The FDA urges healthcare providers not to mix and match vaccines, halve doses, or extend time between shots

elderly woman vaccine
A medical worker gives an elderly woman an influenza vaccine in Zoetermeer, Netherlands.

  • As the coronavirus vaccine rollout stalls in the US, some public health and scientific leaders are suggesting altering the shots’ administration in order to protect more people faster. 
  • But the FDA warned healthcare providers not to halve doses, mix and match shots, or widen the window between the doses’ delivery. 
  • Until we know how protective a single shot is and how long that protection might last, “making such changes that are not supported by adequate scientific evidence may ultimately be counterproductive to public health,” the agency said. 
  • Visit Business Insider’s homepage for more stories.

By the morning of January 4, only 2.8 million Americans had received their first dose of the coronavirus vaccine, despite the Trump administration’s goal of 20 million vaccinated in 2020. Meanwhile, an American dies of COVID-19 every 33 seconds

The dire situation has led some healthcare leaders to consider bending the vaccine administration protocol in order to, in theory, protect more people quicker. 

But on Monday, the US Food and Drug Administration tried to quash such attempts in the US, issuing a statement urging healthcare providers to administer coronavirus vaccines as they’ve been studied – that is, in two complete doses, made by the same company, and given three weeks apart for the Pfizer vaccine or four weeks apart for Moderna’s. 

The chief of Operation Warp Speed mulled giving out half doses, and the UK has discussed mixing vaccines

Moncef Slaoui, chief of Operation Warp Speed, said on Sunday that officials may give out half doses of Moderna’s COVID-19 shot in order to double the number of people immunized. 

There have also been contested discussions in the UK about mixing vaccines – that is, giving someone a first dose of the Pfizer vaccine and a second dose of Moderna’s, or vice versa, depending on availability. And, the UK’s health service has widened the window between recommended doses in an effort to maximize the number of people with some protection. 

In its statement, the FDA said whether such tweaks work are “reasonable questions to consider and evaluate in clinical trials.” 

“However, at this time, suggesting changes to the FDA-authorized dosing or schedules of these vaccines is premature and not rooted solidly in the available evidence. Without appropriate data supporting such changes in vaccine administration, we run a significant risk of placing public health at risk, undermining the historic vaccination efforts to protect the population from COVID-19.” 

The Infectious Diseases Society of America concurred, issuing a statement Tuesday in support of FDA’s stance. 

Changes to the vaccination schedule “carry the risk of both undermining the effectiveness of vaccines and eroding the public trust necessary for successful vaccine uptake,” it says. “As always, our approach against this pandemic must be founded in science, leadership, funding, collaboration and cooperation.” 

We don’t know for sure how protective a single dose is or how long protection from it lasts 

Some scientists have looked at the evidence and concluded that a single dose should provide some protection for at least a month beginning two weeks after vaccination.

However, experts say it would be a mistake to hope for full protection after one shot, when the vaccines currently available globally (from Pfizer, Moderna, and AstraZeneca) are all designed to be given in two doses.

The FDA said we can’t know much about how long a single dose is protective, or how strong that protection might be, since those questions weren’t studied and their answers may be related.

Until we better understand those questions, dolling out single or meager doses “is concerning,” the FDA said. 

“If people do not truly know how protective a vaccine is, there is the potential for harm because they may assume that they are fully protected when they are not, and accordingly, alter their behavior to take unnecessary risks.” 

The agency acknowledged that suggested tweaks to the vaccines’ delivery are well-intentioned, but said, “making such changes that are not supported by adequate scientific evidence may ultimately be counterproductive to public health.” 

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Gov. Andrew Cuomo says some of Moderna’s vaccine vials contain extra doses, just like Pfizer’s

cuomo
New York Gov. Andrew Cuomo at a press conference in September.

  • New York Gov. Andrew Cuomo said the state has found additional doses in its vaccine vials from Moderna.
  • The vials, which were thought to hold 10 doses, could hold up to 11.
  • Cuomo’s announcement follows similar news about the Pfizer vaccine: Pharmacists found many five-dose vials held six or seven doses.
  • Visit Business Insider’s homepage for more stories.

New York Gov. Andrew Cuomo said on Wednesday that vaccine providers in the state have found extra doses in vials from Moderna, the biotech company whose vaccine was authorized by the FDA on Friday.

“Some good news: Many Moderna vaccine vials hold an extra dose. Vaccinators can often get 11 doses, not just 10, per vial,” Cuomo tweeted on Wednesday

“That means there are more doses than anticipated in the state’s existing supply,” he added.

A letter from the New York Department of Health stated that those administering vaccines would be allowed to draw more than 10 doses from the vials if enough remained, though they are not allowed to mix remnants from different containers. 

Moderna did not immediately respond to Business Insider’s request for comment on the extra doses.

Cuomo also announced that 89,000 New Yorkers have received vaccine shots as of Wednesday. Of those, 22,000 doses went to residents and workers in 90 nursing homes across the state. 

Coronavirus vaccine canada
A nurse is inoculated with the Pfizer/BioNTech coronavirus vaccine in Toronto, Canada, December 14, 2020.

Cuomo’s announcement followed similar news about Pfizer’s vaccine. Though each Pfizer vial was supposed to contain five doses, pharmacists discovered last week that they could squeeze out six or seven.

At first, some pharmacists threw the extra doses away, not wanting to violate the Food and Drug Administration’s emergency-use guidelines, which state there are five doses per vial.

But on December 16, the agency said those extra doses could be used, according to Politico.

“Given the public-health emergency, FDA is advising that it is acceptable to use every full dose obtainable,” an agency spokesperson said. 

If all of Pfizer’s vials actually contain seven doses instead of five, and all of those doses can be used, that could expand the US’s supply of that vaccine by up to 40%. But it’s more likely that not every vial has two additional doses.

It’s also not yet clear how many additional doses Moderna’s vials hold added up. The FDA has not yet provided official guidance as to whether those doses should be used.

