By Sumudu Chamara
Despite ups and downs, Sri Lanka’s Covid-19 vaccination drive is continuing, and most people are struggling to get at least one dose of the vaccine amidst the huge competition to share only a limited number of vaccines.
Sri Lanka’s vaccination drive, which began early this year, has been criticised, questioned, and admired over the last few months, and it has unfortunately caused controversy on several occasions due to priority lists, price per dose, and scientific reasons such as the efficacy and side effects of the vaccines.
Due to the Moratuwa Mayor’s attempt to get people of his choice vaccinated outside the standard priority list while claiming that such is taking place in other places too, and allegations concerning a consent form requiring people to accept one dose of the vaccine, the country’s vaccination drive was once again a topic of discussion and centre of controversy.
However, amidst myriad discussions about the present situation and the future of the vaccination drive, Sri Lanka has now begun a new discussion about the Sputnik V vaccine manufactured by the Gamaleya Research Institute of Epidemiology and Microbiology of Russia’s Ministry of Health, especially about the protection a single dose can provide. In a context where Sri Lanka has paid attention to the efficacy of the Sputnik V vaccine, today’s Spotlight looks into what the global scientific community thinks about the Sputnik V vaccine and its single-dose use.
Sputnik V: The single dose controversy
The Ministry of Health recently said that the health authorities are currently looking into the possibility of limiting the Sputnik V vaccine to just one dose as opposed to two doses, based on information received from the Gamaleya Research Institute.
Gamaleya had informed the health authorities that one dose may be sufficient to provide immunity against Covid-19, according to Public Health Services Deputy Director General and Health Ministry Communications Director Dr. Hemantha Herath.
The health authorities made this revelation after the administration of the Sputnik V vaccine triggered a discussion in society, especially due to a consent form that required the signature of those who wanted to get Sputnik V. More specifically, the consent form in question had reportedly required them to consent to receiving only one dose of the Sputnik V vaccine.
To make matters worse, according to some groups including the Frontline Socialist Party (FSP), in the Kandy area, those who had refused to sign the said consent form due to the terms they were required to agree to, had been denied the vaccine.
Meanwhile, The Morning learnt that Sri Lankan researchers have also begun to look into the matter.
The University of Sri Jayewardenepura early this week commenced a study on Sputnik V, with the main objective of testing the efficacy of the vaccine.
According to the University’s Allergy, Immunology, and Cell Biology Unit Director Dr. Chandima Jeewandara, those who have received the first jab of the Sputnik V vaccine will participate in this study, and their antibody level and t-cell responses to the vaccine will be evaluated during the study. An antibody is a protective protein produced by the immune system in response to the presence of a foreign substance while a t-cell is a type of white blood cell which plays a role in the body’s immune system.
He said that several samples would be taken from the participants of the study – one sample before vaccination, one sample a month after vaccination, and one sample three months after vaccination. Depending on the results of the study, another sample may be taken six months after the vaccine is administered. He, however, added that these types of tests are conducted on other types of vaccines as well.
Sputnik V and Sputnik Light 
The efficacy of the Sputnik V vaccine, according to the results of Gamaleya’s trials, is as high as 91.6%.
Sri Lanka’s National Medicines Regulatory Authority (NMRA) on 4 March approved the emergency use of the Sputnik V vaccine, and on 23 March, the Cabinet of Ministers granted approval to purchase the vaccine from Russia. Sri Lanka received the first batch of the Sputnik V vaccine last month, and so far, a total of 65,000 doses have been imported to Sri Lanka. According to the Health Ministry’s Epidemiology Unit statistics, over 16,000 first doses of this vaccine have already been administered.
Sputnik V is becoming one of the most popular Covid-19 vaccines in the world. As of April, more than 60 countries had granted approval to use it.
The Sputnik V vaccine was originally a two-dose vaccine, and evaluating the efficacy of a single-dose vaccine or the use of only one dose of the Sputnik V vaccine was not part of these initial trials, as per the reports published by Gamaleya early this year.
The results of the trials published in The Lancet, a leading international general medical journal, claimed that even though the study had not been designed to assess the efficacy of a single dose regimen, the researchers’ early starting point had allowed them to observe a possible partial protective effect of a single dose.
