AstraZeneca Finds 90% Vaccine Success, Will Seek Approval

By Kevin Stawicki
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Law360 (November 23, 2020, 8:50 PM EST) -- AstraZeneca said Monday that one of its coronavirus vaccine candidates achieved 90% effectiveness, while the average efficacy of its two dosing regimens hit only 70% — well below the rates recently reported for Pfizer and Moderna's vaccine candidates.

The U.K.-based pharmaceutical giant said an initial review of clinical trials of its proposed vaccine — dubbed AZD1222 — has shown positive results in preventing COVID-19. One dosing regimen was found to be 90% effective while another was significantly less effective. The average of the two dosing regimens was 70% effective, according to the company.

AstraZeneca also said Monday that it will immediately seek authorization in countries around the world, including an emergency use listing from the World Trade Organization to make the vaccines available in low-income countries. If approved, the company expects to be able to produce up to 3 billion doses in 2021.

Pascal Soriot, the company's chief executive officer, said that Monday's announcement is "an important milestone in our fight against the pandemic."

"This vaccine's efficacy and safety confirm that it will be highly effective against COVID-19 and will have an immediate impact on this public health emergency," Soriot said in a statement. "The vaccine's simple supply chain and our no-profit pledge and commitment to broad, equitable and timely access mean it will be affordable and globally available, supplying hundreds of millions of doses on approval."

Medical humanitarian organization Doctors Without Borders urged AstraZeneca on Monday to publicize its vaccine licenses so that its efficacy can be independently determined and properly priced. The organization also said that the company must follow through with its previous commitment that it would not profit from the vaccine during the pandemic. 

Roz Scourse, a Doctors Without Borders policy advisor, said that the organization "welcomes AstraZeneca's commitment to sell the vaccine at a 'no-profit' price during the pandemic, but the reality is that it's an empty promise unless we're able to substantiate these important claims with data."

AstraZeneca must be more transparent about its internal research and pricing, Scourse added.

"If AstraZeneca is truly committed to non-profit pricing and equitable access, they must open up their books now and share transparently all research and development, clinical trial, manufacturing costs, and product price breakdowns, as well as make all licenses and agreements public," Scourse said.

The 90% rate, if confirmed, would be a bit lower than what Pfizer and Moderna have recently reported, but still far better than the minimum 50% rate that the U.S. Food and Drug Administration has demanded. On Nov. 16, the independent Data and Safety Monitoring Board said Moderna's COVID-19 vaccine candidate is 94.5% effective. Pfizer announced on Nov. 18 that its vaccine candidate is 95% effective.

On Friday, Pfizer and its German partner BioNTech filed an emergency approval request with the FDA, asking the regulator to sign off on their vaccine candidate.

Moderna recently announced that it has entered a supply agreement with the U.K. to begin distribution in March, pending the vaccine's approval, adding that it's ramping up production to be able to deliver roughly 500 million doses per year and possibly up to 1 billion doses per year starting in 2021.

The race to develop a COVID-19 vaccine and secure regulatory approval comes as the U.S. and other nations around the world are experiencing unprecedented spikes in the number of new coronavirus cases reported daily. As of Monday, over 59 million cases and nearly 1.4 million deaths have been reported around the globe since January, according to data from Johns Hopkins University. 

Since the coronavirus pandemic was first identified in December 2019 in Wuhan, China, there has been a global push for wider access to vaccines. AstraZeneca's vaccine would be a much cheaper alternative and easier to ship than the Pfizer and Moderna vaccines, which is good news for low-income countries.

India, South Africa and other developing nations have been spearheading efforts to convince members of the WTO to suspend the trade body's intellectual property protections to mitigate barriers to affordable vaccines. Wealthy countries, including the European Union and the U.S., have argued that solutions to the pandemic can be sought through the existing intellectual property system. The WTO has failed to reach an agreement to date.

--Additional reporting by Dorothy Atkins. Editing by Steven Edelstone.

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