The Food and Drug Administration has authorized distribution of a second COVID-19 from Moderna, as a record 114,751 were hospitalized acro...
The Food and Drug Administration has authorized distribution of a second COVID-19 from Moderna, as a record 114,751 were hospitalized across the U.S.
The FDA's emergency authorization on Friday came exactly one week after Pfizer's shot became the first to be approved for use in America.
'Congratulations, the Moderna vaccine is now available!' President Donald Trump said in a tweet on Friday night.
Meanwhile a record 114,751 were hospitalized with coronavirus on Friday, according to the COVID Tracking Project, on a day that also saw cases increase by 228,825 for the day while an additional 2,751 people died.
Nevada and Arizona currently have the highest per capita hospitalizations in the country, and per capita cases were continuing to increase at an alarming rate in Arizona.
In California, where Governor Gavin Newsom has imposed harsh new lockdown restrictions, the seven-day average for new cases per million people is quickly approaching 1,000.
Since the pandemic hit the U.S. in March, more than 17 million people have been infected and the death toll has exceeded 313,000.
Despite the vaccine rollout, the crack statisticians at the Institute of Health Metrics and Evaluation expect the death toll to climb through the winter.
IHME's forecast projects about 262,000 COVID-19 deaths from December through April, bringing the country's death toll to well over 562,000.
Moderna's 94 per cent effective shot will be available to anyone 18 and older, and vaccinations likely start Monday, with health care workers and nursing home residents as the first recipients.
Ahead of its emergency approval, U.S, officials allocated and readied 5.9 million doses of Moderna's shot to be sent to states and territories over the next week.
Shipments could begin as early as tomorrow.
'With the availability of two vaccines now for the prevention of COVID-19, the FDA has taken another crucial step in the fight against this global pandemic that is causing vast numbers of hospitalizations and deaths in the United States each day,' said FDA Commissioner Dr Stephen Hahn, in a statement announcing the approval.
'Trucks will roll, planes will fly this weekend, 5.9 million doses of Moderna vaccine allocated for next week,' Health and Human Services (HHS) Secretary Alex Azar told Good Morning America early Friday.
A second shot couldn't have come too soon.
More than 310,000 Americans have died of coronavirus, including 3,270 yesterday, and more than 17 million have been infected with more than a million new cases reported in the past week alone.
And doses of Moderna's vaccine will be a critical bolster to the national supply, at a particularly critical moment.
At least a dozen states' claims that they were told will get fewer doses of Pfizer's vaccine than promised next week, and confusion over whether the drugmaker or the Trump administration is to blame.
Moderna's COVID-19 vaccine has become the second to in the US to get emergency approval from the FDA
FDA Commissioner Dr Stephen Hahn's job was allegedly threatened last week, if his agency didn't authorize Pfizer's vaccine by Friday. He has denied the threat
Top U.S. infectious disease expert Dr Anthony Fauci called the arrival of two COVID-19 vaccines to be given to the public less than year after development began 'an historic moment,' according to the New York Times.
Moderna has worked closely with the National Institutes of Health (NIH) where Dr Fauci oversees the infectious disease arm since it first developed its COVID vaccine candidate over the weekend after the virus's genome was sequenced, in January.
Vaccine development was 'not only done in record time, in the sense of never before has anybody even imagined you would get vaccines to people in less than a year from the time that the sequence was made known,' Dr Fauci said.
He called it a 'triumph' and said the successful development and emergency approval of two vaccines was a moment for celebration.
Both Moderna's and Pfizer-BioNTech's shots are so-called mRNA vaccines, made with a groundbreaking new technology.
They don't contain any coronavirus – meaning they cannot cause infection.
Instead, they use a piece of genetic code that trains the immune system to recognize the spike protein on the surface of the virus, ready to attack if the real thing comes along.
The two vaccines work 'better than we almost dared to hope,' NIH Director Dr. Francis Collins told The Associated Press.
'Science is working here, science has done something amazing.'
Collins said it was an astounding development.
'The rigor of the analysis of these vaccines is unprecedented,' Collins said. 'We're not done with this but hope is on the way, and the hope comes from this scientific brain trust that has pulled out all the stops.'
And while 2.9 million doses of Pfizer's vaccine were shipped to every U.S. state and territory this week, at least five states have reported that their allocations for next week have been cut back by federal officials.
Moderna's vaccine prevented more than 94 per cent of infections in clinical trials and the firm plans to ship 20 million doses for Americans by the end of the year.
Moderna has about 5.9 million doses ready for shipment set to begin over the weekend, according to Operation Warp Speed, the government's vaccine development program.
Injections of health workers and nursing home residents continue next week, before other essential workers and vulnerable groups are allowed to get in line.
Just after Vice President Mike Pence received his first dose of coronavirus vaccine - Pfizer's - this morning, he said Moderna's shot could be authorized 'within hours.'
'As President Trump often says, we are rounding the corner,' he added.
The Financial Times also reported on Thursday night that the FDA had already decided to grant the vaccine emergency authorization, citing people familiar with the process.
A panel of FDA experts gave the shot their approval after more some nine hours of discussion and deliberation Thursday.
All but one of the 21 voting experts recommended that the shot get emergency authorization, with one abstaining.
After getting his first dose of Pfizer's COVID-19 vaccine on camera Friday morning, Vice President Mike Pence said Moderna's vaccine could get authorized 'within hours'
'Our vote was even more overwhelming tonight than last week's - I don't think that anyone should interpret the difference in the votes being one way or another comparing the two vaccines that we considered,' said panel moderator Dr Arnold Monto, adding that the benefits of both Moderna's shot and Pfizer's are clear.
Moderna and the federal government are poised and ready to ship 5.9 million doses of the vaccine as soon as it is authorized, Health and Human Services (HHS) Secretary Alex Azar told CNBC on Thursday.
Moderna's shot can be shipped at standard freezer temperatures, unlike Pfizer's shot, which needs to be kept ultra-cold.
However, its vaccine was slightly less effective in trials than Pfizer's 95 percent preventive shot.
Agency scientists confirmed that the shot is more than 94 percent effective in a data review published Tuesday, and the expert panel is expected to recommend it.
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