Pfizer’s CEO will wait to get a COVID-19 vaccine, and says company executives won’t ‘cut the line’

Albert
Pfizer’s CEO Albert Bourla.

  • Pfizer executives, including its CEO Albert Bourla, won’t “cut the line” to get a COVID-19 vaccine, Bourla told CNBC Monday.
  • “I’m 59 years old, in good health, I’m not working on the frontline, so my type it is not recommended to get vaccination now,” he told CNBC.
  • But Bourla noted that polls conducted by Pfizer suggest that people would be more willing to take the vaccine if he, as the company’s CEO, got the shot.
  • “I’m trying to find a way that I will get vaccinated, despite if it is not my time, just to demonstrate the confidence of the company,” he said.
  • A Centers for Disease Control and Prevention (CDC) advisory group has recommended that healthcare workers and nursing home residents should be first in line for the vaccines.
  • Visit Business Insider’s homepage for more stories.

Pfizer’s CEO Albert Bourla hasn’t taken the COVID-19 vaccine his company developed alongside BioNTech yet – and he told CNBC Monday that Pfizer executives will wait until it’s their turn to get a shot.

“As soon as I can, I will,” he said. But he added that he doesn’t want executives to “cut the line” and set a bad example.

“I’m 59 years old, in good health, I’m not working on the frontline, so my type it is not recommended to get vaccination now,” he explained.

However, Bourla said he would consider getting the vaccine earlier than recommended for someone of his age and health “just to demonstrate the confidence of the company.” This could encourage others to take the shot, he said.

The US Food and Drug Administration (FDA) authorized the vaccine for emergency use on December 12. On Monday, Sandra Lindsay, a nurse in New York City, became the first person in America to get the COVID-19 vaccine.

Pfizer runs “a lot of polls” to see what would make people more willing to take the vaccine, Bourla said – and one of the top responses is if he, as CEO, takes it. This ranks even higher than President-elect Joe Biden taking the vaccine, Bourla said.

“With that in mind, I’m trying to find a way that I will get vaccinated, despite if it is not my time, just to demonstrate the confidence of the company,” he said.

“But we have made a decision that if we have to do that we would not do it with our executives, so none of the executives or board members will cut the line.”

They will take it at the appropriate time based on their age and occupation, he added.

Read more: Pharmacies, doctor’s offices, and hospitals are gearing up to give coronavirus vaccines to millions of Americans. Here’s how they’re preparing and how much they stand to profit along the way.

A Centers for Disease Control and Prevention (CDC) advisory group has recommended that healthcare workers and nursing home residents should be first in line for shots – but it’s up to each state to decide how to prioritize their most vulnerable populations. 

Top US officials could also be given early access to the vaccine, Bloomberg reported, but President Donald Trump said he’d wait to receive it.

“People working in the White House should receive the vaccine somewhat later in the program, unless specifically necessary,” he said in a tweet. “I have asked that this adjustment be made. I am not scheduled to take the vaccine, but look forward to doing so at the appropriate time.”

Former US presidents Barack Obama, Bill Clinton, and George W. Bush have all said they are willing to take their COVID-19 shots on camera to show the vaccine is safe, and President Donald Trump doing the same is “certainly under consideration,” White House officials said.

Biden has also said he will take the vaccine when available.

Read more: How the pharma giant Pfizer teamed up with a little-known biotech to develop the first authorized coronavirus vaccine in record time

In the interview with CNBC, Bourla discussed the distribution of Pfizer’s vaccine across the US. The shots have to be kept at -94 degrees Fahrenheit, which is significantly colder than most other vaccines.

“I am very confident that things will go very smoothly,” Bourla said, explaining that the company had been preparing to distribute the shots for months.

He also added that, despite Pfizer saying it will produce 1.3 billion doses of its vaccine next year, this is just a “commitment to the world.” The company actually hopes to make “much more,” he said.

Read the original article on Business Insider

A CDC panel just voted to recommend Pfizer’s COVID-19 shot for people 16 years and older

Pfizer COVID-19 coronavirus vaccine
A nurse prepares a shot of the Pfizer-BioNTech COVID-19 vaccine at Guy’s Hospital in London, Tuesday, Dec. 8, 2020, as the U.K. health authorities rolled out a national mass vaccination program.

  • A CDC committee recommended the new Pfizer coronavirus vaccine for people 16 years and older during a meeting Saturday. 
  • While there’s a lot more to learn, particularly on how the vaccine affects people in certain populations like pregnant and lactating women, and people with autoimmune conditions, the panelists agreed its “desirable consequences clearly outweigh undesirable consequences in most settings.” 
  • The move will help more people get the vaccine covered by insurance, and aligns the agency with the FDA, which just authorized the vaccine for emergency use Friday night. 
  • For more stories like this, sign up here for Business Insider’s daily healthcare newsletter.

The Advisory Committee on Immunization Practices, part of the Centers for Disease Control and Prevention, just voted to recommend Pfizer’s coronavirus vaccine for everyone over age 16.

The move further paves the way for the shots to be rolled out in the US, although CDC Director Dr. Robert Redfield still must accept the panel’s recommendation.

