ECONOMYNEXT – A consent form that the Sputnik V COVID-19 vaccine recipients in Kandy, Sri Lanka, were required to sign on May 31 has raised questions about the rollout, though the government denies any irregularity, assuring the public that the first dose of the Russian vaccine is now called Sputnik Light.
Consent forms distributed at Sri Lanka’s vaccination centres is standard procedure, but residents of Kundasale, Kandy, were surprised to find a detail unique to their form: a seal that read, in Sinhalese, “I consent to receiving at least the first dose of Sputnik V”.
Health officials denied knowledge of the seal on May 31, but two government ministers said the next day that they were aware of its existence.
Co-cabinet spokesman Minister Keheliya Rambukwella told reporters on June 01 that, with over 2,500 new COVID-19 cases reported a day, a decision to administer at least one dose of the Sputnik V vaccine was taken after consulting a committee of experts appointed to oversee the rollout.
The committee comprises doctors S Mahendra Arnold, Neleeka Gunawardana, Hasitha Thisera, Dassanayaka and Prfessor Nileeka Malavige, the minister said.
“Following discussions, the committee reported that the first dose should be enough to bring the situation under control,” he added.
Despite Health Services Deputy Director General Dr Hemantha Herath’s denial of any knowledge of the oddity in Kandy, Rambukwella said the government was aware.
“The rollout is carried out by the health authorities – vaccination specialists,” he said at the weekly cabinet press briefing.
Sputnik V vials are supposed to be stored at temperatures between 2 and 8 degrees Celsius (a standard fridge is roughly 3 to 5 degrees), with the two jabs to be administered 21 days apart.
The Russian vaccine is unique in that it the two doses carry different formulae. Both formulae target the novel coronavirus’s distinctive ‘spike’, and each dose in Sputnik V contains a slightly different vector – the neutralised virus that carries the spike to the body.
State Minister of Pharmaceutical Production, Supply and Regulation, Channa Jayasumana told reporters on June 01 that new research by the manufacturer has shown that the first dose alone may provide sufficient protection.
The newly introduced Sputnik Light is not a new vaccine but in fact the first dose of the regular Sputnik V vaccine, said Jayasumana.
“They have released the first dose to the market under the brand Sputnik Light,” he said.
The state minister said there’s a possibility that the manufacturer, the Gamaleya National Research
Center of Epidemiology and Microbiology, will recommend that only one dose be administered.
The institute has communicated to Sri Lankan authorities the status of their research on the matter, he said.
“Whether or not the second dose should be administered is not the government’s call but is a decision that’s up to the manufacturer,” said Jayasumana.
“If the Russian institute confirms to us that one dose is enough, we will decide in due course to limit the rollout to a single dose,” he added.
The Russian Direct Investment Fund (RDIF) said in a May 06 statement that Sputnik Light is the first component (recombinant human adenovirus serotype number 26 (rAd26)) of the Sputnik V coronavirus vaccine.
“The single dose Sputnik Light vaccine demonstrated 79.4% efficacy according to analysed data taken from 28 days after the injection was administered as part of Russia’s mass vaccination program between
5 December 2020 and 15 April 2021,” RDIF said.
The body said the first dose, also known as Sputnik Light, has proven effective against all new strains of COVID-19 as demonstrated by the Gamaleya centre during laboratory tests.
According to RDIF, Russia gave the authorisation to use only a single dose of Sputnik V from May 06 onwards.
According to the RDIF statement, phase I/II of the Safety and Immunogenicity Study of Sputnik Light has demonstrated that the vaccine can elicit the development of antigen specific IgG antibodies in 96.9% of individuals on the 28th day after vaccination. It also elicits the development of virus neutralising antibodies in 91.67% of individuals on the 28th day post immunisation. Cellular immune response against the S Protein of SARS-CoV-2 develops in 100% of volunteers on the 10th day, while the immunisation of individuals with pre-existing immunity against SARS-CoV-2 with Sputnik Light can elicit the increase of the level of antigen specific IgG antibodies by more than 40 times in 100% of subjects 10 days after immunisation. No serious adverse events were registered after vaccination with Sputnik Light, it added.
RDIF said the Sputnik Light vaccine is based on a well-studied human adenoviral vector platform that has proven to be safe and effective, with no long-term side effects, as confirmed in over 250 clinical trials conducted globally over the past two decades.
“The single dose Sputnik Light vaccine demonstrated 79.4% efficacy according to analysed data taken from 28 days after the injection was administered,” the RDIF said, adding that the jab reports an efficacy of nearly 80% – higher than that of many two-dose vaccines.
“The infection rate among vaccinated subjects from the 28th day from the date of the injection was only 0.277%. Over the same period, the infection rate among the unvaccinated adult population was 1.349% in Russia.”
According to RDIF, on February 21, the Gamaleya Centre and RDIF launched a global efficacy study of Sputnik Light. The Phase III clinical study involving 7,000 people is conducted in multiple countries including Russia, the UAE, Ghana and others with the results are still pending.
RDIF, quoting the Director of the Gamaleya National Research Center of Epidemiology and Microbiology Alexander Gintsburg, said Sputnik Light will help to prevent the spread of coronavirus through the faster immunisation of larger population groups, as well as supporting high immunity levels in those who have already been infected previously.
Data shows that Sputnik Light also offers strong value in initial vaccination and re-vaccination, as well as boosting efficacy when taken in combination with other vaccines.
RDIF said the Price of the Sputnik V light will be less than 10 dollars while it has simple storage requirements, at +2 +8, which provide for easy logistics. The one shot regimen allows for the vaccination of large groups of the population in a short time, helping to speed up the fight against the pandemic during the acute phase.
However, RDIF said two dose Sputnik V vaccine remains the main vaccination tool.
The vaccine has also been approved to be manufactured by the partners of RDIF to meet the global demand.
“The vaccine supplies for the global market will be produced by RDIF’s international partners in India, Brazil, China, South Korea and other countries”
Meanwhile Sri Lanka’s Epidemiology unit published the new guidelines for the Sputnik V vaccine on May 29.
In the guidelines, the epid unit states with the evolving global situation of vaccine manufacturing and supply, there is a possibility of not receiving Component II and recepients are to be informed if and when Component II arrives.
“[Health staff administering the vaccine] are dvised not to indicate a date for a second dose and keep registration notes and contact details at each vaccination centre securely to inform the clients to visit for a second dose,” it said.
By May 31, Sri Lanka health authorities had given the first dose of Sputnik V to 26,821 Sri Lankans. (Colombo/ June 01/2021)