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—Former PAHO Representative calls on Guyana to disclose fully all information on purchase of Russian vaccines
…says vaccines purchase from a middleman unusual in Guyana
By Svetlana Marshall
The Irfaan Ali Administration compromised the health and safety of Guyanese when it opted to source the Sputnik-V vaccine from a “middle man,” former Health Minister, Dr. Richard Van-West Charles said even as he underscored the importance for the government to disclose, fully, information on the acquisition, including the batch numbers of the doses from Sheikh Ahmed Dalmook Al Maktoum of the United Arab Emirates (UAE).
“If you look at Latin America and the countries that have actually purchased Sputnik, they have purchased directly from the manufacturer. I would doubt that our FDA would have approved purchasing via a middle man. This is not the usual, this is not the practice, this is a deviation from the practice by which vaccines have been purchased in this country, never through middlemen; and the issue of safety is an important issue which arises,” Dr. Van-West Charles told the Village Voice Newspaper during an interview on Saturday.
Dr. Van-West Charles has served as Special Advisor Partnerships with the International Financial Institutions at the World Health Organization (WHO), Area Manager for Information and Knowledge Management, PAHO/WHO as well as PAHO/WHO Representative for Jamaica; Cayman Islands and Bermuda. He is also a former Academic Dean of St. Helen University Medical School and Health Sciences.
Under significant pressure from the A Partnership for National Unity + Alliance For Change (APNU+AFC) Coalition, the People’s Progressive Party/Civic (PPP/C) Government disclosed that it had 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. The Sheikh, however, has been tied to individuals with checkered past such as Umar Farooq Zahoor, who is reportedly wanted in Norway as part of an investigation into a massive fraud and Per Morten Hansen, who is reportedly being investigated for money laundering.
THE MIDDLE MAN
Dr. Van-West Charles told Village Voice News that there is a significant risk associated with acquisition of vaccines through “middlemen.”
“They are not necessarily going to have the storage capabilities that the other agencies are going to have; they are not necessarily going to have the record keeping that would be required and so it is important to note that the temperatures required by the manufacturers must be adhered to,” Dr. Van-West Charles explained.
The health minister, while assuring Guyanese that the Sputnik-V vaccines being utilised here are authentic and safe, on Thursday (June 17), said it was the Russian Direct Investment Fund (RDIF) which had referred the Government to a number of suppliers among them the Sheikh. According to Dr. Anthony, the Sputnik V vaccine departed the manufacturer – Gamaleya Research Institute of Epidemiology and Microbiology in Russia – to the UAE, and was then transported from the UAE to Miami, Florida before arriving in Guyana.
However, Dr. Van-West Charles told this newspaper that there still remains many unanswered questions, and as such, the Government should make public all documents on the acquisition of the vaccine from the time the doses were manufactured to the time they arrived in Guyana.
Opposition Leader, Joseph Harmon, in a letter to the Health Minister, has requested information on the quantities and batch numbers of the vaccines purchased from Sheikh Al Maktoum and or Umar Zahoor and their partners; shipping information including transshipment information and the conditions under which vaccines were stored for shipment; and details on the procurement process utilised including the due diligence done on the supplier.
Dr. Van-West Charles said thus far the Health Ministry and by extension the Government have failed to produce any substantial document that would verify the authenticity of the doses identified as the Sputnik-V vaccine produced by Gamaleya, in addition to documents detailing the conditions under which the vaccines were transported to Guyana.
“…we have no date of their manufacture nor have we been able to conclude whether the vaccines did come from the manufacturers in Russia; that is most important,” the former PAHO/WHO official said.
He said such information is critical at a time when other countries are confronted with fake vaccines. BBC, in an article in April, 2021, reported that US pharmaceutical company Pfizer identified counterfeit versions of its coronavirus vaccine in Mexico and Poland. “In Mexico, they had false labels, while the substance in Poland was believed to be anti-wrinkle treatment,” the BBC report said. WHO has warned that fake vaccines “pose a serious risk to global public health.” Reuters, in an article in March 2021, said fake doses of the Sputnik-V vaccine was also found in Mexico.
