21. February 2021

So funktioniert die COVAX Facility für weltweiten Zugang zu Covid-Impfstoffen

With the goal of ensuring that countries have expeditious access to COVID-19 vaccines regardless of their purchasing power, the World Health Organization (WHO) has launched the COVAX initiative and its COVAX Facility. COVAX stands for „Covid-19 Vaccines Global Access“.

The COVAX Facility's mission is to accelerate vaccine development and production. Most importantly, it is responsible for purchasing vaccine doses from manufacturers and allocating them to all states that have declared their participation in COVAX.

In one of our #vfaTonspur podcast editions, radio journalist Philipp Eins asks vfa Managing Director Research Dr. Siegfried Throm about European vaccine procurement: Is lifting patents the solution for more vaccines? How can they be distributed fairly worldwide? And what role does the so-called COVAX facility play in this?

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By the end of 2021, at least two billion quality-assured and need-based vaccine doses should be ready to end the acute phase of the pandemic, according to COVAX's stated goal. Poorer countries are to receive at least 1.8 billion of these vaccine doses (of which 1.3 billion will be free) to protect about 27 percent of their populations in 2021. The idea behind this is solidarity and the conviction that, in a closely interconnected world, the Covid 19 pandemic can only be contained if all regions are adequately protected.

Access to vaccination must be possible and affordable for all countries»
German Chancellor Angela Merkel in late November 2020 in her video message to the G20 Summit

Eine ältere Brasilianerin erhält eine Impfung gegen Covid-19

The COVAX Facility is operated by the World Health Organization (WHO) together with the private-public vaccine alliances Gavi (Global Alliance for Vaccines and Immunizations, lead) and CEPI (Coalition for Epidemic Preparedness Innovations). As a "vaccine pillar," COVAX and COVAX Facility are part of the umbrella organization Access to COVID-19 tools (ACT). ACT is also responsible for diagnostics, medicines, and health systems strengthening.

There are now 190 countries participating in COVAX out of a total of about 200 countries worldwide, including 98 wealthier countries and 92 low- and middle-income countries.

When wealthier nations purchase vaccines through the COVAX Facility, they pay the full price negotiated with vaccine manufacturers. Poorer countries are asked to contribute financially, but if they cannot, they are entitled to free supplies. Many wealthier countries choose not to be supplied by COVAX. However, they support procurement for poorer countries financially or donate purchased quotas. There are also an increasing number of countries that announce that they will later donate surplus vaccine doses from the stocks they have purchased.

When wealthier nations purchase vaccines through the COVAX Facility, they pay the full price negotiated with vaccine manufacturers. Poorer countries are asked to contribute financially, but if they are unable to do so, they are entitled to free supplies. Many wealthier countries choose not to be supplied by COVAX. However, they support procurement for poorer countries financially or donate purchased quotas. There are also an increasing number of countries that announce they will later donate surplus vaccine doses from the stocks they purchase.

The European Union announced at the G7 digital summit on Feb. 19, 2021, that it would increase its support for the COVAX Facility to 1 billion euros, after initially pledging 500 million euros. It sees this as an act of global solidarity and a complement to its bilateral agreements with vaccine manufacturers to supply its own population, for which €2.7 billion has been reserved. Also announced on February 19, Germany is supporting the COVAX Facility with an additional 980 million euros - on top of the high millions already contributed and as part of comprehensive assistance to combat the pandemic.

While China has been a member of the COVAX Facility since October 2020, the USA did not join until after President Joe Biden took office in January 2021. The USA will support COVAX, as Biden announced at the virtual G7 summit, with an expected total of $4 billion in 2021 and 2022.

I thank the United States, Germany, the European Commission, the European Investment Bank, Japan and Canada for their significant funding commitments. Today's news shows us that solidarity is winning.»
Tedros Adhanom Ghebreyesus, Director-General of WHO, on February 19, following the online G7 Summit

A sophisticated mechanism

To ensure coverage of participating countries, the COVAX Facility has developed different approaches:

Well-being nations quantify in advance the proportion of the population (between 10% and 50%) to be protected with vaccines from the COVAX program. COVAX offers two payment models for the appropriate supply. Under the "Committed Purchase Agreement," countries pay half of the calculated price for the required doses of vaccine and sign a purchase commitment for the other half (COVAX calculates $6.40 per person for two doses of vaccine). Under the "Voluntary Purchase Agreement" (Optional Payment Agreement), countries pay US$6.20 per person upfront, purchasing the right to be supplied with the vaccines of their choice from the COVAX range. The vaccines are purchased either directly from the manufacturer or with the help of UNICEF and other intergovernmental organizations. Unused funds will be reimbursed, according to the COVAX Facility.