In an email, FDA spokesperson Stephanie Caccomo referred Business Insider to FDA Commissioner Stephen Hahn’s Twitter account, which said on Saturday that the FDA “is allowing providers to use as many full doses as can be obtained from multidose vaccine vials – about 6 for Pfizer and about 10 for Moderna.”

On Friday, following the FDA authorization of the Moderna vaccine, the US government said it expected 5.9 million doses to be shipped to states within a week. The government has so far purchased 200 million doses of Moderna’s vaccine

Aria Bendix contributed reporting.

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FDA says it will ‘rapidly work toward’ authorizing Moderna’s COVID-19 vaccine

moderna covid vaccine record time 4x3
  • The US Food and Drug Administration announced Thursday that it “will rapidly work toward finalization and issuance of an emergency use authorization” of Moderna’s COVID-19 vaccine.
  • “The agency has also notified the US Centers for Disease Control and Prevention and Operation Warp Speed, so they can execute their plans for timely vaccine distribution,” FDA Commissioner Dr. Steven Hahn said.
  • The announcement comes after an FDA expert panel earlier on Thursday recommended that the vaccine be approved.
  • Visit Business Insider’s homepage for more stories.

The US Food and Drug Administration announced Thursday that it “will rapidly work toward finalization and issuance of an emergency use authorization” of Moderna’s COVID-19 vaccine.

The news comes after an FDA expert advisory panel earlier in the day recommended that the vaccine be approved.

In a statement, FDA Commissioner Stephen Hahn said the agency “also notified the US Centers for Disease Control and Prevention and Operation Warp Speed, so they can execute their plans for timely vaccine distribution.”

Identical language was used earlier this month before the FDA approved the use of Pfizer’s COVID-19 vaccine, which is now being distributed.

Having two authorized vaccines should allow tens of millions of Americans to get vaccinated in the coming months. Operation Warp Speed officials anticipate 20 million Americans will get a shot in December, 30 million more in January, and 50 million more in February.

Read more: Meet the 19 key scientists, executives, and leaders responsible for pushing coronavirus vaccines across the finish line

Healthcare workers and people living in nursing homes are being vaccinated first. Plans vary by state, but essential workers such as teachers and firefighters are generally next in line. Top government scientists, including Dr. Anthony Fauci and Warp Speed chief advisor Moncef Slaoui, have said vaccines should be available to the general public in late-spring or early summer.

Like Pfizer’s vaccine, Moderna’s injection excels at preventing COVID-19. A late-stage clinical trial of the shot enrolled more than 30,000 volunteers and determined that Moderna’s shot was safe and 94% effective at preventing symptomatic disease.

A key advantage of Moderna’s shot is that it’s easier to ship and store. Unlike Pfizer and BioNTech’s vaccine that needs to be stored at negative 94 degrees Fahrenheit, Moderna’s is stable for a month with typical refrigeration.

Have a news tip? Email this reporter: cdavis@insider.com

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LIVE: An FDA expert panel is meeting today to discuss Moderna’s coronavirus vaccine, likely paving the way for the 2nd authorized COVID-19 shot in the US

moderna covid vaccine record time 2x1
  • An influential expert panel is meeting Thursday to vote on authorizing Moderna’s coronavirus vaccine. 
  • By the end of the day, the committee will vote on whether or not to recommend emergency use authorization.
  • The US Food and Drug Administration isn’t required to follow the group’s advice, but often does so. The agency could OK Moderna’s shot as soon as Thursday night or Friday, according to media reports.
  • Healthcare and science reporters Andrew Dunn and Hilary Brueck are providing live updates from the day-long meeting.
  • For more stories like this, sign up here for Business Insider’s daily healthcare newsletter.
3:00 PM: Could Moderna’s shot provide some protection after a single dose? It’s possible, FDA says

Moderna vaccine
A nurse prepares a coronavirus vaccine shot developed by the National Institutes of Health and Moderna Inc.

Moderna’s COVID-19 vaccine trial was designed to measure how well two shots, given 28 days apart, protect people from infections. And it showed the vaccination works very well at that: it is 94% effective at preventing symptomatic COVID-19, 14 days after a second shot. 

But, it’s possible that good protection from infection starts much sooner than that. 

Preliminary trial data suggests the first dose of Moderna’s vaccine likely provides a decent measure of protection from infection all on its own.

Researchers found fewer COVID-19 cases among people who got Moderna’s shot compared to the placebo group after volunteers got their first injection, but before they got the second booster dose. That protection appeared to ramp up over time, generally kicking in a couple weeks after the initial shot. 

“This could suggest some protection after the first dose, but data is limited by the very short follow-up, around 28 days, as the majority of the study subjects received a second dose,” Dr. Rachel Zhang, an FDA medical officer said.

Overall, the single shot appeared to be about 70% effective at preventing symptomatic infections. That looks better than Pfizer’s potential one shot protection, which appeared to be about 54% effective in the 21-day period before participants in that trial got a second injection. 

Evercore ISI biotech analyst Umer Raffat also pointed out how well Moderna’s first dose might work on its own in a recent research note to investors. Data suggests the first dose was about 92% effective compared to a placebo, when looking at first COVID-19 occurrences starting two weeks after the first dose, Raffat said. 

It’s still unclear how protective one dose would be in the long run, without a second shot. But Raffat, along with a handful of thought leaders in the drug industry like Pfizer board member and former FDA head Scott Gottlieb and University of Pittsburgh researcher Walid Gellad, have advocated the potential benefits after one dose should be considered, especially given the state of the pandemic right now. 

Dr. James Hildreth, an immunologist on the committee, and an esteemed HIV researcher, also suggested that since so many people in the US have already had COVID-19, they might receive ample benefit from just one dose of Moderna’s vaccine. 

