In the shadow of the COVID-19-related deaths of more than half a million Americans and far more deaths across the world, the Biden administration is reportedly rethinking its position on a proposal before the World Trade Organization (WTO) to waive intellectual property (IP) protection for SARS-CoV-2 vaccines.

Executives of companies developing the vaccines for the U.S. market argued against such a waiver Feb. 23 as they gave the House Energy and Commerce Subcommittee on Oversight an update on their vaccine programs. They stressed the complexity of manufacturing and the need to ensure the quality of the end product, while reiterating their commitment to ensure global access.

IP is not a limitation to global access, Richard Nettles, vice president of medical affairs at Johnson & Johnson’s (J&J) Janssen Pharmaceutical Cos., told Rep. Janice Schakowsky (D-Ill.), who had expressed concern that, without a waiver, the wealthy countries of the world would monopolize the COVID-19 vaccines.

According to Schakowsky, the proposed waiver, supported by more than 100 countries and led by India and South Africa, will be discussed next week at the WTO. The U.S. should support the waiver, she said, otherwise the billions of dollars being spent to reopen industries impacted by the pandemic will be wasted, as leaving poorer countries defenseless against the coronavirus will continue the global threat.

“This is something we should do so we have plenty for us and we have plenty for the rest of the world,” Schakowsky said.

She claimed that Astrazeneca plc’s vaccine costs more than twice as much in South Africa as it does in Europe. Allowing countries to freely manufacture the vaccines would make them more affordable and accessible, she said, noting that only the rich countries are opposing the waiver. She added that it’s immoral to keep poorer countries from getting the vaccines.

That’s not what’s happening, according to the biopharma executives. Nettles said J&J is donating millions of doses to other countries, and the other executives tried to explain the steps they’re taking to ensure access to their vaccines before Schakowsky cut them off.

For instance, John Trizzino, executive vice president, chief commercial officer and chief business officer for Novavax Inc., said his company is engaged in technology transfers with companies across the world. It already has shared its nanotechnology with India’s Serum Institute and with contract manufacturing organizations (CMOs).

Manufacturing challenges

Given the complex manufacturing and the know-how needed to produce the Novavax vaccine, Trizzino said his company needs to have some oversight to ensure the quality of the vaccine.

Ruud Dobber, executive vice president at Astrazeneca and president of the company’s biopharmaceuticals business unit, echoed that need. In addition to committing millions of doses to the global COVAX effort, Astrazeneca is sublicensing its vaccine IP to ensure quality. Safeguarding quality is more important than allowing companies to freely make knock-off versions of approved vaccines, he said.

While Moderna Inc. President Stephen Hoge didn’t comment on the proposed WTO IP waiver, he stressed the challenges of vaccine manufacturing throughout the hearing and in his written testimony. Those hurdles, as well as ones other companies encountered, would suggest that IP waivers wouldn’t necessarily lead to immediate increased vaccine access.

“It’s a pretty complicated system,” Hoge said of Moderna’s vaccine manufacturing process. Any expansion of capacity requires lining up all the raw materials, supplies, systems and a highly skilled workforce, he said. That process can take from four to nine months.

Explaining why Moderna didn’t meet its original production estimates for the vaccine, Hoge said that when it made those estimates, the company still had a lot to learn because it had never manufactured vaccines at the scale being required. He also noted that as personnel gained experience in manufacturing the vaccine, the process became more efficient, which is resulting in greater output now.

In hindsight, Hoge acknowledged that Moderna may have been able to produce more vaccine doses sooner had it started the process earlier.

Other vaccine developers faced similar challenges. Nettles said that when J&J began scaling up production of its single-dose vaccine, which will be the subject of an FDA adcom meeting Feb. 26, the company assessed more than 100 manufacturing sites for potential partnerships. Many of those didn’t have the capabilities needed to produce the vaccine.

When Pfizer Inc. was scaling up the manufacture of the COVID-19 vaccine it partnered with Biontech SE, it had to invest significantly in its manufacturing sites, adding new lines and working with CMOs, John Young, Pfizer Group president and chief business officer, testified. But even at that, the company faced challenges getting an adequate supply of some of the raw materials required for the vaccine.

Young said the federal government used the Defense Production Act to help the company source hard-to-get supplies. Since then, Pfizer has brought production of some of the raw materials in-house.

Those challenges seem to be in the past, as all five executives testified that their companies have everything they need to meet their U.S. vaccine dose commitments within the next few months. Should that happen, the U.S. would have a surplus of millions of doses by midsummer that could be shared with other countries, Rep. Morgan Griffith (R-Va.) said.

“That’s the hope,” Hoge responded.

Meanwhile, the five companies are continuing to expand their vaccine trials to subpopulations, such as children and pregnant women, that were not included in the original phase III trials. They also are setting to work on boosters and what could be the next generation of vaccines intended to target emerging COVID-19 variants.