Bharat Biotech asked to submit complete phase 2 data of its Covid-19 vaccine before phase 3 trial
NEW DELHI: Bharat Biotech, which had sought DCGI’s nod for conducting phase-3 clinical trials of its Covid-19 vaccine candidate, has been asked to submit complete safety and immunogenicity data of the ongoing phase-2 trial, besides providing some clarifications, before proceeding for the next stage.
The vaccine candidate – ‘Covaxin’ – is being indigenously developed by the Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR).
According to officials, the Hyderabad-based vaccine maker applied to the Drugs Controller General of India (DCGI) on October 2, seeking its permission to conduct phase-3 randomised double-blind placebo-controlled multicentre trial of its Covid-19 vaccine candidate.
The firm in its application said that the study would cover 28,500 subjects aged 18 years and above and would be conducted in 19 sites – including Delhi, Mumbai, Patna and Lucknow – across 10 states.
According to sources, the phase-2 trial of the Covaxin is going on and the second dose is yet to be given to volunteers at some sites.
“The company presented phase-3 clinical trial protocol along with interim data of phase 1 and 2 clinical trials,” an official said.
The subject expert committee (SEC) at the Central Drugs Standard Control Organisation(CDSCO) deliberated on the application on October 5.
“After a detailed deliberation, the committee opined that the design of the phase-3 study is in principle satisfactory except for clarification on definition of asymptomatic, etc.
“However, the study should be initiated with appropriate dose identified from the phase-2 safety and immunogenicity data. Accordingly, the firm should submit safety and immunogenicity data from phase-2 trial for consideration,” the panel said in its recommendations.
The SEC during its discussion also observed that the vaccine was well-tolerated in all dose groups and no serious adverse events have been reported so far, a source said.
The most common adverse event was pain at the injection site, which resolved transiently, the source said.
The phase-3 clinical trial application proposed a dose of 0.5 ml on day 0 and 28, sources said.
Besides, Bharat Biotech, indigenously developed vaccine candidate by Zydus Cadila Ltd is in the phase 2 of the human clinical trials.
The Pune-based Serum Institute of India, which has partnered with AstraZeneca for manufacturing the Oxford Covid-19 vaccine candidate, is also conducting Phase 2 and 3 human clinical trials of the candidate in India.
India calls for complete ceasing of support to terrorist forces in Middle East
UNITED NATIONS: India has called on all concerned parties to completely stop supporting terrorist forces, like the ISIS, while urging all stakeholders in the Middle East to work constructively for peace, stability and development.
India underscored that it has invested considerably in the peace and stability of the region by deploying its personnel as part of UN peacekeeping forces, through humanitarian assistance, development cooperation, capacity building, and will continue contributing towards peace-building in the Middle East.
“India calls on concerned parties to completely stop support to terrorist forces, like ISIL (Islamic State of Iraq and the Levant) and others. India also urges all parties in the region to work constructively and in good faith to promote peace, stability and development for the benefit of all people in the Middle East,” India said in a written statement on Monday on the Security Council’s open debate on ‘The Situation in the Middle East’.
India said the truce between Israel and the Hamas has eased the humanitarian situation in Gaza and expressed hope that the temporary truce is converted into a permanent ceasefire, which can save precious human lives on both sides and create a conducive environment for talks.
“It is an unfortunate reality that the interlinked and mutually reinforcing challenges faced by the people of the Middle East have not yet been resolved. Political instability, long-festering conflicts, sectarian divides, issue of refugees and terrorism continue to plague the region. The COVID-pandemic has only exacerbated the threats posed by these challenges,” India said.
The statement made India’s permanent representative to the UN, Ambassador T S Tirumurti, will go as part of the official record of the Council.
India said it appreciates the agreement between Fatah and Hamas for holding Parliamentary and Presidential elections and also elections for the Palestinian National Council, which will help fulfill the democratic aspirations of the Palestinian people.
India also welcomed the agreements for normalisation of relations between Israel and the UAE and Bahrain. “India has always supported peace and stability in West Asia, which is our extended neighbourhood,” India said.
Further, India said the commencement of discussions on the disputed border between Israel and Lebanon is a significant development, expressing hope that this will provide an opportunity to resolve the longstanding issue between the two countries.
India highlighted that Palestinian aspirations for a sovereign and independent state are yet to be fulfilled and stressed that New Delhi has been unwavering in its commitment to the Palestinian cause and continues to remain supportive of a peaceful negotiated resolution of the Palestinian issue.
