Moderna says COVID-19 vaccine for South Africa strain is ready for human testing

Moderna says COVID-19 vaccine for South Africa strain is ready for human testing

cbaker_admin
Fri, 02/26/2021 – 03:30

Moderna says it has manufactured an initial batch of COVID-19 vaccine doses intended to better safeguard people against the South African coronavirus variant. Moderna says it shipped the modified doses to NIH, whose National Institute of Allergy and Infectious Diseases says it plans to start enrolling volunteers for a Phase I clinical trial of Moderna’s variant vaccine in March. People who previously received two doses of Moderna’s original COVID-19 vaccine will receive the modified dose, and researchers will monitor the vaccine’s safety and ability to induce an immune response to the new variant, the company says. If test results are satisfactory, Moderna will seek regulatory authorization for the new vaccine, dubbed mRNA-1273.351, which could occur in the third quarter, according to Moderna CEO Stephane Bancel. He says the company may eventually add a third dose of its original two-dose vaccine at a lower dosage; administer the new vaccine as a booster to those who already received two doses of the original vaccine; or develop a “multivalent” booster dose that combines Moderna’s original vaccine with the variant vaccine. FDA said this week it intends to assess any variant vaccine booster doses promptly, and would not require large efficacy trials for authorization.