U.S. FDA staff say Moderna did not meet all criteria for COVID-19 boosters

Scientists at the U.S. Food and Drug Administration said on Tuesday that Moderna Inc had not met all of the agency’s criteria to support use of booster doses of its COVID-19 vaccine, possibly because the efficacy of the shot’s first two doses has remained strong.

FDA staff said in documents that data for Moderna’s vaccine showed that a booster does increase protective antibodies, but the difference in antibody levels before and after the shot was not wide enough, particularly in those whose levels had remained high. read more

Data suggests mRNA booster dose generates stronger antibody response after J&J shot – Axios

People who received Johnson & Johnson’s COVID-19 vaccine will have a stronger neutralizing antibody response if they get an mRNA shot as the second dose, Axios reported on Tuesday, citing a person who has seen data collected by the U.S. National Institutes of Health (NIH). The NIH will present the mix-and-match data to the FDA panel on Friday, Axios said.

J&J has asked the U.S. Food and Drug Administration (FDA) to approve a shot of its own single-dose vaccine as the booster dose. The FDA’s advisers are set to consider the need on Friday. There were limitations to the NIH data, according to the report. Neutralizing antibodies only prevent the virus from entering cells and replicating, and the report said it was unclear how long the response would last. read more

South Korea launches panel to debate ‘living with COVID-19

South Korea established a panel on Wednesday to debate a strategy on how to “live with COVID-19” in the long-term, as it seeks to phase out coronavirus restrictions and reopen the economy as vaccination levels rise.

Under the strategy, the government aims to relax coronavirus restrictions for citizens who can prove they have been fully vaccinated, while encouraging asymptomatic and mild COVID-19 patients aged below 70 to recover at home, the health ministry said. The government will also focus on the number of hospitalisations and deaths rather than new daily infections, and will consider not publishing the latter on a daily basis, Yonhap news agency has reported. read more

COVID-19 curbs in Sydney could ease early

New South Wales could ease more restrictions in Sydney a week earlier than planned on Oct. 18 as Australia’s most populous state races towards its 80% double-dose vaccination target, the government said on Wednesday.

The state is expected to hit the mark over the weekend, beating forecasts, and officials previously promised to relax more restrictions on vaccinated residents on the first Monday after reaching that milestone. Shops, pubs and gyms can welcome more vaccinated customers when inoculation reaches 80%. Masks will not be required in offices and nightclubs can reopen for seated drinking, while weddings can have unlimited guests. read more

New York must allow religious exemptions to vaccine mandate, judge rules

A federal judge ruled on Tuesday that New York state cannot impose a COVID-19 vaccine mandate on healthcare workers without allowing their employers to consider religious exemption requests.

The ruling provides a test case as vaccine mandate opponents gear up to fight plans by President Joe Biden’s administration to extend COVID-19 inoculation requirements to tens of millions of unvaccinated Americans.



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