“India has supported the two-state solution as a just and acceptable solution to the conflict. Establishment of a Palestinian State living side-by-side in peace and security with Israel, within mutually agreed borders should be achieved through negotiations directly by the two parties,” India said adding that any stalemate could strengthen the hands of extremists and shut the door to cooperation thereby jeopardising the security, stability and prosperity of the people on both sides and the region.
Accordingly, India urged Israel and Palestine to resume direct negotiations at the earliest and called upon the international community to take concrete steps towards resuming and facilitating these negotiations quickly.
India noted that the decade-long armed conflict in Syria has claimed over 400,000 lives, displaced 6.2 million people internally and compelled another 6.3 million people to seek shelter in neighbouring countries.
“While we are heartened to see return of normalcy to major parts of the country, we are also reminded of the enormous resources that would be required to provide urgent humanitarian aid, rebuild infrastructure, enable return of the refugees and restore a normal and dignified life of all Syrians,” the statement said.
India said in the statement that it is not only contributing to the return of normalcy and rebuilding of Syria, but has also consistently called for a comprehensive and peaceful resolution of the Syrian conflict through a Syrian-led dialogue, taking into account the legitimate aspirations of the people of Syria.
India voiced concern over the security and humanitarian situation in Yemen and said the recent exchange of prisoners by the Government of Yemen and Ansar Allah, who had been detained in connection with the conflict, is a welcome development.
“India hopes that the parties will take more confidence building measures to provide the necessary impetus for the full implementation of the Stockholm Agreement,” the statement read.
India also hopes for peace and stability in Iraq with full respect for Iraq’s sovereignty and territorial integrity.
India noted that in the aftermath of the August blast that brought destruction to vast swathes of Beirut and inflicted heavy loss of lives, India stood in solidarity with Lebanon.
New Delhi sent emergency humanitarian aid of over 58 metric tons to Beirut. “We look forward to the swift formation of a new government that can offer political stability and also tackle the grave socio-economic challenges being faced by the people of Lebanon,” the statement said.
US, India must focus on threat posed by China: Secretary of state Mike Pompeo
NEW DELHI: US secretary of state Mike Pompeo on Tuesday stressed on the need for Washington and New Delhi to work together to counter the threat posed by Beijing to “security and freedom”
Pompeo’s comment came during the crucial 2+2 dialogue between India and the US, which saw the signing of a crucial defence agreement between the two countries.
“There is much more work to do for sure. We have a lot to discuss today: Our cooperation on the pandemic that originated in Wuhan, to confronting the Chinese Communist Party’s threats to security and freedom to promoting peace and stability throughout the region,” Pompeo said during talks with defence minister Rajnath Singh and external affairs minister S Jaishankar. Pompeo was joined by defence secretary Mark Esper.
Esper too focussed on the apparent threat posed by China, specifically in the Indo-Pacific region.
“Our focus now must be on institutionalising and regularising our cooperation to meet the challenges of the day and uphold the principles of a free and open Indo-Pacific well into the future,” Esper said.
The comments assume significance as India is locked in a border standoff with China in eastern Ladakh.
In June this year, 20 Indian soldiers and an unspecified number of PLA soldiers were killed in a clash with Chinese troops in Galwan Valley in eastern Ladakh, hardening the mood in India against China and driving Prime Minister Narendra Modi’s government to seek closer military ties with the United States.
In the US, President Donald Trump has made being tough on China a key part of his campaign to secure a second term in next week’s presidential election and Pompeo has been trying to bolster allies to counter China’s growing influence in the Indo-Pacific region.
This month, India invited Australia to join naval drills it holds each year with the United States and Japan, brushing off Chinese concerns that the exercises destabilise the region.
(With inputs from agencies)
US Secretary of State Mike Pompeo, Defence Secretary Mark Esper meet NSA Doval
NEW DELHI: US Secretary of State Mike Pompeo and Defence Secretary Mark T Esper on Tuesday held talks with National Security Advisor Ajit Doval, covering key aspects of growing strategic ties between the two countries.
Issues of strategic importance were discussed at the meeting, sources said.
The meeting took place ahead of the third edition of 2+2 ministerial dialogue. Esper and Pompeo arrived here on Monday for the crucial talks aimed at further boosting the defence and security ties between the two countries.
Defence Minister Rajnath Singh and External Affairs Minister S Jaishankar held separate talks with their US counterparts on Monday.
Earlier on Tuesday, both the top US administration officials visited the National War Memorial and paid tributes to India’s fallen heroes.
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