U.S. FDA may authorize COVID-19 vaccine for kids based on two months of safety data

[Yo_Mama_Been_Loggin]

(Reuters) -U.S. heath regulators said children in clinical trials testing COVID-19 vaccines should be monitored for at least two months for side effects, suggesting that the agency is considering a quicker path to authorize the shot for emergency use than full approval.

The U.S. Food and Drug Administration said on Friday it was looking to complete the data review as quickly as possible, likely in a matter of weeks rather than months.

The FDA granted full approval last month for the use of Pfizer Inc's vaccine in people over the age of 16 based on a six-month follow-up from the trial. The shot was authorized in December for emergency use based on a shorter, two-month follow up.

The agency is under pressure to approve a vaccine for children below 12 years of age amid a surge in infections fueled by the spread of the Delta coronavirus variant, which has disrupted the reopening of schools.

https://www.msn.com/en-us/news/us/us-fda-may-authorize-covid-19-vaccine-for-kids-based-on-two-months-of-safety-data/ar-AAOiKL0

[CaliforniaPeggy]

1. The situation calls for cautious steps forward, to protect the kids.

I think this is exactly what the FDA is doing, and that means the vaccine for younger children will most likely be approved in a matter of weeks.

[dsp3000]

2. The 2-5 year old can't come soon enough

Nervous as hell sending my kids to daycare

[CaliforniaPeggy]

3. I fully understand where you're coming from! It should be this year. n/t

[hlthe2b]

4. The risk:benefit calculation has changed dramatically with Delta variant. Two months of safety data

--along with all the combined data we have from adults and adolescents-- will undoubtedly weigh heavily towards approval--given the dramatic increase in hospitalized children and adverse outcomes.

Had we still been dealing with the original SARS-COV-2 virus or the alpha strain--with low rates of child hospitalization and severe outcomes, the equation might not be so highly tilted towards emergency authorization with two-months specific safety data.

[LisaL]

5. Very true.

Delta is so much more infectious, and many more children are affected by it.