“There are probably tens of millions of Americans who’ve already been infected,” Hildreth said Thursday during the meeting. “What I’m asking is, if you took the ones who have been infected, and gave them an injection of your vaccine, could that possibly serve as a boost?”

Moderna’s Dr. Jaqueline Miller said that as more study data becomes available in the weeks and months ahead, that could be something to look into.

Operation Warp Speed is holding back half of the available doses to ensure each vaccine recipient gets their booster dose at the right time — after three weeks for Pfizer’s shot, and after four weeks for Moderna’s.

Gottlieb and Gellad have argued it would be better to distribute all the doses right away, getting a first dose to twice as many people. While this opens up a risk that there may not be enough supply for everyone to get their booster shot on time, they say this could be an acceptable risk to take during the most deadly period of the pandemic. 

2:45 PM: One panelist inquires about above-average Bell’s palsy rates, but the numbers are too small to draw conclusions

Dr. Paul Offit, a committee member and vaccine expert at the University of Pennsylvania, highlighted that both Moderna’s and Pfizer’s vaccine studies appeared to have higher rates than usual of Bell’s palsy. 

Bell’s palsy is a typically temporary condition marked by weakness or paralysis in facial muscles. FDA scientists have acknowledged more people getting the coronavirus vaccines developed this condition than those getting placebo.

But the number of cases — seven among more than 30,000 vaccinated volunteers — is too small to say if the vaccine caused these cases. Agency reviewers said the Bell’s palsy cases in the studies were in line with typical incidence rates.

Offit also said it’s important to not fall victim to “the tyranny of small numbers” and conclude a relationship just yet, saying he is pleased the agency will closely monitor these vaccines going forward.

But Offit questioned the notion that the studies had typical rates of Bell’s palsy cases. “I’m just not quite sure how we are so comfortable that this was a background rate,” he said. 

“If you look at the Pfizer trial, there were four cases of Bell’s palsy in a group of 22,000 [vaccinated people] per three months, which works out to about 8 cases per 10,000 per year,” Offit said. “If you look at the Moderna trial, it’s 3 cases for 15,000 for three months, which also works out to about 8 cases per 10,000 per year.”

Combining the two placebo groups together, Offit said those volunteers had about 1.2 cases per 10,000 per year. He said that’s roughly in line with the background rate.

FDA medical officer Dr. Rachel Zhang said the agency is looking into this. 

“There is still no clear basis upon which to conclude a causal relationship, but we definitely see your point with the two studies combined,” she said. 

She did not dispute Offit’s point that the vaccinated groups seemed to have higher-than-normal rates.

11:00 AM: Moderna pitches plan to immunize placebo volunteers without ‘jumping the line’

Moderna has a plan to offer trial volunteers who received placebo shots the actual vaccine, while side-stepping some of the key ethical concerns.

What to do with ongoing placebo-controlled trials during the pandemic has become a top conundrum facing vaccine developers like Pfizer and Moderna. On one hand, researchers want to keep following the placebo group to have high-quality, long-term data to see how these shots work. But ethicists also wonder if studies can, or should, withhold an effective vaccine from volunteers.

Moderna’s proposal is to ask participants whether or not they want to know if they got the real vaccine or a placebo. They can choose to remain blinded and in the study, or they can decide to know which arm they were in. Placebo participants who choose to become unblinded are then offered the real vaccine from clinical trial stocks, if they want it. All of those participants would be followed for long-term data.

Tal Zaks, Moderna’s chief medical officer, said this would not take doses away from priority groups. Instead, placebo recipients would get doses already produced for the sole purpose of clinical trial use that can’t be dispatched to the general public.

“None of our vaccine trial participants would be ‘jumping the line’ ahead of others, because we have clinical trial supplies available that would in fact expire and go to waste if we don’t use them,” Zaks told the panel.

Dr. Lindsey Baden, an infectious-disease expert at Brigham and Women’s Hospital, also spoke as part of Moderna’s presentation as one of the study’s investigators. 

Baden said there have been a “substantial” number of volunteers dropping out of the trial in the last week since Pfizer’s vaccine secured an emergency OK last Friday.

“This dropout undermines the data integrity and what can be learned,” Baden said. “We must be proactive to ensure that the best choice is for our participants to remain in the study.”

Giving placebo recipients the chance to be vaccinated is important, because Zaks said many of the volunteers are at higher risk of infection and also have risk factors for severe disease.

A 54-year-old man with diabetes who got placebo shots in Moderna’s trial ultimately died from COVID-19, Zaks said, highlighting the risk in not immunizing these volunteers. 

9:50 AM: FDA and CDC are investigating allergic reactions to Pfizer’s vaccine, but have no answers or recommendations yet

EpiPen allergic reaction treatment
An EpiPen can be used in an emergency to treat anaphylactic shock by injecting epinephrine through clothing.

Dr. Stanley Perlman, a University of Iowa immunologist, asked about possible explanations for allergic reactions to COVID-19 vaccines, after two healthcare workers in the UK, and then two more in Alaska, had anaphylactic reactions after receiving Pfizer’s vaccine. 

Pfizer’s vaccine ingredients don’t seem to be anything highly allergenic, and at least one of the healthcare workers had no history of allergies, leaving experts (like Perlman) puzzled as to what’s going on. 

“At this point we and CDC are continuing to investigate cases and consider data,” said Doran Fink, an FDA vaccine expert. “At this point, we don’t have enough information to make definitive recommendations one way or another, and as we continue to investigate and evaluate the data we will consider whether additional recommendations need to be made.”

9:00 AM: Panel kicks off, releasing key voting question

FDA advisory committee voting question Moderna coronavirus vaccine
The key voting question facing the FDA’s expert panel on Moderna’s coronavirus vaccine

We are off and running for a marathon meeting expected to wrap up at 5:15 p.m. 

On Tuesday, the FDA released the most detailed results yet from Moderna’s late-stage study in preparation for this meeting. The agency’s summary showed the two-dose vaccine to be overwhelmingly protective at preventing symptomatic COVID-19 with no major safety concerns.

