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Seizing the Coronavirus Vaccine: Global Fairness and Safety (2)

Source:Iris Liang Time:2020-9-15 16:50:40

WHO Director-General Tan Desai pointed out that vaccine nationalism has exacerbated the new crown pandemic and has accelerated the disruption of the entire supply chain. Vaccines developed in one country need to be placed in vials with corks produced in another country, and the high-grade glass material of these bottles must be purchased from a third country. Therefore, sharing a limited number of vaccines on a global scale is in the national interest of each country both strategically and practically. The significance that globalization brings to us is not only in the economic field. Cooperation in the fields of science and technology, culture, and health can bring benefits to all mankind. In recent years, SEKO Machinery's fully automated industrial stainless steel welded pipe production line has been promoted and used in various countries and regions, and it is inseparable from the convenience brought by globalization.

   "We need vaccine multilateralism, not vaccine nationalism or regionalism." Berkley said.

  "Even before the end of 2021 for developing countries

  Providing nearly 1 billion vaccines is far from enough"

"This is a global problem and requires a global solution." COVAX is currently the world's only international cooperation mechanism to promote vaccine distribution. It is jointly initiated by WHO, the Global Alliance for Vaccines and Immunization (Gavi) and the Alliance for Epidemic Prevention Innovation (CEPI). Launched at the end of April. In the first fundraising meeting of COVAX, Gavi CEO Seth Berkley issued the aforementioned statement.

   When Seth Berkley said this, the leaders of the countries present had no objection. But the problem is how to consider other developing countries when the domestic needs cannot be met. This requires a clever mechanism design and a strong lead unit.

   In order to attract the participation of high-income countries, COVAX adopted a risk diversification strategy. The bottom line is that no country can be sure whether the vaccine in its hands will eventually succeed.

   Due to the particularity of this new crown pandemic, vaccine development must be much faster than the normal five-year cycle. The current international consensus is 18 months, which requires vaccine research and development, testing and production must be carried out simultaneously, which brings huge risks.

   Generally, the probability of successful pre-clinical vaccines is about 7%, while for vaccines that reach clinical testing, it rises to 15% to 20%. Therefore, most vaccine candidates may fail. In the traditional steps, due to the development and production first, whether to establish a production line and how to expand the production capacity are all after a safe and effective vaccine has been developed. But when multiple development steps are executed at the same time, the risk taken increases exponentially. The cost of building a vaccine factory is between US$50 million and US$700 million. Pfizer spent $600 million on its vaccine plant in the United States. The Serum Institute of India estimates that it will cost US$164 million to build a new crown vaccine plant. Johnson & Johnson is considering investing US$1 billion to build a factory.

   To "make such a big bet" without knowing whether the vaccine will succeed, for any country, is tantamount to "standing on the tip of a knife and dancing." The most unfortunate result is that the investment in several vaccines all failed, and the country will face a huge risk of vaccine supply. Therefore, unless the United States is as wealthy as the United States to invest in several vaccines, most middle- and high-income countries that only buy "one or two shots" will tremble before the dust settles. But COVAX offers the possibility to "make multiple bets" like the US without spending too much money.

   Buying vaccines is a big bet. Due to the uncertainty of vaccines, in Berkley's view, no country can achieve 100% coverage, and no vaccine is 100% effective. In addition, the success probability of any candidate vaccine in history is less than 10%. "Therefore, if countries adopt a purely'me first' bilateral approach, in the end, all governments will face the risk of not having a vaccine," he said. "This is the background of the start of the COVAX project, and it is for all countries. The safest bet is to ensure that there is a sufficient dose to protect the most dangerous people."

After any country joins COVAX, it will get the right to use all the vaccines invested by COVAX. COVAX promises that if some countries’ own vaccines fail, they can still get a successful vaccine invested by COVAX, but only about 20% of the population can be guaranteed. . Zhang Li, director of the Gavi Center for Strategic Innovation and New Investors, said vividly when explaining the COVAX mechanism in a public occasion: "It's like you are investing, and a single stock may rise or fall, but if you buy a fund, the pool is huge. There are more vaccine candidates, which is equivalent to diversifying the allocation of investment, which can reduce the risk of failure."

