Al Monitor, by Hagar Hosny (Excerpt: How Egypt became hub for Russian Covid-19 vaccine)
A nurse shows the Sputnik V (Gam-COVID-Vac) vaccine against the coronavirus disease (COVID-19) at a clinic in Moscow on December 5, 2020, amid the ongoing coronavirus disease pandemic. - Russian President has told authorities to begin "large-scale" vaccinations among at-risk populations. The drugs should be made generally available to the Russian public in early 2021. Photo by KIRILL KUDRYAVTSEV/AFP via Getty Images.Dec 21, 2020
Egypt may become the hub of coronavirus vaccines in Africa after it agreed to produce the Russian Sputnik-V vaccine against the coronavirus.
CAIRO — Chief executive officer at Russian Direct Investment Fund (RDIF) Kirill Dmitriev recently said there is a possibility that Russia could begin production of its Sputnik V coronavirus vaccine in Egypt and Algeria.Speaking at an online UN session to present the Russian vaccine Dec. 2, Dmitriev said more than 40 countries — involving more than 50% of the global population — expressed interest in the Sputnik vaccine. He noted that RDIF received requests for the production of more than 1.2 billion doses of the vaccine, adding that the price of the dose is less than $10 — which makes it the least expensive coronavirus vaccine developed in the world to date.
During a teleconference with members of his government Aug. 11, Russian President Vladimir Putin said that Russia has become the first country in the world to formally approve a coronavirus vaccine following the necessary trials, and one of his daughters has already been inoculated.
Although it was approved in Russia as the first effective vaccine against the coronavirus, the World Health Organization (WHO) has yet to register Sputnik-V.
Melita Vinovich, the representative of WHO in Russia, told Echo of Moscow radio station Nov. 19 that Russia submitted to WHO an application for a Certificate of Product Registration of its Sputnik V vaccine that was developed by the Gamaleya Research Institute of Epidemiology and Microbiology in Moscow. She added, though, that the organization has yet to register any COVID-19 vaccines, including Sputnik-V, given the procedures that need to be applied prior to the approval of any vaccines.
Mariangela Simao, assistant director-general at WHO, told the press Nov. 28 that WHO needs to review the clinical data and information before approving and registering Russia’s Sputnik V coronavirus vaccine.
Sherine Helmy, chief executive officer at Pharco Pharmaceuticals in Egypt, said in a Nov. 12 press statement that BioGeneric Pharma — a subsidiary of Pharco Pharmaceuticals — and RDIF signed a memorandum of understanding regarding the Sputnik V coronavirus vaccine, and soon they’ll sign contracts that include legal texts and clauses that are binding on both parties, with industrialization beginning April 20.
Helmy said Pharco Pharmaceuticals submitted a request to Health Minister Hala Zayed to begin clinical trials, to be followed by registration procedures for and manufacturing of the Russian vaccine. He explained that the manufacturing of the vaccine will be completed in two phases in Egypt: The first involves the import and filling of the vaccine in Egypt; the second includes transferring the manufacturing of the vaccine to the Egyptian company, paving the way for its distribution in Egypt and Africa. This, Helmy said, will turn Egypt into the main hub of coronavirus vaccine production in Africa.
Mahmoud Fouad, head of the Egyptian Center for the Right to Medicine, told Al-Monitor over the phone that the signing of cooperation contracts to import the Russian vaccine is in the best interest of Egypt, and he hopes for coordination between Pharco Pharmaceuticals, the Health Ministry, and the Egyptian Authority for Unified Procurement and Medical Supplies to ensure the fair distribution of the Russian vaccine to citizens.
Fouad noted that the Sputnik V vaccine has proven to be effective. Any vaccine that Egypt intends to import will be subject to clinical trials in the country in which the vaccine was developed, he added, noting that Pharco Pharmaceuticals has the financial means to import a large number of the Russian vaccine, which Egyptians can afford.
Commenting on vaccine production in Egypt, Fouad said Egyptian labs lack the capacity to produce the vaccine. He said also countries that develop vaccines do not disclose to other countries the scientific secrets on which they spent billions of dollars and strived to obtain, noting that the most important step is to import the vaccine and vaccinate the citizens regardless of where it was produced.
The Egyptian Cabinet authorized Dec. 2 the finance and health ministers to take the necessary measures to make the coronavirus vaccine available and contract with the Gavi Vaccine Alliance to provide 20 million doses in Egypt. The Cabinet also instructed medical teams to prepare agreements with other companies to guarantee the provision of a large number of vaccines.
Islam Anan, a professor of drug economics and epidemiology at Ain Shams University in Cairo, told Al-Monitor via phone that the production of any vaccine in Egypt will have economic benefits, as the vaccine will be distributed among citizens as well as exported to African markets. On the political level, local production of the vaccine allows the state to control the process without having to rely on global supply and demand, Anan said.
He said the production of medications in general is performed through the transfer of manufacturing technology from one country to another, stressing that Egypt can produce the vaccine considering its long experience among African countries in the pharmaceutical industry and given that it is one the largest producer of drugs in the region.
Anan said that in order to begin producing any drug or vaccine, a license is required from the Egyptian Drug Authority after its documentation and approval by an international organization such as the US Food and Drug Administration or the European Union, and after being added to the WHO's list. He said the technology transfer process takes about six months to a year before manufacturing begins.
Commenting on the criteria to choose the right vaccine, he explained that the vaccine is subject to a scientific assessment that includes the success of clinical trials, accreditation by an international body, the manufacturing and preservation criteria, and whether it meets the conditions of the manufacturing country.
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