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AstraZeneca’s COVID-19 Antibody Prevents and Treats COVID-19
In other COVID news, Gavi purchases an additional 176.5 million doses of Moderna’s COVID-19 vaccine and the complete Phase 3 results of Novavax’s vaccine have been published.
AstraZeneca recently announced that its COVID-19 antibody, AZD7442, reduced severe COVID-19 or death compared to placebo in non-hospitalized patients with mild-to-moderate symptomatic coronavirus.
The TACKLE Phase 3 COVID-19 treatment trial enrolled 903 participants to receive 600 milligrams of AZD7442 or placebo. Researchers found that AZD7442 reduced the risk of developing severe COVID-19 or death by 50 percent compared to placebo.
Notably, there were 18 adverse events in the AZD7442 group compared to 37 in the placebo group.
Additionally, a prespecified analysis of participants who received treatment within five days of symptom onset found that AZD7442 reduced the risk of developing severe COVID-19 or death by 67 percent compared to placebo.
About 90 percent of participants enrolled were from populations at high risk of progression to severe COVID-19, including those with co-morbidities.
“These important results for AZD7442, our long-acting antibody combination, add to the growing body of evidence for use of this therapy in both prevention and treatment of COVID-19,” Mene Pangalos, executive vice president of biopharmaceuticals research and development at AstraZeneca, said in the announcement.
“An early intervention with our antibody can give a significant reduction in progression to severe disease, with continued protection for more than six months,” Pangalos continued.
AZD7442 is the first long-acting antibody with Phase 3 data to demonstrate benefit in preventing and treating COVID-19.
AstraZeneca will submit full results from TACKLE for publication in a peer-reviewed medical journal and discuss the data with health authorities.
Gavi Purchases Additional Doses of Moderna’s COVID-19 Vaccine
Moderna recently announced that the Gavi, the Vaccine Alliance, exercised its option to purchase an additional 176.5 million doses of its COVID-19 vaccine for the COVAX Facility.
Nearly 116.5 million vaccine doses will be delivered in the first quarter of 2022, and 60 million doses will be delivered in the second. All doses will be offered at Moderna’s lowest tiered price.
COVAX still has the option to purchase an additional 116.5 million doses for delivery in the fourth quarter of 2021 and 116.5 million vaccine doses for delivery in the third quarter of 2022.
“I would like to thank COVAX for their tireless work to deliver our vaccine to low-income countries. We support COVAX’s mission to ensure broad, affordable and equitable access to COVID-19 vaccines and this agreement is an important pillar of our access strategy,” Stéphane Bancel, chief executive officer of Moderna, said in the announcement.
“We believe our vaccine can play an important role in addressing the needs of low-income countries given its combination of high Phase 3 efficacy against COVID-19, strong durability in the real-world evidence, and superior storage and handling conditions,” Bancel continued.
The 210 million doses purchased to date are 100 micrograms per dose. But Moderna recently requested authorization of a 50 microgram dose as a booster from the same vial to increase the number of usable booster doses available in low-income countries at no additional cost.
The average price across all doses purchased to date is under $10 per 100 microgram dose.
Under the agreement, UNICEF and its procurement partners were also given access to up to 500 million doses of Moderna’s COVID-19 vaccine through 2022.
Overall, the recent supply agreement with Gavi on behalf of the COVAX Facility is an essential pillar of Moderna’s comprehensive plan to bring vaccines to as many people as possible globally.
Novavax’s COVID-19 Vaccine Demonstrates 100% Protection
Novavax recently announced that full results from the Phase 3 trial of its COVID-19 vaccine, NVX-CoV2373, have been posted to the medRxiv preprint server.
In the PREVENT-19 trial, NVX-CoV2373 was 100 percent effective against moderate to severe coronavirus and 90.4 percent effective overall.
PREVENT-19 was a randomized, placebo-controlled clinical trial that enrolled 30,000 adults in the US and Mexico. Patients were randomized to receive two five microgram doses of the vaccine with 50 microgram Matrix-MTM adjuvant, or placebo, 21 days apart.
The trial prioritized racial and ethnic diversity and participants in high-risk areas.
Overall, PREVENT-19 achieved its primary endpoint of efficacy in preventing polymerase chain reaction (PCR)-confirmed, symptomatic mild, moderate, or severe COVID-19 with onset at least seven days after the second dose.
Novavax also submitted the manuscript, “Efficacy and Safety of NVX-CoV2373 in Adults in the United States and Mexico,” for peer review.
