Monoclonal antibodies are targeted towards countering a specific antigen, which is nothing but a foreign element that the immune system recognises to be a threat
India’s Central Drugs Standards Control Organisation cleared the use of the antibody cocktail for use in emergency situations for treatment of COVID-19, here’s a quick lowdown on how it can help patients
Drug regulator says no need for bridging trials on foreign approved vaccines before India roll out
DCGI modifies earlier order on emergency approval of well-established vaccines, waives several requirements, but retains assessment of first 100 beneficiaries before proper roll out.
Himani Chandna 2 June, 2021 10:32 am IST Text Size:
A+
New Delhi: The country’s apex drug regulator Tuesday announced it was waiving off the requirement of conducting post-approval bridging trials in India for well-established vaccines as well as testing each batch of vaccines at the Central Drugs Laboratory (CDL) in Kasauli.
The Drugs Controller General of India (DCGI)’s decision to make these exemptions for all “well established” vaccines was made from the standpoint “that millions of individuals have already been vaccinated”.
The monoclonal antibodies treatment therapy which was used in COVID treatment of former US President Donald Trump and is now known as Trump Cocktail therapy
REGEN–COV a combination of two monoclonal antibodies, casirivimab and imdevimab was found to reduce the risk of hospitalization and death, reduced the duration of symptoms, in outpatients.