All in all, it’s a very similar profile to Pfizer’s vaccine, which was authorized last Friday, and we compared what we know about each shot here.

It’s poised to be a long but important day. The panel’s recommendation on whether or not to OK Moderna’s vaccine is seen as the last remaining barrier to an FDA authorization decision.

Here’s the agenda for the day: 

9:00 a.m. — Introductions

9:30 a.m. — FDA deputy director Doran Fink outlines emergency use authorization

10:05 a.m. — Stanford researcher Steven Goodman discusses the possible options for ongoing placebo-controlled vaccine trials, given COVID-19 shots are now being rolled out

10:45 a.m. — Moderna chief medical officer Tal Zaks and senior vice president Jacqueline Miller present the biotech’s vaccine data

12:00 p.m. — Public comment

1:00 p.m. — Zaks and Miller answer questions from committee members

2:00 p.m. — FDA medical officer Rachel Zhang presents the agency’s perspective on the vaccine data

3:10 p.m. — Committee discusses, ultimately votes, and adjourns

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Your complete coronavirus vaccine calendar: When Moderna’s candidate is likely to get authorized, and when you could receive your Pfizer shot

covid vaccine turkey
Dr. Mustafa Gerek participates in a coronavirus vaccine trial at Ankara City Hospital in Ankara, Turkey on October 13, 2020.

  • Three companies developing COVID-19 vaccines — AstraZeneca, Moderna, and Pfizer — have released positive results from their late-stage trials.
  • Pfizer’s vaccine received emergency authorization from the FDA on Friday, putting it on track to deliver shots as early as Monday.
  • An FDA advisory committee will decide whether to recommend Moderna’s vaccine on December 17.
  • Here’s a timeline of when the leading vaccines could reach the public.
  • Visit Business Insider’s homepage for more stories.

Good news about coronavirus vaccines keeps rolling in.

On Friday, Pfizer’s coronavirus vaccine became the first candidate to receive emergency authorization in the US. The day before, an advisory committee to the Food and Drug Administration recommended the shot for widespread use in peoples ages 16 and older.

Moderna’s shot could be next: The company applied for an emergency use authorization (EUA) from the FDA on November 30. From there, an FDA advisory committee will determine if the vaccine meets their recommendation standards.

But the big question still remains: When can Americans get their shots?

Here are the key milestones ahead before vaccines reach the public

December 14: Americans could start receiving Pfizer’s vaccine as early as Monday morning, when the first hospitals, clinics, and public health systems are scheduled to receive their shipments. An advisory committee to the Centers for Disease Control and Prevention has recommended that frontline healthcare workers and residents of long-term care facilities get priority access.

December 17: An FDA advisory committee made up of independent scientific experts will meet to evaluate Moderna’s EUA request. The meeting will be streamed on the FDA website and on its YouTube, Facebook, and Twitter channels. Moderna will present its safety and efficacy data, then answer questions. After that, the advisory committee will make a recommendation on whether to greenlight the vaccine.

December 18: The FDA is likely to follow the committee’s advice, and the vaccine could be authorized within 24 hours, or perhaps a few days later. 

By December 21: Moderna shots might not be available until four days after the FDA advisory meeting, given the time it takes to greenlight and ship the vaccines.

Pfizer and Moderna’s 2021 vaccine timeline

Moncef Slaoui, the chief advisor to Operation Warp Speed, has estimated that 20 million Americans could get a COVID-19 shot before the end of 2020. But Pfizer’s first shipments only contain 2.9 million doses. People who get these early shots will receive second doses after three weeks.

That means vaccinations for the nation’s 21 million healthcare workers and 3 million residents of long-term care facilities could last through January 2021.

Slaoui estimated that the US could immunize 100 million people by the end of February. That would require another 60 million doses to be distributed in January, followed by 100 million in February.

By April, vaccines could start being distributed to young, healthy Americans. 

Moderna CEO Stéphane Bancel recently told Business Insider that any American who wants a vaccine should have access to one by Memorial Day. Anthony Fauci, director of the National Institute of Allergy and Infectious Disease, has also said that the general population could have access to shots by late spring and early summer.

But those timelines could vary depending on whether additional vaccine candidates besides Pfizer’s and Moderna’s get emergency authorization.

AstraZeneca’s coronavirus vaccine, developed in partnership with the University of Oxford, was found to be 70% effective on average in late-stage clinical trials with more than 20,000 volunteers in the UK and Brazil. The results varied depending on the dosage: A regimen that included two full doses at least one month apart was found to be 62% effective. When volunteers were given a half-dose, followed by a full dose, the effectiveness rose to 90%.

The company still hasn’t concluded its US trial, which was delayed for more than a month, but resumed in October. The more vaccine trials that report success, the sooner shots can be widely distributed to the public. 

What about other vaccine candidates?

Operation Warp Speed has purchased 100 million doses of Pfizer’s vaccine and another 200 million doses of Moderna’s.

Slaoui told Bloomberg in November that the program expects to distribute 400 to 450 million vaccine doses from now through May. “Plan A,” he added, is to distribute vaccines from two other companies – AstraZeneca and Johnson & Johnson – to help reach that goal. 

Slaoui told Business Insider in October that he expects AstraZeneca and Johnson & Johnson’s US trials to produce results in December or January. That could put them on track for authorization this winter. The US has already purchased 100 million doses from each company. 

“Plan B,” Slaoui told Bloomberg, is to order additional doses from Pfizer and Moderna. Agreements with the companies allow the US to acquire another 500 million doses from Pfizer and another 300 million doses from Moderna should it so choose.

The remaining two vaccine candidates backed by Warp Speed come from Novavax and a Sanofi/GlaxoSmithKline partnership. If the companies have trouble finding enough Americans to join their trials once a Pfizer or Moderna vaccine hits the market, Slaoui told Bloomberg, the trials might recruit volunteers in other countries. Both are expected to release pivotal data about their vaccine candidates in early 2021.

