Even if the most optimistic estimates are correct and the Kovid-19 vaccine is approved for US use in November, the vast majority of Americans will not be able to get shots as soon as possible in spring or summer next year Will happen.
Based on interviews and comments from top experts, including Anthony Fauci of the White House Coronovirus Task Force, it is likely that businesses, schoolchildren and families will continue to wait.
In an interview, Fauci, who has also been involved with the White House’s “Operation War Speed” vaccine program, said it may take a long time for the vaccine to reach the general public by 2021.
“I hope the companies will have promised those multi-million doses until we get well into the second half of 2021,” Fauci said.
The reasons are many. US health regulators will have only a small piece of general safety and efficacy data. Major products require two doses, which will limit how many people can help with the initial supply. And government health officials are still developing a plan for who will get the shots, how they will be distributed, and how their effectiveness and safety will be tracked later.
“From three to six to nine months, there will be more people wanting the vaccine,” said Modern Bank chief executive Stephen Banksel.
Banksel said he hoped his company’s product could get an emergency authorization from the Food and Drug Administration for “a very narrow population at very low risk”. In an interview he stated that vaccines for the general population would require full FDA approval, which would likely take longer.
Those comments run counter to the timeline depicted by President Donald Trump, who has said that a vaccine may be ready by November 3, the day of election.
“I’m pushing everybody.” If you had a president other than me, you would not have been vaccinated for two years. I will push it very hard, ”Trump said during a radio interview with Geraldo Rivera last week. “But I’m not doing it for a vote, I’m doing it because it’s the right thing to do and I’m doing it to save lives.”
On Monday in Washington, Trump echoed his ambitious timeline: “I strongly feel that we’ll have a vaccine by the end of the year and put it into service, even if we get it, as we all military set. We are using our military to deliver the vaccine. “
Operation Warp Speed wants to do what has never been done before: research, development, and production of a vaccine for a new virus in months. It is a monumental, risky venture, which would probably result in wastage of billions of dollars, but it could be off the normal growth rate lines. But even if it is successful, the sarcasm will move faster for some people than others. Two other prominent government officials described the sudden, widespread availability of a vaccine as being gradually widened over months and months.
During an Aug. 7 presentation to a panel of experts called by the National Academy of Medicine, which is helping to decide who would be the first to take a shot, Operation War Speed’s chief advisor Monsep Saloui said Significant production ramp-up should begin in November. . Slaoui said it would continue to boom in the following months until “a very large number of doses” are produced on a monthly basis in the second quarter of 2021.
With $ 8 billion in US funds provided for vaccine development and manufacturing through War Speed, the Department of Health and Defense signed contracts for approximately $ 500 million to expand domestic manufacturing of vials and prefabricated syringes for Kovid-19 vaccines. Has ended. Consulting company Deloitte also has a $ 15 million contract to track vaccine delivery and administration. The firm did not respond to a request for comment.
On July 27, Francis Collins, director of the National Institutes of Health, warned that the first round of vaccines would be carefully allocated.
“At that time, millions of tons of doses will be received, which first approves the vaccine,” Collins said. “This will not be enough for everyone, and therefore decisions have to be made about priority.”
Vaccine trials usually require thousands of patients to show that they are sufficient to deliver healthy people. Lack of long-term data may limit access until health officials can better assess any risk.
Modern’s test targets about 10% of the 30,000 people signing, which Fauci said on August. 6. Trial participants are required to obtain shots, which vary, and are then monitored to detect whether or not they are infected. Any side effects.
By early fall, the FDA may have only a few weeks of data. This may be enough to give the virus a shot at high-risk health-care and other front-line workers and other groups, but it will almost certainly not be enough for low-risk people.
In a July 20 note to customers, Geoffrey Porges, an analyst at SVB Lerink, said the data would not arrive until next year.
The first announcement of federal approval for a vaccine would become a political phenomenon “with the reality of the availability, effectiveness, and utility of a vaccine falling short of publicity by government officials”.
Despite the demand for a vaccine and the logistical challenges of rolling out hundreds of Americans, the Trump administration is still early in the planning stages of what a huge effort it will take.
The Department of Defense and the Centers for Disease Control and Prevention are expected to be heavily involved, and the role of the private sector is less clear.
“It might not have been running through CVS,” Fauci told Bloomberg, referring to drugstore chain CVS Health Corp., “DoD is engaging with the CDC to get you guys to supply How the series came together. It has not been worked out yet. “
During a press conference on July 30, the Pentagon’s chief spokesman Jonathan Hoffman said that Tana is also looking at a speed program to use the military.
The Department of Defense is investigating “how we leverage the private sector’s business capability to handle things like distribution, and where the DoD would step in to help manage that process, or if DoD will need to step in if necessary. The items actually physically deliver themselves, ”he said.
At least four states, California, Minnesota, North Dakota and Florida, are helping to develop the initial stages of the plan to deliver the vaccines. Once available, the CQ roll call Reported on Monday. An early-stage plan is to explore a “model approach” on vaccine delivery, the publication reported, describing the program as an extremely early effort.
In a message to Bloomberg, California’s Department of Public Health described the program as a “joint planning mission.” Florida’s Department of Health confirmed its involvement, although no agenda was set for the meeting.
Meanwhile, companies and scientists developing vaccines are rushing to obtain data to retract their use, or move on to more promising targets.
Pfizer Inc. And BioNTech SE, which has a competitive vaccine, is also signing patients. Pfizer CEO Albert Borla said at a Washington Post event last week that the drugmaker expects rapid approval from the FDA for at least emergency use, and that this fall would be enough shot to begin delivery.
“The main goal right now is to make sure we have a vaccine,” Borla said. “There are two enemies – viruses, and time.”
(Adds Trump’s comment to 10th paragraph)