“Not because it has the name Sputnik [it is authentic] because already we know there are reports of fake Sputnik which arose in Mexico; so to say that every Sputnik is what is produced by the Russian manufacturer is the same because the name is Sputnik, is not correct,” Dr. Van-West Charles cautioned.
He submitted that in order to assure Guyanese that what is being used in Guyana is the authentic Sputnik-V vaccine, Government should send samples of the Sheikh-acquired doses to international laboratories for verification.
“In order for us to be transparent, let us take a random sample of the batch but we have to be clear that the batch is the right batch we are taking the samples from, and have laboratories in Argentina, Mexico or Brazil and CDC or one of the UK laboratories test and indicate whether the vaccines are consisting of the [components] as set out by the manufacturer,” the former PAHO/WHO official recommended.
But while some Guyanese have questioned the authenticity of the vaccine procured from the Sheikh, others have questioned Government’s decision to procure a vaccine such as Sputnik-V which is still to receive the approval of WHO.
In response to a statement by Prime Minister of Trinidad and Tobago, Dr. Keith Rowley that the Twin Island Republic has only utilized COVID-19 vaccines that have been authorised for emergency use by WHO, Guyana’s Advisor to the Ministry of Health, Dr. Leslie Ramsammy said the country considered not only data submitted from clinical trials by Russia but 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 Astra Zeneca 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 have repeatedly indicated that the Sputnik vaccine has an efficacy rate of 97% though not approved by WHO.
Dr. Van-West Charles, who from the onset underscored the importance of vaccination in not only combating COVID-19 but other diseases, said WHO’s approval is important in clinical trials.
“There is no doubt that the pandemic is upon us and we have to do a number of things; it is not singularly the vaccine; it is embracing the social distancing, the wearing of mask and sanitising. Those are critical elements of the strategy and it cannot be ignored,” Dr. Van-West Charles said while underscoring the importance of vaccination.
However, he said countries like Guyana whose development is not as advanced as that of the United States, Canada and the United Kingdom, it is important to rely on WHO.
“For many of the underdeveloped countries without the capacity similar to that in the United States of America with CDC and FDA or in Canada or in the UK or the European Union, we have to and we should and must depend on the conclusions of an agency like WHO, for which we are members and it is for that reason that we as small countries have become members of this multilateral institution. It is a specialized agency of the United Nations,” he reasoned.
It was noted that vaccines undergo three clinical trials before approval is considered. “Authorities of any country have to submit all of the data of the trials to ensure that the results that they are reporting are correct and can stand muster in terms of their evaluation,” he explained while pointing out that the Sputnik-V is among vaccines that have not been approved by WHO for emergency use.
“Now Sputnik has not yet submitted all of the data from all of the trials and there are three phases in the clinical trials, and so, this has been going on. They were supposed to submit some data on June 5th, they missed the deadline, and so they have to submit data, visits have got to be made by WHO to conclude,” he explained.
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.
Dr. Van-West Charles has made it clear, however, that even if WHO approves the Sputnik-V vaccine, there would still remain questions to be answered by the PPP/C Administration.
“Even if WHO came out tomorrow and approve it, there will still be questions on the safety of this batch of vaccine, so let us not be confused that it is something against specifically Sputnik but the issue is [the] third man arrangement they have gotten themselves into and not being able to provide the guarantees of the safety is required,” Dr. Van-West Charles said.
Aside from the Sputnik vaccine, Guyana has received 62,400 doses of the Astra Zeneca vaccine through the COVAX facility; 3,000 doses of AstraZeneca as a donation from Barbados; 20,000 Sinopharm doses of vaccines as a donation from China, and 80,000 doses of the AstraZeneca vaccine from India.