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A COVID-19 Vaccine By Nov. 1? ‘Very, Very, Very Unlikely,’ Experts Say

The CDC has alerted states to be prepared to distribute a vaccine by Nov. 1, but immunology experts who spoke with TheWrap say that timeline is improbable

Despite statements from President Trump and the Centers for Disease Control and Prevention pointing to the possibility of a SARS-CoV-2 vaccine being ready by early November, immunology experts who spoke with TheWrap are not banking on such a timeline for a safe and effective vaccine.

“It is very, very, very unlikely it will be ready by November 1st,” John Swartzberg, an infectious diseases and vaccinology specialist at the UC Berkeley-UCSF Joint Medical Program, said. “It’s just highly improbable.”

As reported last week, the director of the CDC sent a letter to state governors in late August “urgently” asking that they be prepared to distribute a coronavirus vaccine by Nov. 1. But none of the three vaccine candidates funded by the U.S. under “Operation Warp Speed” for Phase 3 trials — Moderna’s, BioNTech and Pfizer’s, and AstraZeneca’s, whose trials were paused this week for safety concerns — have an expected completion date before November, let alone the end of 2020.

“Is it possible, in order to gather all the information you need to prove that a vaccine is safe and efficacious, to make that determination before the end of the year? And the answer comes from the actual people who are testing the vaccines, who say no. Otherwise, they would have designed their clinical trial to be done before then,” Robert Siegel, a microbiology and immunology professor at Stanford University, said. “They haven’t even finished recruiting patients.”

Siegel noted that the purpose of doing a clinical trial is to better understand how the vaccine works, which includes figuring out how many boosters the vaccine requires and how long immunity will last. But to gather that data requires the passage of time.

“You don’t know whether the vaccine will be effective in a year in three weeks. How would you know?” Siegel said.

And given that the current clinical trials are not human “challenge” trials, meaning that researchers aren’t intentionally infecting participants with the virus after they receive the vaccine due to the severity of COVID-19, researchers must wait for participants to naturally be infected to determine efficacy, adding another element of time to the equation.

Anthony Fauci, the nation’s top infectious diseases expert, said on Tuesday that the only scenario in which a November vaccine could be possible is if enough people participating in the clinical trials are infected with the virus sooner than expected, allowing researchers to collect enough data to make a determination about the vaccine’s efficacy. But even that scenario, Fauci cautioned, was “unlikely.”

As for the CDC’s letter suggesting the Nov. 1 timeframe, Swartzberg said he was generally supportive of states being prepared in advance for vaccine distribution but found the letter to be “really inappropriate.” Siegel called it “profoundly disappointing.”

“This kind of letter would never have come out from an administration that was concerned about the safety of the American people,” Swartzberg said. “That is not to say that we shouldn’t try to get this vaccine produced as quickly as possible, absolutely, but no one in a responsible governmental position would’ve sent a letter like this out.”