Dror Or's wife Yonat was killed in the October 7 attack and two of their three children were abducted and then freed in November
mena2 hours ago
What does emergency use of a Covid-19 vaccine mean?
It’s when regulators allow shots to be given to certain people while studies of safety and effectiveness are ongoing.
Before any vaccine is permitted in the US, it must be reviewed by the Food and Drug Administration (FDA), which requires study in thousands of people. Normally, the process to approve a new vaccine can take about a decade. But the federal government is using various methods to dramatically speed up the process for Covid-19 vaccines.
During a health crisis, the FDA can loosen its normal scientific standards to allow emergency use of experimental drugs, devices, vaccines and other medical products. The first vaccines to get the provisional green light in the US are almost certain to be made available under this process, known as emergency use authorisation.
Instead of the usual requirement of “substantial evidence” of safety and effectiveness for approval, the FDA can allow products onto the market as long as their benefits are likely to outweigh their risks. It has already used its emergency powers to authorise hundreds of coronavirus tests and a handful of treatments during the pandemic.
But the agency has almost no experience granting emergency use for vaccines and has laid out extra standards it will use to make decisions on upcoming Covid-19 shots.
In October, FDA officials told vaccine makers they should have two months of safety follow-up from half of the people enrolled in their studies before requesting emergency authorisation. That data is expected to be enough for FDA to allow vaccinations of certain high-risk groups, such as front-line health workers and nursing home residents.
Full approval of a vaccine will likely require six months of safety follow-up as well as extensive inspections of company manufacturing sites. The leading vaccine makers are not expected to complete that process until next spring or summer. Only then is the FDA expected to grant full approval, which would allow vaccinations of the general population.
Dror Or's wife Yonat was killed in the October 7 attack and two of their three children were abducted and then freed in November
mena2 hours ago
Lawyer Deepak Bikram Mishra, who filed a petition urging the court to curtail climbing permits back in 2019, confirmed
world3 hours ago
Foreign ministry says the new curbs on four settlers and two groups follow "unprecedented rise" in settler violence over the past year
world3 hours ago
Heavy rains had been pounding the country since midnight on Thursday, prompting authorities to temporarily suspend the service
uae3 hours ago
Sciences Po university authorities give the group of students 20 minutes to leave before forcible evacuation
world3 hours ago
The attacking midfielder joins a roll call of famous names including Stanley Matthews, Bobby Charlton, George Best and Kenny Dalglish
football3 hours ago
Food establishments that are interested in participating in the programme can submit their registration applications through the programme’s online website
uae3 hours ago
Ibrahim's father had previously made a heartfelt plea for his son's safe return
uae4 hours ago