Donald Trump hailed the FDA's approval of the coronavirus vaccine as a 'medical miracle' on Friday evening - and said the drug...
Donald Trump hailed the FDA's approval of the coronavirus vaccine as a 'medical miracle' on Friday evening - and said the drug will 'save millions of lives and end the pandemic once and for all'.
Millions of doses of Pfizer's COVID-19 vaccine are being shipped out across the US, with the first vaccinations due to take place within 24 hours, according to the president.
'This is one of the greatest scientific achievements in history,' Trump said in a video statement from the White House, adding it was a 'medical miracle.' 'I'm thrilled to report the FDA has approved the Phizer vaccine.'
He added that the jab was 'very safe', having passed the gold standard of safety'.
'The first vaccine will be administered in less than 24 hours. The governors decide where the vaccines will go. We want our senior citizens, health care workers and first responders to be first in line,' he added.
He also tweeted triumphantly that: 'FDA APPROVES PFIZER VACCINE FOR EMERGENCY USE!!!'
Congress and President Donald Trump have already enacted legislation that calls for the vaccines to be free to all Americans.
Pfizer's vaccine was given emergency authorization by regulators late Friday after the Trump administration pressed regulators to move quickly.
White House Chief of Staff, Mark Meadows, reportedly even told FDA commissioner, Dr. Stephen Hahn, to consider getting a new job if he didn’t approve the vaccine on Friday, a senior administration official told the New York Times.
Dr. Hahn subsequently ordered vaccine regulators at the agency to approve it by the end of the day.
Approval wasn't issued for more than 24 hours after an expert committee said the shot should be approved, drawing criticism from Trump himself, and alleged threats from his chief of staff.
An estimated 2.9 million doses of Pfizer's vaccine are expected to ship to every U.S. state and territory in the next 24 hours.
It will be up to states to decide who gets vaccinated first, but the CDC has recommended injecting health care workers and nursing home residents (who have equal priority) first.
Donald Trump hailed the FDA's approval of the coronavirus vaccine as a 'medical miracle' on Friday evening - and said the drug will 'save millions of lives and end the pandemic once and for all'
Pfizer's vaccine was given emergency approval by the FDA on Friday night. It is the first shot authorized in the U.S. and the first 2.9 million doses are expected to ship within 24 hours, but will likely not be injected into the arms of high-priority health care workers and nursing home residents until Monday or Tuesday, HHS officials said earlier on Friday. Pictured: Dr. Matilde Castiel receives an injection as partof a clinical trial for a COVID-19 vaccine in September
The Department of Health and Human Services said Friday morning that the first Americans would be vaccinated Monday or Tuesday. At the time, Secretary Alex Azar was expecting the vaccine to be approved within 'a couple of days,' he said on Good Morning America.
But President Trump suggested it could be as soon as within 24 hours, after he urged the FD to speed its approval and hurled insults at regulators, calling the agency a 'big, old, slow turtle' as hours ticked by after the FDA's expert panel said it should approve the vaccine.
The UK and Canada have already approved Pfizer's shot, and the first Britons got their first of two doses on Tuesday.
Moving up the approval time is not expected to move up the timeline for Americans getting injected, HHS sources told the New York Times.
The speed at which the UK approved the US-made vaccine raised eyebrows in Europe and put pressure on the US to follow suit. Britain said they were safety focused but were able to speed through the process by examining trial data from October in a 'rolling review' so findings are made available as soon as they are ready, rather than waiting until the end of the trial.
In the US, FDA commissioner Dr Stephen Hahn said he would resist being pressured into speeding up the process.
White House Chief of Staff Mark Meadows later allegedly Hahn to approve the shot today or hand in his resignation, sources told the Washington Post.
Hahn confirmed that he had spoken to the White House, but denied the threat.
The approval of Pfizer's vaccine is an historic step toward curbing the pandemic, and comes at the end of America's deadliest week since its first COVID-19 case in January 2020. Nearly 16,000 people died of coronavirus in the past seven days, according data from the COVID Tracking Project. Total U.S. infections are nearing 16 million.
