Moderna sends vaccine modified for South African variant to NIH for testing

[jinmori]

Moderna, which produces one of two coronavirus vaccines authorized for use in the U.S., announced on Wednesday that it has shipped a vaccine modified to fight the variant first discovered in South Africa to the National Institutes of Health for testing in humans.

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The company said the National Institute of Allergy and Infectious Diseases, part of the NIH, will conduct a phase one trial to determine if the modified vaccine boosts immunity against the variant, which has caused concerns due to being more resistant to the current vaccines.

"We look forward to beginning the clinical study of our variant booster and are grateful for the NIH's continued collaboration to combat this pandemic," Stéphane Bancel, Moderna's chief executive officer, said in a statement. "As we seek to defeat COVID-19, we must be vigilant and proactive as new variants of SARS-CoV-2 emerge. Leveraging the flexibility of our mRNA platform, we are moving quickly to test updates to the vaccines that address emerging variants of the virus in the clinic."

Moderna said last month that a six-fold reduction in protection was noted for the variant first found in South Africa, versus other strains of the virus, but also said that neutralizing antibodies created by the vaccine "remain above levels that are expected to be protective."

If the booster is proven necessary, and thus subsequently authorized by the U.S. Food and Drug Administration for use, Moderna said the it be "provided to the global community in late 2021 and 2022."

The pharmaceutical company also reported it is taking a three-pronged approach to the variant testing. In addition to the variant-specific booster candidate, it is testing a combination of the current vaccine and the new booster and, finally, a third dose of the current vaccine. Moderna has already begun dosing a cohort of participants with the booster.

Moderna also said its current vaccine still works well against variants and the testing is precautionary.

In addition to the news about testing for the South African variant, Moderna also announced it is stepping up production of its currently authorized vaccine -- now being injected across the U.S.

"We believe from our discussions with governments around the world that there will continue to be significant demand for our COVID-19 vaccine and we now are committed to materially increasing our manufacturing capacity," Bancel said in a statement.

"We expect our additional capital investments to drive our capacity to 1.4 billion doses for 2022, assuming the current 100 μg dose," he added. "If our variant vaccine booster requires a lower dose, such as 50 μg, we could have more than 2 billion doses of capacity for 2022."

Moderna reported it is increasing its plan from delivering 600 million doses in 2021 to 700 million globally.

On Tuesday, executives from the major vaccine companies producing the COVID-19 vaccines told Congress that they remain on track to ramp up production of doses as promised in their government contracts, which President Joe Biden has pledged will deliver enough doses of the Pfizer and Moderna vaccines to fully vaccinate 300 million Americans by the end of July.

To date, the company reports it has shipped 55 million doses to the U.S. government. The U.S. expects to see another 140 million vaccine doses delivered by the end of March, as well another 20 million doses of Johnson & Johnson's single-dose vaccine if the FDA authorizes it for emergency use later this week.

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