Both were developed in a record-breaking 11 months or so.
Moderna, which worked with scientists from the National Institutes of Health, said Monday its vaccine was 94.5% effective against SARS-CoV-2 and the disease it causes, COVID-19. The goal is to maximize the biological potential of the immune system itself.
"We'll drill down on these data", said FDA adviser Dr. Paul Offit of the Children's Hospital of Philadelphia.
A green light would cap the fastest vaccine development program ever in the West, going from laboratory to authorization in less than a year.
It's worth noting that the primary goal is to prevent people from getting sick, with good vaccines also protecting people from severe illness.
Two weeks after warning about a mutated variant of the virus in minks that could threaten the effectiveness of a vaccine, Denmark said Thursday the strain has likely been eradicated.
The companies said their submission will include safety data on 8,000 people under age 18, including 100 in the 12-15 age range - potentially setting the vaccine up for use by teenagers. It took Jonas Salk six years to develop and test the first polio vaccine, starting with the isolation of the virus.
The EU has confirmed a purchase of up to 300 million doses of Pfizer and BioNTech's vaccine and has also inked supply agreements with other frontrunner candidates from AstraZeneca Plc, Sanofi, Johnson & Johnson, and CureVac. That's a game-changer. The EMA has said conditional approval could come as early as the second half of December, von der Leyen told reporters after European Union leaders discussed the Covid-19 pandemic via video conference on Thursday.
Both vaccines rely on synthetic messenger RNA, an ingenious variation on the natural substance that directs protein production in cells throughout the body.
The genetic material mRNA is easy to make in a laboratory.
It will also make it harder to recruit new people to ongoing trials for vaccines that aren't yet as close to applying for approval.
Safety is the first and foremost goal for a vaccine. Pfizer expects to seek emergency use authorization from the FDA presently.
In contrast, Korea has yet to sign a single supply contract with private vaccine developers except for 10 million vaccines secured through COVAX, an global organization related to the Covid-19 vaccine.
The U.S. Food and Drug Administration's outside advisers will meet on December 10 to discuss whether to authorize the COVID-19 vaccine developed by Pfizer Inc and German partner BioNTech for emergency use, the agency said on Friday.
For now, Emergency Use Authorization of these vaccines could allow frontline workers and other essential personnel to receive vaccinations before the end of the year.
News of positive steps towards a vaccine though contrasted with grim figures emerging out of the United States, where 250,000 people have now died from the disease. "If you think about the economic value of a vaccine-I'm not speaking about the human value because there is no way to measure human life-I think the millions of jobs that will not be lost, that hopefully will come back, and the billions in economic value that a successful vaccine will enable-I think it's not appropriate to discuss if we sell it at $19.50 per dose".