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WHO, national regulators and vaccine manufacturers in South-East Asia Region discuss COVID-19 vaccines
New Delhi, 11 December 2020:
The World Health Organization, national regulatory authorities and vaccine manufacturers in WHO South-East Asia Region discussed fast tracking of COVID-19 vaccine rollout in Member countries.
“The vaccine manufacturing and regulatory sectors have a critical role to play in equitable and efficient deployment of vaccines,” said Dr Poonam Khetrapal Singh, Regional Director, WHO South-East Asia Region, at the two-day virtual meeting that ended today.
The meeting deliberated processes and timelines to fast-track registration of COVID-19 vaccines in countries using the Emergency Use Listing procedures while comprehending the landscape of COVID-19 vaccine production in the Region.
Aimed at strengthening collaboration between national programmes, vaccine producers and regulators in the region for COVID-19 vaccine deployment, the meeting provided a platform for interaction and experience sharing for vaccine registration, deployment and regulation.
The Regional Director said all countries in the Region are now developing and finalizing national deployment and vaccination plans for COVID-19, of which regulatory preparedness is a core component.
Establishing expedited regulatory pathways for vaccine approval and adjusting regulatory pathways to the type of vaccine that is developed and filed for approval remains critical as emergency use authorization will precede full licensure, Dr Khetrapal Singh said.
While vaccine licensure systems may need to be modified, having standard operating procedures and stipulated timelines for emergency use authorization would be vital, she said.
The Regional Director emphasized on effective coordination, collaboration and information-sharing. From R&D to production, and from information on country readiness to post-marketing surveillance, manufacturers, regulators, policy-makers and planners must continue to work together to optimize and refine vaccine deployment.
“Countries in our Region are among the world’s largest vaccine manufacturers, and the vaccines produced here are likely to be administered to billions of people globally. I am certain that together, in solidarity with all people of the Region and world, you will effectively contribute to health and well-being of all,” Dr Khetrapal Singh said.
Key global and regional partners such as GAVI and UNICEF participated in the meeting. Among the vaccine manufacturers, from India Bharat Biotech International Ltd, Biological E Ltd, Cadila Healthcare Ltd, Serum Institute of India Pvt. Ltd, Dr Reddy’s Laboratories and Wockhardt Limited; from Indonesia Bio Farma Limited, and from Thailand Government Pharmaceutical Organization (GPO), Bionet Asia Co.Ltd and Siam Bioscience, participated in the meeting.
This was the second such meeting with vaccine manufacturers and regulators organized in WHO South East Asia Region, with the first held in April.
WHO has been supporting Member countries of the Region prepare for COVID-19 vaccines. A special session of the WHO South-East Asia Regional Immunization Technical Advisory Group was organized in November. The expert group made a series of recommendations including a fast tracking of the development of national deployment and vaccination plan, the application of guidelines provided by the ‘Values framework for the allocation and prioritization of COVID-19 vaccines’ and the ‘prioritization roadmap’ to identify priority populations and ensuring equity in delivery of COVID-19 vaccines, especially during the early stages when vaccine supply is expected to be limited.
The expert group also recommended that all countries should ensure availability of high-quality, complete and timely COVID-19 surveillance data on all risk groups, including migrants and remote or displaced populations, for decision-making related to vaccination.
While establishing collaboration with other health programs and sectors for optimum delivery of vaccine, countries should also leverage their experience in vaccine delivery platforms for adults, including experience with seasonal and pandemic influenza vaccination and Measles and Rubella and Japanese Encephalitis vaccination campaigns, to find effective ways to reach eligible adults with COVID-19 vaccines.
Adjustments should be made to vaccination strategies in accordance with the COVID-19 prevention measures and plans developed for demand generation, community engagement and risk communication, with special consideration for overcoming vaccine hesitancy. Countries should leverage the use of existing networks, including those for polio, to support the deployment of COVID-19 vaccines where appropriate.
The expert group highlighted the need for all countries to assess available cold chain space and meticulously plan cold chain requirement, including necessary improvements in storage, stock management, vaccine delivery strategy and waste management.
Earlier, WHO organized a meeting of cold chain managers of countries of the South-East Asia Region to help assess cold chain needs, identify gaps and plan for appropriate measures.
At the global level since April, the ACT-Accelerator partnership, launched by WHO and partners, has supported the fastest, most coordinated, and successful global effort in history to develop tools to fight COVID-19. Its vaccine pillar – COVAX – is co-led by WHO, Gavi and the Coalition for Epidemic Preparedness Innovations. It aims to accelerate the development and manufacture of COVID-19 vaccines, and to guarantee fair and equitable access for every country in the world.
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PCoI on Easter Sunday attacks:
By Shamindra Ferdinando
Attorney General Dappula de Livera, PC is not bound by recommendations made by the Presidential Commission of Inquiry (P CoI) into the 2019 Easter Sunday carnage, or presidential directives in that regard, according to authoritative sources.
They said that the AG couldn’t under any circumstances initiate legal proceedings until he had received the full PCoI report.
President Gotabaya Rajapaksa received the PCoI report on Feb 1. The President’s Office delivered a set of PCoI reports to Speaker Mahinda Yapa Abeywardena on Feb 23, a day after the report was presented to the cabinet of ministers. The Island raised the matter with relevant authorities in the wake of a section of the media reporting the PCoI recommending punitive measures against former President Maithripala Sirisena, Defence Secretary Hemasiri Fernando, IGP Pujitha Jayasundera, Chief of State Intelligence Senior DIG Nilantha Jayawardena, Chief of National Intelligence retired DIG Sisira Mendis and All Ceylon Makkal Congress (ACMC) leader and Samagi Jana Balavegaya MP Rishad Bathiudeen et al over the Easter Sunday carnage.
