World Economic Forum creating consortium to expand COVID-19 vaccine manufacturing capacity

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INTRODUCTION

Protecting the world

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World Economic Forum

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EU Vaccine Strategy

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COVAX created

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Path to 300M doses

The World Economic Forum is leading the establishment of a consortium that will bring the capabilities of vaccine manufacturers outside the U.S. and Europe into the fight against COVID-19. The goal is to produce billions of doses of vaccines for people living in developing countries who are unlikely to be able to access vaccines made in the U.S. and Europe.

The consortium will pair multinational innovator vaccine developers with contract manufacturers in India, South Korea and other countries.

The Manufacturers Alliance for Global Equitable Access to Coronavirus Vaccines (Manage-Cov) will complement the activities of the COVID-19 Vaccine Global Access (COVAX) Facility, a global purchasing pool that is using advanced purchase commitments to guarantee markets for COVID-19 vaccines and ensure equitable global access (see “COVAX Created to Try to Avoid Global Bidding Frenzy”).

Innovators that chose to participate in Manage-CoV will receive payments for IP and royalties, while contract manufacturers will receive funding to cover the costs of expanding capacity to produce COVID-19 vaccines in addition to those they are already producing.

The establishment of Manage-Cov will be publicly announced in late June, individuals involved in creating the consortium told BioCentury.

The WEF has had detailed discussions about Manage-Cov with the Developing Countries Vaccine Manufacturers Network (DCVMN), as well as large-scale vaccine manufacturers in developing countries that are not part of the network. Vaccine manufacturers network members, which include over 40 manufacturers in India, Indonesia, South Korea, Brazil, China, South Africa and other countries, produce 65% of vaccines distributed outside of Europe.

Negotiations for creating Manage-CoV have involved the governments of India and Japan; Coalition for Epidemic Preparedness Innovations (CEPI); Gavi, the Vaccine Alliance; multinational vaccine innovators; and international finance organizations.

The initiative is needed because the billions of dollars the U.S. and European countries are investing in COVID-19 vaccine manufacturing comes with strings attached, including requirements to manufacture in the countries that provide funding to prioritize meeting demand in funding countries, and restrictions on exports.

“Judging by the manufacturing solutions currently being designed for COVID-19 vaccination, the best-case scenario for vaccine delivery outside of the G7 countries is in the magnitude of a few hundred million doses, when up to 4 billion doses could be required to address the needs of the most vulnerable populations on the planet,” according to the WEF.

Adding manufacturing capacity

The goal of Manage-Cov is to increase overall capacity, not to divert capacity from the production of existing vaccines.

The increase is needed because requirements for COVID-19 vaccines dwarf existing production, and it is important that producing new vaccines doesn’t disrupt supplies of existing vaccines.

Excluding seasonal influenza vaccines, every year a total of 3.5 billion doses of vaccines are sold globally. More than 7 billion doses of COVID-19 vaccines could be needed, and depending on the duration of protection, it may be necessary to maintain high levels of production indefinitely.

In its initial discussions, Manage-Cov is considering funding up to six manufacturing hubs over a six-month period. The consortium would provide a portion, possibly 75%, of the cost to expand capacity to enable each hub to produce hundreds of millions of doses of COVID-19 vaccines annually. Funding would be a mix of grants and loans.

Manage-Cov would create a pool of qualified vaccines, allowing contract manufactures to avoid negotiating deals with innovators before the safety and efficacy of specific vaccines has been demonstrated. In the absence of a pool, manufacturing capacity could be obligated to a vaccine that will not be produced.

Companies that operate the hubs would be granted options to select vaccines from a pool of qualified vaccines. They could exercise these options when Phase III trials start, with the goal of having products available when vaccines are authorized.

Conditions for contract manufacturers that participate in Manage-Cov include complying with equitable access principles for distribution, and cooperating with innovators on quality control and lot release procedures.

Manage-Cov would coordinate with global procurement initiatives, including COVAX, so manufacturers would have guaranteed contracts for the vaccines they produce.

Manage-Cov plans to make investments in manufacturing hubs contingent on agreements from national governments where the hubs are located to allow a prespecified portion of vaccines to be exported.

Tech transfer, licensing & royalty payments

Innovators that participate in Manage-Cov would receive compensation for transferring IP, manufacturing technology and technical knowledge.

Technology transfer and licensing would be limited to IP associated with COVID-19 vaccines.

In addition, the manufacturing hubs would pay royalties or enter into profit-sharing agreements with innovators.

Innovators would also be required to support Manage-Cov’s equitable access principles when allocating vaccines they produce in excess of commitments they have already made to government funders.

Options for financing Manage-Cov include receiving contributions from COVAX, international development institutions such as the World Bank and the International Finance Corporation, and national governments.

WEF is also exploring with an investment bank the possibility of selling financial instruments that would yield returns based on the volume and timing of vaccine production.

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