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…says does not recognise it for use
Executive Director of the Caribbean Public Health Agency (CARPHA), Dr. Joy St. John said the Sputnik-V vaccine, developed by the Gamaleya Research Institute of Epidemiology and Microbiology, is not among vaccines currently recommended for use by CARPHA.
“Sputnik V has not been issued Emergency Use Listing or Authorization (EUL/A) from any of the authorities which CARPHA recognises for vaccine EUL/A. It is under consideration by WHO and CARPHA is monitoring for WHO’s notification of approval,” Dr. St. John said while responding to a series of questions posed by the Village Voice Newspaper.
Dr. St. John said CARPHA has recommended Pfizer, Moderna, AstraZeneca, Johnson & Johnson, and Beijing-SinoPharm for use. “The dossier for COVID-19 vaccine by SinoVac is currently under review,” she added.
When asked what are the risks in utilising a vaccine that has not acquired approval from the World Health Organisation (WHO), the Executive Director of CARPHA said: “All the Governments have to take account for the responsibility of liability for any of the vaccines they distribute to the population.” According to WHO’s Guidance Document dated June 16, 2021, no approval date has been set for the Sputnik-V vaccine as information is still outstanding. According to WHO, meetings with Gamaleya on its clinical trials are ongoing. WHO said submission of clinical and CMC data has started, however, additional data is required. “Anticipated date will be set once all data is submitted and follow-up of inspection observations completed,” WHO said.
Under pressure from the A Partnership for National Unity + Alliance For Change (APNU+AFC) Coalition, the Irfaan Ali Administration disclosed that it procured thousands of doses of the Sputnik-V vaccine from Sheikh Ahmed Dalmook Al Maktoum of the United Arab Emirates (UAE). It explained that to ensure sufficient supplies, the Ministry of Health held bilateral discussions with India, China, Russia, the US, the EU, Kuwait and the UAE, in addition to bilateral talks with AstraZeneca, Pfizer, Moderna, Johnson and Johnson, SinoPharm, Covaxin and the Russian Direct Investment Fund, however, when those discussions bore little fruit, it jumped at an opportunity to procure 400,000 doses of Sputnik through the Sheikh. Approximately 305,000 doses have thus far been delivered.
Guyana’s Advisor on health, Dr. Leslie Ramsammy, in defending Government’s decision to utilised an unauthorised vaccine, said the country considered not only data submitted from clinical trials by Russia but it also carefully considered the scrutiny of the clinical trials data done by the Lancet, the British Medical Journal.
“Globally, the use of COVID-19 vaccines became an emergency, an imperative. Individual countries considered clinical trials data and used their national registries to approve emergency use for vaccines. The UK and other European countries began using AstraZeneca before World Health Organization (WHO) approval. The US began using Pfizer, Moderna and Johnson and Johnson before the WHO approval. Russia began using Sputnik V before WHO approval. India, China began using locally produced vaccines before WHO approval.
Given the data available to us and which were submitted to the WHO, Guyana made a decision that saving lives is more important than risking people’s lives and approved Sputnik V, AZ, SinoPharm, Pfizer and other vaccines,” Dr. Ramsammy explained. Both Dr. Ramsammy and the Health Minister, Dr. Frank Anthony have repeatedly indicated that the Sputnik vaccine has an efficacy rate of 97% though not approved by WHO.
But while some Guyanese have questioned the Government’s decision to utilize an unauthorized vaccine, others have questioned the authenticity of the vaccine procured from the Sheikh.
For Dr. Richard Van-West Charles, a former PAHO/WHO Representative, the Government compromised the health and safety of Guyanese when it opted to source the Sputnik-V vaccine from a “middle man.” Like the Leader of the Opposition Joseph Harmon, Dr. Van-West Charles called on the Government to disclose all information on the acquisition of the vaccines, including the batch numbers of the acquired doses from Sheikh.
Heeding to the request of the Opposition, the Health Minister last Tuesday made public a letter from Director-General of the Russian Direct Investment Fund (RDIF), Alexander Christyakov in an attempt to confirmed the authenticity of the shipment of 305,536 doses of Sputnik-V vaccines to Guyana.
In the letter dated June 22, 2021, Christyakov outlined the batch number for the vaccines that were shipped in five dispatches. There were 244, 268 of the first dose and 61,268 of the second. The document included the batch number, expiry date of the vaccines, and the quantity of doses. Some vaccines will expire on July 1, August 1, and October 31, 2021. The Official also noted that all supporting documentation inclusive of batch release, certificate of analysis and packing list have been provided along with the shipments.
Dr. Van-West Charles, in an interview with Village Voice Newspaper on Friday, said the letter leaves more questions than answers. He explained that while Christyakov provided a series of batch numbers, it is unclear which of those batches came to Guyana, if any at all.
“We don’t know if that is the batch that came from UAE,” Dr. Van-West Charles said while noting that shipment information including dates and the conditions under which the vaccines were stored are still unclear.
Iterating a recommendation earlier proposed, the former PAHO/WHO official said in order to confirm the authenticity of the Sputnik-V vaccine, the Government should send samples of the Sheikh-acquired doses to international laboratories for verification.
In the interim, the Opposition Leader has written the Gamaleya requesting that it confirm that it could not provide the Sputnik V vaccines to the Guyana Government either directly or via the RDIF; and that the Sheikh is duly authorized distributor of the Sputnik V vaccine.
Harmon has also requested information on the quantity of Sputnik V vaccines supplied; the date(s) in which they were delivered; port(s) to which they were delivered; and their batch numbers.
Notably, CARPHA’s Executive Director has said that “CARPHA has not received any reports of substandard or falsified or unregistered (unauthorized) COVID-19 vaccines among its Member States.”