Sources pointed out that due to the inordinate delay in sharing the PCoI report with the AG, the department hadn’t been able to take preliminary measures required to initiate the proceedings. Sources said that a team of officers would take at least six weeks or more to examine the report before tangible measures could be taken.
With the AG scheduled to retire on May 24, 2021, even if the AG Department received the P CoI it would be quite a tough task to initiate proceedings ahead of retirement, sources said. However, in terms of the 20th Amendment to the Constitution enacted in last October, both the AG and the IGP could receive extensions beyond 60 at the President’s discretion.
Dappula de Livera received an Acting appointment as the AG a week after the Easter Sunday carnage whereas his predecessor Jayantha Jayasuriya, PC, was elevated to Chief Justice.
Responding to another query, sources said that the Attorney General two weeks ago requested Secretary to the President for a copy of the P CoI. However, the AG was yet to receive one, sources said. In spite of the AG not receiving a P CoI copy, the AG had instructed the IGP to obtain a copy of the report when he requested the police to complete investigations into the Easter Sunday carnage. The AG issued specific instructions after having examined police files pertaining to the investigations.
The IGP, too, hadn’t received a copy so far though some sections of the report were in the public domain.
Agriculture Minister Mahindananda Aluthgamage displayed at a live political programme on Derana a copy of the P CoI report he received at the cabinet meeting earlier in the day.
Sources said that the Attorney General’s Department couldn’t decide on a course of action in respect of the Easter carnage on the basis of a section of the report. In terms of the Commission of Inquiry Act (Section 24), the AG enjoyed significant powers/authority in respect of investigations; sources said adding that the Department urgently required both the P CoI report and police investigations report. The Attorney General’s Department has raised the delay in receiving a P CoI report amidst the Catholic Church attacking the government over the same issue.
Sources said that ministerial committee appointed to study the P CoI report couldn’t decide on how to proceed with the recommendations and the matter was entirely in the hands of the AG. Sources pointed out that the delay on the part of the government to release the report had received the attention of sections of the international media, including the New York Times. Public Security Minister retired Rear Admiral Sarath Weerasekera having met Malcolm Cardinal Ranjith at the Bishop’s House on Dec 8, 2020 said that the AG would get a copy of the P CoI report once the President received it. Minister Weerasekera said that the CID had handed over the relevant files after having completed investigations into eight blasts. Referring to the Parliamentary Select Committee (PSC) report on the Easter Sunday carnage, the former Navy Chief of Staff said that all such documents would have to be brought to one place and considered before initiating legal proceedings. Acknowledging that there could be delays, lawmaker Weerasekera said that on the instructions of the Attorney General a 12-member team of lawyers was working on the case. The minister vowed to expose the mastermind behind the Easter Sunday attacks. Investigations continued while some of those wanted were overseas, the minister said.
The minister acknowledged that the Attorney General couldn’t proceed without the P CoI report. Minister Weerasekera reiterated that once the President received the P CoI report, it would be sent to the Attorney General. The minister said that there were documents two to three feet high that needed scrutiny. The minister assured comprehensive investigation. The minister said that investigations pertaining to eight blasts had been completed and the reports handed over to the AG. However, the Attorney General had found shortcomings in those investigations.
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By Saman Indrajith
The Presidential Commission of Inquiry on the Easter Sunday bombings had failed to identify the mastermind of , the JVP said yesterday.
Addressing the media at the party headquarters in Pelawatte, JVP Propaganda Secretary MP Vijitha Herath said that the PCoI report had levelled accusations against former President Maithripala Sirisena, former IGP and head of intelligence for their dereliction of duty, shirking of responsibilities and not taking action to prevent the attacks and negligence. There were reference to the causes of the terror attacks and actions to be taken to avoid such attacks and the influence of extremist organisations. “However, there is no mention of the mastermind of the attacks, the handlers of the attackers and those whose interests the carnage served. It is also not mentioned whether there has been any foreign or local organisation behind those attacks. As per the PCoI report the attack took place as a result of culmination of extremism.
“According to the PCoI the extremist activities were a result of the prevailing political situation then. The entire nation was waiting to see who was responsible and who masterminded those attacks. The PCoI has failed to identify the true culprits responsible for the terror attacks. The report says that the leader of the suicide cadres killed himself in the attacks and it was a puzzle. That means those who are actually responsible for the attacks are still at large. The report does not provide exact details of the sources of the attacks. The PCoI had sittings for one year and five months. It summoned various persons and got their statements but it has failed to shed any light on the terror attacks. Everybody knows that the top leaders of the government and heads of security and intelligence establishments failed in their duties. Ranil Wickremesinghe was the second in command and he too is bound by the responsibility but the PCoI report fails to identify him as one of the persons against whom legal action should be instituted. The PCoI has treated Wickremesinghe and former President Maithripala Sirisena differently. We are not telling that this report is a total failure but we cannot accept this as a complete report. The PCoI handed over its report to the President on Feb 1. After 23 days it was sent to Parliament. Now, a copy of the report is there in the parliamentary library for the perusal of MPs.”
Herath said that the PCoI did not have powers to take punitive action. “It only has powers to name those responsible and recommend action to be taken against those named.
