Health and human services secretary Alex Azar says there will be enough doses of COVID-19 vaccine for 'all Americans' by March after Pfizer revealed its jab may be 90 percent effective.
Azar gave a timeline on Tuesday for when the coronavirus vaccine would be rolled out after Pfizer said a day earlier it was on track to apply later this month for emergency-use approval from the FDA.
He said the US could receive 20 million doses per month starting at the end of this month if Pfizer moves as quickly as expected to secure regulatory approval.
'We have anticipated that we will have enough vaccine by the end of December to have vaccinated our most vulnerable citizens in nursing homes and otherwise,' Azar told NBC's Today.
'By January, enough for all health care workers and first responders and enough for all Americans by the end of March to early April to have general vaccination programs.'
Dr Anthony Fauci estimated that the vaccine would be rolled out in December if the FDA approves it.
Health and human services secretary Alex Azar gave a timeline on Tuesday for when a coronavirus vaccine would be rolled out after Pfizer said a day earlier it was on track to apply later this month for emergency-use approval from the FDA
“We have anticipated that we will have enough vaccine by the end of December to have vaccinated our most vulnerable citizens… and enough for all Americans by the end of March to early April.” -HHS secretary Alex Azar tells @SavannahGuthrie pic.twitter.com/kxUoXjMgjq
— TODAY (@TODAYshow) November 10, 2020
“We have anticipated that we will have enough vaccine by the end of December to have vaccinated our most vulnerable citizens… and enough for all Americans by the end of March to early April.” -HHS secretary Alex Azar tells @SavannahGuthrie pic.twitter.com/kxUoXjMgjq
HHS SECRETARY'S TIMELINE FOR VACCINE ROLL OUT:
Health and human services secretary Alex Azar gave a timeline on Tuesday for when the COVID-19 vaccine would be rolled out off the back of Pfizer saying it was on track to apply later this month for emergency-use approval from the FDA.
Azar said Pfizer will be delivering 20 million doses of its vaccine each month from December.
Here is his timeline for the roll out:
DECEMBER: Most vulnerable citizens, such as those in nursing homes.
JANUARY: All health care workers and first responders.
MARCH - APRIL: All Americans.
Dr Fauci told MSNBC that Pfizer's preliminary data was 'impressive' in nature and that the drugmaker's application for emergency use authorization 'should go through smoothly'.
'By the time we get into December, we'll be able to have doses available for people who are judged to be at the highest priority.'
He added that he would take the vaccine if the FDA approves it because he has confidence in Pfizer and the government agency.
'I'm going to look at the data, but I trust Pfizer. I trust the FDA. These are colleagues of mine for decades, the career scientists. If they look at this data, and they say this data is solid, let's go ahead and approve it, I promise you, I will take the vaccine, and I will recommend that my family take the vaccine,' he said.
While news of the potential breakthrough in a COVID-19 vaccine has fueled hope, the government now faces logistical challenges, including how to effectively distribute the jab on a wide scale level and the financial burden that will bring for states.
The Trump administration has paid $1.95 billion for 100 million initial doses of the Pfizer vaccine. Pfizer says it could have up to 50 million doses available by the end of this year if approved.
Manufacturers already have begun stockpiling vaccine doses in anticipation of eventual approval but the first shots will be in short supply and rationed.
State health officials have already estimated they will need additional funds to help distribute the vaccine.
The CDC announced $200 million in funding back in September to specifically help states with vaccine planning but state officials have already said that isn't enough.
Pfizer's vaccine also needs to be stored in ultra-cold temperatures that some experts have said match an Antarctic winter.
The CDC asked states last month to identify locations that could store a vaccine in temperatures of 94 degrees Fahrenheit below zero.
Pfizer has already said it plans to personally handle the physical distribution of its vaccine by shipping to those locations.
It will not use the government's main distribution partner, McKesson, on shipping the vaccine.
Pfizer has previously said it will fit its shipments with GPS trackers to stop any potential theft of its vaccines.
State officials started submitting plans to the federal government last month on how they plan to distribute the vaccine.
Virginia was one of the few states that estimated how much it would cost the state to roll out distribution, according to Bloomberg.
The state says it will cost $120 million, including: $2.5 million for freezers and transportation equipment and $71 million to help local health departments set up clinics.
The timing of Pfizer's announcement, which came 48 hours after Joe Biden claimed victory and less than a week after the election, quickly raised questions. Trump has since accused the FDA of holding up Pfizer's vaccine until after the election and said the decision to delay it would cost lives
Trump's son, Don Jr., immediately raised questions about the timing of Pfizer's announcement, tweeting on Monday: 'The timing of this is pretty amazing. Nothing nefarious about the timing of this at all right?'
The timing of Pfizer's announcement, which came 48 hours after Joe Biden claimed victory and less than a week after the election, quickly raised questions.
Trump has since accused the FDA of holding up Pfizer's vaccine until after the election and said the decision to delay it would cost lives.