It also ensures the vaccines will be covered under the Affordable Care Act and aligns the organization with the US Food and Drug Administration, which authorized the shots for emergency use Friday night. They’re now on their way to states across the country, where they’ll begin being administered later next week

The Saturday vote including 11 “yes” votes and three abstentions due to conflicts of interest is “only one step, there is much work left to do,” Dr. Nancy Messonnier, director of CDC’s National Center for Immunization and Respiratory Diseases, said during the meeting. “But it’s a hugely important step.” 

The committee made recommendations regarding pregnant women and those with severe allergies

During ACIP’s meeting, which was bumped up from its originally scheduled date on Sunday, committee members hashed out their comfort recommending a vaccine with many remaining unknowns, particularly in populations including 16- and 17-year-olds, pregnant and lactating women, and those with allergies and people who are immunocompromised.  

They recommended that pregnant and breastfeeding women and immunocompromised people decide for themselves whether or not to get a vaccine while they wait for more data to become available. On Saturday morning, the FDA took a similar stance

“The provider and the individual can make a decision about whether the benefits outweigh the risks, because certainly COVID-19 in a pregnant woman is not a good thing,” Dr. Peter Marks, director of the Center for Biologics Evaluation and Research at the Food and Drug Administration, said during a press conference.

ACIP also said healthcare providers should monitor those with histories of severe allergic reactions for 30 minutes after injecting them. The FDA has said that unless people are allergic to the shot itself or to one of its ingredients, which is extremely rare, they can get the vaccine. 

More detailed materials will spell out the CDC’s recommendations in the coming days, Messonnier said. 

Despite the unknowns in certain populations, ACIP was united in recommending the vaccine, agreeing its “desirable consequences clearly outweigh undesirable consequences in most settings.” 

Committee member Dr. Beth Bell, director of the CDC’s National Center for Emerging and Zoonotic Infectious Diseases, said the process used to come to the decision “is transparent, is science-based, keeps equity in mind, and, for this moment, is the absolute best that we can do.” 

“I can say quite confidently that, yes I certainly will take this vaccine when I’m able, and I would give it to my family members,” she added. “I think the risk-benefit is pretty clear.”  

The vote makes sure the coronavirus vaccine is covered under the Affordable Care Act 

Government officials have been calling for coronavirus vaccines to be free once authorized, passing legislation in March that called for it. 

And as part of Operation Warp Speed, the government has ordered hundreds of millions of doses from drugmakers. 

But getting the recommendation from the CDC’s ACIP is an important step to making sure the vaccine is covered under the Affordable Care Act. 

While ACA requires most insurers and employers to fully cover preventive services, including vaccines, not all vaccines are included in this requirement. It’s up to ACIP to make that call, which they did today. 

“If you are in health coverage that is covered by the Affordable Care Act – and that’s a caveat because we know there are lots of people who may be in plans not subject to the ACA, like short-term plans – and a vaccine is recommended by this committee, health plans within 15 days have to cover it and they can’t charge you a deductible or coinsurance or copayment for that vaccine,” Sabrina Corlette, a Georgetown University research professor and expert on private insurance, previously told Business Insider

That 15-day-timeline is especially speedy: In the past, health insurers could take up to two years after ACIP recommended a vaccine before they were forced to begin covering it. March’s CARES act changed that for COVID-19 vaccines. 

AHIP committee member Bell acknowledged that while the committee is recommending the vaccine for those 16 and over, and insurers will now need to swiftly cover it, their vote doesn’t mean enough vaccines will be immediately available for everyone who should get one. 

“This vaccine and future vaccines do provide a promise of a lot of progression in the future, while of course … our vaccine supplies are going to be limited for quite some time to come,” she said. 

Read the original article on Business Insider

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.

Read the original article on Business Insider

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.”

Read the original article on Business Insider

Margaret Keenan, the first person in the West to receive a COVID-19 vaccine, called the experience a ‘whirlwind’, and urged people to get the shot

Margaret Keenan coronavirus Pfizer vaccine

Margaret Keenan, the first person in the West to get a COVID-19 vaccine, called the experience a “whirlwind” and said other people should get it too.

Keenan, a grandmother of four who turns 91 next week, got Pfizer and BioNTech’s shot at University Hospital in the English city of Coventry Tuesday morning.

“I would urge everybody to get their vaccine as and when they are asked to do so,” she said in a statement shared by the NHS. Experts fear anti-vaccination concerns could slow the end of the pandemic.

The UK became the first country in the West to both approve and distribute a COVID-19 vaccine for emergency use. The US hasn’t yet made a decision on its authorization.

Keenan described Tuesday as “a massive day,” and said “everything hasn’t really sunk in yet.”

“I feel great,” she added. Keenan had previously called the shot “the best early birthday present I could wish for.”

She thanked the NHS staff and said she looked forward to spending time with her family.

Read more: People can’t get enough of the festive penguin T-shirt worn by the first person to receive Pfizer’s shot, and the charity that makes it says it’s almost sold out

The FDA is meeting Thursday to review Pfizer’s vaccine for emergency use, and the first shots could be given out as early as Friday, though an FDA advisor said there could be delays to distribution.

Canada approved the shot on Wednesday. When asked how Canada’s health department “beat the FDA” to approval, the country’s health advisor said “we’re not in a race against any other regulator.”

Read the original article on Business Insider