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Moderna's coronavirus vaccine is set to get the FDA's emergency approval today, becoming the second shot available in the U.S.
Regulators have promised to 'rapidly work toward' authorizing the jab today, after a panel of experts recommended Moderna's vaccine get the green light in a 20-0 vote (with one abstaining) yesterday, FDA commissioner Dr Stephen Hahn said Friday.
It comes a week after the FDA issued emergency approval for Pfizer's shot, amid frustration from the American people and President Trump that more than 24 hours passed between the committee recommendation and FDA action.
A second shot can't come soon enough.
More than 310,000 Americans have died of coronavirus, including 3,270 yesterday, and more than 17 million have been infected.
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 percent of infections in clinical trials and the firm plans to ship 20 million doses for Americans by the end of the year.
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.'
© Provided by Daily MailModerna's COVID-19 vaccine is expected to get approved by the FDA, with the head of the agency promising they will 'work rapidly' toward authorization
© Provided by Daily MailFDA 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
'As President Trump often says, we are rounding the corner,' he added.
For his part, President Trump tweeted early this morning that Moderna's shot has been approved, despite no such announcement from the FDA.
'Moderna vaccine overwhelmingly approved. Distribution to start immediately,' he said.
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.
Trump also may have been referring to the resounding endorsement a panel of FDA experts gave the shot 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.
'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.
© Provided by Daily MailAfter 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'
So what's the hold up?
Regulators have to put the finishing touches on labels and prescribing information - including a warning that the injection could cause facial swelling in people who have dermal fillers - for the vaccine between the committee vote and distribution.
Officials may be holding back on approval so as to prevent longer lags between approval and distribution.
The rollout of the second shot is not being watched quite as anxiously in as the first.
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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© Provided by Daily Mail During the all-day, and the experts discussed whether the vaccine has been adequately tested in at-risk black and Latinx Americans and its side effects.
Dr Anthony Fauci said Wednesday that emergency approval could 'hopefully' come on Thursday, but the FDA did not more quite that quickly.
Moderna's doses will be critical to meeting Operation Warp Speed's - the U.S. COVID-19 vaccine initiative - goal of vaccinating 20 million Americans by the end of 2020, which will require 40 million collective doses of Moderna's and Pfizer's shots.
Pfizer's first wave of 2.9 million vaccine doses are shipping this week. All states have now received their first doses and Operation Warp Speed says the rollout is 'on track,' but it is slow going.
Only 5,200 people have been vaccinated in New York City, as well as 19 in Michigan and 10 in Idaho. Most states are not yet reporting vaccination tallies, and a small number doses of Pfizer's delicate vaccine have had to be sent back to the manufacturer or thrown out due temperature control issues.
MODERN HAS NOT YET TRIGGERED ANAPHYLACTIC SHOCK LIKE PFIZER'S - BUT THAT COULD CHANGE WHEN MORE PEOPLE GET IT
A handful of people - including two health care workers in Alaska - have had severe allergic reactions to Pfizer's vaccine. Moderna's is the same type of vaccine, these reactions, including anaphylactic shock will undoubtedly be central to Thursday's panel debate.
One of the Alaska health care workers had to be admitted to the ER for treatment.
That was an immediate topic of concern for Thursday's FDA panel.
WHAT ARE THE POSSIBLE SIDE EFFECTS OF MODERNA'S SHOT?
There weren't any dangerous side effects definitively linked to Modern's shot in trials.
But there were a handful of alarming, though temporary effects.
If you have dermal filings, your face may get extra puffy after the shot.
Two people with fillers had facial swelling - in their lips and cheeks - after getting the shot.
It turned out that one had had the same reaction when they got a different vaccine too.
There's no clear cause of Bell's palsy - a temporary form of facial paralysis - but having herpes or diabetes are risk factors.
Three people who got Moderna's shot in the trial developed Bells's palsy (as did one in the placebo group).
Moderna said this doesn't seem to be caused by the vaccine, but it and the FDA will keep a close eye out for more cases if the shot gets approved.
'While the totality of data at this time continue to support vaccinations under the Pfizer EUA without new restrictions, these cases underscore the need to be vigilant during the early stage of the campaign,' Doran Fink, deputy director of the FDA's vaccine arm.
It remains to be seen if this will be a concern with Moderna's vaccine.