Wealthier countries can also anonymously donate purchased procurement rights for use by destitute countries. Among others, Germany and the EU Commission make use of this option, but also non-governmental organizations such as the Gates Foundation. In addition, richer countries can make vaccines that they have secured in bilateral contracts with manufacturers available to poorer countries on fair terms. The procedure is governed by the principles published by the COVAX Facility, "Principles for Dose-Sharing."

Low- and middle-income countries are supplied with vaccines with the help of the Gavi COVAX Advance Market Commitment (AMC). Donations from wealthy countries have enabled the program to get off the ground, with a total of $2.4 billion available at the end of 2020. Further funding is to be secured via bonds, among other sources. Recipient countries can apply for up to $150 million to prepare for the upcoming vaccination campaign, with advice from institutions such as WHO, UNICEF and the World Bank. Before receiving vaccines, countries must demonstrate proper infrastructure, as well as well-trained health workers and community education activities. Detailed vaccine requests have been made so far by 86 of 92 poorer participating countries. In January 2021, WHO announced a "Country Readiness Portal" through which AMC participants can submit their final national deployment and vaccination plans.

An own mechanism to channel surplus vaccines to poorer countries is currently being developed by the European Union (see below).

News from participating countries

UK, which has ordered 400 million vaccine doses and will have many left over, has pledged at the virtual G7 summit on Feb. 19, 2021, to donate most of its surplus supply to poorer countries via COVAX. Similar pledges had previously been made by Canada, France, Norway and the European Union.

North Korea will receive close to two million doses of the AstraZeneca/Oxford vaccine via COVAX, according to the current distribution plan. The country, which says it has no COVID-19 infections, had asked for this shipment.

China plans to provide COVAX with ten million vaccine doses from three Chinese manufacturers. As the Ministry of Foreign Affairs in Beijing announced, they want to contribute to the urgent need in developing countries contribute. The World Health Organization is currently reviewing the approval of Chinese vaccines for emergency use.

A plan to store, distribute and administer BioNTech/Pfizer vaccines is currently being developed by Bangladesh. The government there had responded to a purchase offer for a vaccine contingency submitted by the COVAX Facility in early January 2021. So far, nothing has been disclosed about the conditions.

For the same vaccine, COVAX also made a purchase offer to South Africa as a middle-income country. The proposed price of ten U.S. dollars per dose is half the regular price in the United States. The South African government rejected the purchase offer as prohibitively expensive, citing bilateral negotiations with "at least two other manufacturers." For its vaccination campaign, which is expected to start in the second quarter of 2021, South Africa has so far relied largely on supplies through the COVAX initiative.

African countries can expect initial shipments of nearly 90 million COVID-19 vaccine doses from the COVAX program in February 2021, with larger quantities later, according to the WHO regional director for Africa, Matshidiso Moeti. Because the total 600 million doses of vaccine from the COVAX Facility earmarked for Africa in 2021 will only cover about 20 percent of the population, government agencies on the continent are seeking to secure additional doses through separate agreements. The goal is to reach a vaccination rate of 60 percent of the population to achieve herd immunity against the virus. Against this backdrop, the African Union has secured 270 million COVID-19 vaccine doses directly from manufacturers BioNTech/Pfizer, Janssen (Johnson & Johnson) and AstraZeneca through the Serum Institute of India for member states, as announced on Jan. 14, 2021.

Vaccine supplies in the future could also come directly from the European Union, which is currently developing a strategy to distribute surplus vaccine doses to less affluent countries in the Balkans, Middle East and Africa. The new mechanism will get vaccines to poorer countries "before COVAX is fully operational," EU Health Commissioner Stella Kyriakides said. According to Reuters news agency, it is still unclear whether the EU will donate or sell its surplus doses and when the vaccines can be made available. Sweden has already set up a mechanism to sell its surplus vaccines, according to the agency.

Cooperation with Manufacturers

Vaccine manufacturers collaborating with the COVAX Facility will be enabled to rapidly and extensively expand their production capacity through upfront purchase commitments and upfront payments. To this end, the COVAX Facility aims to provide $5.7 billion. The pre-purchase commitments will specify supply volumes, delivery dates and prices, with the COVAX Facility seeking to negotiate prices that are at most on par with bilateral supply contracts with individual countries. How vaccine supplies are allocated to participating countries and are to be used is to be governed by WHO guidelines.

In an agreement published together with the Bill & Melinda Gates Foundation on Sept. 30, 2020, 16 leading pharmaceutical companies pledge to support global initiatives such as COVAX and to offer their innovations worldwide at affordable prices.