If those two vaccines get authorized – that would most likely happen in the spring – the US is prepared to distribute 100 million doses of each as well. 

In a recent NPR interview, Fauci said additional vaccine candidates besides Pfizer’s and Moderna’s “are going to be essential if we want to get enough vaccine to give to everyone who would need it or want it in the country.”

This story has been updated with new information about Pfizer’s authorization and Moderna’s EUA application. It was originally published on November 25.

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Operation Warp Speed’s co-leader says every US state will start receiving Pfizer’s coronavirus vaccine Monday morning, with immunizations starting by the end of the week

General Gustave Perna, chief operating officer for the Defense Department's Project Warp Speed, speaks during a White House Coronavirus Task Force press briefing
General Gustave Perna, chief operating officer for the Defense Department’s Project Warp Speed, speaks during a White House Coronavirus Task Force press briefing

  • The largest vaccination campaign in the history of the US has begun, with Pfizer preparing to ship the first doses out Sunday morning. 
  • Gen. Gustave Perna, chief operating officer of the federal government’s vaccine initiative Operation Warp Speed, said the first shipments should arrive in every US state on Monday morning. 
  • The US Food and Drug Administration authorized Pfizer’s two-dose vaccine for emergency use on Friday night. 
  • The first doses could start going into American arms “as early as the end of next week,” Perna told reporters at a Saturday morning press conference. 
  • For more stories like this, sign up here for Business Insider’s daily healthcare newsletter.

The first doses of a coronavirus vaccine should arrive in every US state on Monday morning, Operation Warp Speed co-leader Gen. Gustave Perna said Saturday. 

The US Food and Drug Administration authorized Pfizer’s two-dose vaccine for emergency use on Friday night, effectively launching the largest vaccination campaign in US history. 

Perna, a four-star general, stands at the forefront of the mammoth logistical challenge to immunize a nation of 328 million. He likened the challenge to D-Day, a crucial turning point in World War II that sparked the liberation fo German-occupied France.

“D-Day was the beginning of the end, and that’s where we are today,” Perna said at a Saturday morning news conference.

But the end remains in the distant future, with the worst days of the pandemic likely still ahead. Infections, hospitalizations, and deaths have all surged over the past two months, routinely setting new record highs. On Friday, the US recorded 2,951 deaths and 280,514 new cases.

“We are not taking a victory lap,” Perna said. “We know that the road ahead of us will be tough. We know that situations will occur, but we will figure it out together collectively.”

Sites will receive doses starting Monday

The first shipments are expected to leave Pfizer’s manufacturing plant in Kalamazoo, Michigan, on Sunday morning. Perna said he expects 145 sites – encompassing every US state – to receive doses on Monday. 

Perna said 425 more sites should receive shipments on Tuesday, and the final 66 sites will get the vaccine on Wednesday. That will complete an initial shipment of 2.9 million doses of Pfizer’s shot, with Warp Speed holding back another 2.9 million doses to ensure each immunized person can get a second booster dose 21 days later.

From there, local officials from states, counties, and cities will take the lead. Perna said vaccines could be going into people’s arms “as early as the end of next week.” 

States will determine how to prioritize the initial vaccine doses

States are making their own decisions on how they wish to prioritize the limited supply. An advisory panel for the Centers for Disease Control and Prevention has recommended that frontline healthcare workers and nursing home residents be placed at the front of the line.

Perna said Saturday he has talked to many states that plan to start vaccinating those two populations simultaneously to start.

Overall, Warp Speed is expecting to soon start shipping doses of another vaccine developed by Moderna. The FDA’s expert panel will debate Moderna’s emergency use authorization application next Thursday, likely setting up agency scientists to make an equally speedy review decision.

Based on supply estimates from Pfizer and Moderna, Warp Speed projects that 20 million Americans will begin to be immunized in December, 30 million more in January, and 50 million more in February. 

“We are not done until every American has access to this vaccine, until every American that wants it, receives it,” Perna said. “This is our only goal.”

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Most people with allergies should get Pfizer’s coronavirus shot, according to the FDA

covid vaccine trial
Lisa Taylor receives a COVID-19 vaccination during a clinical trial.

  • The newly authorized Pfizer coronavirus vaccine appears to be safe for people with food or environmental allergies, the FDA said on Saturday.
  • Two people in the UK reported severe allergic reactions after getting the shot.
  • After careful consideration, the FDA decided not to include warnings against the vaccine for people with a history of severe allergies, since that’s a large segment of the population and such complications didn’t occur in clinical trials. 
  • Still, there’s more to learn, and all vaccine distribution sites will be equipped to treat any allergic reactions that may occur, which the FDA will continue to closely monitor. 

People with common allergies to foods or to things in the environment like pollen or dust probably don’t have to worry about having a serious reaction to the just-authorized Pfizer coronavirus vaccine, the US Food and Drug Administration said during a press conference on Saturday. 

Even people who’ve had a severe allergic reaction to food or to something in the environment in the past should be OK to get the shot, Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said during the briefing. FDA said that people who are allergic to the shot itself or to one of its ingredients shouldn’t get it.

“We’re telling people that unless they’ve had a severe allergic reaction to the vaccine or one of its components, they can receive it,” Marks said. 

FDA held the briefing to provide more information on Pfizer’s coronavirus vaccine, after clearing the shot late Friday for emergency use in people 16 and older. In authorizing the vaccine, the FDA said it’s generally safe and highly effective at preventing symptomatic cases of COVID-19, the disease caused by the new coronavirus.

The clarification for people with allergies came after two people in the UK with known, severe allergies had non life-threatening anaphylactic reactions soon after being injected with the vaccine. UK health officials said that people with a history of severe, or anaphylactic, reactions to vaccines, medicines, or food should not get the shot.

“I just want to reassure the public that, although there were these few reactions in Great Britain, these we’re not seeing in the larger clinical trial data sets,” Marks said.