'As I have long said, @Pfizer and the others would only announce a vaccine after the election, because they didn't have the courage to do it before. Likewise, the @US_FDA should have announced it earlier, not for political purposes, but for saving lives!' Trump tweeted on Monday night.
'The @US_FDA and the Democrats didn't want to have me get a Vaccine WIN, prior to the election, so instead it came out five days later - As I've said all along!'
President-elect Joe Biden welcomed Pfizer's news but cautioned that it could be many months before vaccinations become widespread in the US. He warned Americans to rely on masks and social distancing in the meantime, saying the country still faces a 'dark winter'.
Pfizer, which developed its vaccine with German drugmaker BioNTech, became the first to release promising preliminary findings of its jab based on early and incomplete test results.
With a possible 90 percent efficacy rate, Pfizer is on track to apply later this month for emergency-use approval from the FDA once it has the necessary safety information in hand.
Authorities have stressed, however, that it is unlikely any vaccine will arrive much before the end of the year and the limited initial supplies will be rationed.
The drugmaker had initially said it would know if its vaccine was effective by October but shifted that timeline last month to say it expects to seek FDA authorization in the third week of November.
Pfizer is still on track to meet that timeline.
The Trump administration has paid $1.95 billion for 100 million initial doses of the Pfizer vaccine. Pfizer says it could have up to 50 million doses available by the end of this year if approved
PFIZER'S VACCINE TIMELINE SO FAR
SEPTEMBER 13: Pfizer CEO Anthony Bourla says they will know if the vaccine is effective by the end of October
OCTOBER 16: In an open letter, Bourla promises again to know if the vaccine is effective by the end of October
He said the company wouldn't know if all three components - efficacy, safety and manufacturing - were up to par until the third week of November
OCTOBER 30-NOVEMBER 8: No update on efficacy of the vaccine
NOVEMBER 3: Presidential election
NOVEMBER 7: The election is called for Joe Biden
NOVEMBER 9: Pfizer announces results of efficacy study, says they expanded perimeters of it after consulting the FDA but doesn't say when or why
The company said the results of its preliminary analysis came after a discussion with the FDA but it is not yet clear exactly what those discussions involved or when they occurred.
Nearly 44,000 people are enrolled in Pfizer's final testing of the vaccine. Pfizer has said that 94 people in the trial have so far tested positive for COVID-19.
Over 90 percent effectiveness implies that no more than eight of the 94 people who caught COVID-19 had been given the vaccine.
Doing the math, that would mean almost all the infections counted so far had to have occurred in people who got the dummy shots.
The efficacy rate is well above the 50 percent effectiveness required by the FDA for a vaccine. To confirm the efficacy rate, Pfizer said it will continue the trial until there are 164 COVID-19 cases among participants.
The FDA has also said companies must track half their participants for side effects for at least two months, which Pfizer says it expects to reach later this month.
Pfizer's initial plans called for evaluating the vaccine when just 32 infections had been counted. Many scientists, however, warned that was simply too small to draw conclusions about a vaccine needed by billions.
Pfizer said it reconsidered and went back to the FDA for permission to change the plan and do its first interim analysis when there were more cases.
By the time Pfizer made the change and caught up with a backlog of virus tests, the board had 94 infections to analyze.
Meanwhile, the FDA on Monday allowed emergency use of the first antibody drug to help the immune system fight COVID-19.
The FDA cleared the experimental drug from Eli Lilly for people 12 and older with mild or moderate COVID-19 not requiring hospitalization.
It's a one-time treatment given through an IV.
The therapy is still undergoing additional testing to establish its safety and effectiveness.
It is similar to a treatment Trump received after contracting the virus last month.
Early results suggest the drug, called bamlanivimab, may help clear the coronavirus sooner and possibly cut hospitalizations in people with mild to moderate COVID-19.
A study of it in hospitalized patients was stopped when independent monitors saw the drug did not seem to be helping in that situation.
The government previously reached an agreement to buy and supply much of the early production of Lilly's drug.
Only one drug - Gilead Science' remdesivir - has full FDA approval for treating COVID-19.
Government treatment guidelines also back using dexamethasone and other steroids for certain severely ill, hospitalized patients.
FDA regulators authorized the Lilly drug using their emergency powers to quickly speed the availability of experimental drugs and other medical products during public health crises.
In normal times the FDA requires 'substantial evidence' to show that a drug is safe and effective, usually through one or more large, rigorously controlled patient studies. But during public health emergencies the agency can lower those standards and require only that an experimental treatment´s potential benefits outweigh its risks.
The emergency authorization functions like a temporary approval for the duration of the COVID-19 pandemic. To win full approval, Lilly will have to submit additional research to fully define the drug´s safety and benefit for patients.
