FDA commissioner says he hopes the first coronavirus vaccine in the US could be administered on Monday

AP20236798154000
President Donald Trump listens as Dr. Stephen Hahn speaks during a media briefing in the James Brady Briefing Room of the White House, August 23, 2020.

  • Stephen Hahn, the commissioner of the Food and Drug Administration, said Sunday the first COVID-19 vaccinations could occur as soon as Monday following the agency’s emergency approval on Friday.
  • Trucks carrying the vaccine could be seen pulling out of Pfizer’s facilities in Michigan earlier Sunday as they make their way to a UPS hub in Kentucky before they are shipped across the US.  
  • While vaccinations will soon begin, it will be a months-long rollout that depends on state government plans that will likely prioritize vaccinations for healthcare workers and at-risk populations. 
  • Hahn also Sunday refuted reports the White House pressured him to approve the emergency use authorization for the Pfizer vaccine, saying the decision was guided by “science and data.” 
  • Visit Business Insider’s homepage for more stories.

Stephen Hahn, the commissioner of the US Food and Drug Administration, said Sunday he hoped the COVID-19 would begin to be administered in the US as early as tomorrow following the agency’s emergency use authorization for Pfizer’s vaccine on Friday.

“My hope, again, is that this happens very expeditiously, hopefully tomorrow,” Hahn said of the first vaccination in the US during an appearance Sunday on CNN’s “State of the Union” with Jake Tapper.

Hahn said he wasn’t sure why Robert Redfield, the director of the Centers for Disease Control and Prevention hadn’t accepted a panel’s vote Saturday to clear the vaccine for emergency use, but predicted there would be an announcement “very soon.”

“I don’t know the answer to that question,” Hahn responded. “I do know I’ve had a lot of conversations with director Redfield and he is certainly on top of this, and has a lot of confidence in the process.”

As Business Insider’s Andrew Dunn previously reported, the FDA on Friday approved a highly effective COVID-19 vaccine developed by the drugmakers Pfizer and BioNTech. The approval followed a prior endorsement from an independent expert panel that reviewed data on the vaccine.

Trucks carrying the vaccine were seen leaving Pfizer’s Michigan manufacturing center earlier Sunday. The vaccines will head to a UPS hub in Kentucky before they’re shipped across the US.

Still, even when the rollout begins this week, it will take months to become available to all Americans who want it. Last week, Dr. Deborah Birx, the White House coronavirus response coordinator, said the vaccine is imperative to bringing the pandemic to the end but won’t stop the ongoing surge of cases in the US and is not an excuse to end other measures meant to reduce the spread of the disease.

While the final distribution plans for the vaccine are left to state governments, an advisory panel for the CDC recommended that frontline healthcare workers and nursing home residents be placed at the front of the line.

Hahn on Sunday also refuted reports that he had been pressured by high-ranking officials in the White House to issue the emergency use authorization for the vaccine. The Washington Post reported that White House Chief of Staff Mark Meadows on Friday delivered an ultimatum to the Hahn, telling him to announce the vaccine’s approval by the end of the day or submit his resignation.

“Nothing guided our decision, no external comments, no external pressure, other than the science and data, guided our decision-making,” Hahn told CNN’s Jake Tapper.

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