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ALLISON GATLIN

Moderna Asks FDA To Sign Off On Updated Covid Booster, Trailing Pfizer By A Day

Moderna on Tuesday asked the Food and Drug Administration to authorize its updated Covid shot, trailing Pfizer and BioNTech by a day. But Moderna stock only inched higher in after-hours trading.

The booster shot has been tweaked to target the BA.4 and BA.5 subvariants of omicron. It's known as a bivalent shot, meaning it can target two viral strains in one dose. The news comes hours after a report that a filing from Moderna would be imminent.

"We have worked closely with the FDA to ensure that Americans will have access to Moderna's updated, bivalent booster which, if authorized, may offer higher, broader and more durable protection against Covid-19 compared to the currently authorized booster," Chief Executive Stephane Bancel said in a written statement.

Moderna stock ended the regular session with a 0.9% gain, at 143.78, and climbed a small fraction higher in after-hours action.

Moderna Stock: Quick Turnaround For Booster Update

Moderna's request to the FDA is based on laboratory testing of the shot designed to block BA.4- and BA.5, as well as testing in people of an earlier iteration targeting the BA.1 subvariant. However, the BA.1 strain no longer accounts for any cases in the U.S. The FDA asked companies to rapidly develop new boosters capable of handling the newest subvariants.

The company also is testing the updated booster shot in people. Meanwhile, the U.S. government has signed a deal for an initial 66 million doses of the new booster shot. If authorized, Moderna says it can begin delivering doses in September.

Similarly, Pfizer and BioNTech said Monday they could ship their BA.4- and BA.5-targeting booster shot starting in September. They also tested an earlier version of the booster against BA.1 before tailoring another update to the BA.4 and BA.5 omicron cousins.

"The agility of the mRNA platform, together with extensive clinical experience with the Pfizer-BioNTech Covid-19 vaccine, has allowed us to develop, test and manufacture updated, high-quality vaccines that align to circulating strains with unprecedented speed," Pfizer CEO Albert Bourla said in a written statement.

The vaccine stocks have trended down recently, however. Moderna stock and BioNTech stock slipped below their 50-day moving averages last week, according to MarketSmith.com. Pfizer stock made a similar move in late July.

Follow Allison Gatlin on Twitter at @IBD_AGatlin.

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