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Tuesday, 2 February 2021 00:29 - - {{hitsCtrl.values.hits}}
Pic by Upul Abeyasekara
By Shailendree Wickrama Adittiya
COVAX, led by the World Health Organization (WHO), Coalition for Epidemic Preparedness Innovations (CEPI), and Gavi, will begin to provide participant countries with COVID vaccines this month, but supply will be limited to a small quantity.
At a webinar titled Vaccination as a strategy for control and prevention of COVID-19 organised by the College of Community Physicians of Sri Lanka on 29 January, WHO SAGE Working Group on COVID-19 Vaccines Member Dr. Annelies Wilder-Smith said this was due to supply constraints and technical manufacturing issues.
“February and even March is a drop in the ocean and will not change the world, but I think as the months go by, we will see that COVAX will increasingly ship out the vaccines to those countries in COVAX that have signed up and show that they are ready,” Dr. Wilder-Smith said.
She added that COVAX is in the process of making deals with vaccine producers with emergency use listings, with some vaccine developers having already agreed to provide doses of the COVID vaccine to COVAX.
“COVAX is the pillar with WHO, CEPI, GAVI working towards an equitable distribution of vaccines with the aim to distribute two billion doses of COVID vaccines by the end of 2021,” Dr. Wilder-Smith went on to say, adding that the Oxford-AstraZeneca vaccine made a good candidate as it is affordable, easy to store and handle, and has a very good safety profile. However, she added: “The downside is that efficacy is lower than reported.”
Sri Lanka is banking on the COVAX facility to provide vaccinations to 20% of the country’s population, in addition to the reception of 500,000 doses of the Oxford-AstraZeneca vaccine from the Government of India last week.
However, with the uncertainty surrounding COVAX, the Government is also considering donations from other governments as well as procurement. As of now, China has offered to provide 300,000 doses of Sinopharm and Russia has shown willingness to permit manufacture of Sputnik V in Sri Lanka. However, neither vaccines have been approved by the National Medicines Regulatory Authority (NMRA). At present, the NMRA has only approved the Oxford-AstraZeneca vaccine for emergency use in Sri Lanka.
While the vaccine was administered to over 5,000 frontline workers on Friday in 10 hospitals in the Western Province, no adverse events have been reported yet. The first round of the campaigns will be completed within five to seven days, with first dose coverage of the target groups to be completed during a week since commencement.
The second round of the campaign will take place in a month, leaving a four-week gap between the doses. However, studies are surfacing to show that the Oxford-AstraZeneca vaccine is more effective with a 12-week interval between doses.
“We have now learned that the efficacy of this vaccine increases with a longer inter-dose interval, so if you have an interval between two doses of up to 12 weeks, you will see better efficacy than if the interval is shortened down to four weeks,” Dr. Widler-Smith said.
Consultant epidemiologist of the Health Ministry’s Epidemiology Unit Dr. Deepa Gamage, who also participated in the webinar, said the second round of the vaccine will be conducted in four weeks as this is the recommendation based on existing evidence based on trial data. Regarding the new studies on the interval between doses, Dr. Gamage said the data and recommendations can be used in another campaign when it is made available.
Factors and requirements being considered at the moment with regard to vaccination in Sri Lanka include different guidelines for different vaccines, following up the second dose with same vaccine, different preparation requirements with logistics for different vaccines, training requirements, requirement to address any confusion if different vaccines are available in the country in future, requirements of well-focused mass awareness campaign, and the requirement of a discussion with media.
Dr. Gamage went on to explain the process implemented in Sri Lanka when preparing for COVID-19 vaccine deployment, saying the National Immunisation Technical Advisory Group (NITAG) incorporated into Advisory Committee on Communicable Disease plays a key role in the immunisation process with specific expert working groups formed depending on requirement.
For the COVID-19 vaccine introduction process, the Health Ministry first recognised it as a national focal point. The process was directed to NITAG and the National Coordinating Committee (NCC), with NITAG directing the expert technical working group to recommend Evidence to Decision as well as a sub-committee on vaccines.
The NCC directed the sub-committee on vaccines as well, in addition to the sub-committee on logistics and the sub-committee on costing.
Regarding the identification of priority groups, Dr. Gamage said: “We have followed the SAGE priority group recommendations or the roadmap for prioritisation.”
The process identified different priority groups based on the supply of vaccines the country would receive, with frontline workers, comorbid groups, and age taken into consideration. She added that the Health Ministry was targeting vaccination of 50% of the eligible population by the end of the year.
While vaccine preparation and administration was carried out in a strategic manner, Dr. Gamage said there were several enabling factors like well-established public health infrastructure, manpower availability, and mechanisms for regular training in immunisation that contributed to the process.
