Most Americans will not be able to get a vaccine against Coronavirus until 2021

Photographer: Kevin Dietsch / UPI / Bloomberg

Even if the most optimistic projections are true and a Covid-19 vaccine is released for US use in November, the vast majority of Americans will not be able to get the shooter early until spring or summer next year.

That likely timeline, based on interviews and comments from top specialists including Anthony Fauci of the White House Coronavirus Task Force, means companies, schoolchildren and families will continue to wait.

In an interview, Fauci, who has also been involved with the White House’s Operation Warp Speed’s fax program, said it could take until well into 2021 for faxes to reach the general public.

“I would hope that by the time we get well into the second half of 2021, the companies will have delivered the hundreds of millions of doses they have promised,” Fauci said.

The reasons are many. U.S. health regulators will have only a small sliver of the usual data on safety and effectiveness. The leading products require two doses, which will limit how many people early deliveries can help. And government health officials are still developing a plan for who will receive the shots, how they will be distributed, and how their effectiveness and safety will be monitored thereafter.

“For three, to six, to nine months, there will be more people wanting a vaccine than there are vaccines,” said Stephane Bancel, chief executive of Moderna Inc., the biotechnology company that develops one of the most far-reaching inoculations. .

Bancel said he expects his company’s product could receive an emergency permit from the Food and Drug Administration for “a very narrow, high-risk population.” Vaccines for the general population will require full FDA approval, which is likely to take significantly longer, he said in an interview.

Those comments run counter to the timeline pictured by President Donald Trump, who has said a fax could be ready by election day on November 3rd.

“I’m pushing everyone. If you had a president other than me, you would not speak faxes for two years. I’m going to push it hard, “Trump said last week in a radio interview with Geraldo Rivera.” But I’m not doing it for votes, I’m doing it because that’s the right thing to do and I’m doing it to save people. . “

On Monday in Washington, Trump reiterated his ambitious timeline: “I feel strongly that at the end of the year we will have a fax and it will come into service, perhaps even if we get it, because we are all militarily prepared, we use our army to spread the vaccine. ”

Restricted access

Operation Warp Speed ​​is trying to do what has never been done before: research, develop and produce a vaccine for a new virus in months. It is a monumental, risky venture that is likely to result in billions of dollars in waste, but years may deviate from typical development timelines. But even if successful, warp speed will move faster for some people than others. Two other key government officials described a gradually increasing trickle of access over months and months, not the sudden, widespread availability of a vaccine.

In a presentation on August 7 to a panel of experts convened by the National Academy of Medicine, which helps decide who will be the first in line for a shot, Operation Warp Speed ​​chief adviser Moncef Slaoui said it was important production ramp-up in November should begin. It will continue to accelerate over the next few months until a “very large number of doses” are produced on a monthly basis in the second quarter of 2021, Slaoui said.

Together with $ 8 billion in US funding for vaccine development and production through Warp Speed, the Department of Health and Defense has raised nearly $ 500 million in total to increase domestic bottle manufacturing and provide syringes for Covid-19 vaccines. The consulting firm Deloitte also has a $ 15 million contract to monitor the distribution and administration of faxes. The company did not respond to a request for comment.

On July 27, National Institutes of Health Director Francis Collins 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 will not be enough for everyone, and so decisions must be made about priorities.”

Vaccine tests typically require tens of thousands of patients and months of follow-up to show that they are safe enough to give to healthy people. A long-term lack of data could limit access until health officials can better assess all risks.

The Moderna trial has registered about 10% of the 30,000 people enrolled in it, Fauci said on August 6. Subjects should receive the shots, which are on top of each other, and then be checked to see if they are infected or have any side effects.

By early fall, the FDA can only have data for a few weeks. That may be enough to give the shot to health care and other frontline workers and other groups at higher risk of the virus, but it will almost not be enough for people at lower risk.

That data will only come next year, said Geoffrey Porges, an analyst at SVB Leerink, in a July 20 note to clients.

The first announcement of federal clearance for a vaccine is more likely to become a political event “with the reality of the availability, effectiveness and usefulness of the vaccine being far short of promotion by government officials,” he said.

Early plans

Despite the demand for a fax machine and the logistical challenges of rolling out to hundreds of millions of Americans, the Trump administration is still early in the planning stages for how that immense effort will go.

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 can not continue through CVS,” Fauci told Bloomberg, referring to the CVS Health Corp. drugstore chain. “The DOD together with the CDC is very involved in how to get the supply chain to the people. That has not been worked out yet.”