The trial included people with common issues like asthma and food allergies, but excluded people with severe allergies to vaccines.

Allergies are common, but serious reactions to this vaccine are not  

About 30% of the global population has seasonal allergies, 10% have drug allergies, and 8% of children worldwide have food allergies, according to the American Academy of Allergy, Asthma, and Immunology. In the US, 1 in 10 adults has food allergies, Food Allergy Research and Education reports. 

Marks said that 1.6% of the population has had a severe allergic reaction to a food or something in the environment. 

“We would really not like to have that many people not be able to receive the vaccine,” he said.  

That’s why, after careful consideration, the agency decided not to include a warning about allergic reactions, outside of those to the vaccine itself and its components, in its fact sheets. 

Still, all vaccination sites will have EpiPens, Benadryl, and hydrocortisone on hand to treat any potential reactions that pop up, which the agency will track. 

“We have very good safety surveillance systems in place in conjunction with the Centers for Disease Control and Prevention, and we may have to modify things as we move forward,” Marks said. “But for right now, we’re comfortable with this [advice], and the extra piece of this is that centers will have the ability to treat allergic reactions.”

Most of the components in the Pfizer shots are benign 

Marks said people with a history of allergic reactions should still talk to their doctor, who can help them figure out if they may be allergic to one of the components in the new vaccine, including lipids, potassium, chlorine, salt, and sugar. A full list of the components is available here

“None of those ingredients appear to be highly allergenic,” Dr. Sanjeev Jain, a board-certified allergist, immunologist, and CEO of Columbia Allergy told Business Insider’s Hilary Brueck, stressing that most of the chemicals in the new shot are quite benign. 

He said there could be a few explanations, then, for why the two people in Britain experienced severe reactions. In rare cases, people can react to polyethylene glycol, a component of one of the ingredients.  

It’s also possible the people had “non-specific” mast cell reactions, or that something about the vaccine particles triggered the body’s response to allergens. 

Finally, the two people with reactions could have recently had an allergy treatment or come in contact with another allergen, which, in combination with the effect of a vaccine on the immune system, “sent it into overdrive,” Brueck reported. 

“The fact that their immune system got stimulated by the vaccine, that could have triggered a reaction,” Jain said.

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Pfizer’s vaccine authorization means 2.9 million high-risk people will get the shot within days – the first step in a 9-month path to normalcy

pfizer vaccine distribution UK
A nurse prepares to inject staff with the Pfizer/BioNtech COVID-19 vaccine at Bradley Manor residential care home in the UK on December 9, 2020.

It’s the news Americans have been waiting on: The first coronavirus vaccine has been authorized by the Food and Drug Administration, clearing it for widespread emergency use in the US. 

The two-dose regimen was developed by US pharmaceutical company Pfizer and German biotechnology company BioNTech. The vaccine was 95% effective in preventing COVID-19 in clinical trials.

The third phase of the trial involved more than 43,000 volunteers across six countries and 16 US states. Just eight COVID-19 cases were recorded in the group that got the vaccine, compared to 162 cases in the placebo group.

An independent FDA advisory committee met to discuss that data on Thursday. The committee determined the vaccine was safe to administer to the public, since most immunized volunteers just reported temporary side effects like fatigue, headache, and pain at the injection site. 

“Today’s action follows an open and transparent review process that included input from independent scientific and public health experts and a thorough evaluation by the agency’s career scientists to ensure this vaccine met FDA’s rigorous, scientific standards for safety, effectiveness, and manufacturing quality needed to support emergency use authorization,” FDA Commissioner Stephen Hahn said in a statement.

The FDA’s authorization, he added, “is a significant milestone in battling this devastating pandemic that has affected so many families in the United States and around the world.”

The Centers for Disease Control and Prevention has recommended that the nation’s 21 million healthcare workers and 3 million residents of long-term care facilities – including assisted living and nursing homes – get priority access to the shots. 

With the FDA’s authorization, Pfizer can distribute shots using its own delivery system, which is centered in Kalamazoo, Michigan, and Pleasant Prairie, Wisconsin. Pfizer has 6.4 million vaccine doses available, but the company’s first shipments will only contain 2.9 million doses. That’s because the 2.9 million people who get those early shots will need second doses after three weeks. Another 500,000 doses are being held back for emergency situations.

Some individuals could receive their first shot within 24 to 48 hours. Then they’ll need a second shot 21 days later (a single dose is only 52% effective at preventing COVID-19).

Hospitals must decide, however, how to allocate the shots among staff. Some many use a lottery system, though many will likely select employees with the highest risk of exposure to COVID-19, such as emergency physicians. 

To help nursing homes administer vaccines to residents, the federal government has contracted with CVS and Walgreens.

Since states were required to come up with their own distribution plans, some have elected to prioritize certain vulnerable groups over others. Mississippi will give its first doses to hospital workers and first responders, including police officers and firefighters. Utah is also planning to deliver doses to frontline workers before residents and staff at long-term care facilities.

New York, on the other hand, will give nursing home residents first access to its 170,000 doses, followed by nursing home staff and high-risk hospital workers. And Kentucky will divide up its first batch, giving 12,600 doses to hospitals and 25,400 doses to long-term care residents and staff.

Vaccines for priority groups will continue into 2021

Moderna vaccine
Moderna protocol files for COVID-19 vaccinations at the Research Centers of America in Hollywood, Florida, on August 13, 2020.

Not all 24 million Americans in the first priority group will get vaccinated before January.

Federal officials estimate that the US could distribute 40 million doses by the end of 2020 – enough to immunize 20 million people. That total includes doses from both Pfizer and Moderna. 

The FDA advisory committee will evaluate the vaccine from Moderna on December 17. Assuming its shot gets authorized quickly, the company expects to distribute 20 million doses before the end of the year. Trial data has shown Moderna’s shot to be 94.5% effective at preventing COVID-19. 

