The US Food and Drug Administration granted full approval this week for the Pfizer/BioNTech Covid-19 vaccine for people 16 years of age and older. This is the first of the coronavirus vaccines to receive full approval from the FDA.
What does full approval mean for those who are already vaccinated? What about for those who have yet to vaccinated — could it help to reduce hesitancy? Does it have any impact on expediting vaccines for younger children?
To help us with these questions, we turned to CNN Medical Analyst Dr. Leana Wen. Wen is an emergency physician and visiting professor of health policy and management at the George Washington University Milken Institute School of Public Health. She’s also author of a new book, “Lifelines: A Doctor’s Journey in the Fight for Public Health.”
CNN: What does “full approval” mean? How does it differ from what the vaccine’s status was before? And does the full approval apply only to the Pfizer vaccine?
Dr. Leana Wen: For months now, there have been three vaccines that were approved under emergency use authorization, or EUA. These are the vaccines made by Pfizer/BioNTech, Moderna and Johnson & Johnson. The Pfizer was the first of the vaccines to receive the EUA, and it’s also the first of the vaccines that applied for full approval.
Full FDA approval is a process that usually requires at least six months of safety data. The EUA was given after two months of safety data because this is a global pandemic and a public health emergency. Hundreds of millions of people around the world have now received the Pfizer vaccine, and there is more than enough evidence that the vaccine is safe and effective. The final stamp of approval came via the FDA on Monday.
Pfizer’s vaccine is now fully approved for people 16 years of age and older. Moderna’s vaccine is under review, and I’d expect that approval will come within a matter of weeks. Johnson & Johnson’s request for full approval has not yet been submitted to the FDA. These two other vaccines continue to available under the EUA.
CNN: What does full approval mean for those who already got the Covid-19 vaccine?
Wen: Many of us in public health expect that full FDA approval will have a significant impact on increasing vaccination numbers for those who are not yet vaccinated. There really isn’t an impact on those who already got vaccinated.
CNN: Do you think it could convince some people to finally get vaccinated?
Wen: Possibly, yes. Some polls, including from the Kaiser Family Foundation, have suggested that as many as 3 in 10 people cite lack of full approval as a primary reason for not getting the vaccine. It’s possible that some of these individuals will now overcome their hesitancy, but I suspect there will be a much smaller number who will line up to get vaccinated soon after full approval.
The much bigger impetus, I think, is going to come from vaccine mandates. Many companies and colleges have already mandated vaccines, but many others have been waiting for full approval to take this step. There are many people who might not have gotten the vaccine on their own, but if required to, would do so.
CNN: Are there actual medical reasons as to why someone should choose not to be vaccinated at this point?
Wen: It would be extraordinarily unusual for someone to have a medical reason in which they absolutely could not receive the Covid-19 vaccine. An individual could have a severe allergic reaction to one of the components of the vaccine, but then they could probably get another vaccine. Someone who has an autoimmune condition could have concerns about an immune reaction, but if they’ve been able to get other vaccines, they should be able to get this one, with careful monitoring from their physician.
There are individuals concerned about the impact of the vaccine on pregnancy and fertility, but the US Centers for Disease Control and Prevention and American College of Obstetricians and Gynecologists recommend the vaccine for pregnant women as well as women looking to conceive. Then there are people who may not respond as well to the vaccine because they may not mount enough of an immune response including people with cancer or HIV. These are people who may need three vaccine doses and still need to mask and distance to protect themselves even after vaccinated — but there is no reason why they shouldn’t be vaccinated in the first place.
CNN: Why wasn’t the vaccine fully approved for kids ages 12 to 15? Should parents still get kids in this age group vaccinated if it’s not fully approved yet?
Wen: The initial Pfizer studies were done in those 16 and above. Those are the data that were submitted for full approval. The vaccine is authorized under the EUA for kids ages 12 to 15. There just haven’t been enough time for the vaccine in this age group to receive full approval.
That said, the EUA is sufficient to demonstrate the vaccine is safe and effective in the adolescent 12- to 15-year-old age group. Especially as kids are returning back to school and Covid-19 cases are surging across the country, it’s really important to protect as many kids as possible who are eligible to be vaccinated. I’d strongly recommend for children 12 and over to be vaccinated now.
CNN: Will the full FDA approval speed up vaccine development for kids under age 12?
Wen: No. Those studies are still ongoing. Dr. Anthony Fauci said to CNN’s Anderson Cooper on Monday night that it’s possible that vaccines for younger children will be available in 2021, but results from these studies have not yet been presented to the FDA.
CNN: Some parents are wondering if they should ask their doctor to vaccinate their 10- or 11-year-old kids. Is this something that can be done?
Wen: Technically, full approval of the vaccine means that it can be prescribed off-label like any other medication or therapeutic, meaning that doctors can use their clinical judgment to prescribe the vaccine to patients. However, the acting FDA commissioner specifically warned against off-label use of the vaccine to younger children, citing the need for more studies, including testing of different dosages that are still in progress.
There are other ways to protect younger children in the meantime. Indoor masking remains imperative, and vaccinating all adults around the child is also of paramount importance. Which brings me back to the central point of this week’s FDA announcement. There really should be no reason to wait — now is the time to get vaccinated for those who have not yet already.
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