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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;

Serum India told to halt recruitment for vaccine trials

India's drug regulator has directed Serum Institute of India to suspend recruitment of new volunteers for phase 2 and 3 clinical trials of the Oxford Covid-19 vaccine candidate

India's drug regulator has directed Serum Institute of India to suspend recruitment of new volunteers for phase 2 and 3 clinical trials of the Oxford Covid-19 vaccine candidate. The directive came in the backdrop of pharma giant AstraZeneca pausing the trials in other countries. The DCGI on Friday also directed Serum Institute to increase the safety monitoring of the subjects already vaccinated as part of the trial, and submit the plan and report. The drugmaker&nbsp;had on Thursday hit a pause after AstraZeneca put the trials on hold following an unexplained illness in a volunteer in the UK.

New Delhi, PTI: Drugs Controller General of India (DCGI) has directed Serum Institute of India to suspend till further orders new recruitment in phase 2 and 3 clinical trials of the Oxford Covid-19 vaccine candidate in the backdrop of pharma giant AstraZeneca pausing the trials in other countries.
In an order, a copy of which has been accessed by PTI, DCGI Dr V G Somani on Friday also directed Serum Institute of India (SII) to increase the safety monitoring of the subjects already vaccinated as part of the trial, and submit the plan and report.
Somani also asked the firm to submit clearance from Data and Safety Monitoring Board (DSMB) in the UK as well as in India to obtain clearance from his office (DCGI) prior to resumption of future recruitment in the trial. The central drug regulator DCGI had issued a show-cause notice to SII on September 9 for not informing it about AstraZeneca pausing clinical trials of the vaccine candidate in other countries and also for not submitting casualty analysis of the "reported serious adverse events".
Following which the Pune-based firm, which has partnered with the British-Swedish biopharmaceutical giant AstraZeneca for manufacturing the Oxford vaccine candidate, on Thursday said it is pausing the clinical trials in India.
Earlier this week, AstraZeneca said it had paused the trials because of 'an unexplained illness' in a participant in the study. "We are reviewing the situation and pausing India trials till AstraZeneca restarts the trials," SII said in a statement on Thursday. According to the DCGI's order issued on Friday, the SII in its reply stated that DSMB has noted no safety concerns from the Indian study (part 1-phase-2 study) with the first dose and seven days post vaccination safety data. In its reply, SII also stated that DSMB further recommended "to pause further enrolment into the study until ongoing investigations of SAE reported in the UK study is completed and the sponsor and the UK DSMB are satisfied that it doesn't pose any safety concerns".
"In the view of the above, I Dr V G Somani, Drugs Controller General of India, Central Licensing Authority, after careful examination of your reply and the recommendations of the DSMB in India, in exercise of the powers vested under Rule 30 of the New Drugs and Clinical Trials Rules, 2019, direct to you suspend any new recruitment in the phase 2 and 3 clinical trial till further orders," the order read.
"Increase the safety monitoring of the subjects already vaccinated with the vaccine under trial and submit the plan and report," the order further stated.

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.

India mulls phase 3 trial of Russia's vaccine this month

Russia shares 'comprehensive data' of Sputnik V vaccine's clinical trials with India, experts say Phase 3 trials could be held in India

Russia shares Sputnik V clinical trial data with India

After the medical journal 'The Lancet' published the outcome of Phase-1 and Phase-2 clinical trial data of Russia's potential Covid-19 shot Sputnik V, Moscow has now shared the 'comprehensive data' on the vaccine&rsquo;s safety with Indian authorities. India is now 'deeply engaged' with Russia on the vaccine and the&nbsp;Indian experts feel that with the&nbsp;comprehensive data, Phase 3 clinical trials can be an option, the Indian Express reported quoting sources. While the production of the vaccine is expected to start in September itself, Russia claims that at least 20 countries including India have expressed interest in obtaining Sputnik V. The Russian Ambassador to India, Nikolai Kudashev&nbsp;also&nbsp;formally reached out to India last month, seeking a partnership in the production of Sputnik V.&nbsp;

After medical journal 'The Lancet' published the outcome of Phase-1 and Phase-2 clinical trial data of Russia's potential Covid-19 shot Sputnik V, Russia has now shared the 'comprehensive data' on the vaccine&rsquo;s safety with Indian authorities.
The Indian Express reported, that had asked for these details from the Gamaleya Research Institute of Epidemiology and Microbiology based in Moscow. The report added, that India is now 'deeply engaged' with Russia on the vaccine. With this comprehensive data, Indian experts feel conducting Phase 3 clinical trials is an option that's on the table.
The vaccine induced a "strong" immune response in Phase 1 and Phase 2 clinical trials on 76 individuals. Russia aims to conduct Phase 3 clinical trials in several countries, including Saudi Arabia, UAE and Brazil.
Russian Ambassador to India, Nikolai Kudashev, formally reached out to India last month, seeking a partnership in the production of Sputnik V, says reports.

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