Sunday, April 11, 2021

Moderna Says COVID-19 Variant Shot Ready for Human Testing

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Moderna said Wednesday its updated COVID-19 vaccine to fight variants of the virus was ready to be tested on humans.

The new Moderna shot was designed to protect people against a coronavirus strain, first identified in South Africa late last year, that showed some resistance to the company’s original vaccine.

Moderna said it shipped initial doses of the updated vaccine to the National Institutes of Health, which will conduct the first human study. Testing could start within weeks, per The Wall Street Journal.

People who received the two doses of Moderna’s original vaccine will be given the new shot. Those patients will be tracked to find out the vaccine’s safety, and ability to induce an immune response to the new variant, the Cambridge, Mass., company said.

If test results are positive, Moderna will seek U.S. regulatory authorization for the new vaccine. Chief Executive Officer Stephane Bancel said that could happen in the year’s third quarter.

“Moderna is going to keep chasing those variants of concerns until this pandemic is fully under control,” said Bancel, who added the drug maker could move quickly to produce a variant-focused shot because the messenger RNA technology it uses allowed rapid design and quick manufacturing of new or modified vaccines. 

The U.S. Food and Drug Administration said this week it would evaluate any variant vaccine booster shots quickly, and wouldn’t require large efficacy trials for authorization.

Producer of the second COVID-19 shot authorized in the U.S., Moderna might be the first vaccine maker to have finished the laboratory work for vaccines targeting variants.

Pfizer Inc., which produced the first authorized COVID-19 vaccine in the U.S., and Johnson & Johnson have said they were tweaking their drugs or working on boosters that better match variants.

Moderna said there were three potential options to protecting people from the variants — a third shot of its original two-dose vaccine at a lower dosage; a booster to people who received two doses of the original shot; and a “multivalent” booster shot that combines the original vaccine with the one targeting the variant into a single shot.

Initial vaccines hadn’t worked as well against the strain first identified in South Africa, and experts said difficult new strains could also emerge.

Fighting COVID-19 could become a long fight to combat a changing virus, instead of seeking a total end to the pandemic.

Health experts said staying ahead of a changing virus could prove crucial to allowing schools, businesses, and other establishments to reopen.

In a separate announcement, Moderna said it was expanding production capacity and expected to make about 1.4 billion doses of its COVID-19 vaccine in 2022.

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