Biotech firm Moderna on Monday said it will ask the Food and Drug Administration (FDA) to approve its experimental COVID-19 vaccine for emergency use.
Moderna is the second pharmaceutical company to request a so-called emergency use authorization (EUA) for a COVID-19 vaccine after Pfizer filed their application earlier this month. Moderna said new data showed the vaccine was 94.1% effective in its late-stage clinical trial, just under Pfizer’s efficacy rate of 95%. The Moderna vaccine was developed in conjunction with the Trump administration’s Operation Warp Speed.
“We believe that our vaccine will provide a new and powerful tool that may change the course of this pandemic and help prevent severe disease, hospitalizations and death,” Moderna CEO Stéphane Bancel said in a statement. Bancel said last week that 20 million doses will be available by the end of the year.
The FDA’s vaccine advisory committee is set to meet Dec. 17 to review data from the two companies.
Pfizer said on Nov. 9 that its developmental vaccine for COVID-19 may be 90% effective at inoculating people against the disease. The rate of effectiveness was calculated by analyzing early data from 94 trial participants in a study involving 43,538 subjects from all over the world. The small early sample means that the protection rate could change by the time the study ends and all the participants are accounted for, according to the AP.
A key advantage of Moderna’s vaccine is that it does not need sub-zero storage like Pfizer’s, which will make it easier to distribute.
“Overall, if both the Moderna and Pfizer vaccines are approved by the FDA, the U.S. could have as many as 60 million doses of vaccine available by the end of the year,” Fox reported. “[T]he government could have access to more than 1 billion doses from the two vaccine makers alone by 2021.”
A third vaccine is also in the pipeline. AstraZeneca and Oxford University last Monday said their jointly created COVID-19 vaccine has proven to be up to 90% effective and the makers claims will be easier to distribute.
“These findings show that we have an effective vaccine that will save many lives,” said Oxford University professor Andrew Pollard, who served as the lead investigator for the drug’s trials. “Because the vaccine can be stored at fridge temperatures, it can be distributed around the world using the normal immunization distribution system. And so our goal … to make sure that we have a vaccine that was accessible everywhere, I think we’ve actually managed to do that.”
The results are based on interim analysis of trials in the United Kingdom and Brazil and there were no hospitalizations or severe cases of COVID-19, The Associated Press reported.
The Oxford-AstraZeneca vaccine is cheaper than the others. “AstraZeneca, which has pledged it won’t make a profit on the vaccine during the pandemic, has reached agreements with governments and international health organizations that put its cost at about $2.50 a dose. Pfizer’s vaccine costs about $20 a dose, while Moderna’s is $15 to $25, based on agreements the companies have struck to supply their vaccines to the U.S. government,” the AP reported.