Vaccine communication and awareness is one area that will be given more focus, especially when vaccination of the senior population beings. “In previous occasions the Epidemiology Unit handled vaccine communication and demand creation because we thought special technical expertise is required. But this time, together with us, the Health Promotion Bureau took over the responsibility so they are working on that,” Dr. Gamage explained.
While more information regarding vaccination is expected to be released in the future, Dr. Gamage reminded the audience that vaccine communication and demand creation had to be organised within a very short period with the current campaign being carried out in the island.
An important aspect of the campaign will be data collection. The Epidemiologist explained that the COVID vaccine campaign is not like a routine vaccination program. “In a campaign, within a short period, a lot of people will be vaccinated, so we have to think about feasibility, country requirement, and also how soon we can give the vaccine.”
The campaign must also not be delayed. Given these considerations, limited variables will be gathered to analyse the campaign and vaccine recipients.
While Dr. Gamage’s presentation considered the country situation, Dr. Wilder-Smith looked at the global situation. Her segment touched on the COVID-19 vaccine landscape and she compared the available vaccines, saying all currently available platforms are in use, for instance, virus vaccines and protein-based vaccines. Oxford-AstraZeneca vaccine, for instance, is a viral vector, Moderna and Pfizer are RNA, Sinopharm is an inactivated virus, and Novavax is a protein subunit.
Discussing the different vaccines available, Dr. Wilder-Smith explained that although the Pfizer and Moderna vaccines have a high efficacy, their use is limited because of the ultra-cold chain requirement, which is -80 degrees for the Pfizer vaccine and -20 degrees for the Moderna vaccine.
However, the Oxford-AstraZeneca, Gamalaya, and Sinopharm vaccines require storage fridge temperatures between two and eight degrees.
“At SAGE, we use Evidence to Recommendations (EtR) framework and it helps us to have a transparent process which is graded by the strength of the evidence and also looks at questions beyond efficacy and safety. So regulators look at efficacy and safety and we, as policymakers, have to look beyond,” she said, while discussing the process behind approval.
Dr. Wilder-Smith also addressed conspiracy theories and rumours about the vaccine, from genetically modifying humans to infertility to microchips for global tracking, saying there is no truth to these. Regarding concerns about development taking place too fast, she said the process could be accelerated due to the resources and platforms in place. “We did not take any shortcuts in the Phase 1, 2 and 3 trials,” she stressed.
With healthcare workers among the first to receive the vaccine, there are questions regarding the need for PPE and other safety measures after vaccination. In response to such a question, Dr. Wilder-Smith said the current recommendation is that the use of PPE must continue. So should the use of non-pharmaceutical intervention from a societal point of view.
The reason for this is that no vaccine guarantees 100% protection. Secondly, healthcare workers who are vaccinated could still be shedding the virus and the use of PPE was required for the protection of the healthcare worker as well as the patients exposed to them.
“Non-pharmaceutical protection can only be lifted when you have very high coverage,” Dr. Wilder-Smith said. According to her, global vaccine coverage is necessary to interrupt COVID-19 globally and will likely only be achieved by the end of 2022 or even 2023 unless manufacturing capabilities surge.
The webinar also considered the South East Asia region, with WHO South East Asia Regional Office representatives Dr. Jayantha Liyanage and Dr. Anil Chawla speaking about the COVID-19 vaccine deployment process.
Dr. Liyanage began by sharing key numbers to show the state of vaccines as of 27 January, saying the first vaccination programs started 52 days ago, with 71 million doses administered to date. There are currently seven different vaccines in three platforms being administered.
A total of 62 countries, of which 45 are high income, 11 are upper middle, three are lower middle, and three are lower income, are currently carrying out vaccination programs. In the South East Asia region, the countries include Bangladesh, India, Indonesia, Myanmar, Nepal, and Sri Lanka.
In terms of critical considerations for COVID-19 vaccine deployment, Dr. Liyanage said National Coordinating Committees have been established in all countries and they have a very critical role in vaccine deployment and vaccination coordination.
The responsibilities of these committees include incorporating the latest COVID-19 vaccine information into planning and preparation, seeking and using the National Immunisation Technical Advisory Group recommendations, estimating costs, establishing operations processes and communicating with partners and the media. The committees must also coordinate and support the implementation of health services readiness and capacity assessments and monitor progress.
He went on to stress that this process will not end in 2020 or 2021, but will continue with evaluations and adjustments being made.
Dr. Liyanage also shared the key safety and pharmacovigilance challenges to consider. This includes multiple vaccines, manufacturers, contents, presentation forms and appearance as well as the use of different vaccination platforms and strategies at the same time.
The employment of previously unlicensed new technologies and novel target pathogen with many unknowns are also challenges, along with varying capacities between and within countries to identify, report, investigate and respond to adverse events following immunisation (AEFI).
Despite these challenges, Dr. Liyanage said: “Vaccine deployment is a process where we can use our previous experience and public health knowledge to do it in a sustainable way.”