Other priority groups, including people over 65 and those with preexisting health conditions, are likely to get vaccinated at the start of 2021. 

Moncef Slaoui, who is spearheading Operation Warp Speed, recently estimated that the US could immunize 100 million people by the end of February. That would require another 60 million doses to be distributed in January, followed by 100 million in February. 

By April, vaccines could start being distributed to young, healthy Americans. Moderna CEO Stéphane Bancel recently told Business Insider that any American who wants a vaccine should have access to one by Memorial Day. 

Slaoui recently told the Washington Post that most Americans could be immunized by mid-year 2021. 

Americans could breathe a sigh of relief in fall 2021

face mask kid school covid 19
Kindergartner Grace Truax, 5, removes her mask before posing for a portrait during “picture day” at Rogers International School on September 23, 2020 in Stamford, Connecticut.

Vaccine authorization doesn’t bring an automatic end to the pandemic. 

Researchers still don’t know whether coronavirus vaccines are safe for young children, pregnant women, or immunocompromised individuals. It’s also not known yet whether the vaccines prevent people from getting infected or spreading the virus. Cases were only tested and counted based on symptoms, so it’s possible some trial participants got asymptomatic infections. If the shots only prevent symptoms, it could take longer for transmission to slow in the US. 

Public-health experts say most of 2021 will likely involve some degree of mask wearing and social distancing, particularly in areas where transmission is high.

“We’re still going to have to change our habits a little bit, realistically, until we get to next fall,” Megan Ranney, an emergency-medicine physician at Brown University, told Business Insider. “Most of us in public health are looking at kind of late summer, early fall as being when things really get back to normal.”

But over the spring, she added, Americans could “start to see a light at the end of the tunnel.”

By the end of summer, outdoor concerts could resume and corporations may start to fully reopen office buildings, she said. Universities could also resume in-person classes in the fall semester.

“It will not be until the fall that we’ll be able to take a true sigh of relief,” Ranney said.

Still, she added, “we are probably going to wear masks on airplanes or trains or buses for a long time to come.”

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An influential expert panel just gave its blessing to Pfizer’s 2-dose coronavirus shot, teeing up the FDA to imminently authorize the US’ first COVID-19 vaccine

Pfizer
Oil markets surged in the hours after Pfizer announced positive results from its coronavirus vaccine study.

  • A committee of more than 20 leading scientists and doctors is encouraging the FDA to grant emergency use authorization for Pfizer’s COVID-19 vaccine in the US.
  • Their vote is not a final verdict, it’s really just advice.
  • Ultimately, it’s up to the scientists working inside the FDA to decide whether or not to approve the two-dose vaccine candidate for an emergency OK. That decision could come in minutes, hours or days. 
  • For more stories like this, sign up here for Business Insider’s daily healthcare newsletter.

A committee of 22 leading scientists and doctors just voted 17 to 4, with one abstention, encouraging the US Food and Drug Administration to grant emergency use authorization for Pfizer’s COVID-19 vaccine in the US.

Their vote is not a final verdict, it’s really just advice.

Ultimately, it’s up to the scientists working inside the FDA to decide whether or not to approve the two-dose vaccine candidate for an emergency OK. That decision could come just minutes, hours, or days from now. 

Screen Shot 2020 12 10 at 5.07.24 PM
The question committee members voted on Thursday evening.

“FDA staff feel the responsibility to move as quickly as possible,” FDA Commissioner Stephen Hahn tweeted shortly after the vote. “However, they know they must carry out their mandate to protect the public health & ensure any authorized vaccine meets our rigorous safety and effectiveness standards that the American people have come to expect.” 

Hahn has already indicated that he is near-ready to give the green light for the Pfizer vaccine, though.

“Our initial assessment is that this is a vaccine that does meet our criteria,” he said on NBC News’ TODAY Thursday morning, before the meeting. 

Pfizer’s vaccine has already been OK’d for emergency use in the UK, Canada, and Bahrain. The New York-based drugmaker and its German partner, BioNTech, said in November the shot was 95% effective at preventing symptomatic COVID-19 in a massive clinical trial. 

The FDA convened an independent expert panel Thursday to weigh in on Pfizer’s application. The group included some of the top virologists and medical experts in the nation, including Dr. Eric Rubin, an infectious-disease specialist and editor-in-chief of The New England Journal of Medicine, and Dr. Paul Offit, a top vaccine expert at the University of Pennsylvania who co-invented the rotavirus vaccine.

There were 4 ‘no’ votes, but no substantial concerns raised about rolling this shot out to Americans

16-year-old participates in coronavirus vaccine trial for Pfizer at Cincinnati Children's Hospital, pediatric vaccine studies COVID-19
A 16-year-old participates in Pfizer’s clinical trial to test its coronavirus vaccine candidate. She was the first adolescent patient at Cincinnati Children’s Hospital to enroll in the study.

In a virtual meeting hosted on Adobe Connect, and punctuated by many mute and WiFi issues, committee members listened to hours of presentations and debated lightly at the end of the day.

Before the vote, there was some debate among experts about whether or not there was enough data to support OK’ing the vaccine for 16- and 17-year-olds, who were included in the wording of the FDA’s voting question. No one under the age of 18 got sick with COVID-19 during the trial. Some on the committee expressed a desire to increase the minimum vaccination age to 18.

The exact reasons four members voted “no” were unclear, though. The group adjourned promptly, leaving no time for members to explain why they voted the way they did.  

Throughout the meeting, no panel member expressed substantive doubts about the overall merits of the vaccine, particularly in the benefits it could provide to the most vulnerable Americans who will be prioritized.

The largest vaccination campaign in US history is around the corner

vaccine
A half-dose of Oxford-AstraZeneca’s COVID-19 vaccine initially could mean we have double the number doses available when it’s approved by regulators.

If and when the FDA does allow Pfizer’s shot to be used, that would kick off the largest vaccination campaign in the history of the US.