Emergency approval to vaccinate Americans 16 and older is a crucial step, but plenty of challenges lie ahead. Pfizer's 95 percent effective vaccine has to be stored at ultra-cold temperatures, raising concerns it will take longer to ship or accidents in the complicated administration process will ruin precious doses.
Already, supply chain issues forced the firm to reduce its planned global distribution for 2020 from 100 million to 50 million.
The US has a contract for 100 million doses in total, with the option to purchase more, but the Trump administration reportedly turned down Pfizer's offer to purchase more earlier this year. Other countries have snapped up doses, so the US may struggle to acquire more in the coming months.
A panel of expert advisors to the FDA recommended the agency give Pfizer's shot emergency approval on Thursday night, after nine hours of deliberation.
Seventeen of the 23 were in favor of authorizing the shot, despite concerns over reports of anaphylactic shock and severe allergic reactions in two UK health workers with histories of food and drug allergies. Some were also skeptical that Pfizer hadn't tested the shot in enough minorities or 16- and 17-year-olds.
The panel's endorsement was all but a guarantee that that the vaccine would be authorized .
So, many Americans, including and most notably President Trump, were furious when Secretary Azar said it could be days before the FDA issued emergency use authorization (a form of temporary approval with a lower bar to prove it works and is safe, which regulators give under special circumstances, like the pandemic).
According to the Washington Post, the FDA commissioner's job was even on the line after Mark Meadows allegedly told him to approve the vaccine Friday or hand in his resignation.
Pfizer has a $1.95 billion deal with the U.S. government to provide Americans with 100 million doses of its coronavirus vaccine
'This is an untrue representation of the phone call with the Chief of Staff,' he told NBC News.
'The FDA was encouraged to continue working expeditiously on Pfizer-BioNTech’s EUA request. FDA is committed to issuing this authorization quickly.'
According to anonymous sources cited by The New York Times, staffers spent Friday rushing to get the paperwork complete and it'll be done by the end of the day.
Earlier, Trump raged at the administration and told them to 'stop playing games and start saving lives'.
Health and Human Services (HHS) Secretary Alex Azar had said official approval may still take 'a couple of days'.
After Trump's Twitter warning, the HHS said the vaccine would be approved by Friday evening, rather than Saturday.
A panel of 23 independent scientists voted in favor of the vaccine on Thursday and recommended it to the FDA after a day of long, drawn-out talks over whether or not it is safe.
Vaccines will ship to all U.S. states and territories within 24 hours of getting emergency FDA approval, Operation Warp Speed officials have promised.
But it was not clear whether approval on Friday night will mean vaccines reach Americans any sooner, sources to the Times.
The White House told Dr Stephen Hahn, FDA commissioner (right) to approve Pfizer's coronavirus vaccine today or turn in his resignation letter. It came after President Trump (center) slammed the agency as an 'old, slow turtle' on Friday
Speaking on Good Morning America, Health and Human Services Alex Azar says the FDA has told Pfizer it 'intends to approve' its COVID vaccine after an excruciating two-and-a-half week wait but inexplicably, it still hasn't
Shots should go to health care workers and long-term care facilities first, according the CDC. Elderly prisoners in long-term care facilities run by corrections departments are included in the first wave of vaccinations under the CDC guidance.
But it will ultimately be up to each state who gets vaccinated first. Some, including Massachusetts and New Mexico will include inmate in their first round of vaccinations.
Most governors expect to run out of their first shipments within days of arrival, which could come as soon as Monday, they told Operation Warp Speed.
The first Americans will have 'shots in arms' within 96 hours (four days) of emergency approval, General Gustave Perna, co-head of the U.S. vaccine initiative has said.
But the FDA still has not officially given it approval and the first doses haven't been distributed yet, even though the UK and Canada have both given it the green light.
Health and Human Services Alex Azar says the FDA has told Pfizer it 'intends to approve' its COVID vaccine after an excruciating two-and-a-half week wait but inexplicably, it still hasn't and there is still no date for when the first people will receive it in America.