   Another advantage is that the price of getting the vaccine is lower. In Zhang Li's words, it is "group buying." COVAX, as a large buyer that brings together the needs of all parties, has signed purchase agreements with several large vaccine manufacturers at advantageous prices.

   Under the COVAX mechanism, the main measure to ensure the fair distribution of vaccines is a financing model advocated by Gavi: Early Purchase Agreement (AMC). When joining COVAX, there are no requirements for the ability of low- and middle-income countries to pay, but high-income countries must be responsible for their own profits and losses, and join by signing an AMC agreement. These funds will be used to purchase vaccines for 92 low- and middle-income countries. Gavi pioneered the AMC mechanism in 2009, which was first applied to the procurement of pediatric pneumonia vaccines. In the past ten years, 225 million children in 60 low- and middle- and low-income countries have been vaccinated against pneumonia.

The list of 92 countries is determined by the Gavi Council. It mainly includes all economies whose per capita gross national income is less than US$4,000, and other economies that are eligible for the World Bank’s International Development Association (IDA). These countries also have to pay at least a portion of the cost .

In light of the current epidemics in various countries, COVAX's current tentative goal is to obtain at least 2 billion doses of vaccine by the end of 2021, of which 950 million doses will be provided to middle- and high-income countries pre-purchased through AMC, and another 950 million doses will be provided to low- and middle-income countries , There is an emergency buffer stock of 100 million doses to deal with emergencies.

   In order to ensure that low- and middle-income countries can obtain vaccines fairly, AMC must raise at least 5.5 billion in funds, of which 2 billion in seed funding is the most urgent and must be raised in the next six months. As of July 15, AMC has raised 600 million US dollars, but there is still a big gap between 2 billion.

   Berkley told China News Weekly that at present, there are 9 vaccine candidates selected by COVAX, and the other 9 are still being evaluated. In the confirmed list of vaccines, three vaccines are from the United States, namely Novio, Moderna and Novavax; two are from China, respectively, a recombinant protein subunit vaccine developed by China Clover Biopharmaceuticals, and a vaccine developed by the University of Hong Kong. The vaccine of the University of Hong Kong is still in the development stage and has not yet entered human testing. Several other vaccines come from the UK, Germany and Australia.

   At present, 172 countries have pledged to join COVAX and submitted letters of intent. These countries cover more than 60% of the world's population and more than half of the G20 countries. Among them, there are 76 developed countries, including Japan, Germany and the United Kingdom. The European Union has always stated that it is not interested in COVAX, and has also euphemistically advised EU countries not to purchase vaccines through COVAX, because there are some exclusive clauses in the EU's own purchase agreement. If EU countries join COVAX privately, "there will be legal problems." However, on August 31, the European Union suddenly changed its tone and decided to join COVAX and provided a donation of 400 million euros, but said it would still conduct its own bilateral negotiations at the same time.

   In fact, August 31 was originally the deadline to join COVAX, but now this date has been postponed to September 18, and the final date for the initial payment of participating countries has also been postponed to October 9.

   The United States has clearly stated that it will not participate in COVAX, and Russia has not expressed its intention. At the regular press conference of the Ministry of Foreign Affairs on September 2, China expressed its support for COVAX, but there is no clear response to whether it is sure to join and how much it plans to contribute.

Kate Elder, a vaccine policy expert of the international public interest organization "Doctors Without Borders", which is concerned about global health, pointed out to China News Weekly that what is worrying is that COVAX has not yet received the promise of some major vaccine countries, so it cannot change the rules of the global game. .

   She remembered that at a fundraising meeting in early August, more than 30 countries participated. These countries have raised many questions, such as who will manage the money, how it will be used, what is the screening and post-review mechanism for candidate vaccines, and what should be done if all selected vaccines fail. These questions are not received. answer.