'We have not seen any significant safety concerns' trials, said Moderna chief medical officer for Moderna during Thursday's meeting.
During its trial, two participants had anaphylactic shock allergic reactions, but neither were linked to Moderna's vaccine.
One of the people who went into anaphylactic shock got the placebo shot.
Video: Moderna looks to get FDA approval as Pfizer vaccinations continue (Daily Mail)
Moderna looks to get FDA approval as Pfizer vaccinations continue
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The other did get the real vaccine, but their allergic reaction happened 63 days after they got their second dose. The participant had asthma and a known shellfish allergy.
Moderna scientists concluded it was unrelated to the shot.
Both of the Alaska health care workers went into anaphylactic shock within 10 minutes of their first doses of Pfizer's vaccine, and allergic reactions are generally fairly immediate.
But, as Dr Fauci pointed out Wednesday night, if the vaccine is approved, it will be given to far more people than were involved in trials, so, statistically it's very possible that bad reactions that weren't seen in the smaller trial group will crop up in the general population.
There were also four cases of Bell's palsy - a form of temporary facial paralysis - in Moderna's trial, including three in the vaccine group.
Four cases were also reported in Pfizer's trial.
Both drugmakers said that these case numbers were consistent with how common the condition is in the general population.
No one is quite sure what causes Bell's palsy, though it was linked to one spray flu vaccine in Switzerland that was quickly removed from the market.
'I don't quite see how are so comfortable that this was a background rate,' said FDA panelist Dr Paul Offit, of the cases in Moderna's trial.
FDA scientists simply said that they and Moderna will keep an eye out to monitor if more cases of Bell's palsy if the vaccine is rolled out.
© Provided by Daily MailMost people had pain after getting their first injection of Moderna's shot
© Provided by Daily MailSerious side effects were rare, and not much more common among people who got the real shot versus the placebo. They included GI problems, heart problems, infections, nervous system issues and blood vessel disorders
There were also two cases of facial swelling in patients who got the vaccine.
Both of them had dermal fillings - in other words, lip, cheek or other injections.
Dr Rachel Zheng, the FDA scientist who presented the agency's analysis of Moderna's data said that the swelling was isolated to the cheeks or lips, and went away once the participants were treated with steroids or an antihistamine.
One of the participants had actually had a similar reaction to getting a different vaccine since getting their dermal filler.
Dr Zheng said that the FDA did some digging and found there were a number of reports linking vaccines to swelling in people who have dermal fillings, and that this possibility will be mentioned in info given to clinicians giving the shots.
Moderna's vaccine uses genetic material from a small part of the virus to teach human cells to make and respond to this small, defanged part of coronavirus.
Moderna also assured the panel that it's not possible for the vaccine alter human DNA to cause or worsen COVID-19 infections.
© Provided by Daily Mail Moderna's shot has shown some early signs it could prevent asymptomatic infections and could give some protection after just one dose. Pfizer's data trial data didn't address either matter.
'Protection may begin before the second dose,' said Jacqueline Miller, a Moderna scientist.
'There were nearly two-third fewer positive swabs in the vaccine group as compared to the placebo [at the time of the second dose]...suggesting the possibility for asymptomatic protection,' said Dr Miller.
Shares for Moderna were up 2.15 percent, to $139.97, on Thursday morning as the FDA meeting got underway.
Moderna's coronavirus vaccine got a good review from the FDA so far, according to documents published by agency scientists on Tuesday, bringing the U.S. a step closer to having enough doses of various shots to protect the most vulnerable Americans.
© Provided by Daily MailThere were two anaphylactic reactions in Moderna's trial, but the FDA and Moderna said neither were linked to the vaccine
The positive news came as hospitals across the U.S. begin ramping up vaccinations with the shot developed by Pfizer and BioNTech's, which the FDA cleared last week.
Shares for Moderna fell three percent this morning after the release of the FDA documents, and were down seven percent at $144.20 a share at midday.
THE FIRST SHOT IS HERE - BUT QUICK APPROVAL FOR A SECOND IS KEY TO GETTING 20 MILLION AMERICANS VACCINATED IN 2020
Thursday's meeting comes almost three weeks after Moderna requested emergency approval of its vaccine by the FDA.
Americans, including the president, have been frustrated by the pace of vaccine approval.