“The cumulative Covid-19 incidence curves of Covid-19 cases among the placebo and vaccine groups begin to diverge 16 to 18 days after the first immunisation, showing the early onset of a partially protective effect after a single dose immunisation. However, the study design does not allow us to draw conclusions from these observations,” the researchers said in their reports.
However, later, Gamaleya commenced a trial which involved giving people only the first dose of a single dose version called “Sputnik Light”. It contained the adenovirus type Ad26 vector, or a modified recombinant adenovirus (a group of viruses that infect many parts of the body including airways and lungs) type 26. According to The New York Times (NYT), on 12 February, the Director of the Gamaleya Institute had stated that it would likely provide protection for a period of only four to five months.
The developers of the Sputnik Light vaccine have claimed that this single-dose vaccine provides an efficacy of 79.4%, as opposed to the 91.6% double-dose Sputnik V. However, no research data had been provided to prove it or to reveal as to how long the efficacy of the Sputnik Light vaccine would last.
Russia’s Ministry of Health had also stated that Sputnik Light would provide sufficient protection on its own to be used without a second dose, and authorised the single-dose version of the vaccine under the name Sputnik Light. Authorisation for the vaccine was officially announced on 6 May, claiming that it can help countries affected by high numbers of Covid-19 cases. Numerous researchers also claim that it is effective against all newly identified variants as well.
The Russian Direct Investment Fund (RDIF), Russia's sovereign wealth fund responsible for marketing the vaccine abroad, expressed hope that the single dose regimen solves the challenge of immunising large groups in a shorter time period, which is especially important during the acute phase of the spread of Covid-19, achieving herd immunity faster.
However, even though the Sputnik Light vaccine appears to be a good solution to the rising number of Covid-19 cases and deaths as well as the lack of or limited availability of resources to procure and administer the vaccine, in terms of efficacy, however, its long-term efficacy has been questioned and remains unclear due to the lack clinical data about the matter.
However, expressing uncertainty about the long-term benefits of the Sputnik Light vaccine, GlobalData Healthcare Infectious Diseases and Ophthalmology Director Michael Breen has stated that Sputnik Light is a good choice for a shortage situation or to control an outbreak, but is not ideal.
He had further told a foreign media outlet: “It should be noted that these developers have not sought approval as a single dose, and this is likely driven by the fact that long-term protection from a single dose is unclear, and likely not to be as durable as two doses. So, from a long-term standpoint, Sputnik Light is not ideal, but in terms of rapidly controlling the outbreak, with a second dose to come later, it is very promising.”
Even though The Morning attempted to contact Director General of Health Services Dr. Asela Gunawardena and State Minister of Primary Healthcare, Epidemics, and Covid-19 Disease Control Dr. Sudarshini Fernandopulle to inquire as to whether the single-dose vaccine the health authorities are planning to administer in Sri Lanka is Sputnik V or Sputnik Light, which is the single dose version of Sputnik V, they were not reachable.
Single-dose vaccines
Even though most of the Covid-19 vaccines are double-dose vaccines, overall, most of them provide considerable protection against Covid-19. However, according to researchers, what makes single-dose vaccines different from double-dose vaccines is their efficacy and how long the efficacy of the first or single dose lasts. The double-dose version of the Moderna and Pfizer-BioNTech vaccines, for example, can be effective up to 80% in preventing Covid-19 infections, according to a study conducted by the US’ national public health agency, the Centres for Disease Control and Prevention (CDC).
The Sputnik Light vaccine is not the only single-dose vaccine. Study findings published on various websites show that while a number of single-dose vaccines are currently being developed, several such vaccines have already been approved and are in use.
Cuban researchers at the Finlay Vaccine Institute have developed a single-dose vaccine named Soberana Plus. However, developers of this vaccine have specifically tailored it for people who have been infected with Covid-19 before, making it the only one of its kind. They claim that this vaccine can help prevent re-infection and also limit the spread of newly identified variants of the Covid-19 virus.
Another single-dose vaccine that has received approval from scientists is the Johnson & Johnson’s single-dose vaccine, manufactured by Janssen, a pharmaceutical company of Johnson & Johnson. Earlier this year, the Johnson & Johnson vaccine was found to be 67% effective in preventing Coivd-19 infections and 85% effective in preventing moderate to severe cases of Covid-19 as well as hospitalisations. The efficacy of the vaccine has been proved through trials with over 43,000 participants across the US, Latin America, and South Africa.
