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EU regulator backs wider use of AstraZeneca COVID therapy

This photo shows a general view of the offices of British-Swedish multinational pharmaceutical and biopharmaceutical company AstraZeneca PLC in Macclesfield, Cheshire on July 21, 2020. (PAUL ELLIS / AFP)

JOHANNESBURG / BERLIN / LOS ANGELES / LONDON – Europe's medicines regulator has backed using AstraZeneca's preventative COVID-19 therapy as a treatment for the disease and also endorsed another medicine as preventative option for another common virus.

The regulator's recommendations are usually followed by the European Commission when it takes a final decision on drug approvals.

AstraZeneca said on Friday the European Medicines Agency had backed Evusheld as a treatment for adults and adolescents with COVID who do not need supplemental oxygen and who are at increased risk of their disease worsening.

Last month, Japan became the first country to approve the long-acting antibody as a treatment for COVID – making Evusheld the first such therapy authorised for both prevention and treatment of the viral disease.

Evusheld had previously had largely secured global approvals, including in Europe, as a preventative therapy for people with compromised immune systems who see little or no benefit from COVID vaccines.

AstraZeneca is leaning on Evusheld to help offset tepid sales of its COVID vaccine that has rapidly lost ground to mRNA shots in the fight against the rapidly evolving virus.

A doctor vaccinates a student with the Moderna COVID-19 vaccine as part of the vaccination campaign called '#HierWirdGeimpft', #Here We Vaccinate, during a visit of German President Frank-Walter Steinmeier (not in frame) at Ruth Cohn School in Berlin, Germany, Sept 13, 2021. (MARKUS SCHREIBER / AP)

Germany

Demand for booster vaccinations against COVID-19 is low in Germany, the association of general practitioners said on Thursday, with some patients waiting for a booster designed to combat the currently circulating Omicron BA.4/5 subvariants.

General practitioners were supplied at the start of the week with the booster vaccine directed at the BA.1 version of Omicron and the original virus first detected in China, said Jens Lassen, chairman of their Schleswig-Holstein association.

"We haven't seen a big jump in demand in the few days we've been vaccinating BA.1," Lassen told reporters in Berlin.

There were definitely patients waiting for a vaccine developed by Pfizer and BioNtech against the BA.4 and BA.5 variants, he said.

This updated vaccine could be ordered from next week, Lassen said, adding: "We wouldn't be surprised if demand increased."

The European Medicines Agency (EMA) on Monday recommended the COVID-19 booster designed to combat the Omicron BA.4/5 subvariants, days after endorsing a pair of boosters tailored to target the older BA.1 Omicron variant.

A nurse working in a dental department receives a dose of Johnson & Johnson's COVID-19 vaccine at a vaccination center at Chris Hani Baragwanath Academic Hospital in Johannesburg, South Africa, March 26, 2021. (THEMBA HADEBE / AP)

South Africa

The National Health Department on Thursday confirmed the detection of a new sub-variant of COVID-19 Omicron called BA.2.75 but said that the new sub-variant has not had any impact at present.

Health department spokesperson Foster Mohale said that this sub-variant was first detected in July in one sample in Gauteng and since then, it was yet to be detected in other areas again.

"It is of interest, and not of concern. Thus, it has not had any impact and severity as compared to the dominant sub-variants BA.4 and BA.5," Mohale said.

Mohale told Xinhua that BA.4 and BA.5 continued to be the most dominant sub-variants in South Africa but they were less severe due to higher levels of immunity. The department called on the public not to panic.

With South Africa having lifted all major COVID-19 lockdown restrictions as new cases continued declining, the health department, however, said the pandemic was not over.

Mohale encouraged those who remained unvaccinated to get the vaccines and receive booster shots to protect themselves. More than 50 percent of the population in South Africa has been vaccinated.

A 6 year-old child is comforted by her mother as she receives her first dose of the Pfizer-BioNTech COVID-19 vaccine by a medical assistant at the Child Health Associates office in Novi, Michigan on Nov 3, 2021. (JEFF KOWALSKY / AFP)

US

Over 14.6 million children in the United States have tested positive for COVID-19 since the onset of the pandemic, according to the latest report by the American Academy of Pediatrics (AAP) and the Children's Hospital Association.

Over 340,000 of these cases have been added in the past four weeks. Approximately 6.7 million reported cases have been added in 2022, according to the report.

For the week ending Sept. 8, about 83,300 child COVID-19 cases were reported, but the reported cases are likely a "substantial undercount" of COVID-19 cases, according to the report.

There is an urgent need to collect more age-specific data to assess the severity of illness related to new variants as well as potential longer-term effects, said the AAP.

"It is important to recognize there are immediate effects of the pandemic on children's health, but importantly we need to identify and address the long-lasting impacts on the physical, mental, and social well-being of this generation of children and youth," said the AAP.