Even if the most optimistic prediction holds and the Covid-19 vaccine is licensed for use in the United States in November, the vast majority of Americans will not be able to get it until early spring or summer next year.
Based on interviews and remarks from top specialists including Anthony Forch of the White House Coronavirus Task Force, this timeline means businesses, schoolchildren and families await.
In an interview, Fauci, who is also involved in the White House “Operation Warp Speed” vaccine program, said it could take some time before 2021 for the vaccine to reach the majority of the public.
“By the end of 2021, we hope to be able to deliver hundreds of millions of promised doses to companies,” Fauci said.
There are many reasons. Health regulators in the United States provide only a small amount of normal safety and efficacy data. The main product requires two doses. This limits the number of people the initial supply can help. And government health officials still have a plan about who gets the shots, how they are distributed, and how their effectiveness and safety are subsequently tracked. I am.
“People who want to be vaccinated will be more than vaccines for three to six to nine months,” says Moderna Inc, a biotechnology company developing one of the furthest vaccinations. . Chan Stephane Bancel said.
Bansel said he expects his products to be subject to urgent approval from the Food and Drug Administration for “a very high-risk population with a very narrow risk.” A vaccine for the general public would require full FDA approval, which would probably take quite some time, he said in an interview.
These comments run counter to the timeline drawn by President Donald Trump, who said the vaccine might be ready by the election day on November 3.
“I’m putting everyone on the table. I haven’t spoken to vaccines for two years if I had another president. Mr. Trump said last week in a radio interview with Gerald Rivera. “But I vote. I’m not doing it for the sake of it because it is right and I am doing it to save lives.”
On Monday in Washington, Trump echoed his ambitious timeline: “We strongly believe we will have the vaccine by the end of the year. We will use the military to distribute the vaccine. I am.”
Operation Warp Speed aims to do new things: research, develop and manufacture vaccines against new viruses in a matter of months. It’s a monumental and risky business that will probably cost billions of dollars, but can be cut off from a typical development timeline for years. However, even if it succeeds, some warps move faster than others. Two other major government officials explained that the availability of the vaccine was not suddenly widespread, but that access was gradually expanding over the months.
A presentation to an expert panel convened by the National Academy of Medical Sciences on August 7 helps to determine who will be the first to shoot. He said the raising should start in November. .. Slaui said it will continue to accelerate over the next few months until a “very high dose” is produced each month in the second quarter of 2021.
In addition to the $8 billion in U.S. dollars granted to develop and manufacture vaccines through Warp Speed, the Department of Health and Defense has added a total of approximately $500 million to increase domestic production of vials and prefilled syringes for Covid-19 vaccines. Signed a dollar contract. Consulting firm Deloitte has a $15 million contract to track vaccine distribution and management. The company did not respond to requests for comment.
On July 27, Francisco Linds, director of the National Institutes of Health, warned that the first round of vaccines would be carefully assigned.
“There will be tens of millions of doses by the time the first vaccine is approved,” Collins said. “It’s not enough for everyone, so you’ll have to make decisions about priorities.”
Vaccine trials usually require tens of thousands of patients and months of follow-up to show that they are safe enough to administer to healthy people. In the absence of long-term data, access may be limited until health authorities can better assess risk.
Moderna’s trial registered about 10 percent of the 30,000 people seeking to register, Mr Fouch said on August 6. Side effects.
At the beginning of autumn, the FDA may have only a few weeks’ worth of data. This may be enough to give shots to health care and other frontline workers, and other groups at high risk of the virus, but not to those at low risk.
That data won’t come until next year, SVB Relink analyst Jeffrey Poges said in a memo to customers on July 20.
The initial announcement of a federal license for vaccines is likely to be a political event “with the reality of availability, efficacy, and practicality of vaccines far beyond publicity by government authorities,” he said. ..
Despite the demand for vaccines and the logistical challenges of deploying it to hundreds of millions of Americans, the Trump administration is still in the early planning stages of how its enormous efforts will go.
The Pentagon and the Centers for Disease Control and Prevention are expected to be deeply involved and the role of the private sector is less clear.
“It may not have gone through CVS,” Fauci told Bloomberg, referring to drugstore chain CVS Health Corp. It has not been resolved yet. “
Pentagon spokesman Jonathan Hoffman said at a press conference on July 30 that the Warp Speed program is also considering using the military.
The Department of Defense said, “How to use the commercial capacity of the private sector to handle things such as distribution, and where the DOD intervenes to help manage that process, or where necessary the DOD intervenes to actually We actually deliver the item itself,” he said.
At least four states-California, Minnesota, North Dakota, and Florida-support the early development of plans to distribute vaccines as they become available, CQ Roll Call report on Monday. Early-stage planning seeks to explore a “model approach” for vaccine distribution.
In a message to Bloomberg, the California Department of Public Health described the program as a “co-planning mission.” The Florida Department of Health confirmed the participation, but said the meeting’s agenda had not been set.
Meanwhile, companies and scientists developing vaccines are in a hurry to put the data back into use or move it to more promising targets.
Pfizer and BioNTech SE, who have competing vaccines, are also enrolling patients. Pfizer’s CEO Albert Bora said at a Washington Post event last week that pharmaceutical companies are hoping for immediate approval from the FDA for at least emergency use, and there are enough shots to launch this fall. Told.
“The main goal now is to make sure we have the vaccine,” Bourla said. “There are two enemies—virus and time.”
(Added Trump’s comment to the 10th paragraph)
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