Moderna’s COVID Vaccine Overwhelmingly Passes Key Committee Vote – FDA Approval Expected As Early As Friday

Plus, CVS Health and Walgreens are starting to offer COVID-19 vaccinations for residents and staff at long-term care facilities, Darden Restaurants shares are down after disappointing earnings, and Dick’s Sporting Goods has teamed up with Instacart to offer same-day shipping. 

Stocks slipped lower to start Friday with the Dow dropping 198 points, or 0.65%. The S&P 500 slid 0.6%, while the Nasdaq traded 0.4% lower.

The FDA’s Vaccines and Related Biological Products Advisory Committee overwhelmingly backed Moderna’s coronavirus vaccine for emergency use late Thursday, paving the way for the agency to approve the shot as early as today. The nonbonding decision passed 20-0 with one abstention by the committee exactly one week after the group voted to recommend Pfizer and BioNTech’s vaccine for emergency use authorization. The FDA told Moderna that “it will rapidly work toward finalization and issuance of emergency use authorization. The agency has also notified the U.S. Centers for Disease Control and Prevention and Operation Warp Speed, so they can execute their plans for timely vaccine distribution.” Dr. Anthony Fauci, the top U.S. infectious disease expert, said that he expected Moderna’s vaccine would begin to be administered “by the very early part of next week.I would hope Monday or Tuesday.”

CVS Health and Walgreens are beginning to offer COVID-19 vaccinations for residents and staff at long-term care facilities today. Walgreens said its pharmacists will administer the shots at nursing homes and assisted living facilities beginning in Connecticut, Florida, and Ohio, while CVS said it will provide them at facilities in Connecticut and Ohio, with both companies expanding to facilities in other states starting next week. As the Pfizer and BioNTech vaccine starts to be distributed nationwide, some U.S. states say the federal government has cut their allocations of the shots for next week without explanation. Oregon’s allotment for the vaccine was cut by 40%, Governor Kate Brown said in a tweet, while Washington state had expected more than 74,000 doses for next week but was informed by Operation Warp Speed that it would receive 44,850 instead. “This was a federal decision,” Brown said about her state’s COVID-19 vaccine supply cut, “and I am seeking answers from the CDC about the reliability of the data we are receiving from week-to-week as Oregon builds our vaccine distribution plan.” Washington state said in a statement, “We were not given an explanation as to why our allocation was reduced, and we do not currently have allocation numbers beyond next week.”

It wouldn’t be a day without talking about stimulus. Congress is working to put the finishing touches on a coronavirus relief deal as Washington draws closer to letting the government shut down and allowing millions of Americans to lose unemployment benefits. Congressional leaders say they are closer to an agreement on $900 billion in aid, and have just until 12:01 a.m. on Saturday to pass a government funding and pandemic rescue package before federal funding lapses. Senate Majority Leader Mitch McConnell said a “bipartisan, bicameral agreement appears to be close at hand,” adding that it was “highly likely” Congress would work through the weekend, and said lawmakers may have to pass a short-term funding measure to buy enough time to approve legislation. 

Darden Restaurants shares are down more than 2% this morning after the Olive Garden-parent reported its same-store sales fell 20.6% in its fiscal second quarter. Darden reported earnings per share of $0.73 on revenue of $1.66 billion, compared to estimates for earnings of $0.71 per share on revenue of $1.69 billion. The company said it expects sales to plunge 30% to 35%, and CEO Rick Cardenas said the company doesn’t anticipate significant sales improvements until the fiscal fourth quarter of 2021, which ends in May. “We’ve been able to wind down the businesses effectively and switch to off-premise, and we’ll be able to wind them back up,” Darden CEO Gene Lee said, also noting that the company is “working around the clock” to capitalize on the buzz created by Taylor Swift name-dropping Olive Garden in her new song “No Body, No Crime.”

And Dick’s Sporting Goods is teaming up with Instacart to offer same-day delivery from more than 150 stores in states including Georgia, Maryland, New Jersey, New York, and Virginia. “We’re planning on rolling this out to more stores. But with the holidays, we just wanted to make sure to get something up and running for a considerable amount of our customers,” said Joe Pietropola, senior vice president of e-commerce at Dick’s. “We were able to get that done headed into this final rush, with the last 10 days to [Christmas]. Our customers have been asking for convenience and speed, and that’s what led us to look at a partnership with Instacart, to really broaden our portfolio of being able to meet the customer wherever, whenever.”

Stocks We’re Watching

Aqua Metals Inc (NASDAQ: AQMS): Aqua Metals shares are up 20% today following news that it has retired its $9 million debt obligation with Veritex Bank, leaving the company essentially debt free. “The retirement of our loan with Veritex Bank is yet another positive step for Aqua Metals as we have accelerated our transition to a capital light business model. With this action, our team has achieved our previously guided goal to retire the debt by year-end. Eliminating our debt significantly strengthens the balance sheet and completely removes the burden of restrictive loan covenants. In addition, this step improves the Company’s cash burn rate by eliminating $0.9 million annually in debt service payments, including $0.6 million in interest expense. We are also pleased with the continued progress made in recovering losses through our insurance collection efforts,” said Judd Merrill, Chief Financial Officer.

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