Operation Warp Speed, the federal government’s vaccine initiative, plans to start shipping doses to states within 24 hours of authorization. Warp Speed officials said 2.9 million doses of Pfizer’s vaccine will be sent out in an initial shipment. 

The Centers for Disease Control and Prevention has suggested that healthcare workers and nursing home residents, both groups who’ve been hard-hit by the pandemic, should be first in line. That’s just a recommendation, however, and states are free to decide how they want to allocate their vaccine supply.

The vaccine authorization couldn’t come at a more critical time, as the number of COVID-19 deaths per day in the US just surpassed 3,000 for the first time. 

“We have been looking forward to presenting our robust data package to the committee of vaccine experts for the U.S. government since we began our efforts to develop a novel COVID-19 vaccine earlier this year,” Pfizer CEO Albert Bourla said in a statement. “We are pleased with the vote, and if the FDA issues an authorization, stand at the ready to bring this vaccine to people in the US in an effort to help combat this devastating pandemic.”

Additional help is on the way. The FDA is also reviewing another coronavirus vaccine developed by the Massachusetts biotech Moderna. The agency is planning to have another advisory committee meeting next Thursday to discuss that application. Moderna has said its two-dose vaccine was 94% effective at preventing COVID-19 in a late-stage clinical trial.

Warp Speed officials have estimated 20 million Americans could begin the vaccination process before the end of 2020, based on supply estimates for Pfizer’s and Moderna’s shots. Moncef Slaoui, the chief advisor for Warp Speed, has also projected 30 million more Americans will be immunized in January, and 50 million more in February. 

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US stocks dip as stimulus hopes waver and jobless claims hit 11-week high

Worried trader
  • US stocks edged lower on Thursday amid disappointing economic data and slowed stimulus progress.
  • New US weekly jobless claims jumped to an unadjusted 853,000 for the week that ended Saturday, handily exceeding the 725,000 estimate. The reading also marks the highest total in 11 weeks.
  • Democrats and Republicans remain at odds over a new fiscal relief package. The House voted Wednesday night to fund the government for an additional week and buy more time for stimulus negotiations.
  • The US Food and Drug Administration will evaluate Pfizer’s coronavirus vaccine on Thursday and vote on whether its benefits outweigh its risks for use in people at least 16 years old.
  • Watch major indexes update live here.

US stocks fell slightly on Thursday as jobless claims leaped to unexpected highs and Congress hit a new snag in stimulus negotiations.

New filings for unemployment benefits climbed to an unadjusted 853,000 for the week that ended Saturday, the Labor Department said Thursday. Economists surveyed by Bloomberg expected a reading of 725,000 claims. The jump places claims at their highest level in 11 weeks and marks a sharp reversal from the previous week’s revised total of 716,000.

Continuing claims, which track Americans receiving unemployment benefits, jumped to 5.8 million for the week that ended November 28. That similarly came in above economist forecasts and marked the first weekly increase since August.

Here’s where US indexes stood shortly after the 9:30 a.m. ET open on Thursday:

Read more: Cathie Wood is beating 99% of fund managers this year. The ARK CEO and her team share their outlooks for 2021 – including thoughts on Tesla’s $5 billion stock sale, the Salesforce-Slack tie-up, and bitcoin’s meteoric rise.

“The jump in weekly unemployment claims was partially due to a rebound from lower claims during Thanksgiving week, but the trend of more Americans losing jobs is clearly rising over the last month,” Robert Frick, corporate economist at Navy Federal Credit Union, said.

On the stimulus front, Democratic and Republican leaders remain at odds over key elements of their respective proposals. Senate Majority Leader Mitch McConnell offered a package that omitted pandemic-related liability protections for businesses and state and local government aid. House Speaker Nancy Pelosi balked at the proposal, and Senate Minority Leader Chuck Schumer emphasized the need for more state and local relief.

The House voted Wednesday night to fund the government for another week and buy extra time for stimulus talks.

Read more: We spoke to the top 5 European fund managers of 2020 to uncover their tips and tools for delivering stellar returns – and their star stock-picks for 2021

The tech-heavy Nasdaq composite underperformed peer indexes as Facebook slid lower. The social media giant fell after the US Federal Trade Commission filed lawsuits that could force Facebook to divest Instagram and WhatsApp.

The US Food and Drug Administration convened to evaluate Pfizer’s coronavirus vaccine. A panel will vote on Thursday on whether the benefits of the vaccine outweigh its risks for use in people at least 16 years old.

Airbnb is set to begin trading on Thursday after raising $3.5 billion in its initial public offering. The debut comes after DoorDash shares nearly doubled in the company’s first day of public trading.

Bitcoin fell to a 24-hour low of $18,021.45 before bouncing back above $18,100. The token has steadily trended lower after hitting record highs in early December.

Read more: Morgan Stanley is warning that the stock market’s economic recovery trade may soon be over. Here are 4 strategies they recommend for finding the returns that still exist.

Gold edged as much as 0.4% higher, to $1,847.75 per ounce. The US dollar weakened against a basket of Group-of-20 currencies and Treasury yields fell. 

Oil prices gained on vaccine hopes. West Texas Intermediate crude rose as much as 1.8%, to $46.33 per barrel. Brent crude, oil’s international benchmark, jumped 1.9%, to $49.77 per barrel, at intraday highs.

Now read more markets coverage from Markets Insider and Business Insider:

Emmet Peppers grew his accounts from $30,000 in 2010 to over $70 million this year. The newly minted hedge fund manager breaks down how he spotted early opportunities in Tesla, Facebook, and the COVID-19 market crash – and shared one IPO on his radar.

‘Not only overvalued, but dramatically so’: Tesla stock should be avoided ahead of the automaker’s S&P 500 inclusion, JPMorgan says

Legendary investor Jeremy Grantham made an accidental $265 million profit on a SPAC deal after previously criticizing blank-check companies

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