NOVEMBER 25, 2020
- Three companies developing COVID-19 vaccines — AstraZeneca, Moderna, and Pfizer — have released positive results from their late-stage trials.
- Pfizer already applied for emergency authorization from the FDA. Its shot could get authorized as early as December 10, then delivered to Americans 24 to 48 hours after that.
- Here’s a timeline of when the leading vaccine candidates are expected to get authorized, and the milestones they must pass before reaching the public.
Good news about coronavirus vaccines keeps rolling in: On November 9, Pfizer became the first pharmaceutical company to announce that its shot successfully prevented COVID-19 in clinical trials. Moderna followed suit with positive results on November 16, then AstraZeneca revealed its promising data on Monday.
Now the big question in the US is: When can Americans get a shot?
Pfizer has already applied for an emergency use authorization (EUA) from the Food and Drug Administration (FDA). Moderna is expected to do so by the end of this month.
Once the FDA grants those authorizations, some Americans could start receiving shots within one to two days.
Here are the key milestones ahead before vaccines reach the public
By Friday: The FDA is expected to release a Federal Register notice with details about its upcoming meeting to discuss Pfizer’s EUA request. At that time, the public is invited to submit comments.
End of November: Moderna is expected to submit its EUA request any day now. When announcing its results, Moderna said to expect an EUA application “in the coming weeks.” Given the speed of Pfizer’s filing, it’s reasonable to assume that Moderna will do so by the end of the month.
December 8: The FDA will release briefing materials for its meeting about Pfizer’s vaccine.
December 10: An FDA advisory committee made up of independent scientific experts will meet to evaluate Pfizer’s EUA request. The meeting will be streamed on the FDA website and on its YouTube, Facebook, and Twitter channels. Pfizer will present its safety and efficacy data, then answer questions. After that, the advisory committee will make a recommendation on whether to greenlight the vaccine. The FDA is likely to follow the committee’s advice, and the vaccine could be authorized within the same day.
December 11-12: Once Pfizer’s vaccine is authorized, Americans could start receiving shots within 24 to 48 hours. An advisory committee to the Centers for Disease Control and Prevention is expected to finalize guidelines about which Americans will get priority access. First in line will likely be frontline healthcare workers and people at highest risk of becoming critically ill, such as elderly Americans with preexisting health conditions.
Mid-December: Assuming Moderna files its EUA request by the end of November, an FDA advisory committee will likely meet to evaluate it in mid-December. The vaccine could be authorized that same day, with Moderna shots going into people’s arms 24 to 48 hours after that.
Pfizer and Moderna’s 2021 vaccine timeline
Moncef Slaoui, the chief advisor to Operation Warp Speed, has estimated that 20 million Americans could get a COVID-19 shot before the end of 2020. In each subsequent month after that, another 25 to 30 million Americans could get vaccinated, he said.
That would put the US on track to vaccinate roughly 70 million to 80 million people — as much as a quarter of the population — by the end of February. By April, vaccines could start being distributed to young, healthy Americans.
Moderna CEO Stephane Bancel recently told Business Insider that any American who wants a vaccine should have access to one by Memorial Day. Anthony Fauci, director of the National Institute of Allergy and Infectious Disease, has also said that the general population could have access to shots by late spring and early summer.
But those timelines could vary depending on whether additional vaccine candidates besides Pfizer’s and Moderna’s get emergency authorization. The more vaccine trials that report success, the sooner shots can be widely distributed to the public.
What about other vaccine candidates?
Operation Warp Speed has purchased 100 million doses of Pfizer’s vaccine and another 100 million doses of Moderna’s. The program hopes to distribute 400 to 450 million vaccine doses from now through May.
Slaoui told Bloomberg that “Plan A” is to distribute vaccines from two other companies — AstraZeneca and Johnson & Johnson — to help reach that goal. Though AstraZeneca’s trials in Brazil and the UK showed positive data, the company hasn’t yet released findings from its US trial.
Slaoui told Business Insider last month that he expects AstraZeneca and Johnson & Johnson’s US trials to produce results in December or January. That could put them on track for authorization this winter. The US has already purchased 100 million doses from each company.
“Plan B,” Slaoui told Bloomberg, is to order additional doses from Pfizer and Moderna. Agreements with the companies allow the US to acquire another 500 million doses from Pfizer and another 400 million doses from Moderna should it so choose.
The remaining two vaccine candidates backed by Warp Speed come from Novavax and a Sanofi/GlaxoSmithKline partnership. If the companies have trouble finding enough Americans to join their trials once a Pfizer or Moderna vaccine hits the market, Slaoui told Bloomberg, the trials might recruit volunteers in other countries. Both are expected to release pivotal data about their vaccine candidates in early 2021.
If those two vaccines get authorized — that would most likely happen in the spring — the US is prepared to distribute 100 million doses of each as well.
In a recent NPR interview, Fauci said additional vaccine candidates besides Pfizer’s and Moderna’s “are going to be essential if we want to get enough vaccine to give to everyone who would need it or want it in the country.”
Courtesy/Source: Business Insider