A health worker administers a photograph of the Modern COVID-19 vaccine to a woman at a pop-up vaccination site operated by SOMOS Community Care during the coronavirus disease pandemic (COVID-19) in New York, January 29, 2021.
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Moderna said on Wednesday that it had sent the 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 that is spreading in South Africa.
The vaccine – which Moderna calls mRNA-1273.351 – is ready to be tested in an early-stage 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 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 bringing as many updates to our vaccine as possible until the pandemic is under control,” the company’s CEO, Stephane Bancel, said in a press release. “We hope to demonstrate that booster doses, if necessary, can be done at lower dose levels, which will allow us to provide much more doses to the global community at the end of 2021 and 2022, if necessary.”
US health officials are increasingly concerned about new emerging variants of the virus, especially strain B.1.351, which has been shown to reduce the effectiveness of vaccines both on the market and in developing countries. In recent weeks, White House chief medical officer Dr. Anthony Fauci has pushed Americans to get vaccinated as soon as possible before potentially new and even more dangerous variants of the virus appear.
As of Tuesday, the Centers for Disease Control and Prevention identified 1,881 cases of variant B.1.1.7, found for the first time in the UK. The US agency said it had identified 46 cases of strain B.1.351 in South Africa, as well as five cases of P.1, a variant first discovered in Brazil. The more people become infected, the more likely they are to become more problematic, say medical experts.
On Monday, the Food and Drug Administration released updated guidelines that modified Covid-19 vaccines that act to protect against new emerging variants can be licensed without the need for lengthy clinical trials. The FDA would eliminate the new vaccine as a modification of the emergency request originally approved by a company, thus speeding up the regulatory review process.
Moderna announced for the first time on January 25 that it is working on a booster shot to protect itself from the South African variant.
The company said Wednesday it intends to evaluate three approaches to boosting immunity. The first approach would use variant-specific booster photographs, such as mRNA-1273351, but at a lower dose than the original vaccine. The second would combine the original vaccine with a variant-specific vaccine in a single injection at 50 micrograms or less, Moderna said. The third would test a third shot of the original vaccine at a lower dose.
Moderna also said it intends to test the original vaccine and the new booster vaccine shot as a two-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 estimate of global core production from 600 million. doses to 700 million doses this year.
Moderna said that the 1.4 billion doses in 2022 assume that the vaccine will be administered at the current level of 100 micrograms. If the vaccine is found to be effective at a lower dosage level, the company said it could deliver up to 2.8 billion doses by 2022.
Moderna has an agreement with the US government for 300 million doses. The company has delivered approximately 55 million doses to the United States so far. It is expected to complete the 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.