Moderna to begin testing of Covid vaccine booster injections for a South African variant – tech2.org

Moderna to begin testing of Covid vaccine booster injections for a South African variant


A healthcare worker administers an injection of Moderna COVID-19 vaccine to a woman at an pop-up vaccination site operated by SOMOS Community Care during the coronavirus disease (COVID-19) pandemic in New York, January 29. of 2021.

Mike Segar | Reuters

Moderna said Wednesday that it sent doses of a new Covid-19 vaccine designed to provide better protection against the highly contagious variant of the coronavirus spreading in South Africa to the National Institutes of Health.

The vaccine, which Moderna calls mRNA-1273.351, is ready to be tested in an early-stage clinical trial to determine whether it can be used as a booster vaccine against the South African strain, also known as B.1.351, the company said. . Moderna found that its current two-dose regimen elicits a weaker immune response against the South African strain, although the company said antibodies in patients remain above levels expected to be protective against the virus.

“Moderna is committed to making as many updates to our vaccine as necessary until the pandemic is under control,” Moderna CEO Stephane Bancel said in a press release. “We hope to demonstrate that booster doses, if necessary, can be administered at lower dose levels, allowing us to provide many more doses to the global community by the end of 2021 and 2022 if necessary.”

US health officials are increasingly concerned about new emerging variants of the virus, particularly the B.1.351 strain, which has been shown to reduce the effectiveness of vaccines both on the market and in development. In recent weeks, White House Chief Medical Adviser Dr. Anthony Fauci has lobbied Americans to get vaccinated as quickly as possible before potentially new and even more dangerous variants of the virus emerge.

As of Tuesday, the Centers for Disease Control and Prevention has identified 1,881 cases of the B.1.1.7 variant, first identified in the U.K. The US agency said it has identified 46 cases of the B. 1,351, from South Africa, as well as five cases of P.1, a variant first identified in Brazil. As more people become infected, even more troublesome mutations are more likely to emerge, medical experts say.

On Monday, the Food and Drug Administration released updated guidance saying that modified Covid-19 vaccines that work to protect against new emerging variants can be licensed without the need for lengthy clinical trials. The FDA would approve the new vaccine as an amendment to the emergency use application originally approved by a company, thus speeding up the regulatory review process.

Moderna first announced on January 25 that it was working on a booster injection to protect against the variant in South Africa.

The company said Wednesday that it plans to evaluate three approaches to boost immunity. The first approach would use variant-specific booster injections, such as mRNA-1273,351, but at a lower dose than the original vaccine. The second approach would combine the parent vaccine with a specific vaccine variant in a single injection of 50 micrograms or less, Moderna said. The third approach would try a third injection of the parent vaccine at a lower dose.

Moderna said it also plans to test the original vaccine and the new booster vaccine as a two-dose regimen in people without antibodies to the coronavirus.

Separately, the company also announced that it expects to produce up to 1.4 billion doses of Covid-19 vaccine in 2022. It has also raised its global base-case production estimate from 600 million doses to 700 million doses this year.

Moderna said the 1.4 billion doses in 2022 assume the vaccine will be delivered at its current level of 100 micrograms. If the vaccine is found to be effective at a lower dose level, the company could supply up to 2.8 billion doses in 2022, the company said.

Moderna has an agreement with the United States government for 300 million doses. So far, the company has shipped about 55 million doses to the United States. It expects to complete delivery of the first 100 million doses to the US by the end of the first quarter of 2021, the second 100 million doses by the end of May 2021, and the third 100 million doses by the end of July 2021. .

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