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US hits game-changing moment in COVID-19 fight

The U.S. is on the cusp of a game-changing moment in the fight against COVID-19 after a one-dose shot from Johnson & Johnson passed a key regulatory hurdle on Wednesday, giving it a clear path to emergency-use authorization. 

A Food and Drug Administration (FDA) review of a large clinical trial found the company's vaccine completely prevented hospitalizations and death and was also mostly effective against preventing moderate and severe cases of COVID-19.

The vaccine may also provide better protection than expected against new variants of the virus.

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The information was published ahead of an FDA advisory committee meeting Friday, which will debate whether to grant the vaccine emergency authorization. 

The positive development gives hope that there will be a third vaccine against COVID-19 on the market as soon as this weekend, just days after the U.S. passed the milestone of half a million Americans killed by the virus.

“Obviously, the prospect of a potential third approved vaccine is very encouraging and will help to increase the overall vaccine supply, which will allow more Americans to get vaccinated sooner,” White House COVID-19 coordinator Jeff ZientsJeff ZientsCDC: 30 percent of US adults fully vaccinated, nearly 50 percent have received at least one dose The Hill's Morning Report - Presented by Tax March - US vaccine effort takes hit with Johnson & Johnson pause The Memo: Specter of vaccine hesitancy rises after J&J blow MORE said Wednesday.

Overall coronavirus cases and hospitalizations are declining and as the U.S. heads toward spring, experts are starting to see a light at the end of the tunnel. 

According to the Centers for Disease Control and Prevention, average daily cases declined 25 percent in the past week, to about 64,000 cases per day. That number is slightly less than the summer peak of 67,000 daily cases reported last July.

The number of reported deaths is also dropping, with a seven-day average of slightly less than 2,000 per day.  

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“I'm definitely encouraged that we're having a more coherent federal response, that there's more vaccine, and the vaccination campaign is getting ramped up,” said Jesse Goodman, a professor of medicine and infectious diseases at Georgetown University and former FDA chief scientist.

“We could have problems with production, because there's always uncertainties, but definitely encouraged,” Goodman said.

Johnson & Johnson is the first company with a single-dose vaccine, meaning the 20 million doses represent 20 million people. 

It can also be transported and stored for months at normal refrigerator temperatures, unlike the vaccines developed by Moderna and the Pfizer-BioNTech group, which need to be kept frozen at ultra-cold temperatures.

Leana Wen, a public health professor at George Washington University and former Baltimore health commissioner, said those advantages make the vaccine “a total game-changer, because it allows for community health centers, pharmacies, regular doctor’s offices, to have the ability to administer this vaccine.”

To date, supply has been the primary constraint to the ramping up of the U.S. vaccination effort. Pfizer has only shipped approximately 40 million doses, while Moderna has shipped about 45 million doses. 

Johnson & Johnson will only have about 4 million doses available to ship immediately upon authorization, but that number will increase to 20 million by the end of next month.

When the Trump administration first signed a contract with Johnson & Johnson, the company said it expected to have at least 10 million doses available by the end of February. 

Zients acknowledged the manufacturing delays and said it was “disappointing” to discover when his team first took over the country’s COVID-19 response, but said he was confident the company is “in a better place now.”

“We've helped them with equipment and raw materials, which I think is helping to increase greater capacity and accelerate. I think the progress is real,” Zients said

At the same time, Moderna and Pfizer-BioNTech have pledged to dramatically ramp up production and delivery. 


 
Company executives told Congress this week they will be able to deliver more than 130 million additional doses combined by the end of March.

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The companies said they are no longer facing shortages of raw materials and have largely solved the manufacturing challenges that limited the initial production and resulted in bottlenecks, as demand has far outstripped supply.

Combined, the two companies have contracts to provide 600 million doses, which they say will be ready by the end of July.

The possibility of having enough supply from multiple companies to vaccinate everyone in the country is encouraging, but the realities of vaccine manufacturing means experts are also taking a realistic view of the situation. 

“A single vaccine isn't going to make a huge immediate difference, U.S. or globally, but like several of the other manufacturers they [Johnson & Johnson] are making very high predictions, but we'll have to see,” Goodman said. 

Despite the positive developments, there is still a long road ahead.

“At some point we are going to have enough supply, and then the ability to vaccinate is going to be the limiting factor, and then a couple months after that ... the acceptance of the vaccine, potential vaccine hesitancy is going to be the limiting factor,” said Wen. 

“So I think we're going to be toggling between these three barriers for some time to come,” she said.