Don’t expect a coronavirus vaccine before the election – here’s the likely timeline according to doctors, government officials and analysts

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  • President Trump has suggested that a coronavirus vaccine could become available “just around” the November 3 election.
  • But public health experts, financial analysts and U.S. government officials have said the timeline is unrealistic.
  • Most experts believe there is little hope that a vaccine will be ready before the end of the year.
  • In the most optimistic scenario, pharmaceutical companies like Pfizer and Moderna could publish positive results from their human trials in October.
  • Visit the Business Insider homepage for more stories.

The answer to one of the biggest questions of the year – when will a coronavirus vaccine be ready? – differs depending on who you ask.

Last month, the Centers for Disease Control and Prevention told public health officials in each state to prepare for vaccine distribution by November 1. Robert Redfield, CDC director, said the goal was to get a head start, as the agency expects one or more vaccines to be ready by November or December.

President Donald Trump has also suggested that a vaccine could become available “just around” the November 3 election.

“We remain on track to deliver a vaccine before the end of the year and possibly even before November 1,” Trump said at a White House press conference on Friday. “We think we can probably have it sometime in October. ”

But public health experts say there is little hope of a vaccine being ready before the end of the year, let alone before the election.

On Tuesday, the CEOs of nine pharmaceutical companies issued a rare joint pledge promising to put safety before speed when developing a vaccine. The companies have pledged to seek emergency FDA approval only after demonstrating their vaccines to be safe and effective through a Phase 3 trial – the final testing of a vaccine before it can. be distributed to the public.

In the most optimistic scenario, pharmaceutical companies could publish positive results from Phase 3 trials in October. Pfizer and Moderna each said it was a possibility.

But when it comes to rolling out this vaccine, most experts agree it won’t happen until 2021. Here is the most likely timeline according to government officials, public health experts and Wall Street analysts.

What government officials anticipate: vaccine widely available by mid-2021

The United States is lining up an army of vaccine candidates. Through Operation Warp Speed, the government is funding the manufacture of six promising candidates in bulk while clinical trials are still ongoing. The program hopes to deliver 300 million doses of a safe and effective vaccine by January 2021.

So far, three pharmaceutical companies participating in this program – AstraZeneca, Moderna and Pfizer – have shown in early data that their vaccines generate immune responses without causing serious side effects. But AstraZeneca has just suspended its Phase 3 trial due to a potential adverse reaction in a UK participant.

Moderna and Pfizer’s Phase 3 trials both began in July and are expected to include 30,000 volunteers. Last week, Pfizer said it recruited 23,000 people, while Moderna had enrolled more than 21,000.

Moncef Slaoui, the chief advisor on Operation Warp Speed, told NPR last week that it was “extremely unlikely but not impossible” for the trials to end at the end of October. A more realistic estimate, he said, is that a vaccine would become available to high-risk populations, including healthcare workers and people 70 years of age or older, by the end of 2020. By that time, the United States might have sufficient capacity to vaccinate between 20 and 25 million people, he added.

Dr. Barney Graham, deputy director of the Vaccine Research Center at the National Institutes of Health, speaks with President Donald Trump during a lab visit March 3, 2020 in Bethesda, Maryland.
Evan Vucci / Associated press

The vaccine could then become widely available to Americans by the second quarter of 2021, Slaoui previously told Business Insider. By then, he added, the United States might have already immunized around 70 or 80 million people.

It is similar to the schedule proposed by Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases.

On Tuesday, Fauci said experts will likely know if a vaccine is safe and effective by the end of 2020. That could put the country on track to have tens of millions of doses available by early 2021, and more hundreds of millions by the middle of the year.

Fauci added that it is “unlikely” that a vaccine will be ready before the elections.

At a Senate hearing on Wednesday, Francis Collins, director of the National Institutes of Health, also said he was cautiously optimistic that at least one vaccine would prove to be safe and effective by the end of this year. .

“Trying to predict whether this will happen in a particular week before or after a particular date in early November is way beyond anything any scientist could tell you and be sure they know what they are saying,” Collins said.

What public health experts think: it is unrealistic to expect results this fall

Before a vaccine can be distributed to the public, the Food and Drug Administration must issue an Emergency Use Authorization (EUA). EUAs require less rigorous review than full FDA approval.

FDA Commissioner Stephen Hahn told the Financial Times last month that his agency would consider issuing an EUA for a vaccine before human trials are completed if a trial shows enough positive data to prove that the benefits of the vaccine authorization outweighed the risks.

“If a vaccine is extraordinarily effective – let’s say over 90% effective – we may find out before all 30,000 people are enrolled in the trial,” Luciana Borio, former acting chief scientist of the trial, recently wrote. the FDA. on Twitter.

But Fauci said in a recent question-and-answer session with Brown University School of Public Health that the chances of a vaccine being 98% effective are “not great.” Scientists are hoping for a vaccine that is at least 75% effective, he added, although US regulators have said they will allow a vaccine that is 50% effective.

Many public health experts are optimistic that at least one candidate will meet this standard, but are less certain that they will be ready before the end of the year.

Scientist Xinhua Yan works in the Moderna laboratory in Cambridge, Massachusetts, February 28, 2020.
David L. Ryan / Le Boston Globe / Getty Images

“The start of fall is unrealistic,” Ashish Jha, dean of Brown’s School of Public Health, told MSNBC in July. “We just need time to follow people to make sure they don’t have any unwanted reactions. ”

The fact that Moderna and Pfizer vaccines require participants to receive two injections further complicates the timeline.

Dr Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia, told WebMD that it would be “remarkable” for volunteers to receive their second dose in September. And after that, he says, they would have to wait another two weeks to see if they develop an immune response.

“I can’t imagine we would have data on this until the start of next year,” Offit said.

Jha, similarly, told Business Insider that researchers should have “a lot more information” about a vaccine in January. He predicts that a candidate could be ready to distribute in early 2021.

Dr Naor Bar-Zeev, associate professor at the Johns Hopkins Bloomberg School of Public Health, offered a less optimistic timeline to CBS Baltimore: he believes a vaccine will likely not be widely available until the end of 2021.

What Wall Street Analysts Say: Pfizer and Moderna May Have Test Results By November

Moderna and Pfizer both remain optimistic about their timelines.

Last week, Pfizer CEO Albert Bourla said he expected to know if the company’s vaccine was working by the end of October.

Getting results in October would be a “best case scenario” for Moderna, the company’s CEO, Stéphane Bancel, recently told Business Insider. In the worst case, Moderna could wait until December or January.

In a research note to investors, analysts at Morgan Stanley predicted Moderna and Pfizer would produce test results by mid-November. Goldman Sachs analysts, meanwhile, estimated Moderna could know if its vaccine candidate is effective by the end of November, while Pfizer’s could be approved as early as October. This would put the company on track to deliver 100 million doses by the end of 2020 and 1.2 billion doses by 2021.

Analysts at Jefferies Financial Group, however, estimated Moderna’s vaccine would not get emergency approval until early 2021.

It is not yet clear what effect AstraZeneca’s trial break might have on its schedule, but SVB Leerink analyst Andrew Berens predicted on Wednesday that results could be delayed by weeks to months. The company had previously estimated that it could find out if its vaccine was working as early as this month.

However, even a widely available vaccine will not bring an instant return to normal. The first coronavirus vaccines may not completely prevent infection and will face huge distribution challenges, which could mean Americans should continue to wear masks in public.

“I’m pretty convinced that we’re not going to have some sort of vaccine that will somehow immediately eliminate the pandemic,” Jha said. “We will have to continue to take these public health measures for a long time. ”

Andrew Dunn contributed reporting.

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