   "Many of the mechanisms of this project are not yet transparent." Elder said.

   "The existing intellectual property system must be broken"

In fact, COVAX has put aside the most sensitive and core intellectual property issues in vaccine distribution, and still obtains vaccines through agreements with several vaccine companies. This is essentially a bilateral agreement because COVAX as a whole is equivalent to a large Buyers.

Shashikant emphasized that this pandemic is different from previous ones. The gap between supply and demand of production capacity is very huge. It is impossible for any vaccine company to produce a vaccine that meets global demand. Therefore, it is necessary to open up and share vaccine patents so that developing countries can use their own Excavating production capacity is the most critical point in solving vaccine allocation.

   Third World Network Director Chee Yoke Ling told China News Weekly that during the 2009 H1N1 influenza pandemic, the United States had pre-purchased 600 million of the world’s at least 1 billion production capacity. The United States and many European countries have pledged to donate 10% of their vaccine stocks to underdeveloped countries, but it turns out that these donated vaccines are only provided to poor countries after they have given priority to the supply of their own populations. At this moment, the pandemic has already Subside. Several large private pharmaceutical companies in Europe and the United States have formed a monopoly on vaccines by applying for patents. These companies ostensibly claim to be "dedicated to assisting developing countries as much as they can," but they are essentially chasing commercial profits, not for global public health security.

   "If this new crown pandemic is to stop repeating the same mistakes, it is necessary to break the monopoly of several major private pharmaceutical companies in Europe and the United States on vaccines, that is, to break the existing intellectual property system." She said. The existing intellectual property system is derived from the Agreement on Trade-Related Intellectual Property Rights (TRIPS) passed in 1994. Prior to this, due to the special public product properties of drugs, it was not required to apply for patent registration in drug development and production, and all drugs were open to the world. This model is not conducive to the enthusiasm of private companies for R&D and innovation. Therefore, under the lobbying of large pharmaceutical companies in Europe and the United States for years, TRIPS was born and introduced drug patents. It also requires that any drug production and sales must be authorized and licensed by pharmaceutical companies.

  Ling suggested that when reforming the intellectual property system, one can try to refer to the traditional model before TRIPS in 1994 and make certain adjustments to achieve a better balance between public health safety and patent protection. The international community must reach a mandatory and binding treaty through negotiation. The WHO is a good platform. Unfortunately, the WHO still avoids this sensitive issue. Tan Desai bluntly accused vaccine nationalism, but in terms of the sharing of vaccine patents, he only said lightly that "vaccine requires public investment and public enjoyment."

An expert on international intellectual property law who did not want to be named also pointed out to China News Weekly that the key to the above-mentioned reforms lies in the revision of the law. Not only must the TRIPS be revised, the World Intellectual Property Organization (WIPO) will also convene the Assembly of Contracting Parties to revise the patent law and promulgate it. A new agreement. It is extremely difficult to complete the revision of the two laws at the same time, coordinate the interests and demands of all parties, and obtain the consent of all contracting states. Even after the agreement is reached, the contracting states will have to sign before it can take effect, and it will usually take at least several years to complete a set of national legislative procedures within each country.

  Shashikant believes that in order to establish a brand-new intellectual property framework, it is impossible to rely on developed countries such as the United States and Europe. Developing countries must strengthen their voice and intervene more actively in this matter.

   On August 3, at the TRIPS Council meeting, developing countries dominated by South Africa and developed countries dominated by the United States had a heated debate. South Africa emphasized the need to share knowledge and technology for successful vaccines in order to achieve the widest distribution at the lowest cost. Developed countries pointed out that intellectual property rights must be protected and enforced, and TRIPS flexibilities not related to patents can be discussed.

South African President Ramaphosa said that vaccines should be used in a fair and equitable manner worldwide, and it is time to put them into action. This is true, as COVAX’s slogan says-“In the rapidly spreading new crown pandemic, no one can be safe unless everyone is safe.”

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Iris Liang
SEKO Machinery & Technology Co., Ltd
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