This single-dose vaccine is being used in several locations including the US and several countries in the European Union (EU). Last week, the UK’s medicine regulators also approved this vaccine for use.
However, like several other Covid-19 vaccines, this vaccine too is suspected to have links with blood clots. the benefits of the vaccine, however, according to UK-based researchers, outweigh the potential risks.
This single-dose vaccine is based on Ad26, on which the Sputnik Light vaccine is also based.
In addition, Moderna, another Covid-19 vaccine manufacturer, had announced that it is planning to launch a single-dose version of a Covid-19 vaccine in India next year.
Meanwhile, foreign media reports claimed that Covid-19-stricken India is considering using Sputnik Light and that official work in this connection is likely to commence soon. Private healthcare service providers have already commenced talks with the Indian health authorities to bring the Sputnik Light vaccine to India.
In this regard, Indian media agency the Press Trust of India (PTI) had reported: “The Indian Government is hopeful of a speedy launch of the single dose of the Covid-19 vaccine Sputnik Light in India and all stakeholders, including the Russian manufacturer and its Indian partners, have been directed to fast-track the application and regulatory approval procedures for the jab to boost the country's vaccination drive.”
As far as the Covid-19 pandemic is concerned, the rulers and authorities remain hopeful and encourage the people to do the same, and according to the health authorities, by the end of this year, the majority of the people would be vaccinated.
Preventing infections is always the best solution. The next best solution, which seems like the best solution when prevention is extremely difficult due to the contagiousness of the Covid-19 virus, is vaccination. If done right, it can in fact help mitigate the pandemic. But it has to be done right.
The efficacy of the Sputnik V vaccine, according to the results of Gamaleya’s trials, is as high as 91.6%.
Sri Lanka’s National Medicines Regulatory Authority (NMRA) on 4 March approved the emergency use of the Sputnik V vaccine, and on 23 March, the Cabinet of Ministers granted approval to purchase the vaccine from Russia. Sri Lanka received the first batch of the Sputnik V vaccine last month, and so far, a total of 65,000 doses have been imported to Sri Lanka. According to the Health Ministry’s Epidemiology Unit statistics, over 16,000 first doses of this vaccine have already been administered.
Sputnik V is becoming one of the most popular Covid-19 vaccines in the world. As of April, more than 60 countries had granted approval to use it.
The Sputnik V vaccine was originally a two-dose vaccine, and evaluating the efficacy of a single-dose vaccine or the use of only one dose of the Sputnik V vaccine was not part of these initial trials, as per the reports published by Gamaleya early this year.
The results of the trials published in The Lancet, a leading international general medical journal, claimed that even though the study had not been designed to assess the efficacy of a single dose regimen, the researchers’ early starting point had allowed them to observe a possible partial protective effect of a single dose.
“The cumulative Covid-19 incidence curves of Covid-19 cases among the placebo and vaccine groups begin to diverge 16 to 18 days after the first immunisation, showing the early onset of a partially protective effect after a single dose immunisation. However, the study design does not allow us to draw conclusions from these observations,” the researchers said in their reports.
However, later, Gamaleya commenced a trial which involved giving people only the first dose of a single dose version called “Sputnik Light”. It contained the adenovirus type Ad26 vector, or a modified recombinant adenovirus (a group of viruses that infect many parts of the body including airways and lungs) type 26. According to The New York Times (NYT), on 12 February, the Director of the Gamaleya Institute had stated that it would likely provide protection for a period of only four to five months.
The developers of the Sputnik Light vaccine have claimed that this single-dose vaccine provides an efficacy of 79.4%, as opposed to the 91.6% double-dose Sputnik V. However, no research data had been provided to prove it or to reveal as to how long the efficacy of the Sputnik Light vaccine would last.
Russia’s Ministry of Health had also stated that Sputnik Light would provide sufficient protection on its own to be used without a second dose, and authorised the single-dose version of the vaccine under the name Sputnik Light. Authorisation for the vaccine was officially announced on 6 May, claiming that it can help countries affected by high numbers of Covid-19 cases. Numerous researchers also claim that it is effective against all newly identified variants as well.
The Russian Direct Investment Fund (RDIF), Russia's sovereign wealth fund responsible for marketing the vaccine abroad, expressed hope that the single dose regimen solves the challenge of immunising large groups in a shorter time period, which is especially important during the acute phase of the spread of Covid-19, achieving herd immunity faster.
