{"id":155386,"date":"2021-05-08T19:50:11","date_gmt":"2021-05-08T19:50:11","guid":{"rendered":"http:\/\/radiofree.asia\/?guid=f50d700b0eda65c94c6ef8b5f82c4d9a"},"modified":"2021-05-08T19:50:11","modified_gmt":"2021-05-08T19:50:11","slug":"health-experts-say-expanding-vaccine-access-requires-more-than-patent-waivers","status":"publish","type":"post","link":"https:\/\/radiofree.asia\/2021\/05\/08\/health-experts-say-expanding-vaccine-access-requires-more-than-patent-waivers\/","title":{"rendered":"Health Experts Say Expanding Vaccine Access Requires More Than Patent Waivers"},"content":{"rendered":"\"D.C.<\/a>

Biolyse Pharma Corp., which makes injectable cancer drugs, was gearing up to start making generic biologic drugs, made from living organisms. Then the pandemic hit.<\/p>\n

Watching the covid death toll climb, the company decided its new production lines and equipment could be converted to making vaccines for poorer countries without the means to do so.<\/p>\n

John Fulton, a consultant for the Canadian company, emailed Janssen, the Johnson & Johnson subsidiary that makes the vaccine, which employs a live, though disabled, virus. Biolyse sought a license so it could produce 20 million of J&J\u2019s shots.<\/p>\n

When J&J\u2019s rejection form letter finally arrived, it misspelled his name: \u201cDear Mr. Folton, Thank you for your interest \u2026\u201d<\/p>\n

Smaller companies like Biolyse may command more attention from the big corporate vaccine manufacturers after the Biden administration announced support Wednesday for a proposal<\/a> to waive patent protections for covid-19 vaccines and therapies.<\/p>\n

As coronavirus deaths ravage Brazil<\/a> and India<\/a> and other countries across the globe, pressure to force J&J, AstraZeneca, Novavax, Pfizer and Moderna to waive their intellectual property protections and share their technology reached a crescendo this week.<\/p>\n

Yet while Biden\u2019s support of the waiver might be good optics, experts said, it won\u2019t be enough.<\/p>\n

Moderna, which did not respond to requests for comment, announced in October<\/a> that it would not enforce its covid-related patents during the pandemic. Even so, no known independent producer has used the available patents to replicate the company\u2019s mRNA vaccine. Experts say that\u2019s telling.<\/p>\n

\u201cYou can\u2019t manufacture its vaccine unless you have access to trade secrets as well as the patents,\u201d said Brook Baker, a law professor at Northeastern University who participated in early conversations on the creation of the World Health Organization\u2019s Covid-19 Technology Access Pool, or C-TAP. To date, no vaccine technology has been added to the pool.<\/p>\n

The patents alone wouldn\u2019t be enough. A manufacturer would also need access to internal processes: the technology and know-how that bring a vaccine to life. They\u2019d need skilled scientists and technicians from the original company to train their staff for months. On top of that, every manufacturer in the world would be on the hunt for the limited supplies of single-use bioreactor bags, vials and adjuvants.<\/p>\n

In the best-case scenario, sharing patents is only a tiny step in the vastly complex work of making a covid vaccine, which relies on sophisticated new technologies. At its worst, they say, waiving patents would strain already taxed supply chains and encourage counterfeiting and shoddy production that could result in dangerous or ineffective vaccines, besmirching the reputation of vaccination for years.<\/p>\n

Instead of focusing on patents, some say, global leaders should subsidize additional production of existing vaccines at discount prices through groups like Gavi, the Vaccine Alliance<\/a>, which already funds billions annually in discounted vaccines for the developing world.<\/p>\n

Dr. Stanley Plotkin, the inventor of the rubella vaccine and a consultant to vaccine makers, said allowing inexperienced companies to produce vaccines \u201ccould be a disaster for covid vaccines and for vaccines in general.\u201d<\/p>\n

Plotkin proposed that an intellectual property transfer be allowed to happen only if a regulatory authority, such as the Food and Drug Administration, inspected the receiving company and agreed it was competent.<\/p>\n

Proponents of the waiver argue that without urgent action, many more people will die. \u201cAt this pace,\u201d 9 of 10 people in the developing world will remain unvaccinated this year \u2015 and it could be \u201cat least 2024\u201d before many nations achieve mass immunization, according to an open letter <\/a>to President Joe Biden last month from more than 170 Nobel laureates, former prime ministers and heads of states.<\/p>\n

