A healthcare worker administers a shot of the Modern COVID-19 vaccine to a woman at an emerging vaccination site operated by SOMOS Community Care during the coronavirus disease pandemic (COVID-19) in New York on January 29, 2021 .
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Modern said Wednesday it has sent to the National Institutes of Health doses of a new Covid-19 vaccine designed to provide better protection against the highly contagious variant of the coronavirus that is spreading in South Africa.
The vaccine, which Moderna calls mRNA-1273535, is set to be tested in an early-stage clinical trial to determine if it can be used as a trigger against the South African strain, also known as B.1,351, according to the company. . Moderna has found that its current two-dose regimen generates 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,” Stephane Bancel, CEO of Moderna, said in a press release. “We hope to demonstrate that, if necessary, booster doses can be made at lower dose levels, which will allow us to provide many more doses to the global community by the end of 2021 and 2022 if needed.”
U.S. health officials are increasingly concerned about new emerging variants of the virus, particularly strain B.1.351, which has been shown to reduce the effectiveness of vaccines in both the market and development. In recent weeks, Dr. Anthony Fauci, the White House’s chief medical adviser, has pushed Americans to get vaccinated as quickly as possible before potentially new and even more dangerous variants of the virus appear.
Since Tuesday, the Centers for Disease Control and Prevention have identified 1,881 cases of variant B.1.1.7, first identified in the UK. The U.S. agency said it has identified 46 cases of strain B.1.351, from South Africa, as well as five cases of P.1, a variant first identified in Brazil. The more people become infected, the more likely they are to have even more problematic mutations, medical experts say.
On Monday, the Food and Drug Administration released updated guidelines that modified Covid-19 vaccines that work to protect against new emerging variants without the need for lengthy clinical trials could be authorized. The FDA would eliminate 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 shot to protect itself from the variant in South Africa.
The company said Wednesday it plans to evaluate three approaches to boosting immunity. The first approach would use variant-specific booster shots, such as mRNA-1273351, but at a lower dose than the original vaccine. The second approach would combine the original vaccine with a variant-specific vaccine in a single shot at 50 micrograms or less, Moderna said. The third approach would test a third shot of the original vaccine at a lower dose.
Modern said she also plans to try the original vaccine and the new booster shot as a dose regimen in people without coronavirus antibodies.
Separately, the company also announced that it expects to produce up to 1.4 billion doses of Covid-19 vaccine by 2022. It has also raised its overall production estimate from 600 million doses to 700 million doses this year.
Modern said the 1.4 billion doses in 2022 would mean the vaccine will be administered as the current level of 100 micrograms. If the vaccine is found to be effective at a lower dosage level, the company could supply up to 2.8 billion doses by 2022, the company said.
Modern has an agreement with the US government for 300 million doses. The company has shipped about 55 million doses to the U.S. so far. It expects to complete delivery of the first 100 million doses in the United States 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.