WTO addresses vaccine supply, export restrictions

12 March 2021

Mari Serebrov / BioWorld

With COVID-19 vaccine manufacturing still scaling up and the scarcity of some supplies, most of the vaccine doses available so far have been distributed in 75 countries while 115 countries are still waiting, World Trade Organization (WTO) Director-General Ngozi Okonjo-Iweala said at the March 9 Global C19 Vaccine Supply Chain and Manufacturing Summit.

If that inequity isn’t addressed quickly, it will prolong the pandemic and cause economic harm to all countries, she said, attributing much of the problem to export restrictions and wealthier countries bidding up the price of vaccines.

Rather than throwing her support behind a proposal, led by India and South Africa, to waive intellectual property rights for the vaccines, Okonjo-Iweala called on vaccine manufacturers to ramp up vaccine production in developing countries, “making the most of existing manufacturing capacity – finding existing sites and turning them around.”

Recent experience has suggested that repurposing facilities and vetting them for safety and quality could be done in six or seven months, Okonjo-Iweala said, noting that’s less than half the time previously estimated.

However, given the complexity of the vaccines that have been developed, finding manufacturing sites that can be repurposed to handle the manufacturing processes required for the vaccine is a challenge. Testifying before a U.S. House subcommittee last month, Richard Nettles, vice president of U.S. medical affairs at Johnson & Johnson’s (J&J) Janssen Infectious Diseases and Vaccines unit, said that out of nearly 100 manufacturing sites J&J had assessed globally, eight were identified that could meet the accelerated production timeline.

If sites were repurposed in developing countries, Okonjo-Iweala’s estimated timeframe would mean some lower-income countries would not reach full vaccination until next year, due to the time it takes to scale up and produce the vaccines.

For instance, Nettles said producing the drug substance for J&J’s one-dose vaccine takes two months, because of the time needed to grow the biological cells and then purify the active vaccine. Another five to six weeks is needed to produce, test and release the finished vaccine. That’s another 3.5 months on top of the time needed to repurpose and staff a facility.

End export restrictions

Then there are the other manufacturing constraints vaccine makers face that are common to drug and device manufacturers as well. Three major constraints were identified at the summit – a continuing scarcity of raw materials, shortages of qualified and experienced personnel, and supply chain problems linked to export restrictions and prohibitions, along with excessive bureaucracy.

To help minimize problems in the medical supply chain, Okonjo-Iweala urged all WTO members to drop or reduce their export restrictions, or at least set timelines for phasing them out. As of the end of February, 59 WTO members and seven observers had some pandemic-related export restrictions or licensing requirements in place, many of which pertain to personal protective equipment. On the bright side, that number is down from the 91 countries that had imposed restrictions last year.

WTO rules allow for temporary export restrictions or prohibitions to prevent or relieve critical shortages of essential products, but all members must be notified of the restrictions and a timeline should be given for phasing them out. The restrictions also must be transparent and proportionate to the current problem.

However, some WTO members aren’t following those rules. “Not all pandemic-related export restrictions have been notified,” Okonjo-Iweala said. “Not all of them appear to be temporary. Not all of them are proportionate.”

The day after Okonjo-Iweala’s address, the Pan American Health Organization (PAHO) reported on the expanding rollout of COVID-19 vaccines in the Americas and efforts to accelerate access further.

On March 1, Colombia became the first country in the region to receive vaccines through COVAX. Peru was scheduled to receive its first shipments of the Pfizer Inc.-Biontech AG vaccine March 10 through COVAX, as part of 2.3 million COVAX doses being shipped to Bolivia, El Salvador, Guatemala, Honduras, Jamaica and Nicaragua, as well as Peru, PAHO Director Carissa Etienne said at a weekly briefing.

In addition, Bahamas has received its first COVID-19 vaccines, due to India’s donation of 20,000 doses of the Astrazeneca plc vaccine.

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