At the turn of 2020/2021, COVAX has contractually secured access to at least two billion vaccine doses. This is to enable all participating and adequately prepared countries to vaccinate health workers and vulnerable populations in the first half of the year. Most agreements guarantee COVAX a share of the initial production batches and further supplies as production progresses. Global allocation is scheduled to begin in the first quarter of 2021.

Let's not kid ourselves: The question of who in the world gets which vaccine and when will of course also create new bonds and new memories; because those who receive help in such an emergency naturally remember it much more strongly than would be the case in good times.»
German Chancellor Angela Merkel on Jan. 26, 2021 at the Davos Virtual World Economic Summit

The advised two billion doses of vaccine refer to agreements between COVAX and the following manufacturers, among others:

U.S. manufacturer Novavax expressed its intention to provide COVAX Facility with a total of 1.1 billion doses of its NVX-CoV2327 vaccine candidate, as announced on February 18, 2021. This includes the supply already agreed with the manufacturer Serum Institute of India. Development and manufacturing of NVX-CoV2327 will be supported with funding from the COVAX Facility. The current Memorandum of Understanding initiates negotiations for a right of first refusal agreement.

The Serum Institute of India, which produces vaccines under license from several other manufacturers, has agreed to supply COVAX with 100 million doses each of AstraZeneca/Oxford's candidate vaccine and U.S. manufacturer Novavax's candidate vaccine - at $3 per dose. Negotiations are also underway to supply an additional 300 million to 400 million doses of vaccine. On Feb. 15, the WHO confirmed the suitability of two versions of the AstraZeneca/Oxford vaccine for emergency use. One version is from the Serum Institute of India, and the other is from AstraZeneca - SK Bio (South Korea). Following the positive evaluation of the quality, safety and efficacy of both vaccine variants by the WHO, global delivery under COVAX may begin as early as the first quarter of 2021.

A contract has been signed with Pfizer that secures COVAX the right of first refusal on 40 million doses of the BioNTech/Pfizer vaccine. Negotiations are currently underway on the terms of supply. Pfizer, in a Jan. 22 press release, pledges to make the vaccines available during 2021 and to supply them at cost if they are intended for poorer AMC countries. "Subject to the successful completion of the Pfizer-BioNTech vaccine supply agreement, we expect to begin deliveries of the life-saving COVID-19 vaccines in late February," said Gavi vaccine alliance leader Dr. Seth Berkley.

AstraZeneca has agreed to supply 170 million doses of AstraZeneca/Oxford vaccine in a pre-purchase agreement.

U.S.-based Janssen (or parent company Johnson & Johnson) has entered into a letter of intent to supply 500 million doses of its vaccine

Sanofi/GSK (France/UK) are on the record with a letter of intent to supply 200 million doses of their joint vaccine.

In addition, COVAX has secured a right of first refusal on additional doses of vaccine. It comes into effect when vaccines whose development is currently supported with COVAX funds receive regulatory approval.

Vaccine Distribution Plans

To help member countries prepare, COVAX released an initial supply forecast on January 20, 2021. With numerous caveats (actual vaccine availability, sufficient funding, country readiness, etc.), it announces close to 2.3 billion doses of vaccine for global distribution in 2021. The first vaccines available will be those from AstraZeneca/Oxford and Pfizer-BioNTech, the forecast says, with Novavax and Johnson & Johnson vaccines expected to be added from April 2021. The forecast assumes a steadily increasing supply of vaccines. Because the supply volume is based on the population size of participating countries, about half of the announced vaccine doses are expected to go to Southeast Asia and Africa.

In an initial update dated Feb. 3, 2021, COVAX published a country-by-country distribution plan for the 337 million doses of vaccine expected in the first half of 2021. If all goes according to plan, 1.2 million doses of Pfizer/BioNTech's vaccine will be ready to start as early as the first quarter of 2021, the document states. Within the first half of 2021, another 240 million doses of the AstraZeneca/Oxford vaccine from the Serum Institute of India will be ready for distribution, according to the document, supplemented by 96 million doses from AstraZeneca's own production. During 2021, COVAX expects to receive additional substantial shipments from these contractors under existing agreements. The doses of vaccine expected to be available in the first half of 2021 will enable an average of 3.3% of the total population to be protected, primarily the most vulnerable groups in 145 participating countries, COVAX predicted.

"The fact that the first vaccines are now available is a ray of hope," Tedros Adhanom Ghebreyesus, WHO director-general, was quoted as saying in a press release issued by COVAX on Dec. 18, 2020. "We will only truly end the pandemic if we end it everywhere at the same time. And the only way to do that is to vaccinate some people in all countries, rather than vaccinate all people in some countries."

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