Even if the most optimistic predictions come true and a Covid-19 vaccine is cleared for use in the US in November, most Americans will not be able to get shots until next spring or early summer next year.
This potential timeline, based on interviews and remarks from senior specialists, including Anthony Fauci from the White House Coronavirus Task Force, means that businesses, schoolchildren and families will continue to wait.
In an interview, Fauci, who was also involved in the White House’s “Operation Warp Speed” vaccine program, said it could be until 2021 that the vaccines would reach most of the general public.
“I would hope that by the time we get well into the second half of 2021 the companies will deliver the hundreds of millions of doses they have promised,” Fauci said.
The reasons are many. U.S. health regulators will have only a small summary of common safety and efficacy data. Major products require two doses, which will limit how many people can help with early supplies. And government health officials are still drawing up a plan of who will take the shots, how they will be distributed, and how their effectiveness and safety will be followed up.
“In three, six, 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 remote inoculations.
Bancel said he expects his company’s product could receive urgent authorization from the Food and Drug Administration for “a very narrow population at very high risk”. Vaccines for the general population will need full FDA approval, which is likely to last significantly longer, he said in an interview.
These comments run counter to the timeline portrayed by President Donald Trump, who has said a vaccine could be ready within election day on November 3rd.
“I’m pushing everyone. If you had another president besides me, you would not be talking about vaccines for two years. I’ll push it hard,” Trump said last week during a radio interview with Geraldo Rivera. “But I’m not doing it for the vote, I’m doing it because it’s the right thing to do and I’m doing it to save lives.”
In Washington on Monday, Trump echoed his ambitious deadline: “I feel strongly that we will have a vaccine by the end of the year and it will be put into service perhaps even when we get it, because we are all militarily deployed, we “We are using our army to distribute vaccines.”
Operation Warp Speed seeks to do what has never been done before: research, develop and produce a vaccine for a new virus every month. It’s a monumental, hazardous enterprise that will probably result in billions of dollars of waste, but can survive years past typical development deadlines. But even if it is successful, the breakdown speed will move faster for some people than others. Two other senior government officials describe a gradual complication of months and months of expansion, not the sudden, widespread availability of a vaccine.
During a Aug. 7 presentation to a panel of experts gathered by the National Academy of Medicine, which is helping decide who will be in the front row for a stroke, Warp Speed chief adviser Moncef Slaoui said significant output growth should begin in November. It will continue to accelerate over the coming months until it produces a “very large number of doses” on a monthly basis in the second quarter of 2021, Slaoui said.
Along with $ 8 billion in US funding for vaccine development and production through Warp Speed, the Health and Defense departments have sold contracts totaling nearly $ 500 million to increase domestic production of prefabricated vials and syringes for Covid vaccines. -19. Consulting firm Deloitte also has a $ 15 million contract to track vaccine distribution and administration. The firm did not respond to a request for comment.
On July 27, Director of the National Institutes of Health Francis Collins warned that the first round of vaccines would be carefully distributed.
“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 will have to be made about priorities.”
Vaccine studies typically require tens of thousands of patients and months to follow to show that they are safe enough to give to healthy people. Lack of long-term data may limit access until health officials can better assess any risks.
The Modern Trial has signed about 10% of the 30,000 people it intends to register, Fauci said on August 6th. Trial participants should take shots, which are split away, and then monitored to find out if they are infected or have any side effects.
Until early fall, the FDA may only have a few weeks of data. This may be enough to set the goal for healthcare and other front-line workers and other groups at greater risk of the virus, but it will almost certainly not be enough for people at lower risk. .
That data won’t come until next year, Geoffrey Porges, an analyst at SVB Leerink, said in a July 20 note to clients.
The first announcement of federal permission for a vaccine is more likely to become a political event “with the reality of vaccine availability, effectiveness and utility falling far short of promotion by government officials,” he said.
Despite the demand for a vaccine and the logistical challenges of describing it to hundreds of millions of Americans, the Trump administration is still in the early stages of planning how this 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 may not pass with CVS,” Fauci told Bloomberg, referring to the pharmacy chain CVS Health Corp. “DOD along with the CDC are getting very involved in how you take the supply chain to people. This has not been worked out yet.”
The Warp Speed program is also looking at military use, Pentagon spokesman Jonathan Hoffman told a news conference on July 30.
The Department of Defense is considering “how we can take advantage of the private sector commercial capacity to handle things like distribution, and where it will go or DOD step in to help manage this process, or if necessary will be required from DOD to open and actually hand over the physical items themselves, “he said.
At least four states, California, Minnesota, North Dakota and Florida, are helping develop the early stages of a vaccine distribution plan once it becomes available, CQ Roll Call reported Monday. The early-stage plan aims to explore “model approaches” to vaccine delivery, the publication reported, describing the program as a very preliminary effort.
In a message to Bloomberg, the California Department of Public Health described the program as a “joint planning mission.” The Florida Department of Health confirmed his participation, though he said no agenda had been set for the meeting.
Meanwhile, companies and scientists developing vaccines are rushing to get data to support their use, or move toward more promising targets.
Pfizer Inc. and BioNTech SE, who have a competing vaccine, are also enrolling patients. Pfizer CEO Albert Bourla said at an event at the Washington Post last week that the drug maker is awaiting rapid approval from the FDA, at least for urgent use, and will have enough shots to begin distribution this fall.
“The main goal now is to make sure we have a vaccine,” Bourla said. “There are two enemies – the virus and time.”
(Adds Trump’s comment in the 10th paragraph)