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Moderna to file COVID-19 shot for emergency nod in November, with Pfizer rollout pegged for early next month: Slaoui

November 23, 2020 Fraiser Kansteiner


As a tide of late-stage data rolls in on COVID-19 vaccines from Pfizer, Moderna and AstraZeneca, the U.S. is gearing up for reviews that could see a vaccine authorized and deployed before the year is out. On Saturday, the chief of the White House’s Operation Warp Speed effort laid out a definitive timeline, setting expectations for when the public could expect at least two shots to become available. 

Moderna will file for an emergency nod for its mRNA-based vaccine candidate before the month is out, Moncef Slaoui, Ph.D., head of “Warp Speed” and former vaccine chief at GlaxoSmithKline, said during an interview on ABC News’ “This Week with George Stephanopoulos.” That submission will segue straight into a Dec .17 data review, with the aim to ship vaccines to distributors within 24 hours of approval and potentially start vaccinations two days after the advisory panel makes its call, Slaoui said. 

Moderna last Monday revealed its shot hopeful, mRNA-1273, posted nearly 95% efficacy in phase 3. Only five COVID-19 cases were reported among those who received the shot, compared with 90 cases—including 11 that were severe—confirmed in the placebo arm. 

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Meanwhile, Pfizer and BioNTech’s candidate, submitted for review last Friday, is set to go before the FDA’s independent vaccines advisory committee and the Centers for Disease Control’s Advisory Committee on Immunization Practices (ACIP) on Dec. 10, Slaoui said. Those reviews will take place “in parallel,” ensuring that in the event of an authorization, the CDC can “almost immediately” defer to ACIP on how to prioritize and allocate doses for the U.S. population, he added. 

Last Wednesday, Pfizer revealed its vaccine, BNT162b2, was 95% effective in its phase 3 trial. In the placebo group, 162 subjects developed COVID-19, compared to eight in the vaccine cohort. Nine severe cases cropped up in the control arm versus the vaccine group’s one and, crucially, Pfizer said the shot was 94% effective in patients aged 65 years and older. 

RELATED: Pfizer CEO, facing pushback, shifts COVID-19 vaccine timeline to late November

Slaoui also touched on hesitancy around an approved COVID shot, not just from the public, but among healthcare workers, doctors and nurses, which the Warp Speed chief called “unfortunate.” 

The vaccines in the works have been developed “as thoroughly and as scientifically as ever,” with speed representing the distinguishing factor in the government’s efforts, he said. Slaoui cited politics as the key driver of shot skepticism in recent months, adding that, to his knowledge, there had been no intentional effort on Pfizer’s part to delay its data submission until after the election, as President Donald Trump has recently alleged. 

Elsewhere, Pfizer’s shot could snare U.K. clearance ahead of U.S. authorization. The BioNTech-partnered vaccine may win an emergency nod in England within the week, The Telegraph reported, citing British government sources. As regulators prepare to kick off their formal review, the country’s National Health Service has been advised to prepare to start administering the shot as early as Dec. 1, although that is, admittedly, a “best-case scenario,” the news outlet wrote. 

Plus, AstraZeneca on Monday joined the fray of shot makers to reveal late-stage data. AZ’s candidate, AZD1222—which is based on a chimpanzee viral vector—proved 70% effective in late-stage testing, the drugmaker said early this week. That 70% figure is an average, however, masking the variation of two dosing regimens, one of which proved 90% effective. 



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