The United States is at the peak of a game-changing moment in the fight against COVID-19 after a single-dose shot from Johnson & Johnson overcame a key regulatory hurdle on Wednesday, giving it a clear path to to the emergency use permit.
A review by the Food and Drug Administration (FDA) of a large clinical trial found that the company’s vaccine completely prevented hospitalizations and death and was also effective especially in preventing moderate and severe cases. severe COVID-19.
The vaccine may also provide better protection than expected against new variants of the virus.
The information was released ahead of a meeting of the FDA advisory committee on Friday, which will discuss whether to grant emergency authorization for the vaccine.
The positive development gives hope that there will be a third vaccine on the market against COVID-19 as soon as this weekend, a few days after the United States 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 increase the global supply of vaccines, which will allow more Americans to be vaccinated sooner,” said the COVID-19 coordinator of the White House Jeff Zients
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In general, coronavirus cases and hospitalizations are declining, and as the U.S. heads toward spring, experts are beginning to see a light at the end of the tunnel.
According to the Centers for Disease Control and Prevention, the daily average of cases decreased by 25% last week, reaching 64,000 cases per day. This number is slightly lower than the summer peak of 67,000 daily cases reported last July.
The number of reported deaths is also declining, with an average of seven days of just under 2,000 per day.
“I’m definitely excited to have a more consistent federal response, more vaccines, and the vaccination campaign is intensifying,” said Jesse Goodman, a professor of medicine and infectious diseases at Georgetown University and former head of the FDA scientific.
“We could have problems with production, because there are always uncertainties, but definitely excited ones,” 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 temperatures in the refrigerator, unlike vaccines developed by Moderna and the Pfizer-BioNTech group, which need to be kept frozen at ultra-cold temperatures.
Leana Wen, a professor of public health at George Washington University and a former Baltimore health commissioner, said these benefits make the vaccine “a total game changer, as it allows community health centers, pharmacies and regular medical offices have the capacity to administer this vaccine “.
So far, supply has been the main constraint for increased vaccination effort in the United States. Pfizer has only shipped approximately 40 million doses, while Moderna has shipped approximately 45 million doses.
Johnson & Johnson will only have about 4 million doses available to ship immediately after 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 delays in manufacturing and said it was “disappointing” to find out when his team took over the country’s COVID-19 response, but said he was confident the company was “in a better place now.” .
“We have helped them with equipment and raw materials, which I think contributes to increasing capacity and accelerating. I think progress is real, “Zients said
At the same time, Moderna and Pfizer-BioNTech have committed to drastically increase production and delivery.
Company executives told Congress this week that they will be able to administer more than 130 million additional combined doses by the end of March.
The companies said they no longer face a shortage of raw materials and have largely solved the manufacturing challenges that limited initial production and resulted in bottlenecks as demand has far exceeded the offer.
Altogether, 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 several companies to vaccinate everyone in the country is encouraging, but the reality of vaccine manufacturing makes experts also have a realistic view of the situation.
“A single vaccine will not make a big difference immediately, both in the United States and worldwide, but like many other manufacturers [Johnson & Johnson] they’re making very high predictions, but we’ll have to see, ”Goodman said.
Despite the positive advances, there is still a long way to go.
“At some point we will have enough supply and then the ability to vaccinate will be the limiting factor, and then a couple of months later … the acceptance of the vaccine, the potential hesitation will be a limiting factor,” Wen said. .
“So I think we’ll be alternating between these three barriers for a while,” he said.