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FDA panel makes recommendations on COVID-19 booster shots
On Friday, Sept. 17, the Food and Drug Administration's (FDA) advisory panel rejected a proposal to give Pfizer COVID-19 vaccine boosters to the general public. But the panel recommend boosters for people aged 65 and older — and for other high-risk groups — six months after the initial vaccination series. That includes health care workers. The recommendation will go before the FDA for final approval.
FDA approval is just one step in determining whether booster shots will be made available. The Advisory Committee on Immunization Practices (ACIP) will refine the recommendations for booster shots and provide guidance to health care providers, pharmacies and other COVID-19 vaccine providers. ACIP has scheduled a meeting for Sept. 22-23.
"It's a bit of a complicated path," says Dr. Gregory Poland, an infectious diseases expert and head of Mayo Clinic's Vaccine Research Group. "But we're exercising caution before we proceed into boosters for everyone, and the reason for that is because we do our best to follow the science." The FDA panel requested more safety data on the use of boosters.
On the Mayo Clinic Q&A podcast, Dr. Poland discusses booster recommendations and other COVID-19 updates.
To practice safe social distancing during the COVID-19 pandemic, this interview was conducted using video conferencing. The sound and video quality are representative of the technology used. For the safety of its patients, staff and visitors, Mayo Clinic has strict masking policies in place. Anyone shown without a mask was recorded prior to COVID-19 or recorded in an area not designated for patient care, where social distancing and other safety protocols were followed.
Research disclosures for Dr. Gregory Poland.
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Information in this post was accurate at the time of its posting. Due to the fluid nature of the COVID-19 pandemic, scientific understanding, along with guidelines and recommendations, may have changed since the original publication date.
For more information and all your COVID-19 coverage, go to the Mayo Clinic News Network and mayoclinic.org.
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I believe that sometimes things that are simple, are made much more convoluted simply by overthinking them. If the first and second shot were " GOOD", then why all the extra time "research?" and talk about whether a booster shot would be O.K. for older folks? The Booster shot for Moderna was only half of what the first and second shot were, so how could it possibly be dangerous? If it is not dangerous, then it should be administered. Also lets be a little more charitable in whom we choose for receiving the booster. I am 78 years old, I have severe
COPD. (which as all of you know is a chronic lung problem). I was refused a booster shot of Moderna because I am not "Immunocompromised". What area of the body does Cov-19 wreak havoc?????? (the lungs).......????????? Tim in Seattle
Hi Tim,
Sometimes more is not necessarily better. For example, getting CT scans regularly (i.e., every 6 month or every year) to monitor tumor growth in a cancer patient is recommended. But that doesn't mean that getting a scan every month or every week is better.
The "right amount" for the general population and for people with underlying conditions is what researchers are taking care to study with the vaccine. The goal is to determine the minimum level of dose (and anti-bodies) necessary to provide effective protection.
I agree with you that it is necessary to take all precautions, especially living with COPD or any lung condition.
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1 ReactionHow might a "breakthrough" infection after getting the previous vaccinations impact a booster recommendation? Or someone who had effective levels of anti-bodies before getting the last vaccine?
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2 ReactionsCould Dr Poland comment on this news article from PBS Health news? This would be a god send for immunocompromised people, if it’s true.
“ At least three promising antivirals for COVID are being tested in clinical trials, with results expected as soon as late fall or winter, said Carl Dieffenbach, director of the Division of AIDS at the National Institute of Allergy and Infectious Diseases, who is overseeing antiviral development.
“I think that we will have answers as to what these pills are capable of within the next several months,” Dieffenbach said.
The top contender is a medication from Merck & Co. and Ridgeback Biotherapeutics called molnupiravir, Dieffenbach said. This is the product being tested in the Kellys’ Seattle trial. Two others include a candidate from Pfizer, known as PF-07321332, and AT-527, an antiviral produced by Roche and Atea Pharmaceuticals.”
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1 Reaction@bunzman and @ladydidehart I have submitted your questions to Dr. Poland.
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1 ReactionThank you. Not much was mentioned about anti-bodies as it related to covid-19 or the Delta variant as part on an individual risk assessment. I know we need studies and results, but it does seem there is some info/data available. E.G., my son was told by his doctor when he had tested pos. for anti-bodies that there was a basis for him not to get vaccinated vs. me who has diabetes and over 65...