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Moderna begins medical trials of Covid booster pictures for variants from South Africa and sends them to NIH for investigation

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

Mike Segar | Reuters

Moderna announced on Wednesday that a new Covid-19 vaccine, which is said to offer better protection against the highly contagious variant of coronavirus that is widespread in South Africa, has been delivered to the National Institutes of Health.

The vaccine – which Moderna refers to as mRNA-1273.351 – can be tested in an early clinical trial to see if it can be used as a booster against the South African strain, also known as B.1.351. Moderna has found that its current two-dose regimen produces a weaker immune response against the South African strain, although the company said the antibodies in patients remain above levels expected to protect against the virus.

"Moderna is committed to making as many updates as necessary to our vaccine until the pandemic is under control," said the company's CEO, Stephane Bancel, in a press release. "We hope to show that booster doses can be given at lower doses when needed, which will allow us to make many more doses available to the global community when needed in late 2021 and 2022."

US 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 both in market and in development. Over the past few weeks, the White House Chief Medical Officer, Dr. Anthony Fauci, urging 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 had identified 1,881 cases of variant B.1.1.7, which were first found in the UK. The US authorities said they had identified 46 cases of the strain B.1.351 from South Africa and five cases of P.1, a variant first discovered in Brazil. The more people become infected, the more likely it is that even more problematic mutations will occur, say medical experts.

On Monday, the Food and Drug Administration released updated guidelines that modified Covid-19 vaccines that work to protect against new, emerging variants may 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 filing, thereby expediting the regulatory review process.

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

The company announced on Wednesday that it plans to evaluate three approaches to increasing immunity. The first approach would use variant-specific booster vaccinations such as mRNA-1273.351, but at a lower dose than the original vaccine. The second would combine the original vaccine with a variant-specific vaccine into a single shot at 50 micrograms or less, Moderna said. The third would test a third shot of the original vaccine at a lower dose.

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

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

According to Moderna, the 1.4 billion doses in 2022 assume the vaccine will be given at its current level of 100 micrograms. If the vaccine turns out to be effective at a lower dose, the company could deliver up to 2.8 billion doses by 2022.

Moderna has signed a contract with the US government for 300 million cans. The company has shipped approximately 55 million cans to the US to date. The first 100 million cans are expected to be shipped to the US by the end of the first quarter of 2021, the second 100 million cans by the end of May 2021, and the third 100 million cans by the end of July 2021.

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