\u201cI think we\u2019re going to find very soon that this Canadian company is just a drop in the bucket,\u201d said Niko Lusiani, a senior adviser for Oxfam America who helped gather signatures. \u201cThere are many manufacturers ready to come on line.\u201d Even more, he said, there is capacity to be built if those technologies are available and the investors are not facing trade sanctions for doing so.<\/p>\n

U.S. Trade Representative Katherine Tai\u2019s statement on Wednesday was carefully worded, saying the U.S. will \u201cactively participate in text-based negotiations\u201d on the global stage to support the waiver. It would require the approval of all 164 member nations.<\/p>\n

Tai, picked by Biden in December, met with more than two dozen parties integral to the global vaccine supply chain, including executives of AstraZeneca, Novavax, J&J, Pfizer and Moderna as well as nonprofit proponents of the waiver and Bill Gates. The Microsoft founder and philanthropist, who helped establish global vaccination efforts, has come out in opposition to the waiver. Gates had urged Oxford<\/a> to commercialize its vaccine after it initially promised to donate the rights to any drugmaker to manufacture for the public good. Oxford gave AstraZeneca sole rights, with no guarantee it would be offered at a low cost, and retained a stake in the profits.<\/p>\n

Michael Watson, a longtime vaccine industry official and current consultant to Moderna, called forcing companies to give away their licenses a \u201cdangerous precedent.\u201d<\/p>\n

\u201cThe problems that we are trying to solve are reliability, quality, cost and access to vaccine supply,\u201d he said. \u201cThese can all be done through established market mechanisms of partnerships, licensing, disruptive innovation, tax breaks, incentives and government funding without attacking the market mechanisms that made all of this possible in the first instance.\u201d<\/p>\n

Bio Farma, the state vaccine producer in Indonesia, is planning to produce one of the Chinese vaccines. The Brazilian company Fiocruz is making AstraZeneca\u2019s vaccine, as is the Serum Institute of India. All these deals involve technology transfer and training, as well as raw materials.<\/p>\n

Dr. George Siber, a vaccine expert currently consulting with six vaccine companies worldwide, including mRNA vaccine maker CureVac, said that without the technology transfer \u201cwe\u2019re talking about years of work\u201d to figure out how to replicate a vaccine.<\/p>\n

Vaccine manufacturers have partnered across the globe — and it has been akin to a high-end matchmaking process with the vaccine makers signing voluntary licensing deals only with trusted manufacturers.<\/p>\n

Thomas Cueni, director-general of the International Federation of Pharmaceutical Manufacturers and Associations, said that with each partnership the original vaccine manufacturer is stretched \u201cto the limits because really there\u2019s a lot of hand-holding, there\u2019s a lot of knowledge sharing, training of skilled workers.\u201d<\/p>\n

To emphasize the work involved, Cueni pointed to the mRNA vaccine of Pfizer-BioNTech, which has more than 280 components and 86 suppliers from 19 countries.<\/p>\n

It\u2019s not likely, Cueni added, that the covid vaccine makers will willingly partner with a company unless they mutually agreed to do so.<\/p>\n

\u201cDo you think that if you try to coerce companies already stretched out, they would then give you not just the recipe, the blueprint, but really show you how to do it?\u201d he said.<\/p>\n

J&J spokesperson Jake Sargent declined to confirm the email interaction with Biolyse. But he said in an email that only a limited number of manufacturers can produce its vaccine safely, with high quality, and to scale. J&J assessed nearly 100 production sites and, in the end, selected fewer than a dozen.<\/p>\n

For the manufacturers, supplies are also a hurdle. As more companies get into the game of making vaccines globally, there simply won\u2019t be enough ingredients.<\/p>\n

Pfizer\u2019s Sharon Castillo wrote in an email that if companies begin to buy up scarce supplies in the hope of manufacturing a vaccine using technology developed by others, \u201cit will make it harder, not easier, to manufacture vaccines in the near term.\u201d<\/p>\n

Through COVAX, Castillo said, Pfizer will deliver up to 40 million doses in 2021 to countries across the globe such as Bosnia, Tunisia, Rwanda, Peru, the West Bank and the Gaza Strip, and Ukraine.<\/p>\n

Nicole Lurie, a senior adviser at the Coalition for Epidemic Preparedness Innovations<\/a>, said the waiver does not address the short-term need for supplies or the potential for countries to donate excess doses.<\/p>\n