The UK approved Pfizer's vaccine on December 3.
Pfizer's shot didn't get FDA approval until more than 24 hours after the FDA panel recommended it get authorized last week, prompting President Trump to call the agency a 'slow turtle.'
White House chief of staff Mark Meadows allegedly threatened FDA head Dr Stephen Hahn's job if the agency didn't approve Pfizer's vaccine by last Friday. Dr Hahn has denied that this was the case.
Nonetheless, the hope is that, with one COVID-19 vaccine authorization under its belt, the FDA will move more quickly this week on Moderna's vaccine.
The first 2.9 million shots are being strictly rationed to front-line health workers and elder-care patients, with hundreds of millions more shots needed over the coming months to protect most Americans.
A second vaccine can't come soon enough as the country's daily death count continues to top 2,400 amid over 210,000 new daily cases, based on weekly averages of data compiled by Johns Hopkins University.
The devastating toll is only expected to grow in coming weeks, fueled by holiday travel, family gatherings and lax adherence to basic public health measures.
MODERNA'S SHOT BLOCKS 94% OF COVID-19 CASES AND MAY PREVENT SEVERE ONES - BUT IS LESS EFFECTIVE FOR OVER-65S
Last month, Moderna and NIH reported that their shot appeared to be nearly 95 percent effective across various ages and racial groups, according to results from an ongoing 30,000-person study.
The FDA's analysis found the shot o be a little less protective, but not much: 94.1 percent effective, rather than 94.5 percent.
And the scientists reiterated the impressive findings for severe disease. In the placebo group, 11 people developed severe COVID-19.
In the group that got the real Moderna vaccine, no one developed severe COVID-19.
Neither Moderna's nor Pfizer's vaccine trials were designed to test whether their shots could completely block the virus from entering human cells and prevent asymptomatic infection.
The first goal of the vaccines is to keep coronavirus from making people sick and especially from making them life-threateningly ill.
Moderna's shot seems to do that very well.
In trial participants ages 18 to 65, the vaccine prevented an overwhelming 95.6 percent of infections.
For people ages 65 and over, the effect was a bit diminished, with 86.4 percent fewer cases among the vaccinated group compared to those who got a placebo shot.
Elderly people are among the groups most at-risk of dying from coronavirus, so having a vaccine that protects them well is crucial.
But it's also typical that shots not work quite as well in over-65s because, with age, the immune system slows down and just doesn't respond to anything as robustly.
Pfizer's vaccine, however, performed a bit better, preventing more than 90 percent of infections in over 55- and over 65-year-olds.
JUST ONE SHOT MIGHT WORK - EVEN TO PREVENT ASYMPTOMATIC CASES, EARLY DATA SUGGESTS
There's some early signs from the shot might be protective after just one shot.
Moderna also didn't design its trial to test this, but at the time that Moderna did its early analysis of the data on November 7, there were 2,075 participants who had received just one dose of either the vaccine or a placebo.
So far, the only company testing a single-dose coronavirus vaccine is Johnson & Johnson - and it will likely be February before it applies for FDA emergency approval.
A one-dose vaccine would be a massive boon to combatting the pandemic.
If just one shot of Moderna's vaccine is protective, then its first anticipated rollout of 20 million doses by the end of the month could help shield 20 million people, instead of 10 million protected by two doses.
People who got just one dose of the real vaccine were 80.2 percent less likely to get coronavirus compared to the group who got a sham vaccine.
That first shot might even prevent asymptomatic infection, an addendum to the FDA's document posted by Moderna suggests.
A small dataset showed that 52 trial participants tested positive for coronavirus when they came for their second dose, but had not reported any symptoms of the virus.
About two-thirds of those 52 had gotten a placebo shot to begin with, suggesting that the first dose of the real vaccine was offering protection against asymptomatic infection.
The data reviewed by the FDA staff is promising, but it doesn't prove one shot is enough.
Dr Peter Marks, director of the FDA's Center for Biologics Evaluation and Research (CBER) told JAMA in a Monday interview that there are studies planned to firm up whether one or two doses of Moderna's shot can really prevent asymptomatic infection and transmission of coronavirus.
Two shots, however, were clearly ruled effective and safe, and the staff scientists said they saw no issues that would 'preclude' emergency approval for the vaccine.
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