A health worker administers an injection of the Moderna COVID-19 vaccine to a woman at a pop-up vaccination site managed by SOMOS Community Care during the coronavirus disease (COVID-19) pandemic in New York, January 29, 2021.
Facebook Facebook logo Sign up for Facebook to connect with Mike Segar Reuters
Moderna said on Wednesday it has sent doses of a new Covid-19 vaccine to the National Institutes of Health designed to provide better protection against the highly contagious variant of coronavirus spreading in South Africa.
The vaccine – which Moderna calls mRNA-1273,351 – is ready to be tested in an early clinical trial to determine if it can be used as a booster shot against the South African strain, also known as B.1.351, the company said. . Moderna has found that the current two-dose regimen generates a weaker immune response against the South African strain, although the company said antibodies in patients remain above the levels expected to protect against the virus.
“Moderna is committed to updating our vaccine as often as needed until the pandemic is under control,” said Stephane Bancel, Moderna’s CEO in a press release. “We hope to demonstrate that booster doses can be made at lower dose levels, if needed, allowing us to provide many more doses to the global community as needed by the end of 2021 and 2022.”
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, urged Americans to get vaccinated as soon as possible before potentially new and even more dangerous variants of the virus emerge.
As of Tuesday, the Centers for Disease Control and Prevention have identified 1,881 cases of the B.1.1.7 variant, first identified in the UK. The US agency said it has identified 46 cases of the B.1.351 strain from South Africa as well as five cases of P.1, a variant first identified in Brazil. As more people become infected, the more likely it is that more problematic mutations will develop, medical experts say.
On Monday, the Food and Drug Administration released updated guidelines stating that modified Covid-19 vaccines that work to protect against new, emerging variants can be approved without the need for lengthy clinical trials. The FDA would approve the new vaccine as an amendment to a company’s originally approved emergency application, speeding up the regulatory review process.
Moderna first announced on January 25 that it was working on a booster shot to protect the variant in South Africa.
The company said Wednesday it plans to evaluate three approaches to bolster immunity. The first approach would use variant-specific booster shots, such as mRNA-1273,351, 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 of 50 micrograms or lower, Moderna said. The third approach would test a third injection of the original vaccine at a lower dose.
Moderna said it also plans to test the original vaccine and new booster shot as a two-dose regimen in humans without coronavirus antibodies.
Separately, the company also announced that it expects to produce up to 1.4 billion doses of Covid-19 vaccines by 2022. It has also increased its baseline estimate of global production from 600 million doses to 700 million doses this year.
Moderna said the 1.4 billion doses by 2022 are under the assumption that the vaccine will be delivered at the current level of 100 micrograms. If the vaccine proves to be effective at a lower dose level, the company could deliver up to 2.8 billion doses by 2022, the company said.
Moderna has a deal with the US government for 300 million doses. The company has shipped approximately 55 million doses to the US to date. 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.