Even if the most optimistic predictions are true and the Covid-19 vaccine is approved for use in the United States in November, the vast majority of Americans will not be able to get vaccinated until spring or summer at the earliest. after.
That likely timeline, based on interviews and comments from top experts including White House Coronavirus Task Force’s Anthony Fauci, means businesses, students and families will continue to wait.
In an interview, Fauci, who also participated in the White House’s “Operation Speed Campaign” vaccine program, said it may take until 2021 for the vaccine to reach the general public.
“I hope that by the time we go into the second half of 2021, companies will deliver hundreds of millions of doses they promised,” said Fauci.
The reasons are many. US health regulators will only have a small fraction of the usual safety and efficacy data. Top products require two dosages, which will limit the number of early supplies that may help. And government health officials are still developing a plan about who will be injected, how they will be distributed, and how their effectiveness and safety will be monitored later.
Stephane Bancel, chief executive of Moderna Inc., a biotech company that is developing one of the furthest inoculants, said: “In three, six, nine months, more people will want a vaccine. there is a vaccine.
Bancel said he hopes his company’s products can receive emergency licensing from the Food and Drug Administration because “a very narrow population is at a very high risk”. Vaccines for the general public will need full FDA approval, which is likely to take significantly longer, he said.
Those comments contradict the timeline portrayed by President Donald Trump, who said a vaccine could be ready on election day Nov. 3.
“I am pushing people. If you had a president other than me, you wouldn’t talk about vaccines for two years. I will push it very hard, ”Trump said last week in a radio interview with Geraldo Rivera. “But I don’t do it because of the vote, I do it because it’s the right thing to do and I’m doing it to save a life.”
On Monday in Washington, Trump repeated his ambitious timeline: “I feel strongly that we will have the vaccine by the end of the year and it will be put to use even if we get it. , because we are all militarily prepared, we are using our army to deliver vaccines. “
The Warp Speed campaign seeks to do something that has never been done before: research, develop and produce a vaccine for a new virus for months. It’s an epic, risky job that could waste billions of dollars, but can take years off typical development milestones. But even if it succeeds, the warp speed will travel faster for some people than for others. Two other key government officials have described a gradual increase in accessibility over the past several months, rather than the sudden, widespread availability of the vaccine.
During a presentation on August 7 in front of a panel of experts convened by the National Academy of Medicine, which is helping to decide who should be the first to line up for the scene, War’s chief advisor Moncef Slaoui Warp Speed says a substantial production boost will begin in November. Slaoui said it will continue to accelerate in the coming months until producing a “very large quantity of doses” monthly in Q2 2021.
Along with the US $ 8 billion in funding for vaccine development and production through Warp Speed, the Ministry of Health and Defense signed contracts worth nearly $ 500 million to increase domestic production of jars. and the syringe with Covid-19 vaccine available. Consulting firm Deloitte also has a $ 15 million contract to track vaccine delivery and administration. The company did not respond to a request for comment.
On July 27, National Institutes of Health Director Francis Collins warned that the first batch of vaccine would be carefully distributed.
“There will be tens of millions of doses by the time the vaccine is first approved,” Collins said. “It won’t be enough for everyone, and so decisions will have to be made on priorities.”
Vaccine trials typically require tens of thousands of patients and monthly follow-up to show they are safe enough to inject into healthy people. A lack of long-term data could limit access until health officials can better assess any risks.
Fauci said on Aug. 6. Moderna’s test participants have registered about 10 percent of the 30,000 people it targets to register. any side effects.
In early fall, the FDA may have only a few weeks of data. That may be enough to inject health workers and other frontline workers as well as other groups at higher risk from the virus, but certainly not enough for those at lower risk.
Geoffrey Porges, an analyst at SVB Leerink, said that data won’t arrive next year, said in a July 20 note to clients.
The first federal announcement to allow vaccines to become a political event “given the fact that the availability, effectiveness and use of the vaccine were not advertised by government officials,” he said. fox “.
Despite the need for a vaccine and the logistical challenges of rolling it out to hundreds of millions of Americans, the Trump administration is still early in the planning stages for that massive effort to take place. how.
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 go through CVS,” Fauci told Bloomberg, referring to the pharmacy chain CVS Health Corp. “DOD with CDC is getting involved a lot in the way you bring your supply chain to the public. That has yet to be resolved. “
Jonathan Hoffman, the Pentagon’s chief spokesperson, said the Warp Speed program is also looking at the military use at a news conference on July 30.
The Department of Defense is examining “how do we leverage the commercial capacity of the private sector to handle things like distribution and where DOD goes to help manage that process or, if necessary, DOD will be asked to join and he said.
At least four states, California, Minnesota, North Dakota and Florida, are helping to develop early stages of a vaccine delivery plan once available, CQ Roll Call reported on Monday. The first-phase plan to explore “paradigmatic approaches” to vaccine delivery, the publication said, describes the program as a highly preliminary attempt.
In a statement to Bloomberg, California’s Department of Public Health described the program as a “general planning task”. Florida’s Department of Health has confirmed their participation, although it said there is no agenda for the meeting yet.
Meanwhile, the companies and scientists that are developing vaccines are rushing to get data back to restore use or move to more promising goals.
Pfizer Inc. and BioNTech SE, which has a competitive vaccine, is also registering patients. Pfizer chief executive Albert Bourla said at a Washington Post event last week that the drug’s manufacturer expects quick approval from the FDA, at least for use in an emergency, and there will be Enough medication to begin distributing this fall.
“The main goal right now is to make sure we have the vaccine,” Bourla said. “There are two enemies – viruses and timing.”
(Add Trump’s comment in the 10th paragraph)