However, even though the Sputnik Light vaccine appears to be a good solution to the rising number of Covid-19 cases and deaths as well as the lack of or limited availability of resources to procure and administer the vaccine, in terms of efficacy, however, its long-term efficacy has been questioned and remains unclear due to the lack clinical data about the matter.
However, expressing uncertainty about the long-term benefits of the Sputnik Light vaccine, GlobalData Healthcare Infectious Diseases and Ophthalmology Director Michael Breen has stated that Sputnik Light is a good choice for a shortage situation or to control an outbreak, but is not ideal.
He had further told a foreign media outlet: “It should be noted that these developers have not sought approval as a single dose, and this is likely driven by the fact that long-term protection from a single dose is unclear, and likely not to be as durable as two doses. So, from a long-term standpoint, Sputnik Light is not ideal, but in terms of rapidly controlling the outbreak, with a second dose to come later, it is very promising.”
Even though The Morning attempted to contact Director General of Health Services Dr. Asela Gunawardena and State Minister of Primary Healthcare, Epidemics, and Covid-19 Disease Control Dr. Sudarshini Fernandopulle to inquire as to whether the single-dose vaccine the health authorities are planning to administer in Sri Lanka is Sputnik V or Sputnik Light, which is the single dose version of Sputnik V, they were not reachable.
Single-dose vaccines
Even though most of the Covid-19 vaccines are double-dose vaccines, overall, most of them provide considerable protection against Covid-19. However, according to researchers, what makes single-dose vaccines different from double-dose vaccines is their efficacy and how long the efficacy of the first or single dose lasts. The double-dose version of the Moderna and Pfizer-BioNTech vaccines, for example, can be effective up to 80% in preventing Covid-19 infections, according to a study conducted by the US’ national public health agency, the Centres for Disease Control and Prevention (CDC).
The Sputnik Light vaccine is not the only single-dose vaccine. Study findings published on various websites show that while a number of single-dose vaccines are currently being developed, several such vaccines have already been approved and are in use.
Cuban researchers at the Finlay Vaccine Institute have developed a single-dose vaccine named Soberana Plus. However, developers of this vaccine have specifically tailored it for people who have been infected with Covid-19 before, making it the only one of its kind. They claim that this vaccine can help prevent re-infection and also limit the spread of newly identified variants of the Covid-19 virus.
Another single-dose vaccine that has received approval from scientists is the Johnson & Johnson’s single-dose vaccine, manufactured by Janssen, a pharmaceutical company of Johnson & Johnson. Earlier this year, the Johnson & Johnson vaccine was found to be 67% effective in preventing Coivd-19 infections and 85% effective in preventing moderate to severe cases of Covid-19 as well as hospitalisations. The efficacy of the vaccine has been proved through trials with over 43,000 participants across the US, Latin America, and South Africa.
This single-dose vaccine is being used in several locations including the US and several countries in the European Union (EU). Last week, the UK’s medicine regulators also approved this vaccine for use.
However, like several other Covid-19 vaccines, this vaccine too is suspected to have links with blood clots. the benefits of the vaccine, however, according to UK-based researchers, outweigh the potential risks.
This single-dose vaccine is based on Ad26, on which the Sputnik Light vaccine is also based.
In addition, Moderna, another Covid-19 vaccine manufacturer, had announced that it is planning to launch a single-dose version of a Covid-19 vaccine in India next year.
Meanwhile, foreign media reports claimed that Covid-19-stricken India is considering using Sputnik Light and that official work in this connection is likely to commence soon. Private healthcare service providers have already commenced talks with the Indian health authorities to bring the Sputnik Light vaccine to India.
In this regard, Indian media agency the Press Trust of India (PTI) had reported: “The Indian Government is hopeful of a speedy launch of the single dose of the Covid-19 vaccine Sputnik Light in India and all stakeholders, including the Russian manufacturer and its Indian partners, have been directed to fast-track the application and regulatory approval procedures for the jab to boost the country's vaccination drive.”
As far as the Covid-19 pandemic is concerned, the rulers and authorities remain hopeful and encourage the people to do the same, and according to the health authorities, by the end of this year, the majority of the people would be vaccinated.
Preventing infections is always the best solution. The next best solution, which seems like the best solution when prevention is extremely difficult due to the contagiousness of the Covid-19 virus, is vaccination. If done right, it can in fact help mitigate the pandemic. But it has to be done right.