The government has signed an agreement with Lilly to spend $375 million to buy 300,000 vials of the drug. How many doses that would provide is unclear. Each vial contains 700 milligrams and that dose proved ineffective in the early results. It took four times that amount - 2,800 milligrams - to show any effect.
When will the COVID-19 vaccine be rolled out and who will get it first? Everything you need to know about Pfizer's breakthrough shot
The global race to find a COVID-19 vaccine took a leap forward today when US drugmaker Pfizer revealed its jab is 90 percent effective.
Pfizer, which developed a vaccine with German drugmaker BioNTech, is the first to release successful data based on an interim analysis from a large-scale coronavirus vaccine clinical trial.
The announcement from the two pharma companies fueled hope that the global pandemic could come to an end as Pfizer hailed the vaccine victory a 'great day for science and humanity'.
The United States has already paid $1.95 billion for 100 million initial doses of the vaccine and Pfizer says it could have up to 50 million doses available by the end of this year if approved.
So what do you need to know about Pfizer's vaccine?
DOES THIS MEAN A VACCINE IS READY?
Not quite yet.
Pfizer has released preliminary findings that suggests its vaccine is more than 90 percent effective in preventing COVID-19.
The vaccine has been tested on nearly 44,000 people in six different countries and no safety concerns have been raised so far.
Pfizer is now planning to apply to the Food and Drug Administration for emergency approval to use the vaccine by the end of the month.
WHEN COULD IT BE READY FOR THE PUBLIC?
The general public will not benefit from the vaccine - if it is approved - for weeks or months to come.
Pfizer said they will try to apply for FDA approval within the next month if all goes well with the rest of their trial.
The FDA's scientific advisers will debate each company's study findings in a public meeting before the agency decides.
Manufacturers already have begun stockpiling vaccine doses in anticipation of eventual approval but the first shots will be in short supply and rationed.
Pfizer expects to produce up to 50 million doses, or enough to protect 25 million people, by the end of this year.
They expect to produce up to 1.3 billion doses of the vaccine next year.
HOW MANY DOSES HAS THE US BOUGHT?
The United States has already paid $1.95 billion for 100 million initial doses of the vaccine.
It is enough to treat 50 million Americans.
WHO WILL GET IT FIRST?
There is no official government announcement on who will get the COVID-19 vaccine first.
A federal advisory that is putting together recommendations to be approved by the CDC is currently considering four groups to possibly recommend for early COVID-19 vaccination if supply is limited.
They include: Healthcare personnel, workers in essential and critical industries, people at high risk for severe COVID-19 illness due to underlying medical conditions and people 65 years and older.
HOW DOES THE TRIAL WORK?
Nearly 44,000 people are enrolled in Pfizer's final testing of the vaccine.
Neither participants, their doctors or Pfizer know who gets the real vaccine and who gets a dummy shot.
They get a second dose about three weeks after the first and tracking begins a week after the second dose.
The tracking involves counting anyone who experiences COVID-19 symptoms and tests positive for the virus as participants go about their daily routines, especially in hotspots.
WHAT DO THE NEW TRIAL RESULTS SHOW?
The companies said that 94 people in the trial have so far tested positive for COVID-19.
Over 90 percent effectiveness implies that no more than eight of the 94 people who caught COVID-19 had been given the vaccine.
Doing the math, that would mean almost all the infections counted so far had to have occurred in people who got the dummy shots.
The efficacy rate is well above the 50 percent effectiveness required by the Food and Drug Administration for a vaccine.
To confirm the efficacy rate, Pfizer said it will continue the trial until there are 164 COVID-19 cases among participants.
The FDA has also said companies must track half their participants for side effects for at least two months, which Pfizer says it expects to reach later this month.
HOW TO TELL IF THE VACCINE WORKS?
Every vaccine study is overseen by an independent board that include scientists and statisticians who have no ties to the vaccine makers.
Before a study is complete, only the board has the power to unlock the code of who got real vaccine and who got placebo and to recommend if the shots are working well enough to stop testing early.
Those boards take sneak peeks at pre-determined times agreed to by the manufacturer and the FDA.
The first interim analysis for Pfizer came on Sunday.
The company reported its data monitors had counted 94 infections so far - and that among those initial cases, the vaccine appeared 90 percent effective.
To be sure of protection, the study is set to run until there are 164 infections. The more COVID-19 cases occur in the trial, the better idea scientists will have of just how protective the shots really are.
COULD THAT SNEAK PEEK HAVE COME EARLIER?
Pfizer's initial plans called for evaluating when just 32 infections had been counted. Many scientists, however, warned that was simply too small to draw conclusions about a vaccine needed by billions.
Pfizer said it reconsidered, going back to the FDA for permission to change the plan and do its first interim analysis when there were more cases.
By the time Pfizer made the change and caught up with a backlog of virus tests, the board had 94 infections to analyze.
Moderna, AstraZeneca and other companies not quite as far along in their final testing all have set slightly different timepoints for when their data monitors will peek at how the shots are working.
