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Pfizer, BioNTech propose to expand Phase-3 trials for Covid vaccine

Pharma giants Pfizer and BioNtech&nbsp;have urged the US&nbsp;Food and Drug administration department to allow them to expand the Covid-19 vaccine trials.
The 2 companies have suggested to take forward the Phase 3 trials on as many as 40,000 individuals with diverse backgrounds to collect more safety and efficacy data.&nbsp;Currently, both companies in their joint statement claimed&nbsp;that they will complete the trial on 30,000 individuals by next week.
The proposed expansion, if approved, will allow the companies to carry out trials on people as young as 16 and on&nbsp;people with&nbsp;HIV, Hepatitis C, and Hepatitis B.
Meanwhile, both companies&nbsp;are likely to be among the first in the US to report efficacy data from Phase 3 trials; they are expecting a conclusive readout on the efficacy of the vaccine candidate&nbsp;by the end of October.&nbsp;

Pfizer, BioNTech propose to expand Phase-3 trials

Pfizer, BioNTech propose to expand Phase-3 trials USFDA&nbsp;yet to approve expansion proposal for trial Companies&nbsp;want to do trials on 44,000 individuals Individuals from diverse backgrounds to be used Trials to be carried&nbsp;out on young and ailing people

Pharma giants Pfizer and BioNtech&nbsp;have urged the US&nbsp;Food and Drug administration department to allow them to expand the Covid-19 vaccine trials.
The 2 companies have suggested to take forward the Phase 3 trials on as many as 44,000 individuals with diverse backgrounds to collect more safety and efficacy data.&nbsp;Currently, both companies in their joint statement claimed&nbsp;that they will complete the trial on 30,000 individuals by next week.
The proposed expansion, if approved, will allow the companies to carry out trials on people as young as 16 and on&nbsp;people with&nbsp;HIV, Hepatitis C, and Hepatitis B.
Meanwhile, both companies&nbsp;are likely to be among the first in the US to report efficacy data from Phase 3 trials; they are expecting a conclusive readout on the efficacy of the vaccine candidate&nbsp;by the end of October.&nbsp;

Russian vaccine: India ready for human trials & production

Russia has approached India for conducting phase-3 clinical trial and manufacturing of its Covid-19 vaccine Sputnik V by Indian firms

Russia has approached India for conducting phase-3 clinical trial and manufacturing of its Covid-19 vaccine Sputnik V by Indian firms. The Indian govt has said that it is working to facilitate Moscow's request. Niti Aayog member Dr V K Paul, who also chairs the national expert group on Covid-19 vaccine administration, has said that Indian scientists have looked at the data on Sputnik V, which is in the public domain now, and there would be a need for the phase-3 trial. Dr Kaul said that that there has been considerable movement on Russia's request and several Indian companies are currently studying the proposal.

New Delhi, PTI: India is considering Russia's request for conducting phase-3 clinical trial and manufacturing of its Covid-19 vaccine Sputnik V by Indian firms, officials said Tuesday. There has been "significant movement" on both these fronts and specific outcomes are expected soon.
Dr V K Paul, Member (Health) Niti Aayog, who also chairs the national expert group on Covid-19 vaccine administration, said the government attaches "great importance to this offer of partnership from a very special friend to this nation".
He said that Indian scientists have looked at the data on Sputnik V, which is in the public domain now, and there would be a need for the phase -3 trial.
&ldquo;We are paving way for such a phase-3 trial or bridging studies, as per requirements of the regulatory system, to be facilitated by the government of India," he told a press conference here.
The Russian government has approached the government of India through appropriate channels to consider the manufacturing of Sputnik V through Indian companies and also conducting its phase-3 clinical trials here, Paul said.
"On both the tracks there has been significant movement,&rdquo; he said.
Several Indian companies are currently studying the proposal, he said.
"The outreach has been extended to several companies in India and a few of them have come forward while others are in discussions with the Russian counterparts and the government is facilitating that process of how that connect can be made. And there may be specific outcomes very soon in that regard," Paul said.
It is a "win-win situation" for India and the world, he said, underlining the county's ability to manufacture high quality vaccine in large and significant quantities.
It is good for Russia, good for India, and also excess capacities or specific part of the capacities can be offered to the rest of the world, he said.
Sputnik V has been developed by Russia's Gamaleya Research Institute of Epidemiology and Microbiology, along with the Russian Direct Investment Fund (RDIF). The vaccine has not been tested in phase-3 or larger clinical trials.

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