With Two Effective Vaccines, Approval And Delivery Plans Next To Be Tested
The FDA will work "as quickly as possible" to review testing data for Pfizer and Moderna's COVID-19 vaccine candidates to clear their emergency use, HHS Secretary Alex Azar said. Meanwhile, Pfizer begins a pilot distribution program in four states.
CNBC:
HHS Secretary Azar Says The FDA Will Move ‘As Quickly As Possible’ To Clear Moderna And Pfizer’s Covid Vaccines
The U.S. Food and Drug Administration will move “as quickly as possible” to clear Pfizer and Moderna’s coronavirus vaccines for emergency use, the top official at the U.S. Department of Health and Human Services said Monday. HHS Secretary Alex Azar told CNBC’s “Squawk Box” that the “incredible” interim results from Moderna, which announced on Monday that its vaccine candidate is more than 94% effective in preventing Covid-19, paired with similar results from Pfizer last week make for a “historic day in public health.” (Higgins-Dunn, 11/16)
Reuters:
Pfizer To Start Pilot Delivery Program For Its COVID-19 Vaccine In Four U.S. States
Pfizer Inc has launched a pilot delivery program for its experimental COVID-19 vaccine in four U.S. states, as the U.S. drugmaker seeks to address distribution challenges facing its ultra-cold storage requirements. Pfizer’s vaccine, which was shown to be more than 90% effective in preventing COVID-19 based on initial data, must be shipped and stored at -70 degrees Celsius (minus 94°F), significantly below the standard for vaccines of 2-8 degrees Celsius (36-46°F). (11/16)
In related news about the COVID vaccines from Pfizer and Moderna —
Stat:
On Covid-19, Two Vaccines Offer More Answers About The Road Ahead
The success of a second vaccine against Covid-19 means the world is a big step closer to curbing the coronavirus pandemic. Moderna, joined by U.S. government scientists, announced Monday that their mRNA vaccine candidate was 94.5% effective in preventing Covid-19, the disease caused by the novel coronavirus, according to an interim analysis of a 30,000-patient clinical trial. (Feuerstein, Garde and Joseph, 11/16)
NPR:
Why Moderna And Pfizer Vaccines Have Different Cold Storage Requirements
Two drugmakers, Pfizer and Moderna, have announced promising interim results for their vaccine candidates, raising hopes in the U.S. and abroad that the end of the pandemic may be in sight. But, if and when the vaccines are authorized by the Food and Drug Administration, distributing them presents a daunting challenge. One big reason? One of the frontrunners in the vaccine race — the one made by Pfizer — needs to be kept extremely cold: minus 70 degrees Celsius, which is colder than winter in Antarctica. Moderna has said that its vaccine needs to be frozen too, but only at minus 20 Celsius, more like a regular freezer. (Simmons-Duffin, 11/17)
USA Today:
There Are Now Two Promising Potential COVID Vaccines. This Is What We Know About Them.
Nearly seven months after Operation Warp Speed was created, Americans are finally starting to get answers about the candidate vaccines that could potentially slow the coronavirus pandemic. Operation Warp Speed, the White House-led task force on coronavirus vaccine treatment and development, was created on May 15. Since then, vague and contradicting timelines made by both the Trump administration and leading scientists have muddled predictions about when a COVID-19 vaccine would be available to the public. (Rodriguez and Weintraub, 11/16)
The New York Times:
What To Know About Moderna's Covid-19 Vaccine
Like Pfizer, however, Moderna released only early data from their trial. There’s more work to be done before they’ll know if the vaccine really is safe and effective. And even if Moderna’s vaccine gets the green light from the F.D.A., it will take months to reach widespread distribution. In the meantime, the United States is suffering a devastating explosion of new cases of Covid-19. Here’s where things stand with the development of coronavirus vaccines. (Zimmer, 11/16)
Reuters:
We Can Stop COVID-19: Moderna Vaccine Success Gives World More Hope
Unlike Pfizer’s vaccine, Moderna’s shot can be stored at normal fridge temperatures, which should make it easier to distribute, a critical factor as COVID-19 cases are soaring, hitting new records in the United States and pushing some European countries back into lockdowns. “We are going to have a vaccine that can stop COVID-19,” Moderna President Stephen Hoge said in a telephone interview. (Steenhuysen and Erman, 11/16)
