LONDON - The foundation stone of a system to ensure equitable access to COVID-19 vaccines was put in place by the global vaccines summit on June 4, with 12 donors pledging $567 million in seed money for an advance market commitment (AMC) program.

The AMC, being set up by Gavi, the vaccines alliance, will assist in the distribution of any approved COVID-19 vaccines in low- and middle-income countries. Gavi has set an initial target of raising $2 billion for the program, which it says will provide sufficient funding for at-risk health care workers and vulnerable individuals to be vaccinated, and also will enable it to build an emergency stockpile.

Astrazeneca plc is the first company to sign up to the AMC, announcing it has reached a $750 million agreement with Gavi and the Coalition for Epidemic Preparedness and Innovation, to support the manufacturing , procurement and distribution of AZD-1222, the vaccine it is developing with Oxford University. Assuming positive results in clinical trials, the first doses will be available before the end of the year.

At the same time, Astrazeneca said it has agreed to a licensing deal for the world’s largest vaccines manufacturer, the Serum Institute of India, to produce 1 billion doses of AZD-1222, with 300 million doses to be delivered by the end of 2020.

“To beat the COVID-19 pandemic, the world needs more than breakthrough science. It needs breakthrough generosity,” said Bill Gates, co-chair of the Gates Foundation, which has pledged money for the AMC program. “When COVID-19 vaccines are ready, this funding and global coordination will ensure that people all over the world will have access to them,” Gates said.

Other donors helping to get the AMC program off the ground are the governments of Canada, Italy, Norway and the U.K.

“One thing that has been made all too clear over the past months is that this disease does not respect borders,” said Seth Berkley, CEO of Gavi. “[That] is why this global problem requires a global solution.”

The COVID-19 vaccines fund is inspired by similar initiatives put in place by Gavi that have secured equitable access to pneumococcal and Ebola vaccines. By providing advance purchase guarantees for specific products before they are approved, manufacturers have the confidence to invest in production capacity, reducing the length of time it takes for licensed vaccines to become available in the poorest countries.

According to Gavi, that mechanism means pneumococcal vaccine coverage rates are now as high in the developing world as the developed world, with more than 160 million doses shipped each year.

The global vaccines summit, hosted by the U.K. government, raised $8.8 billion to support all of Gavi’s vaccines programs over the next five years.

Leaders who spoke at the summit expressed concerns that COVID-19 is undermining regular immunization programs, after Gavi published research last week showing the pandemic is diverting health care workers from regular campaigns against diseases, including diphtheria, polio and measles.

More than 80 million children under the age of 1 are at risk of disease due to disruption to immunization programs because of COVID-19, according to Gavi.

Testing approved in Brazil

Commenting on Astrazeneca’s support for the AMC program, Berkley called for further commitments from the private sector. “We encourage other vaccines manufacturers to work with us towards the shared global goal of finding solutions for this unprecedented pandemic,” he said.

The agreements with GAVI and the Serum Institute mean Astrazeneca now has capacity exceeding 2 billion doses in place for AZD-1222. The company is “working tirelessly” to honor its commitment to ensure broad and equitable access to the vaccine across the globe and at no profit, said Pascal Soriot, CEO.

The new agreements are “an important step in helping us supply hundreds of millions of people around the world, including in those countries with the lowest means,” Soriot said.

Astrazeneca says it recognizes AZD-1222 may not work, but it will progress the clinical trial program at speed and scale-up manufacture at risk.

AZD-1222 is the most advanced of the 10 COVID-19 vaccines worldwide that are in clinical development, currently recruiting 10,000 participants in the U.K. and 30,000 in the U.S., in a phase IIb/III study.

However, there is real concern that with infection rates falling, it will take too long, or may not be possible, to demonstrate efficacy in field trials. The Oxford University vaccines group has now announced the Brazilian Regulatory Agency has approved testing in Brazil, where the infection rate is on the rise.

Around 2,000 people are to be recruited to the phase III trial in Brazil. The Oxford vaccines group said opening that arm of the study is a “priority” because of the “ascendant curve” of COVID-19. Brazil reported 30,925 cases on June 4. To date, 619,000 infections have been confirmed and 34,072 people have died from the infection. The country now has the third highest number of cases after the U.S. and Russia.

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