Sunday, July 25, 2021
ADVT 
Health

What does emergency use of a COVID-19 vaccine mean?

Darpan News Desk The Canadian Press, 20 Nov, 2020 08:10 PM
  • What does emergency use of a COVID-19 vaccine mean?

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 U.S., it must be reviewed by the Food and Drug Administration, 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 U.S. are almost certain to be made available under this process, known as emergency use authorization.

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 authorize 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 authorization. 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.

___

MORE Health ARTICLES

Pfizer issues more promising vaccine results

Pfizer issues more promising vaccine results

Pfizer and its German partner BioNTech just last week estimated the vaccine was more than 90 per cent effective after 94 infections had been counted in a study that included 44,000 people.

Pfizer issues more promising vaccine results

How to embrace Diwali this year

How to embrace Diwali this year

Here are a few steps I hope to follow for the upcoming Diwali, and enjoy this time with my family.

How to embrace Diwali this year

UN: 870K measles cases in 2019, highest number in 23 years

UN: 870K measles cases in 2019, highest number in 23 years

To prevent measles outbreaks, WHO estimates about 95% of the population must be immunized.

UN: 870K measles cases in 2019, highest number in 23 years

News of potential COVID vaccine 'encouraging': PM

News of potential COVID vaccine 'encouraging': PM

The prime minister says news from Pfizer today that one of its vaccine candidates appears very effective in clinical trials is "very encouraging" but won't help anyone who catches the virus in the meantime.

News of potential COVID vaccine 'encouraging': PM

FDA panel urges rejection of experimental Alzheimer's drug

FDA panel urges rejection of experimental Alzheimer's drug

Friday’s meeting follows months of skepticism about the drug, developed by Cambridge, Massachusetts-based Biogen Inc. and Japan’s Eisai Co.

FDA panel urges rejection of experimental Alzheimer's drug

Health Canada approves first HIV self-test

Health Canada approves first HIV self-test

Health Canada granted a medical device licence on Monday to a one-minute, finger-prick blood test manufactured by Richmond, B.C.-based bioLytical Laboratories.

Health Canada approves first HIV self-test

PrevNext