a moment of silence for the young woman. 

Americas

The US booster shot vaccination campaign got off to "a very strong start," White House COVID-19 coordinator Jeff Zients said.

More than 400,000 Americans got BioNTech/Pfizer booster shots last weekend through local pharmacies in the opening days of the vaccine drive.

As many as 25 million people qualify for the third dose of the Pfizer shot, which was authorized last week for those 65 or older, those with pre-existing conditions or facing an elevated risk at their workplace.

Zients said the White House expects an additional 1 million people to have scheduled booster shots for the coming weeks.

The US Centers for Disease Control (CDC) put out a statement on Wednesday urging women who are pregnant, recently pregnant, or trying to get pregnant to get vaccinated. The CDC has said pregnant women are more likely to get severely ill from the virus. 

Whistleblowers in Brazil told the country's senate that a Brazilian hospital chain had tested unproven drugs on elderly COVID-19 patients without their knowledge, as part of an effort to prove President Jair Bolsonaro's preferred 'miracle cure' for the disease.

At least nine people died of COVID-19 during the trials from March to April 2020, but their charts were altered to hide the cause of death, 12 whistleblower doctors said through an attorney.

The company threatened and fired doctors who disagreed with a predetermined "COVID kit" that included hydroxychloroquine, erythromycin and ivermectin, even though there is no scientific evidence that those drugs work against COVID-19.

Asia and Pacific

China said it had fully vaccinated some 1.05 billion people with its COVID-19 vaccine as of September 28, Mi Feng, a spokesperson at China's National Health Commission (NHC), said on Wednesday. The Asian nation has delivered a total of 2.206 billion doses, the NHC data showed.

The government in Australia will wind down emergency funding for people who lost work during COVID-19 shutdowns, as vaccination rates rise. 

Canberra has spent some A$9 billion ($6.5 billion) since June to support around 2 million people affected by the pandemic.

Hamas, the Islamist ruling organization of the Gaza Strip, said Wednesday that unvaccinated government employees who contract the coronavirus will not be eligible for sick pay during their days off from work. A similar policy is also in effect for unvaccinated state employees in the West Bank, which is governed by the Palestinian Authority. 

jcg, wd/rc (Reuters, AP, AFP, dpa)