Friday, March 29, 2024
spot_img

Regulators, experts take up thorny vaccine study issues

Date:

Share post:

spot_img
spot_img

The US regulators who will decide the fate of COVID-19 vaccines are taking an unusual step: Asking outside scientists if their standards are high enough.
The Food and Drug Administration may have to decide by year’s end whether to allow use of the first vaccines against the virus. Thursday, a federal advisory committee pulls back the curtain on that decision process, debating whether the guidelines FDA has set for vaccine developers are rigorous enough.
We will not cut corners, and we will only use science and data to make that determination, FDA Commissioner Stephen Hahn pledged at a meeting of the Milken Institute Wednesday.
Exactly how much data his agency needs to be sure a vaccine is safe and effective is a key question for the advisers. An even bigger one: If the FDA allows emergency use of a vaccine before final testing is finished, will that destroy chances of ever learning just how well that shot — and maybe competitors still being studied — really work?
We can’t lose sight of the fact that it is in our societal interest to see these trials to completion, said Dr. Luciana Borio, a former FDA acting chief scientist who will be watching the advisers’ debate.
Plus, multiple vaccines are being studied — shots made with different technologies that each have pros and cons.
The first vaccine is not necessarily the best vaccine, cautioned Dr M. Miles Braun, a former FDA scientist now with Georgetown University School of Medicine. If the trials aren’t allowed to finish, it may be difficult or impossible to ever know for sure. (AP)

spot_img
spot_img

Related articles

Bird flu outbreak reported at Bulgarian farm

Shillong, March 29: The Bulgarian Food Safety Agency (BFSA) has reported an outbreak of the highly pathogenic bird...

Punjab Police bust criminal network led by US-based gang

Shillong, March 29: In a major breakthrough, the Punjab Police on Friday said they have dismantled the criminal...

Security beefed up ahead of INDIA bloc protest in Delhi

Shillong, March 29: Following a protest call by the INDIA bloc, security measures have been intensified on the...

Mukhtar Ansari’s death: Oppn in Uttar Pradesh seeks high-level probe

Shillong, March 29: Opposition parties in Uttar Pradesh are demanding a high-level probe into the death of jailed...