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More than two million petitions were sent to the White House in hopes of convincing the Biden administration to support a proposal that would temporarily waive trade agreement provisions in a bid to widen access to Covid-19 vaccines in low and middle-income countries.

The effort was promoted by several U.S. lawmakers and dozens of advocacy groups amid ongoing controversy over the proposal, which was introduced last fall at the World Trade Organization. Since then, however, the effort has stalled amid push back by the pharmaceutical industry and some wealthy nations, including the U.S., over concerns that intellectual property rights will be compromised.

The clash, which remained deadlocked yesterday at yet another WTO council meeting, emerges as Covid-19 has claimed more than 3 million lives worldwide and new variants threaten to make it harder to contain the coronavirus. Meanwhile, low-income countries have received just 0.3% of the nearly 900 million doses that have been administered globally, according to the World Health Organization.

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Over the past year, the U.S. and other wealthy nations reached deals with vaccine makers for more than half of the nearly 9 billion doses locked up in purchase agreements, according to the Duke Global Health Innovation Center. Some middle-income countries have vaccine development programs, but low-income nations lack manufacturing and clinical testing capacity, so they cannot participate in the dealmaking.

“This is an all-hands-on-deck global emergency and it doesn’t make sense to grant pharmaceutical companies monopolies, especially since taxpayers have provided funding” to develop some of the vaccines, said Abby Maxman, who heads the Oxfam America advocacy group that supports free global access to Covid-19 vaccination. “We need to use every tool at our disposal.”

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Maxman made her remarks during what amounted to dueling press briefings that were held on Friday and focused on the proposal at the WTO. A few hours earlier, three pharmaceutical industry trade groups also held a briefing and while the topic was billed as a discussion of Covid-19 vaccine supply chain issues, many of the questions focused on intellectual property.

The proposal before the WTO, which was introduced by South Africa and India, has galvanized concern over access to medicines, an issue that previously played out on a drug-by-drug, country-by-country basis. The Covid-19 pandemic, however, has underscored a need to ensure that as many people as possible are vaccinated across the globe in order to increase the success of eradicating the virus.

The implications are dire. The inability to contain the coronavirus — especially if further variants take hold — will prevent the global economy from recovering. The International Chamber of Commerce Research Foundation has warned that the global economy stands to lose as much as $9.2 trillion if governments fail to ensure access to Covid-19 vaccines for what it called developing economies.

To address the problem, the WHO worked with the GAVI Vaccine Alliance and CEPI, the Coalition for Epidemic Preparedness Innovations, to create COVAX, which hopes to arrange for vaccines to be supplied to 92 low- and middle-income countries. For now, though, this would only cover about 20% of their populations.

Meanwhile, COVAX remains underfunded. The program’s proposed budget for 2020 and 2021 is $11.7 billion, but total contributions have so far only reached $8.6 billion, leaving a funding gap of $3.1 billion. And not every vaccine maker has signed a supply deal. At the moment, COVAX is largely relying on the AstraZeneca (AZN) shot, which has been linked to very rare but serious blood clots, mostly in women.

So far, COVAX has shipped more than 40 million doses to 118 countries, including 61 lower-income nations, and the Biden administration has agreed to donate up to $4 billion to the program. Consequently, 24 countries have started their first Covid-19 vaccination campaigns. By the end of the year, the program hopes to secure 2 billion doses for distribution.

The various constraints, however, are what prompted the WTO proposal. Over the past few months, as Covid-19 has claimed more lives, a growing number of countries have backed the suggestion, which would also make it easier for countries that permit compulsory licensing to export vaccines. But the pharmaceutical industry has strenuously objected.

As drug makers view the issue, breaching patent rights — even temporarily — would remove needed incentives and threaten future innovation. The companies also argue that sharing confidential blueprints will not readily solve the global access problem. Industry executives maintain that manufacturing expertise is also required to successfully produce a vaccine, particularly in a short amount of time.

“Vaccine manufacturing is not just in the patents,” said Sai Prasad, executive director of quality operations at Bharat Biotech, an Indian company that makes the Covaxin vaccine, and who also heads the Developing Countries Vaccine Manufacturers’ Network, during the industry briefing. “If I give that to just anybody, I don’t think they’ll be able to do anything about it. They need know how and expertise… It’s needed in a package.”

Toward that end, the pharmaceutical industry has further argued that licensing deals are more appropriate, since such arrangements would govern the technology to be transferred and could be reached with companies that have the necessary ability to produce a vaccine. AstraZeneca (AZN), for instance, reached such a deal with the Serum Institute of India.

Some dispute this. In Canada, a company called Biolyse approached AstraZeneca and Johnson & Johnson (JNJ) to obtain licenses to manufacture Covid-19 vaccines to distribute in low and middle-income countries. Biolyse pitched itself as a good candidate since it already makes injectable medicines and has spare plant capacity, and so could produce a vaccine in about six months. But it was turned away.

At the WTO council meeting on Thursday, a representative of the Indian government noted that approximately 10 billion Covid-19 vaccine doses will be needed each year, but that voluntary licensing deals provided only 4% — or 31 million doses — in 2020. By issuing a waiver, supporters of the proposal argue that the WTO could speed the process of putting more production in place.

Last week, WTO Director-General Ngozi Okonjo-Iweala said she expects the vaccine makers to “advance negotiations” on the proposal, but the European Union, the U.K. and Switzerland continued to maintain that any move that could undermine intellectual property rights would effectively be seen as dead on arrival.

Whether the U.S. will change gears and consider the proposal remains to be seen. But also last week, U.S. Trade Representative Katherine Tai appeared to signal that the Biden administration may keep an open mind. Earlier this month, she met with advocacy groups about the proposal and, in remarks last week at a WTO virtual conference, she mentioned that “modifications and reforms” are needed.

  • Agdin, what happened to Sinopharm’ Sinovac? Why is the WHO procrastinating in the review of this vacvune that has already been given to hundreds of millions of Chinese citizens? Didn’t the manufacturer disclose that they can produce as many as 3 billion doses per year?

    Is this a case of Sinophobia?

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