Manufacturers have already announced that they hope to supply up to 14 billion doses of vaccines globally in 2021 \u2015 that\u2019s triple the previous annual vaccine output, according to a discussion paper<\/a> posted by IFPMA and organized for an international summit on shortages.<\/p>\n

The report warned that a shortage of supplies may result in several current covid manufacturers not being able to meet current vaccine manufacturing commitments. There\u2019s concern about the need for single-use bioreactor bags used for cell culture and fermentation for all vaccines. And, the lipid nanoparticles used to create mRNA vaccines are also in tight supply, with only a few capable suppliers currently operating at scale.<\/p>\n

So far, more than 1.21 billion vaccines doses have been administered worldwide, but mostly in the U.S. and other wealthy countries. Canada\u2019s Biolyse said that if it can manufacture the J&J vaccine, a small developing country has committed to buying it.<\/p>\n

Without a voluntary consent from the manufacturer, though, Biolyse is now working to obtain a compulsory license to produce the J&J vaccine, which would force J&J to waive its intellectual property rights. Such a legal maneuver is allowed under current international law, but the Canadian government would have to support Biolyse\u2019s license application. So far, it has not.<\/p>\n

Canadian officials have met with Biolyse and other companies, as well as international vaccine developers, about the feasibility of making their products in Canada, said Sophy Lambert-Racine, a spokesperson for Innovation, Science and Economic Development Canada.<\/p>\n

The \u201cexisting Canadian biomanufacturing assets were deemed to be of an insufficient scale or utilized technology platforms which were not suitable to the needs of these firms,\u201d said Lambert-Racine, adding that the Canadian government is now investing more than <\/a>$1 billion<\/a> into covid vaccine and therapeutics research and development.<\/p>\n

Biolyse is a small company with about 50 employees, including \u201cscientists who have spent their working lives producing vaccines,\u201d Fulton said. The company has said it still needs about $4 million in financing to finish setting up manufacturing lines.<\/p>\n

Claude Mercure, a co-founder of Biolyse, said that even if the company doesn\u2019t share the patent and the technology, he is confident his company can figure out how to make the J&J vaccine, which uses a disabled adenovirus to deliver instructions to the body on fighting the coronavirus. In recent weeks, though, other independent scientists have reached out to collaborate and potentially develop a new vaccine.<\/p>\n

Trying to remake the J&J vaccine without a technology transfer and partnership would potentially take years, but with a strategic partnership Biolyse could be making vaccines within four to six months, Biolyse executives said.<\/p>\n

Regardless of what happens with the waiver, the tenor of international conversation about intellectual property rights puts pharmaceutical companies on notice, said Mara Pillinger, a senior associate in global health policy and governance at Georgetown\u2019s O\u2019Neill Institute for National and Global Health Law.<\/p>\n

\u201cLarge parts of the world are not going to suffer with covid until [the industry] gets around to prioritizing them,\u201d she said.<\/p>\n

KHN<\/a> (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF<\/a> (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.<\/em><\/p>\n

<\/p>\n\n

This post was originally published on Latest \u2013 Truthout<\/a>. <\/p>","protected":false},"excerpt":{"rendered":"

\"D.C.<\/a><\/p>\n

In the best-case scenario, sharing patents is only a tiny step in the vastly complex work of making a COVID vaccine.<\/div>\n","protected":false},"author":1731,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[338,6582,304,10114,13775,4],"tags":[],"_links":{"self":[{"href":"https:\/\/radiofree.asia\/wp-json\/wp\/v2\/posts\/155386"}],"collection":[{"href":"https:\/\/radiofree.asia\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/radiofree.asia\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/radiofree.asia\/wp-json\/wp\/v2\/users\/1731"}],"replies":[{"embeddable":true,"href":"https:\/\/radiofree.asia\/wp-json\/wp\/v2\/comments?post=155386"}],"version-history":[{"count":1,"href":"https:\/\/radiofree.asia\/wp-json\/wp\/v2\/posts\/155386\/revisions"}],"predecessor-version":[{"id":155387,"href":"https:\/\/radiofree.asia\/wp-json\/wp\/v2\/posts\/155386\/revisions\/155387"}],"wp:attachment":[{"href":"https:\/\/radiofree.asia\/wp-json\/wp\/v2\/media?parent=155386"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/radiofree.asia\/wp-json\/wp\/v2\/categories?post=155386"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/radiofree.asia\/wp-json\/wp\/v2\/tags?post=155386"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}