Speaking on Good Morning America, he said: 'I've got some good news for you. Just a little bit ago, the FDA informed Pfizer that they intends to proceed towards approval for its vaccine.
'In the next couple of days probably as we work to negotiate with Pfizer the information doctors need to prescribe appropriately, we should be seeing the authorization and we'll be working with Pfizer to get that shipped out so we could be seeing people getting vaccinated Monday, Tuesday of next week.'
The first shots in the arm in the US won't be until Monday or Tuesday at the very earliest. Above, someone getting the vaccine in the UK on December 8
The United States has recorded its most deadly week of the coronavirus pandemic with a 44 percent increase in fatalities nationwide compared to last week
Hours later, after President Trump's furious tweets, HHS officials said that the hour had moved up to Friday evening.
That means Americans could get vaccines as early as Monday.
Once distributed to the states, each state must set up its own schedule and plan for distributing it among the people.
The FDA released a statement on Friday morning claiming it was working to approve the vaccine quickly.
'Following yesterday’s positive advisory committee meeting outcome regarding the Pfizer-BioNTech COVID-19 vaccine, the U.S. Food and Drug Administration has informed the sponsor that it will rapidly work toward finalization and issuance of an emergency use authorization.
'The agency has also notified the U.S. Centers for Disease Control and Prevention and Operation Warp Speed, so they can execute their plans for timely vaccine distribution,' Commissioner Steve Hahn said in a statement on Friday morning.
Pfizer is expected to ship out 2.9 million doses of its vaccine upon authorization.
Distribution is slated to begin within 24 hours of the FDA's go-ahead.
Operation Warp Speed says the the doses will go out to all 50 states and all U.S. territories within that period.
Pfizer, a $16 billion company, is taking charge of distribution of its own vaccine using special dry ice-packed boxes to keep its shot at the necessary -94 degrees F.
The boxes will be delivered by Fedex and UPS.
Pfizer has a $1.95 billion contract with US for 100 million doss of the shot.
Both it and Moderna - whose shot will be reviewed by the FDA advisory panel on December 17 - plan to sell their vaccines for a profit.
The two firms are slated to make a combined $32 billion on their vaccines next year alone, a Wall Street analysts project.
In New York, for example, Governor Cuomo says he'll start dishing out the shots on December 15, starting with nursing home staff, residents and healthcare workers.
Azar said the first shots in the arm would be December 14 or 15.
'We're looking at 20million Americans being vaccinated in the next couple weeks, 50million by the end of January.
'We believe we could have 100million vaccinations in arm by the end of February.
'The products just keep rolling out, especially if we get to add AstraZeneca and Johnson & Johnson to our arsenal,' he said.
By that timeline, optimistically, that would mean less than a third of the US population would be vaccinated by the end of February.
All the experts however say at least 70 percent of population needs to be vaccinated for life to return to pre-pandemic levels and there's no telling how long that will take or if it ever will.
There remains a huge amount of skepticism surrounding the vaccine that scientists are trying now to fight against.
On Friday morning, former CDC Director Dr. Rich Besser told Today: 'There was an overwhelming feeling that this is a very safe and effective vaccine, and that the FDA should approve it.
The scientists at yesterday's panel also all voted that the vaccine was safe.
'An EUA is a starting point but in all likelihood, the FDA will request the company will continue to do additional studies.
'There was overwhelming feeling that this is a very safe and effective vaccine and that the FDA should approve it,' he said.
He went on to say there was concern over the fact that it had been rolled out quickly and said the FDA will likely ask Pfizer to keep studying trial participants to get more information.
'We've never had a vaccine approved this quickly and that will raise a lot of concerns for many people. Those concerns have to be addressed.
'You're not going to be able to address those concerns by just putting out ads saying "everyone get this vaccine."
'It's going to take federal dollars so that communities and states can work with everybody to understand what are people's concerns, who are the trusted leaders in each community, what needs to be done.
'This is being approved base on two months of safety data which isn't a lot and as we saw in the UK they were detecting issues in people who had severe allergic reactions.'
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