Coronavirus: Moderna starts dosing patients in mid-stage vaccine study

A view of Moderna headquarters on May 08, 2020 in Cambridge, Massachusetts. Moderna was given FDA approval to continue to phase 2 of Coronavirus (COVID-19) vaccine trials with 600 participants. (AFP)

Moderna Inc said on Friday it had started dosing patients in a mid-stage study with its experimental coronavirus vaccine and eventually plans to enroll 600 patients for the trial.

Read the latest updates in our dedicated coronavirus section.

There are currently about 10 coronavirus vaccines being tested in humans and experts have predicted that a safe and effective vaccine could take 12 to 18 months from the start of development.

Earlier this month, Moderna had released early-stage data that showed the vaccine, mRNA-1273, was safe and produced protective antibodies in a small group of healthy volunteers.

The drug developer also reiterated its plans to begin late-stage trials in July.

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Maximizing number of doses

“In the context of a pandemic, we expect demand to far outstrip supply and the lower the dose the more people we expect to be able to protect,” said Chief Medical Officer Tal Zaks.

The US government in April placed a big bet on Moderna, backing its vaccine with $483 million from the Biomedical Advanced Research and Development Authority (BARDA), a part of the U.S. Department of Health and Human Services (HHS).

The company said that grant will enable it to supply millions of doses per month in 2020 and, with further investments, tens of millions a month in 2021 if the vaccine proves successful.

“We are investing to scale up manufacturing so we can maximize the number of doses we can produce to help protect as many people as we can from SARS-CoV-2,” Moderna Chief Executive Stéphane Bancel said, using the official name for the new virus.

In May, Moderna struck a 10-year strategic collaboration with Lonza Group that over time will allow the company to make up to 1 billion 50 mcg doses by the end of 2021, Zaks said in an interview.

The company is working out a plan to provide vaccine to countries outside of the United States, Zaks said.

“The US is poised to be the first beneficiary of this vaccine,” Zaks said, adding that the company believes it has an "ethical obligation to make this vaccine available to whoever needs it globally.”

Moderna said it expects to start a larger late-stage, or Phase III, trial in July.

There are currently no approved treatments or vaccines for COVID-19, and experts predict a safe and effective vaccine could take 12 to 18 months from the start of development, which in Moderna’s case was in January.

The most notable side effects reported from the early testing of Moderna's vaccine were three participants with “flu-like” symptoms following a second shot of the highest dose. The company said it believed the symptoms were an indirect measure of a strong immune response.

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Last Update: Saturday, 30 May 2020 KSA 07:44 - GMT 04:44
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