Covid Vaccine Frontrunner Moderna Says Vaccine Won’t Be Approved Until Spring 2021

Published 4 years ago
Coronavirus Covid-19 vaccine concept –  three glass vials on black table, hypodermic syringe needle near, closeup detail (label own design – dummy data and barcode, not real product)

Pharmaceutical company Moderna, one of the companies in the lead pack in the race to develop a coronavirus vaccine, won’t be in a position to widely distribute it until at least next spring, CEO Stéphane Bancel told the Financial Times, echoing public health experts who predict a similar timeline for other vaccine candidates.

KEY FACTS

“November 25 is the time we will have enough safety data to be able to put into an emergency use authorization file that we would send to the FDA,” Bancel said, adding that an approval wouldn’t be expected until late first quarter or early second quarter of 2021.

The timeline matches up with what public health experts have previously laid out, which is that a vaccine could be found to be safe and effective by the end of the year at the earliest but widespread distribution wouldn’t occur until further into 2021.

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One of the frontrunners to develop a safe vaccine first, Moderna earlier in the month said it was slowing its trial enrollment to ensure it was representing disproportionately affected minority groups but later added it could have enough data by November to know if its vaccine candidate works.

The comments follow President Trump’s claim during Tuesday’s U.S. presidential debate that, “We’re weeks away from a vaccine,” citing Moderna as well as Pfizer and Johnson & Johnson.

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Pfizer is another frontrunner—Johnson & Johnson are further behind their late-stage clinical trials—and while its CEO Albert Bourla said it will have an “answer” by the end of October on its candidate’s efficacy, a spokesperson for the company later told the New York Times that Pfizer wouldn’t be close to the completion of its clinical trial by then.

There are currently 11 vaccines in expansive Phase 3 clinical trials, according to data from the Times.

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CHIEF CRITIC

Trump has pushed the notion that a vaccine will be ready before the November election, fueling fear in the U.S. that anything approved could have been rushed. Even with wide distribution of a vaccine, the upwards of 60% to 70% will need to be immunized to put an end to the pandemic. That could take until 2022, according to billionaire and philanthropist Bill Gates and Dr. Soumya Swaminathan, the World Health Organization’s chief science officer.

KEY BACKGROUND

A Covid-19 vaccine is being developed at an unprecedented speed, with a typical immunization taking 10 years to develop, test, approve, and distribute. The U.S. leads the world in confirmed cases of the coronavirus with 7,221,278, as well as reported deaths with 206,693. In total, there are 33,802,841 global infections and 1,010,477 deaths.

-By Matt Perez, Forbes Staff

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